Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00042289
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 1,578
• Locations: 62
• Actual Duration (Months): 207.7
• Patients Per Site: 25.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

IMPAACT P1026s is a Phase IV prospective clinical study to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study also evaluated the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs were evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: atazanavir/cobicistat; Drug: darunavir/ritonavir dosage #1; Drug: darunavir/ritonavir dosage #2; Drug: darunavir/ritonavir dosage #3; Drug: elvitegravir/cobicistat; Drug: dolutegravir; Drug: tenofovir alafenamide fumarate (TAF); Drug: TAF w/cobicistat; Drug: TAF w/cobicistat or ritonavir; Drug: efavirenz; Drug: darunavir/cobicistat; Drug: lopinavir/ritonavir dosage #1; Drug: atazanavir/ritonavir/tenofovir dosage #1; Drug: rifampicin; Drug: ethambutol; Drug: isoniazid; Drug: pyrazinamide; Drug: kanamycin; Drug: amikacin; Drug: capreomycin; Drug: moxifloxacin; Drug: levoflaxacin; Drug: ofloxacin; Drug: ethionamide/prothionamide; Drug: terizidone/cycloserine; Drug: para-aminosalicylic acid (PAS); Drug: high dose INH; Drug: bedaquiline; Drug: clofazamine; Drug: delamanid; Drug: linezolid; Drug: pretomanid; Drug: ethinyl estradiol; Drug: etonogestrel implant; Drug: nevirapine; Drug: amprenavir; Drug: abacavir; Drug: lopinavir/ritonavir dosage #2; Drug: indinavir/ritonavir dosage #1; Drug: fosamprenavir/ritonavir; Drug: lopinavir/ritonavir dosage #3; Drug: atazanavir/ritonavir dosage #1; Drug: didanosine delayed release (Videx® EC); Drug: emtricitabine; Drug: tenofovir; Drug: nelfinavir dosage #1; Drug: tipranavir/ritonavir; Drug: lopinavir/ritonavir dosage #4; Drug: raltegravir; Drug: etravirine; Drug: maraviroc; Drug: atazanavir/ritonavir dosage #2; Drug: tenofovir/atazanavir/ritonavir dosage #2; Drug: nelfinavir dosage #2; Drug: indinavir/ritonavir dosage #2; Drug: rilpivirine; Drug: darunavir/ritonavir dosage #4

Detailed Description

Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug PKs. Unfortunately, there have been few clinical trials to study the PKs of ARV, TB, and hormonal contraceptive drugs in pregnant women. The development of appropriate dosing regimens for the HIV-infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study evaluated the PKs of ARVs used during pregnancy; the PKs of TB drugs used during pregnancy, both in women who are HIV-positive and also taking ARVs and in women who are HIV-negative and not taking ARVs; and the PKs of hormonal contraceptive medications taken along with ARVs.

P1026s is a Phase IV clinical study. Participants were not assigned to the drugs under study, but were already receiving the drugs for clinical care by prescription of their clinical care providers. They were enrolled into study arms according to the drugs they were receiving through clinical care, and if on multiple drugs of interest, were able to enroll into multiple arms simultaneously. No drugs were provided as part of this study. This observational study was added to an existing investigational new drug (IND) number because several of the drugs were studied at a higher does than the approved dose after the PK results for the approved dose were found to be inadequate.

P1026s went through 10 protocol versions, with the first and last versions of the protocol finalized in 2002 and 2016, respectively. New study arms were added and analyzed separately with each update of the protocol version. In general, there were five main groups of study arms: HIV-infected pregnant women taking ARVs without TB treatment, HIV-infected pregnant women taking ARVs with first-line TB treatment, HIV-uninfected pregnant women taking no ARVs with first-line TB treatment, HIV-infected and HIV-uninfected pregnant women with or without ARVs with second-line TB treatment for drug-resistant TB, and HIV-infected postpartum women taking ARVs and hormonal contraceptives. The primary analysis of each arm was designed and conducted as a separate single arm evaluation of the drug (or combination of drugs) of interest.

Women who were 20 0/7 weeks to 37 6/7 weeks pregnant were enrolled in this study and remained in the study for up to 12 weeks after delivery. Postpartum women were enrolled at 2 to 12 weeks after delivery and followed until 6 to 7 weeks after starting contraceptives. Infants were enrolled in-utero and followed for 16 to 24 weeks of life. At all study visits, participants underwent a medical history, a physical exam, and blood collection. At some visits, women in some arms underwent a vaginal swab. Blood collection from the mother and the detached umbilical cord occurred during delivery. Intensive PK sampling was performed at study visits during the second and third trimester of pregnancy and/or postpartum, depending on the study arm. Additional study visits may have occurred depending on the ARV drug regimen prescribed. Infant washout PK samples were collected at 2-10, 18-28, 36-72 hours after birth, and 5-9 days of life.

There are a total of 49 study arms across all versions of P1026s protocols. Out of the 49 study arms, 2 did not have PK data* [didanosine delayed release (DDI) and lopinavir/ritonavir (LPV/RTV) African sites only]; 2 never enrolled any participants [amprenavir (APV) and nevirapine/rifampicin (NVP/RIF) with at least one first line TB drug]; 9 are in the line to be tested/analyzed due to batched analysis which has to be done after the end of the study, the lengthy process of development, validation and approval (regulatory burdens), and laboratory delays related to the COVID-19 pandemic [all TB arms and all but 3 contraceptive arms (atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) with etonogestrel (ENG), efavirenz (EFV) with ENG, and LPV/RTV with ENG)]; and 8 had completion dates earlier than December 26, 2007 [nevirapine (NVP), abacavir (ABC), LPV/RTV 400/100 mg twice daily (b.i.d.), LPV/RTV 400/100mg then 533/133mg b.i.d, nelfinavir (NFV), emtricitabine (FTC), indinavir/ritonavir (IDV/RTV), and tipranavir/ritonavir]. In this submission, the Results Section presents participant flow, baseline characteristics and adverse events for all study arms (except the 2 arms that never enrolled), and outcome measure results for the 28 remaining study arms that have been completed and have final results available. For study arms completed prior to December 26, 2007, refer to the study publications in the References section for outcome measures.

For arms with very low enrollment (N<3), some results throughout the record (e.g. baseline characteristics and outcome measures) were not reported in order to avoid making individual participant data identifiable.

In the Outcome Measures section, there could be multiple outcome measures for same PK parameters (e.g. AUC12) depending on different units or summary statistics used in the analyses (such as median with range vs. median with interquartile range (IQR)).

Study Design

• Study Type: Observational
• Actual Enrollment: 1578 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
• Actual Study Start Date: Jun 9, 2003
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) 600/100 mg twice daily (b.i.d.) or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn.	Drug: darunavir/ritonavir dosage #1; darunavir/ritonavir twice daily 600/100 mg b.i.d.; Drug: darunavir/ritonavir dosage #2; darunavir/ritonavir twice daily 800/100 mg b.i.d.; Drug: darunavir/ritonavir dosage #3; darunavir/ritonavir twice daily 900/100 mg b.i.d.
DTG 50mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg once a day (q.d.).	Drug: dolutegravir; dolutegravir 50 mg q.d.
TAF 25mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting.	Drug: tenofovir alafenamide fumarate (TAF); TAF 25 mg q.d. without cobicistat or ritonavir boosting
TAF 10mg q.d. w/COBI HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI).	Drug: TAF w/cobicistat; TAF 10 mg q.d. with cobicistat
TAF 25mg q.d. w/COBI or RTV boosting HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting.	Drug: TAF w/cobicistat or ritonavir; TAF 25 mg q.d. with cobicistat or ritonavir boosting
EVG/COBI 150/150mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d	Drug: elvitegravir/cobicistat; elvitegravir/cobicistat 150/150 mg q.d.
DRV/COBI 800/150 mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.	Drug: darunavir/cobicistat; darunavir/cobicistat 800/150 mg q.d.
ATV/COBI 300/150 mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.	Drug: atazanavir/cobicistat; atazanavir/cobicistat 300/150 mg q.d.
EFV 600 mg q.d. (outside THA) HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only)	Drug: efavirenz; efavirenz 600 mg q.d.
EFV 600mg q.d. and at least one 1st line TB drug HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	Drug: efavirenz; efavirenz 600 mg q.d.; Drug: rifampicin; rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: ethambutol; ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.; Drug: isoniazid; isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: pyrazinamide; pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	Drug: lopinavir/ritonavir dosage #1; lopinavir/ritonavir 800/200mg b.i.d.; Drug: rifampicin; rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: ethambutol; ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.; Drug: isoniazid; isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: pyrazinamide; pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
No ARVs and at least two 1st line TB drugs HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	Drug: rifampicin; rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: ethambutol; ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.; Drug: isoniazid; isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: pyrazinamide; pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
At least two 2nd line TB drugs w/ or w/out ARVs HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: kanamycin amikacin capreomycin Fluoroquinolones: moxifloxacin levofloxacin ofloxacin Oral bacteriostatic second-line agents: ethionamide/prothionamide terizidone/cycloserine para-aminosalicylic acid (PAS) Other agents: high dose INH bedaquiline clofazamine delamanid linezolid pretomanid	Drug: kanamycin; kanamycin (2nd line TB drug); Drug: amikacin; amikacin (2nd line TB drug); Drug: capreomycin; capreomycin (2nd line TB drug); Drug: moxifloxacin; moxifloxacin (2nd line TB drug); Drug: levoflaxacin; levofloxacin (2nd line TB drug); Drug: ofloxacin; ofloxacin (2nd line TB drug); Drug: ethionamide/prothionamide; ethionamide/prothionamide (2nd line TB drug); Drug: terizidone/cycloserine; terizidone/cycloserine (2nd line TB drug); Drug: para-aminosalicylic acid (PAS); para-aminosalicylic acid (PAS) (2nd line TB drug); Drug: high dose INH; high dose INH (2nd line TB drug); Drug: bedaquiline; bedaquiline (2nd line TB drug); Drug: clofazamine; clofazamine (2nd TB drug); Drug: delamanid; delamanid (2nd line TB drug); Drug: linezolid; linezolid (2nd line TB drug); Drug: pretomanid; pretomanid (2nd line TB drug)
DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol	Drug: atazanavir/cobicistat; atazanavir/cobicistat 300/150 mg q.d.; Drug: darunavir/cobicistat; darunavir/cobicistat 800/150 mg q.d.; Drug: ethinyl estradiol; oral contraceptives formulated with 30-35 μg ethinyl estradiol
DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. postpartum and starting etonogestrel (ENG) implant	Drug: atazanavir/cobicistat; atazanavir/cobicistat 300/150 mg q.d.; Drug: darunavir/cobicistat; darunavir/cobicistat 800/150 mg q.d.; Drug: etonogestrel implant; etonogestrel implant contraceptive
EFV 600mg q.d. with 30-35ug EE HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz (EFV) 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)	Drug: efavirenz; efavirenz 600 mg q.d.; Drug: ethinyl estradiol; oral contraceptives formulated with 30-35 μg ethinyl estradiol
ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)	Drug: atazanavir/ritonavir/tenofovir dosage #1; atazanavir/ritonavir/tenofovir 300/100/300mg q.d.; Drug: ethinyl estradiol; oral contraceptives formulated with 30-35 μg ethinyl estradiol
NVP 200mg b.i.d HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine (NVP) 200 mg twice a day	Drug: nevirapine; nevirapine 200 mg twice a day
APV 1200mg b.i.d HIV-infected pregnant women ≥ 26 weeks gestation who received amprenavir (APV) 1200mg twice a day	Drug: amprenavir; amprenavir 1200mg twice a day
ABC 300mg b.i.d HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir (ABC) 300mg twice a day	Drug: abacavir; abacavir 300mg twice a day
LPV/RTV Arm 1: 400/100mg b.i.d HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 400/100mg twice a day	Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day
IDV/RTV Arm 1: 800/100mg b.i.d HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir (IDV/RTV) 800/100 mg twice a day	Drug: indinavir/ritonavir dosage #1; indinavir/ritonavir 800/100mg twice a day
FPV/RTV 700/100mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day	Drug: fosamprenavir/ritonavir; fosamprenavir/ritonavir 700/100 mg twice a day
LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra (LPV/RTV) 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available	Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day; Drug: lopinavir/ritonavir dosage #3; lopinavir/ritonavir (Kaletra) 533/133 mg twice a day
ATV/RTV Arm 1: 300/100mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day	Drug: atazanavir/ritonavir dosage #1; atazanavir/ritonavir 300/100 mg once a day
DDI 400mg or 250mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) (DDI) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg	Drug: didanosine delayed release (Videx® EC); didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg
FTC 200mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine (FTC) 200 mg once a day	Drug: emtricitabine; emtricitabine 200 mg once a day
TFV 300mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day	Drug: tenofovir; tenofovir 300 mg once a day
TFV/ATV/RTV Arm 1: 300/300/100mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day	Drug: atazanavir/ritonavir/tenofovir dosage #1; atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
NFV Arm 1: 1250mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day	Drug: nelfinavir dosage #1; nelfinavir [625 mg tablets] 1250 mg twice a day
EFV 600mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day	Drug: efavirenz; efavirenz 600 mg q.d.
TPV/RTV 500/200mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day	Drug: tipranavir/ritonavir; tipranavir/ritonavir 500/200 mg twice a day
LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn	Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day; Drug: lopinavir/ritonavir dosage #4; lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day
RAL 400mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day	Drug: raltegravir; raltegravir 400 mg twice a day
ETR 200mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day	Drug: etravirine; etravirine 200 mg twice a day
MVC 150 or 300mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day	Drug: maraviroc; maraviroc 150 mg or 300 mg twice a day
DRV/RTV 800/100mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day	Drug: darunavir/ritonavir dosage #4; darunavir/ritonavir once daily 800/100 mg q.d.
DRV/RTV 600/100mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day	Drug: darunavir/ritonavir dosage #1; darunavir/ritonavir twice daily 600/100 mg b.i.d.
ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn	Drug: atazanavir/ritonavir dosage #1; atazanavir/ritonavir 300/100 mg once a day; Drug: atazanavir/ritonavir dosage #2; atazanavir/ritonavir 400/100mg once a day
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn	Drug: atazanavir/ritonavir/tenofovir dosage #1; atazanavir/ritonavir/tenofovir 300/100/300mg q.d.; Drug: tenofovir/atazanavir/ritonavir dosage #2; tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d. HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn	Drug: nelfinavir dosage #1; nelfinavir [625 mg tablets] 1250 mg twice a day; Drug: nelfinavir dosage #2; nelfinavir [625 mg tablets] 1875 mg twice a day
IDV/RTV Arm 2: 400/100mg q.d. (only THA) HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand	Drug: indinavir/ritonavir dosage #2; indinavir/ritonavir 400/100 mg twice a day
LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites) HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV, Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda	Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day; Drug: lopinavir/ritonavir dosage #4; lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day
RPV 25mg q.d. HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.)	Drug: rilpivirine; rilpivirine (25 mg q.d.)
NVP 200mg b.i.d. and RIF and at least one 1st line TB drug HIV-infected pregnant women > 20 weeks gestation who received nevirapine (NVP) 200 mg b.i.d AND rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. and at least one of the following drugs at study entry: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	Drug: ethambutol; ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.; Drug: isoniazid; isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.; Drug: pyrazinamide; pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.; Drug: nevirapine; nevirapine 200 mg twice a day
ATV/RTV/TFV 300/100/300mg q.d. with ENG HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant	Drug: atazanavir/ritonavir/tenofovir dosage #1; atazanavir/ritonavir/tenofovir 300/100/300mg q.d.; Drug: etonogestrel implant; etonogestrel implant contraceptive
LPV/RTV 400/100 b.i.d. with 30-35ug EE HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)	Drug: ethinyl estradiol; oral contraceptives formulated with 30-35 μg ethinyl estradiol; Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day
LPV/RTV 400/100 b.i.d. with ENG HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant	Drug: etonogestrel implant; etonogestrel implant contraceptive; Drug: lopinavir/ritonavir dosage #2; lopinavir/ritonavir (Kaletra) 400/100mg twice a day
EFV 600mg q.d. with ENG HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant	Drug: efavirenz; efavirenz 600 mg q.d.; Drug: etonogestrel implant; etonogestrel implant contraceptive

Outcome Measures

Primary Outcome Measures

1. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs [Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

2. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs [Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

3. PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs [Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.]

   Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

4. PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.

5. PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.

6. PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

7. PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

8. PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

9. PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.]

   Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.

10. PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

11. PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

12. PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.

13. PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted.

14. PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.

15. Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V.

16. Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs [Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V. No results are available for this outcome measure at this time. The TB drugs are being assayed in batches (not real-time) after the study completion. Labs have been experiencing additional delays due to urgent COVID-19 pandemic related work.

17. Plasma Concentration for Contraceptives [Measured at 6-7 weeks after contraceptive initiation postpartum]

    Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs.

18. Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms [Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule.

19. Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms [Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.]

    Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule.

Secondary Outcome Measures

1. PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs [Measured at time of delivery with single cord blood and single maternal plasma sample.]

   Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio.

2. PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs [Measured at time of delivery with single cord blood and single maternal plasma sample.]

   Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated.

3. Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs [Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.]

   Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations.

4. Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs [Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.]

   Infant plasma concentrations were collected and measured during the first 9 days of life.

Other Outcome Measures

1. ARV Concentrations in Plasma [Measured at intensive PK visit]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belong with Other outcome measures (see SAP).

2. ARV Concentrations in Vaginal Secretions [Measured at intensive PK visit]

   The original study protocol listed this PK parameter under secondary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

3. Drug Parameter: Half-life (t1/2) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

4. Drug Parameter: Volume of Distribution Over Systemic Availability (V/F) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

5. Drug Parameter: Clearance Over Systemic Availability (Cl/F) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

6. Drug Parameter: Time After Administration of Drug When Maximum Plasma Concentration is Reached (Tmax) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

7. Drug Parameter: Minimum Concentration (Cmin) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

8. Drug Parameter: Pre-dose Concentration (Cdose) [Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.]

   The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).

9. Adverse Events of Grade 3 or Higher [Measured through 24 weeks postpartum]

   The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.

10. Infant Neurological Events of Grade 1 or Higher [Measured through 24 weeks of life]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.

11. Adverse Pregnancy Outcome: Preterm Birth [Measured through delivery]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.

12. Adverse Pregnancy Outcome: Low Birth Weight [Measured at delivery]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.

13. Adverse Pregnancy Outcome: Fetal Demise [Measured through 24 weeks postpartum]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.

14. Adverse Pregnancy Outcome: Congenital Anomalies [Measured through 24 weeks of life]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which werenot conducted (see SAP). See Adverse events section for adverse events.

15. Infant HIV Infection Status [Measured through 24 weeks of life]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

16. Ratio of Unbound/Total Drug Concentrations [Measured at time of delivery]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

17. Rate of Detection of Study Drugs in Vaginal Secretions [Measured at intensive PK visit]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

18. Ratio of Vaginal Drug Concentrations to Simultaneous Blood Concentrations [Measured at intensive PK visit]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

19. Rate of Detection of HIV RNA/DNA in Vaginal Secretions and Comparison to Level in Blood [Measured at intensive PK visit]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

20. ARV Exposure (as Measured by Area Under the Curve or Other PK Parameters) During Pregnancy and Postpartum According to Genotype [Measured at intensive PK visit]

    The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Maternal Inclusion Criteria:

• Participant must belong to one of the following 5 groups:

1. HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol

2. HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry

3. HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry

4. HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry

5. HIV-infected women 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol

• The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling

• If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation

• HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final PK sampling is completed

• For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.

• HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available.

• Participants enrolling in the 3rd trimester must enroll by 37 6/7 weeks gestation

• Participant can provide legal informed consent per local regulations

• If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment

Maternal Exclusion Criteria:

• Women on medicines known to interfere with absorption, metabolism, or clearance of the drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions

• If pregnant, carrying multiple fetuses

• Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study

Infant Enrollment Criteria:

• All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment.

Infant Requirements for Washout Pharmacokinetic Sampling:

• Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs)

• Birth weight greater than 1000 grams

• Is NOT receiving disallowed medications described in Section 7 of the protocol

• Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator

• Born after singleton delivery (not after multiple birth)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Pediatric Infectious Diseases CRS	Birmingham	Alabama	United States	35233
2	University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program	La Jolla	California	United States	92093-0672
3	Miller Children's Hosp. Long Beach CA NICHD CRS	Long Beach	California	United States	90806
4	Usc La Nichd Crs	Los Angeles	California	United States	90089
5	David Geffen School of Medicine at UCLA NICHD CRS	Los Angeles	California	United States	90095-1752
6	Univ. of California San Francisco NICHD CRS	San Francisco	California	United States	94143
7	Harbor UCLA Medical Ctr. NICHD CRS	Torrance	California	United States	90502
8	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States	80045
9	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut	United States	06510
10	Washington Hosp. Ctr. NICHD CRS	Washington	District of Columbia	United States	20010
11	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida	United States	32209
12	Pediatric Perinatal HIV Clinical Trials Unit CRS	Miami	Florida	United States	33136
13	USF - Tampa NICHD CRS	Tampa	Florida	United States	33606
14	Emory University School of Medicine NICHD CRS	Atlanta	Georgia	United States	30322
15	Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Augusta	Georgia	United States	30912
16	Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program	Chicago	Illinois	United States	60608
17	Rush Univ. Cook County Hosp. Chicago NICHD CRS	Chicago	Illinois	United States	60612
18	Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.	Chicago	Illinois	United States	60612
19	Lurie Children's Hospital of Chicago (LCH) CRS	Chicago	Illinois	United States	60614-3393
20	Tulane Univ. New Orleans NICHD CRS	New Orleans	Louisiana	United States	70112
21	Univ. of Maryland Baltimore NICHD CRS	Baltimore	Maryland	United States	21201
22	Johns Hopkins Univ. Baltimore NICHD CRS	Baltimore	Maryland	United States	21287
23	Children's Hosp. of Boston NICHD CRS	Boston	Massachusetts	United States	02115
24	Boston Medical Center Ped. HIV Program NICHD CRS	Boston	Massachusetts	United States	02118
25	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
26	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts	United States	01605
27	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan	United States	48201
28	Rutgers - New Jersey Medical School CRS	Newark	New Jersey	United States	07103
29	Bronx-Lebanon Hospital Center NICHD CRS	Bronx	New York	United States	10457
30	Jacobi Med. Ctr. Bronx NICHD CRS	Bronx	New York	United States	10461
31	Nyu Ny Nichd Crs	New York	New York	United States	10016
32	Metropolitan Hosp. NICHD CRS	New York	New York	United States	10029
33	Columbia IMPAACT CRS	New York	New York	United States	10032
34	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States	11794
35	DUMC Ped. CRS	Durham	North Carolina	United States	27710
36	Philadelphia IMPAACT Unit CRS	Philadelphia	Pennsylvania	United States	19104
37	Regional Med. Ctr. at Memphis	Memphis	Tennessee	United States	38103
38	St. Jude Children's Research Hospital CRS	Memphis	Tennessee	United States	38105-3678
39	Seattle Children's Research Institute CRS	Seattle	Washington	United States	98101
40	Hosp. General de Agudos Buenos Aires Argentina NICHD CRS	Ciudad de Buenos Aires	Buenos Aires	Argentina	C1221ADC
41	Gaborone CRS	Gaborone	South-East District	Botswana
42	Molepolole CRS	Gaborone		Botswana
43	SOM Federal University Minas Gerais Brazil NICHD CRS	Belo Horizonte	Minas Gerais	Brazil	30.130-100
44	Hosp. Santa Casa Porto Alegre Brazil NICHD CRS	Porto Alegre	Rio Grande Do Sul	Brazil	90020-090
45	Hosp. dos Servidores Rio de Janeiro NICHD CRS	Rio de Janeiro		Brazil	20221-903
46	Hospital Federal dos Servidores do Estado NICHD CRS	Rio de Janeiro		Brazil	20221-903
47	Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS	Rio de Janeiro		Brazil	21941-612
48	Hosp. Geral De Nova Igaucu Brazil NICHD CRS	Rio de Janeiro		Brazil	26030
49	Univ. of Sao Paulo Brazil NICHD CRS	Sao Paulo		Brazil	14049-900
50	IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS	San Juan		Puerto Rico	00935
51	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico	00936
52	Wits RHI Shandukani Research Centre CRS	Johannesburg	Gauteng	South Africa	2001
53	Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS	Cape Town	Western Cape Province	South Africa	7505
54	Famcru Crs	Tygerberg	Western Cape Province	South Africa	7505
55	Kilimanjaro Christian Medical Centre (KCMC)	Moshi		Tanzania
56	Siriraj Hospital ,Mahidol University NICHD CRS	Bangkok	Bangkoknoi	Thailand	10700
57	Bhumibol Adulyadej Hosp. CRS	Sai Mai	Bangkok	Thailand	10220
58	Phayao Provincial Hosp. CRS	T.Tom, Muang	Phayao	Thailand	56000
59	Prapokklao Hosp. CRS	Chanthaburi		Thailand	22000
60	Chiangrai Prachanukroh Hospital NICHD CRS	Chiang Mai		Thailand	50100
61	Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS	Chiang Mai		Thailand	50200
62	Chonburi Hosp. CRS	Chon Buri		Thailand	20000

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Study Chair: Mark Mirochnick, MD, Boston Medical Center

Study Documents (Full-Text)

• Study Protocol: P1026s Protocol Version 10.0_02Feb2016 - Feb 2, 2016
• Study Protocol: P1026s Protocol Version 10.0_Letter of Amendment 1_14Dec2016 - Dec 14, 2016
• Study Protocol: P1026s Protocol Version 10.0_Letter of Amendment 2_13Apr2018 - Apr 13, 2018
• Statistical Analysis Plan: PK SAP - Jul 27, 2021
• Statistical Analysis Plan: Primary SAP - Sep 13, 2021
• Informed Consent Form - Feb 2, 2016

More Information

Additional Information:

• Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
• Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

Publications

• Loutfy MR, Walmsley SL. Treatment of HIV infection in pregnant women: antiretroviral management options. Drugs. 2004;64(5):471-88. Review.
• Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43(15):1071-87. Review.
• Rakhmanina NY, van den Anker JN, Soldin SJ. Safety and pharmacokinetics of antiretroviral therapy during pregnancy. Ther Drug Monit. 2004 Apr;26(2):110-5. Review.
• Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. Review.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00042289
• Other Study ID Numbers: P1026s; 10040; IMPAACT P1026s
• First Posted: Aug 1, 2002
• Last Update Posted: Jul 22, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Pregnancy; Pharmacokinetics; Treatment Experienced
• Additional relevant MeSH terms: HIV Infections; Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir; Nelfinavir; Indinavir; Fosamprenavir; Amprenavir; Tenofovir; Emtricitabine; Raltegravir Potassium; Nevirapine; Maraviroc; Dolutegravir; Abacavir; Didanosine; Cobicistat; Rilpivirine; Tipranavir; Elvitegravir; Cobicistat mixture with darunavir; Moxifloxacin; Efavirenz; Rifampin; Isoniazid; Linezolid; Cycloserine; Amikacin; Pyrazinamide; Ethambutol; Bedaquiline; Etravirine; Clofazimine; Ofloxacin; Aminosalicylic Acid; Ethionamide; Kanamycin; Capreomycin; Prothionamide; Ethinyl Estradiol; Etonogestrel; Estradiol

Study Results

Participant Flow

Recruitment Details

Participants enrolled between 9Jun2003 and 30Dec2019 at US and non-US clinical research sites and could enroll in multiple arms, simultaneously; thus, reporting groups are not mutually exclusive and totals do not reflect the number of unique participants. There were 1578 unique participants (1037 mothers and 541 infants), including 8 mothers enrolled in 3 arms, 36 mothers enrolled in 2 arms, and 24 mother-infant pairs enrolled in 2 arms. Each arm was designed as a separate single-arm evaluation.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	DTG 50mg q.d.	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	EFV 600mg q.d. and at Least One 1st Line TB Drug	LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug	No ARVs and at Least Two 1st Line TB Drugs	At Least Two 2nd Line TB Drugs w/ or w/Out ARVs	DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE	DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG	EFV 600mg q.d. With 30-35ug EE	ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE	NVP 200mg b.i.d	ABC 300mg b.i.d	LPV/RTV Arm 1: 400/100mg b.i.d	IDV/RTV Arm 1: 800/100mg b.i.d	FPV/RTV 700/100mg b.i.d.	LPV/RTV Arm 2: 400/100mg b.i.d. Then 533/133mg b.i.d.	ATV/RTV Arm 1: 300/100mg q.d.	DDI 400mg or 250mg q.d.	FTC 200mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	NFV Arm 1: 1250mg b.i.d.	EFV 600mg q.d.	TPV/RTV 500/200mg b.i.d.	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	MVC 150 or 300mg b.i.d.	DRV/RTV 800/100mg q.d.	DRV/RTV 600/100mg b.i.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	LPV/RTV Arm 4: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites)	RPV 25mg q.d.	ATV/RTV/TFV 300/100/300mg q.d. With ENG	LPV/RTV 400/100 b.i.d. With 30-35ug EE	LPV/RTV 400/100 b.i.d. With ENG	EFV 600mg q.d. With ENG
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat. TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. efavirenz: efavirenz 600 mg q.d. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. lopinavir/ritonavir dosage #1: lopinavir/ritonavir 800/200mg b.i.d. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: kanamycin amikacin capreomycin Fluoroquinolones: moxifloxacin levofloxacin ofloxacin Oral bacteriostatic second-line agents: ethionamide/prothionamide terizidone/cycloserine para-aminosalicylic acid (PAS) Other agents: high dose INH bedaquiline clofazamine delamanid linezolid pretomanid kanamycin: kanamycin (2nd line TB drug) amikacin: amikacin (2nd line TB drug) capreomycin: capreomycin (2nd line TB drug) moxifloxacin: moxifloxacin (2nd line TB drug) levoflaxacin: levofloxacin (2nd line TB drug) ofloxacin: ofloxacin (2nd line TB drug) ethionamide/prothionamide: ethionamide/prothionamide (2nd line TB drug) terizidone/cycloserine: terizidone/cycloserine (2nd line TB drug) para-aminosalicylic acid (PAS): para-aminosalicylic acid (PAS) (2nd line TB drug) high dose INH: high dose INH (2nd line TB drug) bedaquiline: bedaquiline (2nd line TB drug) clofazamine: clofazamine (2nd TB drug) delamanid: delamanid (2nd line TB drug) linezolid: linezolid (2nd line TB drug) pretomanid: pretomanid (2nd line TB drug)	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting etonogestrel implant atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol efavirenz: efavirenz 600 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine 200 mg twice a day nevirapine: nevirapine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir 300mg twice a day abacavir: abacavir 300mg twice a day	HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir 800/100 mg twice a day indinavir/ritonavir dosage #1: indinavir/ritonavir 800/100mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #3: lopinavir/ritonavir (Kaletra) 533/133 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg	HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day emtricitabine: emtricitabine 200 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir 500/200 mg twice a day tipranavir/ritonavir: tipranavir/ritonavir 500/200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Kaletra) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)	HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel implant atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting postpartum etonogestrel implant etonogestrel implant: etonogestrel implant contraceptive lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV-infected women 2-12 weeks postpartum who received efavirenz 600mg q.d. postpartum and starting postpartum etonogestrel implant efavirenz: efavirenz 600 mg q.d. etonogestrel implant: etonogestrel implant contraceptive
Period Title: Overall Study
STARTED	26	30	27	33	29	31	28	12	27	24	2	27	13	2	6	29	28	12	26	17	1	30	29	22	18	21	28	25	29	25	1	35	43	16	12	32	36	38	35	18	26	25	32	25	27	27	28
Infant Started	25	30	27	32	28	31	27	12	26	23	2	27	14	0	0	0	0	0	0	0	0	9	0	22	4	5	0	21	0	21	0	0	6	6	4	0	9	38	35	0	26	25	30	0	0	0	0
Infant Completed	21	28	27	29	26	25	26	10	25	20	2	24	11	0	0	0	0	0	0	0	0	9	0	20	3	5	0	20	0	21	0	0	6	4	4	0	8	35	34	0	26	21	27	0	0	0	0
COMPLETED	19	29	27	25	26	25	22	10	26	23	2	27	11	2	6	28	27	12	18	13	1	26	27	17	17	20	20	22	21	25	0	26	38	10	10	27	32	36	33	13	26	22	25	22	27	26	27
NOT COMPLETED	7	1	0	8	3	6	6	2	1	1	0	0	2	0	0	1	1	0	8	4	0	4	2	5	1	1	8	3	8	0	1	9	5	6	2	5	4	2	2	5	0	3	7	3	0	1	1

Baseline Characteristics

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	DTG 50mg q.d.	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	EFV 600mg q.d. and at Least One 1st Line TB Drug	LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug	No ARVs and at Least Two 1st Line TB Drugs	At Least Two 2nd Line TB Drugs w/ or w/Out ARVs	DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE	DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG	EFV 600mg q.d. With 30-35ug EE	ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE	NVP 200mg b.i.d	ABC 300mg b.i.d	LPV/RTV Arm 1: 400/100mg b.i.d	IDV/RTV Arm 1: 800/100mg b.i.d	FPV/RTV 700/100mg b.i.d.	LPV/RTV Arm 2: 400/100mg b.i.d. Then 533/133mg b.i.d.	ATV/RTV Arm 1: 300/100mg q.d.	DDI 400mg or 250mg q.d.	FTC 200mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	NFV Arm 1: 1250mg b.i.d.	EFV 600mg q.d.	TPV/RTV 500/200mg b.i.d.	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	MVC 150 or 300mg b.i.d.	DRV/RTV 800/100mg q.d.	DRV/RTV 600/100mg b.i.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	LPV/RTV Arm 4: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites)	RPV 25mg q.d.	ATV/RTV/TFV 300/100/300mg q.d. With ENG	LPV/RTV 400/100 b.i.d. With 30-35ug EE	LPV/RTV 400/100 b.i.d. With ENG	EFV 600mg q.d. With ENG	Total
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat. TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. efavirenz: efavirenz 600 mg q.d. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. lopinavir/ritonavir dosage #1: lopinavir/ritonavir 800/200mg b.i.d. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w. rifampicin: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol: ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid: isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide: pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.	HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: kanamycin amikacin capreomycin Fluoroquinolones: moxifloxacin levofloxacin ofloxacin Oral bacteriostatic second-line agents: ethionamide/prothionamide terizidone/cycloserine para-aminosalicylic acid (PAS) Other agents: high dose INH bedaquiline clofazamine delamanid linezolid pretomanid kanamycin: kanamycin (2nd line TB drug) amikacin: amikacin (2nd line TB drug) capreomycin: capreomycin (2nd line TB drug) moxifloxacin: moxifloxacin (2nd line TB drug) levoflaxacin: levofloxacin (2nd line TB drug) ofloxacin: ofloxacin (2nd line TB drug) ethionamide/prothionamide: ethionamide/prothionamide (2nd line TB drug) terizidone/cycloserine: terizidone/cycloserine (2nd line TB drug) para-aminosalicylic acid (PAS): para-aminosalicylic acid (PAS) (2nd line TB drug) high dose INH: high dose INH (2nd line TB drug) bedaquiline: bedaquiline (2nd line TB drug) clofazamine: clofazamine (2nd TB drug) delamanid: delamanid (2nd line TB drug) linezolid: linezolid (2nd line TB drug) pretomanid: pretomanid (2nd line TB drug)	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting etonogestrel implant atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol efavirenz: efavirenz 600 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol	HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine 200 mg twice a day nevirapine: nevirapine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir 300mg twice a day abacavir: abacavir 300mg twice a day	HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir 800/100 mg twice a day indinavir/ritonavir dosage #1: indinavir/ritonavir 800/100mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #3: lopinavir/ritonavir (Kaletra) 533/133 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg	HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day emtricitabine: emtricitabine 200 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir 500/200 mg twice a day tipranavir/ritonavir: tipranavir/ritonavir 500/200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Kaletra) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)	HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel implant atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting postpartum etonogestrel implant etonogestrel implant: etonogestrel implant contraceptive lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV-infected women 2-12 weeks postpartum who received efavirenz 600mg q.d. postpartum and starting postpartum etonogestrel implant efavirenz: efavirenz 600 mg q.d. etonogestrel implant: etonogestrel implant contraceptive	Total of all reporting groups
Overall Participants	26	30	27	33	29	31	28	12	27	24	2	27	13	2	6	29	28	12	26	17	1	30	29	22	18	21	28	25	29	25	1	35	43	16	12	32	36	38	35	18	26	25	32	25	27	27	28	1113
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	28.8	31.8	29.3	33.6	30.8	32.1	27.7	33.1	30.6	31.4	25.9	32.5	33.2	27.1	32.0	29.5	28.4	31.4	30.7	31.8	31.1	28.7	29.6	30.2	31.0	28.7	29.3	30.4	30.5	25.5	23.8	27.6	27.0	31.0	26.9	28.6	30.4	29.0	26.7	26.9	29.4	26.9	24.3	29.4
Sex: Female, Male (Count of Participants)
Female	26 100%	30 100%	27 100%	33 100%	29 100%	31 100%	28 100%	12 100%	27 100%	24 100%	2 100%	27 100%	13 100%	2 100%	6 100%	29 100%	28 100%	12 100%	26 100%	17 100%	1 100%	30 100%	29 100%	22 100%	18 100%	21 100%	28 100%	25 100%	29 100%	25 100%	1 100%	35 100%	43 100%	16 100%	12 100%	32 100%	36 100%	38 100%	35 100%	18 100%	26 100%	25 100%	32 100%	25 100%	27 100%	27 100%	28 100%	1113 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	0 0%	3 10%	4 14.8%	3 9.1%	1 3.4%	3 9.7%	0 0%	2 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	2 6.9%	4 14.3%	1 8.3%	1 3.8%	7 41.2%	1 100%	1 3.3%	6 20.7%	8 36.4%	4 22.2%	1 4.8%	0 0%	6 24%	3 10.3%	0 0%	0 0%	2 5.7%	4 9.3%	0 0%	3 25%	2 6.3%	0 0%	0 0%	1 2.9%	0 0%	0 0%	0 0%	0 0%	74 296%
Black Non-Hispanic	13 50%	21 70%	8 29.6%	20 60.6%	14 48.3%	22 71%	18 64.3%	6 50%	12 44.4%	21 87.5%	14 700%	12 44.4%	3 23.1%	1 50%	6 100%	5 17.2%	14 50%	7 58.3%	13 50%	10 58.8%	14 1400%	5 16.7%	6 20.7%	9 40.9%	12 66.7%	17 81%	1 3.6%	7 28%	21 72.4%	7 28%	4 400%	18 51.4%	12 27.9%	5 31.3%	15 125%	10 31.3%	0 0%	25 65.8%	18 51.4%	6 33.3%	3 11.5%	1 4%	0 0%	456 1824%
Hispanic (Regardless of Race)	12 46.2%	4 13.3%	14 51.9%	10 30.3%	13 44.8%	5 16.1%	10 35.7%	2 16.7%	15 55.6%	1 4.2%	4 200%	0 0%	3 23.1%	16 800%	20 333.3%	4 13.8%	7 25%	7 58.3%	15 57.7%	11 64.7%	7 700%	11 36.7%	7 24.1%	10 45.5%	7 38.9%	11 52.4%	2 7.1%	22 88%	18 62.1%	9 36%	7 700%	11 31.4%	15 34.9%	16 100%	16 133.3%	6 18.8%	0 0%	0 0%	12 34.3%	19 105.6%	24 92.3%	26 104%	20 62.5%	449 1796%
Asian, Pacific Islander	1 3.8%	1 3.3%	1 3.7%	0 0%	0 0%	1 3.2%	0 0%	2 16.7%	0 0%	2 8.3%	9 450%	0 0%	0 0%	12 600%	1 16.7%	0 0%	1 3.6%	1 8.3%	1 3.8%	0 0%	0 0%	0 0%	1 3.4%	0 0%	1 5.6%	0 0%	21 75%	0 0%	0 0%	0 0%	0 0%	0 0%	4 9.3%	17 106.3%	0 0%	0 0%	26 72.2%	0 0%	1 2.9%	0 0%	0 0%	0 0%	8 25%	112 448%
American Indian, Alaskan Native	0 0%	1 3.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 5.9%	0 0%	0 0%	1 3.4%	0 0%	0 0%	0 0%	1 3.6%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 16%
More Than One Race	0 0%	0 0%	0 0%	0 0%	1 3.4%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.5%	0 0%	0 0%	0 0%	0 0%	1 3.4%	0 0%	1 100%	1 2.9%	1 2.3%	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	7 28%

Outcome Measures

1. Primary Outcome

Title	PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Time Frame	Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	FPV/RTV 700/100mg b.i.d.	DRV/RTV 600/100mg b.i.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day
Measure Participants	24	29	34	18
2nd Trimester	55.1	43.50	45.8	NA
3rd Trimester	51.8	32.15	45.9	34.2
Postpartum	79.6	51.60	61.7	33.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.055
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 90%; 0.44 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 90%; 0.55 to 0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 90%; 0.44 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 90%; 0.49 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 90%; 0.64 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 90%; 0.57 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 90%; 0.71 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Time Frame	Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day
Measure Participants	33	42	15	26
2nd Trimester	72	6.6	4.5	14.9
3rd Trimester	96	5.4	8.3	16.1
Postpartum	133	11.6	5.3	27.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 90%; 0.42 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 90%; 0.63 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 90%; 0.34 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 90%; 0.51 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0684
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	1.34
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 90%; 0.49 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 90%; 0.53 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Description	Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Time Frame	Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	MVC 150 or 300mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day
Measure Participants	18
2nd Trimester	NA
3rd Trimester	2717
Postpartum	3645

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments	3rd Trimester vs. Postpartum
	Method	t-test, 2 sided
	Comments	Paired sample t-test on natural log-transformed PK parameter
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 90%; 0.60 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DTG 50mg q.d.	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	ATV/RTV Arm 1: 300/100mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	DRV/RTV 800/100mg q.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI). TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
Measure Participants	29	27	31	29	30	29	11	42	18	37	20	32	37	35
2nd Trimester	47.6	0.171	0.197	0.181	15.3	50.00	25.33	47.30	88.2	1.9	14.5	64.6	30.6	26.2
3rd Trimester	49.2	0.212	0.206	0.257	14.0	42.05	18.85	60.02	41.9	2.4	28.8	63.5	45.7	37.7
Postpartum	65.0	0.271	0.216	0.283	21.0	95.55	36.20	62.70	57.9	3.0	39.6	103.9	48.8	58.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 90%; 0.52 to 0.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 90%; 0.63 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 90%; 0.34 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 90%; 0.54 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.27
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 90%; 0.50 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 90%; 0.66 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 90%; 0.29 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 90%; 0.63 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 90%; 0.57 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 90%; 0.42 to 0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 90%; 0.33 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 90%; 0.36 to 0.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	ATV/COBI 300/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1875
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 90%; 0.53 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	ATV/COBI 300/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1563
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 90%; 0.19 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	EFV 600 mg q.d. (Outside THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.241
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 90%; 0.85 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	EFV 600 mg q.d. (Outside THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.837
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 90%; 0.90 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 1: 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 90%; 0.55 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	TFV 300mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0046
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 90%; 0.72 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 90%; 0.52 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

5. Primary Outcome

Title	PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period. No 2nd trimester data were available for the EFV 600mg q.d. arm.

Arm/Group Title	EFV 600mg q.d.	RPV 25mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)
Measure Participants	25	32
2nd Trimester	1.969
3rd Trimester	55.4	1.669
Postpartum	58.3	2.387

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 90%; 0.83 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 90%; 0.61 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 90%; 0.62 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	DTG 50mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	FPV/RTV 700/100mg b.i.d.	ATV/RTV Arm 1: 300/100mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	EFV 600mg q.d.	DRV/RTV 800/100mg q.d.	DRV/RTV 600/100mg b.i.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day
Measure Participants	26	29	29	11	42	29	18	37	20	25	32	34	37	35	18	26
2nd Trimester	6.22	3.62	4.59	2.82	3.87	5.61	NA	0.250	1.2	6.77	5.64	3.11	2.73	NA	3.89
3rd Trimester	6.55	3.54	3.67	2.20	5.13	5.12	3.6	0.245	2.5	5.44	5.78	5.53	4.51	3.56	5.1	3.62
Postpartum	8.96	4.85	7.04	3.90	4.41	6.75	4.1	0.298	4.1	5.10	8.11	7.78	4.52	5.43	5.0	5.37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.148
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 90%; 0.64 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 90%; 0.62 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0098
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 90%; 0.61 to 0.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0025
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 90%; 0.64 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 90%; 0.46 to 0.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0024
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 90%; 0.41 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.438
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.795
	Confidence Interval	(2-Sided) 90%; 0.499 to 1.269
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.219
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.531
	Confidence Interval	(2-Sided) 90%; 0.186 to 1.512
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.296
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 90%; 0.94 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 90%; 1.01 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments	FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments	2nd Trimester vs Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 90%; 0.56 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments	FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Wilcoxson signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 90%; 0.58 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	ATV/COBI 300/150 mg q.d.
	Comments	This analysis was for ATV.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 90%; 0.68 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	EFV 600 mg q.d. (Outside THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1636
	Comments	Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 90%; 0.79 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 1: 300/100mg q.d.
	Comments	This analysis was for ATV.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 90%; 0.53 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	TFV 300mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments	3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 90%; 0.99 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments	3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 90%; 0.85 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 90%; 0.59 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 90%; 0.55 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	RPV 25mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)
Measure Participants	33	42	15	32
2nd Trimester	8.4	2.250	0.70	0.145
3rd Trimester	10.7	1.770	1.01	0.134
Postpartum	14.6	3.035	0.63	0.134

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 90%; 0.48 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs.Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 90%; 0.62 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.036
	Comments	3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.34
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 90%; 0.69 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 90%; 0.68 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI). TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.
Measure Participants	27	31	29	30
2nd Trimester	69.7	80.4	87.8	1447.1
3rd Trimester	96	91.2	107	1432.8
Postpartum	133	98.2	141	1713.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.61
	Confidence Interval	(2-Sided) 90%; 0.34 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 90%; 0.50 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 90%; 0.49 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 90%; 0.60 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 90%; 0.30 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 90%; 0.58 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.358
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 90%; 0.71 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0156
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 90%; 0.55 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	MVC 150 or 300mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day
Measure Participants	18
3rd Trimester	448
Postpartum	647

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 90%; 0.58 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Primary Outcome

Title	PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	FPV/RTV 700/100mg b.i.d.	DRV/RTV 600/100mg b.i.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day
Measure Participants	24	29	34	18
2nd Trimester	2.84	2.12	2.12	NA
3rd Trimester	2.52	1.64	2.22	0.47
Postpartum	4.51	2.87	2.51	0.52

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 90%; 0.39 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 90%; 0.49 to 0.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 90%; 0.14 to 1.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 90%; 0.43 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 90%; 0.63 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 90%; 0.69 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 90%; 0.71 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Primary Outcome

Title	PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day
Measure Participants	33	42	15	26
2nd Trimester	3.7	0.0621	0.36	0.13
3rd Trimester	5.1	0.064	0.48	0.13
Postpartum	7.2	0.0797	0.38	0.28

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 90%; 0.32 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 90%; 0.58 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 90%; 0.23 to 0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 90%; 0.56 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.036
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	1.41
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 90%; 0.32 to 0.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 90%; 0.41 to 0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Primary Outcome

Title	PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period. No 2nd trimester data were available for the MVC 150 or 300mg b.i.d. arm.

Arm/Group Title	MVC 150 or 300mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day
Measure Participants	18
3rd Trimester	108
Postpartum	128

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments	3rd Trimester vs. Postpartum
	Method	t-test, 2 sided
	Comments	Paired sample t-test on natural log-transformed PK parameter
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 90%; 0.72 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Primary Outcome

Title	PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DTG 50mg q.d.	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	ATV/RTV Arm 1: 300/100mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	DRV/RTV 800/100mg q.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI). TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
Measure Participants	29	27	31	29	30	29	11	42	18	37	20	32	37	35
2nd Trimester	0.73	0.00195	0.00195	0.00195	0.0258	0.33	0.21	1.49	2.0	0.039	0.3	0.99	0.49	0.44
3rd Trimester	0.93	0.00195	0.00195	0.00195	0.0487	0.27	0.21	1.48	0.7	0.054	0.5	1.17	0.71	0.57
Postpartum	1.28	0.00195	0.00195	0.00195	0.3771	1.43	0.61	1.94	1.2	0.061	0.8	2.78	0.90	1.26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0039
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 90%; 0.35 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 90%; 0.52 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EVG/COBI 150/150mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90%; 0.08 to 0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DRV/COBI 800/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 90%; 0.12 to 0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	ATV/COBI 300/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.10
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 90%; 0.20 to 0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	ATV/COBI 300/150 mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.10
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 90%; 0.11 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	EFV 600 mg q.d. (Outside THA)
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.079
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 90%; 0.78 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	EFV 600 mg q.d. (Outside THA)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 90%; 0.77 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 1: 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 90%; 0.37 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	TFV 300mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0325
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 90%; 0.71 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum [Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.]
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 90%; 0.54 to 0.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 800/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments

14. Primary Outcome

Title	PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period. No 2nd trimester data were available for the EFV 600mg q.d. arm.

Arm/Group Title	EFV 600mg q.d.	RPV 25mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)
Measure Participants	25	32
2nd Trimester	0.063
3rd Trimester	1.60	0.056
Postpartum	2.05	0.081

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 90%; 0.73 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	2nd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 90%; 0.55 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	3rd Trimester vs. Postpartum
	Method	Wilcoxon signed-rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 90%; 0.57 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Primary Outcome

Title	Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

All mothers with intensive pharmacokinetic (PK) results taking the dose under study at that time period (2nd trimester, 3rd trimester or Postpartum). Because participants could enter the study at different time period per the study design, they are not expected to have results at every time period.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	DTG 50mg q.d.	TAF 25mg q.d.	TAF 10mg q.d. w/COBI	TAF 25mg q.d. w/COBI or RTV Boosting	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	EFV 600 mg q.d. (Outside THA)	FPV/RTV 700/100mg b.i.d.	ATV/RTV Arm 1: 300/100mg q.d.	TFV 300mg q.d.	TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	EFV 600mg q.d.	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	MVC 150 or 300mg b.i.d.	DRV/RTV 800/100mg q.d.	DRV/RTV 600/100mg b.i.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	RPV 25mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI). TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day tenofovir: tenofovir 300 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)
Measure Participants	26	29	27	31	29	30	29	11	42	29	18	37	20	25	33	42	15	18	32	34	37	35	18	26	32
2nd Trimester	7 26.9%	9 30%	13 48.1%	15 45.5%	10 34.5%	8 25.8%	3 10.7%	1 8.3%	12 44.4%	8 33.3%	1 50%	2 7.4%	1 7.7%	9 450%	11 183.3%	5 17.2%	9 32.1%	7 58.3%	8 30.8%	7 41.2%	NA NaN	10 33.3%	14 48.3%
3rd Trimester	16 61.5%	20 66.7%	23 85.2%	23 69.7%	24 82.8%	10 32.3%	4 14.3%	2 16.7%	33 122.2%	26 108.3%	12 600%	27 100%	11 84.6%	20 1000%	30 500%	33 113.8%	13 46.4%	8 66.7%	19 73.1%	19 111.8%	29 2900%	23 76.7%	15 51.7%	19 86.4%	26 144.4%
Postpartum	22 84.6%	23 76.7%	24 88.9%	22 66.7%	18 62.1%	18 58.1%	14 50%	5 41.7%	34 125.9%	22 91.7%	12 600%	27 100%	12 92.3%	21 1050%	27 450%	30 103.4%	7 25%	7 58.3%	22 84.6%	22 129.4%	27 2700%	32 106.7%	14 48.3%	26 118.2%	25 138.9%

16. Primary Outcome

Title	Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V. No results are available for this outcome measure at this time. The TB drugs are being assayed in batches (not real-time) after the study completion. Labs have been experiencing additional delays due to urgent COVID-19 pandemic related work.
Time Frame	Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Primary Outcome

Title	Plasma Concentration for Contraceptives
Description	Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs.
Time Frame	Measured at 6-7 weeks after contraceptive initiation postpartum

Outcome Measure Data

Analysis Population Description

HIV-infected women 2-12 weeks (14-84 days) post-delivery receiving ARV drug combinations AND starting postpartum contraceptives as listed in the protocol with intensive PK results.

Arm/Group Title	ATV/RTV/TFV 300/100/300mg q.d. With ENG	LPV/RTV 400/100 b.i.d. With ENG	EFV 600mg q.d. With ENG
Arm/Group Description	HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant etonogestrel implant: etonogestrel implant contraceptive lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day	HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant efavirenz: efavirenz 600 mg q.d. etonogestrel implant: etonogestrel implant contraceptive
Measure Participants	22	26	26
Median (Inter-Quartile Range) [pg/mL]	604	428	125

18. Primary Outcome

Title	Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
Time Frame	Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

Outcome Measure Data

Analysis Population Description

HIV-infected women 2-12 weeks (14-84 days) post-delivery receiving ARV drug combinations AND starting postpartum contraceptives as listed in the protocol with intensive PK results.

Arm/Group Title	LPV/RTV 400/100 b.i.d. With ENG
Arm/Group Description	HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d. postpartum and starting postpartum etonogestrel (ENG) implant etonogestrel implant: etonogestrel implant contraceptive lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day
Measure Participants	26
Before contraceptive initiation	115.97
After contraceptive initiation	100.20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments	The statistical analysis is for LPV PK.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments	Before ENG initiation vs. after ENG initiation
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 90%; 0.97 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Primary Outcome

Title	Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
Description	Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
Time Frame	Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

Outcome Measure Data

Analysis Population Description

HIV-infected women 2-12 weeks (14-84 days) post-delivery receiving one of the ARV drug combinations AND starting postpartum contraceptives as listed in the protocol with intensive PK results.

Arm/Group Title	ATV/RTV/TFV 300/100/300mg q.d. With ENG	EFV 600mg q.d. With ENG
Arm/Group Description	HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. etonogestrel implant: etonogestrel implant contraceptive	HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d. postpartum and starting postpartum etonogestrel (ENG) implant efavirenz: efavirenz 600 mg q.d. etonogestrel implant: etonogestrel implant contraceptive
Measure Participants	22	26
Before contraceptive initiation	53.96	53.64
After contraceptive initiation	55.25	56.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.
	Comments	The statistical test is for ATV PK.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.367
	Comments	Before ENG initiation vs. after ENG initiation
	Method	Wilcoxon signed rank test
	Comments
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 90%; 0.84 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FPV/RTV 700/100mg b.i.d.
	Comments	The statistical test is for EFV PK.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.561
	Comments
	Method	Wilcoxon signed rank test
	Comments	Before ENG initiation vs. after ENG initiation
Method of Estimation	Estimation Parameter	Geometric mean of ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 90%; 0.92 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
Description	Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio.
Time Frame	Measured at time of delivery with single cord blood and single maternal plasma sample.

Outcome Measure Data

Analysis Population Description

All participants with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery.

Arm/Group Title	DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.	DTG 50mg q.d.	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	ATV/COBI 300/150 mg q.d.	TFV 300mg q.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day tenofovir: tenofovir 300 mg once a day
Measure Participants	16	18	12	13	6	28
Median (Inter-Quartile Range) [unitless]	0.15	1.25	0.91	0.07	0.07	0.88

21. Secondary Outcome

Title	PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
Description	Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated.
Time Frame	Measured at time of delivery with single cord blood and single maternal plasma sample.

Outcome Measure Data

Analysis Population Description

All participants with cord blood drawn immediately after the cord was clamped and maternal blood samples drawn at the time the cord was clamped at delivery. Notes: a) Ratios were not calculated for the TAF 25mg q.d. and TAF 25mg q.d. w/COBI or RTV Boosting arms since all cord blood samples were below the lower limit of quantification. b)These arms were combined for analysis: (1) ATV/RTV 300/100mg q.d. & TFV/ATV/RTV 300/300/100mg q.d. and (2) DRV/RTV 800/100mg q.d. & DRV/RTV 600/100mg b.i.d.

Arm/Group Title	TAF 10mg q.d. w/COBI	EFV 600 mg q.d. (Outside THA)	EFV 600mg q.d.	LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	RAL 400mg b.i.d.	ETR 200mg b.i.d.	MVC 150 or 300mg b.i.d.	ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	RPV 25mg q.d.	ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d.	DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d.
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI). TAF w/cobicistat: TAF 10 mg q.d. with cobicistat	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day efavirenz: efavirenz 600 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day raltegravir: raltegravir 400 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day etravirine: etravirine 200 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day	HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day	HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)	HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day or tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day or darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.
Measure Participants	1	17	23	26	29	6	10	27	28	10	19	19	29	28
Median (Full Range) [unitless]	0.97	0.67	0.49	0.2	1.5	0.52	0.33	0.14	0.16	0.19	0.12	0.55	0.18	0.18

22. Secondary Outcome

Title	Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
Description	Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations.
Time Frame	Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Outcome Measure Data

Analysis Population Description

All infants who met the requirement for washout PK sampling (as specified in Protocol Section 4.4) with plasma samples drawn after delivery.

Arm/Group Title	DTG 50mg q.d.	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	EFV 600 mg q.d. (Outside THA)
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.
Measure Participants	16	17	26	18
Median (Inter-Quartile Range) [hour]	32.8	7.6	NA	65.6

23. Secondary Outcome

Title	Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
Description	Infant plasma concentrations were collected and measured during the first 9 days of life.
Time Frame	Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Outcome Measure Data

Analysis Population Description

All infants who met the requirements for washout PK sampling (as specified in Protocol Section 4.4) with plasma samples drawn after delivery. Infants don't need to contribute to all time points to be included. For DRV/COBI 800/150mg q.d. arm, infants with concentrations below detection limit were not summarized.

Arm/Group Title	DTG 50mg q.d.	EVG/COBI 150/150mg q.d.	DRV/COBI 800/150 mg q.d.	EFV 600 mg q.d. (Outside THA)
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.	HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.
Measure Participants	22	27	26	23
2-10 hours after birth	1.73	0.132	0.35	1.1
18-28 hours after birth	1.53	0.032	1.43	1.0
36-72 hours after birth	1.00	0.005	1.87	0.9
5-9 days after birth	0.06	0.005	1.72	0.4

24. Other Pre-specified Outcome

Title	ARV Concentrations in Plasma
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belong with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Other Pre-specified Outcome

Title	ARV Concentrations in Vaginal Secretions
Description	The original study protocol listed this PK parameter under secondary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Other Pre-specified Outcome

Title	Drug Parameter: Half-life (t1/2)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Other Pre-specified Outcome

Title	Drug Parameter: Volume of Distribution Over Systemic Availability (V/F)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

28. Other Pre-specified Outcome

Title	Drug Parameter: Clearance Over Systemic Availability (Cl/F)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

29. Other Pre-specified Outcome

Title	Drug Parameter: Time After Administration of Drug When Maximum Plasma Concentration is Reached (Tmax)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

30. Other Pre-specified Outcome

Title	Drug Parameter: Minimum Concentration (Cmin)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

31. Other Pre-specified Outcome

Title	Drug Parameter: Pre-dose Concentration (Cdose)
Description	The original study protocol listed this PK parameter under primary outcome measures. However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
Time Frame	Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

32. Other Pre-specified Outcome

Title	Adverse Events of Grade 3 or Higher
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured through 24 weeks postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

33. Other Pre-specified Outcome

Title	Infant Neurological Events of Grade 1 or Higher
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured through 24 weeks of life

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

34. Other Pre-specified Outcome

Title	Adverse Pregnancy Outcome: Preterm Birth
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured through delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

35. Other Pre-specified Outcome

Title	Adverse Pregnancy Outcome: Low Birth Weight
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured at delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

36. Other Pre-specified Outcome

Title	Adverse Pregnancy Outcome: Fetal Demise
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured through 24 weeks postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

37. Other Pre-specified Outcome

Title	Adverse Pregnancy Outcome: Congenital Anomalies
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which werenot conducted (see SAP). See Adverse events section for adverse events.
Time Frame	Measured through 24 weeks of life

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

38. Other Pre-specified Outcome

Title	Infant HIV Infection Status
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured through 24 weeks of life

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

39. Other Pre-specified Outcome

Title	Ratio of Unbound/Total Drug Concentrations
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured at time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

40. Other Pre-specified Outcome

Title	Rate of Detection of Study Drugs in Vaginal Secretions
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

41. Other Pre-specified Outcome

Title	Ratio of Vaginal Drug Concentrations to Simultaneous Blood Concentrations
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

42. Other Pre-specified Outcome

Title	Rate of Detection of HIV RNA/DNA in Vaginal Secretions and Comparison to Level in Blood
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

43. Other Pre-specified Outcome

Title	ARV Exposure (as Measured by Area Under the Curve or Other PK Parameters) During Pregnancy and Postpartum According to Genotype
Description	The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
Time Frame	Measured at intensive PK visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From study entry to the end of study follow-up: • HIV-infected pregnant women without TB: entry to 6-2 weeks after delivery with the exception of women on DRV/r who will be from entry to 2-3 weeks after delivery; • Women receiving TB treatment: entry to 2-8 weeks after delivery; • Postpartum women: entry to 6-7 weeks after the initiation of hormonal contraceptives; • Infants: birth to16-24 weeks of life.
Adverse Event Reporting Description	All adverse events including diagnoses, labs and signs/symptoms after study entry for mothers; all diagnoses, labs and signs/symptoms after birth for infants (AEs were summarized separately for moms and infants). The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017 was followed.
Arm/Group Title	ABC 300mg b.i.d. MOTHER		ATV/COBI 300/150 mg q.d. INFANT		ATV/COBI 300/150 mg q.d. MOTHER		ATV/RTV 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. MOTHER		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs MOTHER		DDI 400mg or 250mg q.d. INFANT		DDI 400mg or 250mg q.d. MOTHER		DRV/COBI 800/150 mg q.d. INFANT		DRV/COBI 800/150 mg q.d. MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG MOTHER		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. INFANT		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. MOTHER		DRV/RTV 600/100mg b.i.d. INFANT		DRV/RTV 600/100mg b.i.d. MOTHER		DRV/RTV 800/100mg q.d. MOTHER		DTG 50mg q.d. INFANT		DTG 50mg q.d. MOTHER		EFV 600 mg q.d. (Outside THA) INFANT		EFV 600 mg q.d. (Outside THA) MOTHER		EFV 600mg q.d. INFANT		EFV 600mg q.d. MOTHER		EFV 600mg q.d. and at Least One 1st Line TB Drug INFANT		EFV 600mg q.d. and at Least One 1st Line TB Drug MOTHER		EFV 600mg q.d. With 30-35ug EE MOTHER		EFV 600mg q.d. With ENG MOTHER		ETR 200mg b.i.d. INFANT		ETR 200mg b.i.d. MOTHER		EVG/COBI 150/150mg q.d. INFANT		EVG/COBI 150/150mg q.d. MOTHER		FPV/RTV 700/100 b.i.d. INFANT		FPV/RTV 700/100 b.i.d. MOTHER		FTC 200mg q.d. INFANT		FTC 200mg q.d. MOTHER		IDV/RTV 400/100mg q.d. (Only THA) INFANT		IDV/RTV 400/100mg q.d. (Only THA) MOTHER		IDV/RTV 800/100mg b.i.d. MOTHER		LPV/RTV 400/100 b.i.d. With 30-35ug EE MOTHER		LPV/RTV 400/100 b.i.d. With ENG MOTHER		LPV/RTV 400/100mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 533/133mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) INFANT		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. MOTHER		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug INFANT		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug MOTHER		MVC 150 or 300mg b.i.d. INFANT		MVC 150 or 300mg b.i.d. MOTHER		NFV 1250mg b.i.d. MOTHER		NFV 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. MOTHER		NVP 200mg b.i.d. MOTHER		No ARVs and at Least Two 1st Line TB Drugs INFANT		No ARVs and at Least Two 1st Line TB Drugs MOTHER		RAL 400mg b.i.d. INFANT		RAL 400mg b.i.d. MOTHER		RPV 25mg q.d. INFANT		RPV 25mg q.d. MOTHER		TAF 10mg q.d. w/COBI INFANT		TAF 10mg q.d. w/COBI MOTHER		TAF 25mg q.d. INFANT		TAF 25mg q.d. MOTHER		TAF 25mg q.d. w/COBI or RTV Boosting INFANT		TAF 25mg q.d. w/COBI or RTV Boosting MOTHER		TFV 300mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. MOTHER		TPV/RTV 500/200mg b.i.d. MOTHER
Arm/Group Description	HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir 300mg twice a day abacavir: abacavir 300mg twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat 300/150 mg q.d. atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day		HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day		HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir dosage #1: atazanavir/ritonavir 300/100 mg once a day atazanavir/ritonavir dosage #2: atazanavir/ritonavir 400/100mg once a day		HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol		HIV- infected women 2-12 weeks (14-84 days) postpartum who received atazanavir/ritonavir/tenofovir 300/100/300 mg q.d. postpartum and starting postpartum etonogestrel implant atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. etonogestrel implant: etonogestrel implant contraceptive		Infants of HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: kanamycin amikacin capreomycin Fluoroquinolones: moxifloxacin levofloxacin ofloxacin Oral bacteriostatic second-line agents: ethionamide/prothionamide terizidone/cycloserine para-aminosalicylic acid (PAS) Other agents: high dose INH bedaquiline clofazamine delamanid linezolid pretomanid		HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents: kanamycin amikacin capreomycin Fluoroquinolones: moxifloxacin levofloxacin ofloxacin Oral bacteriostatic second-line agents: ethionamide/prothionamide terizidone/cycloserine para-aminosalicylic acid (PAS) Other agents: high dose INH bedaquiline clofazamine delamanid linezolid pretomanid		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg		HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg didanosine delayed release (Videx® EC): didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat 800/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d.		HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol		HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat 800/150 mg q.d. or atazanavir/cobicistat 300/150 mg q.d. postpartum and starting etonogestrel implant atazanavir/cobicistat: atazanavir/cobicistat 300/150 mg q.d. darunavir/cobicistat: darunavir/cobicistat 800/150 mg q.d. etonogestrel implant: etonogestrel implant contraceptive		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir twice daily 600/100 mg b.i.d. or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d. darunavir/ritonavir dosage #2: darunavir/ritonavir twice daily 800/100 mg b.i.d. darunavir/ritonavir dosage #3: darunavir/ritonavir twice daily 900/100 mg b.i.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.		HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 600/100 mg twice a day darunavir/ritonavir dosage #1: darunavir/ritonavir twice daily 600/100 mg b.i.d.		HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir 800/100 mg once a day darunavir/ritonavir dosage #4: darunavir/ritonavir once daily 800/100 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir 50 mg q.d. dolutegravir: dolutegravir 50 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz 600 mg q.d. (Participants outside of Thailand only) efavirenz: efavirenz 600 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day efavirenz: efavirenz 600 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600 mg once a day efavirenz: efavirenz 600 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz 600mg q.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol efavirenz: efavirenz 600 mg q.d. ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol		HIV-infected women 2-12 weeks (14-84 days) postpartum who received efavirenz 600mg q.d. postpartum and starting postpartum etonogestrel implant efavirenz: efavirenz 600 mg q.d. etonogestrel implant: etonogestrel implant contraceptive		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day etravirine: etravirine 200 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine 200mg twice a day etravirine: etravirine 200 mg twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat 150/150 mg q.d elvitegravir/cobicistat: elvitegravir/cobicistat 150/150 mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir 700/100mg twice a day fosamprenavir/ritonavir: fosamprenavir/ritonavir 700/100 mg twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day emtricitabine: emtricitabine 200 mg once a day		HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine 200 mg once a day emtricitabine: emtricitabine 200 mg once a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir 400/100 mg twice a day only to participants enrolling in Thailand indinavir/ritonavir dosage #2: indinavir/ritonavir 400/100 mg twice a day		HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir 800/100 mg twice a day indinavir/ritonavir dosage #1: indinavir/ritonavir 800/100mg twice a day		HIV- infected women 2-12 weeks (14-84 days) postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol ethinyl estradiol: oral contraceptives formulated with 30-35 μg ethinyl estradiol lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day		HIV- infected women 2-12 weeks (14-84 days) postpartum who received lopinavir/ritonavir 400/100 b.i.d. postpartum and starting postpartum etonogestrel implant etonogestrel implant: etonogestrel implant contraceptive lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day		HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #3: lopinavir/ritonavir (Kaletra) 533/133 mg twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (Kaletra) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn lopinavir/ritonavir dosage #2: lopinavir/ritonavir (Kaletra) 400/100mg twice a day lopinavir/ritonavir dosage #4: lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc 150 mg or 300 mg twice a day maraviroc: maraviroc 150 mg or 300 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn nelfinavir dosage #1: nelfinavir [625 mg tablets] 1250 mg twice a day nelfinavir dosage #2: nelfinavir [625 mg tablets] 1875 mg twice a day		HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine 200 mg twice a day nevirapine: nevirapine 200 mg twice a day		Infants of HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry: rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w. isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day raltegravir: raltegravir 400 mg twice a day		HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir 400 mg twice a day raltegravir: raltegravir 400 mg twice a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)		HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (25 mg q.d.) rilpivirine: rilpivirine (25 mg q.d.)		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat. TAF w/cobicistat: TAF 10 mg q.d. with cobicistat		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat. TAF w/cobicistat: TAF 10 mg q.d. with cobicistat		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. without cobicistat or ritonavir boosting. tenofovir alafenamide fumarate (TAF): TAF 25 mg q.d. without cobicistat or ritonavir boosting		Infants of HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting		HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat or ritonavir boosting. TAF w/cobicistat or ritonavir: TAF 25 mg q.d. with cobicistat or ritonavir boosting		HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir 300 mg once a day tenofovir: tenofovir 300 mg once a day		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.		HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d.		Infants of HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day		HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn atazanavir/ritonavir/tenofovir dosage #1: atazanavir/ritonavir/tenofovir 300/100/300mg q.d. tenofovir/atazanavir/ritonavir dosage #2: tenofovir/atazanavir/ritonavir 300/400/100 mg once a day		HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day tipranavir/ritonavir: tipranavir/ritonavir 500/200 mg twice a day
All Cause Mortality
	ABC 300mg b.i.d. MOTHER		ATV/COBI 300/150 mg q.d. INFANT		ATV/COBI 300/150 mg q.d. MOTHER		ATV/RTV 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. MOTHER		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs MOTHER		DDI 400mg or 250mg q.d. INFANT		DDI 400mg or 250mg q.d. MOTHER		DRV/COBI 800/150 mg q.d. INFANT		DRV/COBI 800/150 mg q.d. MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG MOTHER		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. INFANT		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. MOTHER		DRV/RTV 600/100mg b.i.d. INFANT		DRV/RTV 600/100mg b.i.d. MOTHER		DRV/RTV 800/100mg q.d. MOTHER		DTG 50mg q.d. INFANT		DTG 50mg q.d. MOTHER		EFV 600 mg q.d. (Outside THA) INFANT		EFV 600 mg q.d. (Outside THA) MOTHER		EFV 600mg q.d. INFANT		EFV 600mg q.d. MOTHER		EFV 600mg q.d. and at Least One 1st Line TB Drug INFANT		EFV 600mg q.d. and at Least One 1st Line TB Drug MOTHER		EFV 600mg q.d. With 30-35ug EE MOTHER		EFV 600mg q.d. With ENG MOTHER		ETR 200mg b.i.d. INFANT		ETR 200mg b.i.d. MOTHER		EVG/COBI 150/150mg q.d. INFANT		EVG/COBI 150/150mg q.d. MOTHER		FPV/RTV 700/100 b.i.d. INFANT		FPV/RTV 700/100 b.i.d. MOTHER		FTC 200mg q.d. INFANT		FTC 200mg q.d. MOTHER		IDV/RTV 400/100mg q.d. (Only THA) INFANT		IDV/RTV 400/100mg q.d. (Only THA) MOTHER		IDV/RTV 800/100mg b.i.d. MOTHER		LPV/RTV 400/100 b.i.d. With 30-35ug EE MOTHER		LPV/RTV 400/100 b.i.d. With ENG MOTHER		LPV/RTV 400/100mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 533/133mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) INFANT		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. MOTHER		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug INFANT		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug MOTHER		MVC 150 or 300mg b.i.d. INFANT		MVC 150 or 300mg b.i.d. MOTHER		NFV 1250mg b.i.d. MOTHER		NFV 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. MOTHER		NVP 200mg b.i.d. MOTHER		No ARVs and at Least Two 1st Line TB Drugs INFANT		No ARVs and at Least Two 1st Line TB Drugs MOTHER		RAL 400mg b.i.d. INFANT		RAL 400mg b.i.d. MOTHER		RPV 25mg q.d. INFANT		RPV 25mg q.d. MOTHER		TAF 10mg q.d. w/COBI INFANT		TAF 10mg q.d. w/COBI MOTHER		TAF 25mg q.d. INFANT		TAF 25mg q.d. MOTHER		TAF 25mg q.d. w/COBI or RTV Boosting INFANT		TAF 25mg q.d. w/COBI or RTV Boosting MOTHER		TFV 300mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. MOTHER		TPV/RTV 500/200mg b.i.d. MOTHER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Serious Adverse Events
	ABC 300mg b.i.d. MOTHER		ATV/COBI 300/150 mg q.d. INFANT		ATV/COBI 300/150 mg q.d. MOTHER		ATV/RTV 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. MOTHER		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs MOTHER		DDI 400mg or 250mg q.d. INFANT		DDI 400mg or 250mg q.d. MOTHER		DRV/COBI 800/150 mg q.d. INFANT		DRV/COBI 800/150 mg q.d. MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG MOTHER		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. INFANT		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. MOTHER		DRV/RTV 600/100mg b.i.d. INFANT		DRV/RTV 600/100mg b.i.d. MOTHER		DRV/RTV 800/100mg q.d. MOTHER		DTG 50mg q.d. INFANT		DTG 50mg q.d. MOTHER		EFV 600 mg q.d. (Outside THA) INFANT		EFV 600 mg q.d. (Outside THA) MOTHER		EFV 600mg q.d. INFANT		EFV 600mg q.d. MOTHER		EFV 600mg q.d. and at Least One 1st Line TB Drug INFANT		EFV 600mg q.d. and at Least One 1st Line TB Drug MOTHER		EFV 600mg q.d. With 30-35ug EE MOTHER		EFV 600mg q.d. With ENG MOTHER		ETR 200mg b.i.d. INFANT		ETR 200mg b.i.d. MOTHER		EVG/COBI 150/150mg q.d. INFANT		EVG/COBI 150/150mg q.d. MOTHER		FPV/RTV 700/100 b.i.d. INFANT		FPV/RTV 700/100 b.i.d. MOTHER		FTC 200mg q.d. INFANT		FTC 200mg q.d. MOTHER		IDV/RTV 400/100mg q.d. (Only THA) INFANT		IDV/RTV 400/100mg q.d. (Only THA) MOTHER		IDV/RTV 800/100mg b.i.d. MOTHER		LPV/RTV 400/100 b.i.d. With 30-35ug EE MOTHER		LPV/RTV 400/100 b.i.d. With ENG MOTHER		LPV/RTV 400/100mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 533/133mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) INFANT		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. MOTHER		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug INFANT		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug MOTHER		MVC 150 or 300mg b.i.d. INFANT		MVC 150 or 300mg b.i.d. MOTHER		NFV 1250mg b.i.d. MOTHER		NFV 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. MOTHER		NVP 200mg b.i.d. MOTHER		No ARVs and at Least Two 1st Line TB Drugs INFANT		No ARVs and at Least Two 1st Line TB Drugs MOTHER		RAL 400mg b.i.d. INFANT		RAL 400mg b.i.d. MOTHER		RPV 25mg q.d. INFANT		RPV 25mg q.d. MOTHER		TAF 10mg q.d. w/COBI INFANT		TAF 10mg q.d. w/COBI MOTHER		TAF 25mg q.d. INFANT		TAF 25mg q.d. MOTHER		TAF 25mg q.d. w/COBI or RTV Boosting INFANT		TAF 25mg q.d. w/COBI or RTV Boosting MOTHER		TFV 300mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. MOTHER		TPV/RTV 500/200mg b.i.d. MOTHER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		3/12 (25%)		3/12 (25%)		0/22 (0%)		1/22 (4.5%)		6/38 (15.8%)		0/38 (0%)		2/28 (7.1%)		0/25 (0%)		8/14 (57.1%)		4/13 (30.8%)		0/4 (0%)		0/18 (0%)		7/27 (25.9%)		5/28 (17.9%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		3/26 (11.5%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		7/30 (23.3%)		3/30 (10%)		8/26 (30.8%)		5/27 (18.5%)		0/21 (0%)		0/25 (0%)		7/23 (30.4%)		6/24 (25%)		3/29 (10.3%)		0/28 (0%)		1/6 (16.7%)		1/16 (6.3%)		5/31 (16.1%)		5/31 (16.1%)		2/9 (22.2%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		3/25 (12%)		3/25 (12%)		1/35 (2.9%)		2/2 (100%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		2/18 (11.1%)		0/12 (0%)		7/27 (25.9%)		6/27 (22.2%)		1/6 (16.7%)		0/43 (0%)		3/30 (10%)		2/32 (6.3%)		10/32 (31.3%)		7/33 (21.2%)		4/27 (14.8%)		4/27 (14.8%)		5/28 (17.9%)		5/29 (17.2%)		0/28 (0%)		2/21 (9.5%)		1/25 (4%)		2/35 (5.7%)		0/35 (0%)		0/1 (0%)
Blood and lymphatic system disorders
Anaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Anaemia of pregnancy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neutropenia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cardiac disorders
Cardiac failure	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tachycardia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital, familial and genetic disorders
Anomalous pulmonary venous connection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Asphyxiating thoracic dystrophy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Atrial septal defect	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cerebral palsy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital anaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital naevus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital pseudarthrosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital syphilis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cryptorchism	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cystic fibrosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Developmental hip dysplasia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dysmorphism	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Heart disease congenital	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hydrocele	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypospadias	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Kidney duplex	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Laryngomalacia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Limb malformation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Polydactyly	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Renal dysplasia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Ventricular septal defect	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Diarrhoea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gastritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Infantile spitting up	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nausea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Umbilical hernia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
General disorders
Drug withdrawal syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Drug withdrawal syndrome neonatal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hyperthermia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sudden infant death syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hepatobiliary disorders
Cholestasis of pregnancy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Drug-induced liver injury	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hepatitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hepatitis fulminant	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hyperbilirubinaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Infections and infestations
Bronchiolitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bronchitis viral	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cellulitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Endometritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Fungal sepsis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gastroenteritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gastroenteritis viral	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Malaria	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Meningitis viral	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pneumonia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pyelonephritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sepsis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sepsis neonatal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Staphylococcal infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Upper respiratory tract infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Urinary tract infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Viral upper respiratory tract infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Injury, poisoning and procedural complications
Clavicle fracture	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Craniocerebral injury	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Exposure to communicable disease	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Perineal injury	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine rupture	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Investigations
Aspartate aminotransferase increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood bilirubin abnormal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood bilirubin increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood creatinine increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood glucose decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood glucose increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
HIV test	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Haemoglobin decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hepatic enzyme increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		3/29 (10.3%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Influenza A virus test	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Weight decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Underweight	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Compartment syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Diastasis recti abdominis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tendonitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Intra-abdominal haemangioma	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Spinal cord lipoma	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nervous system disorders
Extrapyramidal disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypotonia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypoxic-ischaemic encephalopathy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Intraventricular haemorrhage neonatal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal seizure	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Seizure like phenomena	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tonic posturing	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pregnancy, puerperium and perinatal conditions
Eclampsia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Foetal cardiac disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Foetal death	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gestational hypertension	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Low birth weight baby	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Obstructed labour	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Placenta praevia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Placental insufficiency	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Postpartum haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pre-eclampsia	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Premature baby	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		5/32 (15.6%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Premature delivery	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Premature labour	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		2/29 (6.9%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Premature rupture of membranes	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Preterm premature rupture of membranes	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Psychiatric disorders
Major depression	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Renal and urinary disorders
Renal cyst	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Reproductive system and breast disorders
Cervical dysplasia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal testicular torsion	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Peyronie's disease	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vaginal haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Meconium aspiration syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal asphyxia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal respiratory distress	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal respiratory distress syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Respiratory distress	0/26 (0%)		2/12 (16.7%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Respiratory failure	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vascular disorders
Hypertension	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	ABC 300mg b.i.d. MOTHER		ATV/COBI 300/150 mg q.d. INFANT		ATV/COBI 300/150 mg q.d. MOTHER		ATV/RTV 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. MOTHER		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. INFANT		ATV/RTV 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With 30-35ug EE MOTHER		ATV/RTV/TFV 300/100/300mg q.d. With ENG MOTHER		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs INFANT		At Least Two 2nd Line TB Drugs w/ or w/Out ARVs MOTHER		DDI 400mg or 250mg q.d. INFANT		DDI 400mg or 250mg q.d. MOTHER		DRV/COBI 800/150 mg q.d. INFANT		DRV/COBI 800/150 mg q.d. MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With 30-35ug EE MOTHER		DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d With ENG MOTHER		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. INFANT		DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. MOTHER		DRV/RTV 600/100mg b.i.d. INFANT		DRV/RTV 600/100mg b.i.d. MOTHER		DRV/RTV 800/100mg q.d. MOTHER		DTG 50mg q.d. INFANT		DTG 50mg q.d. MOTHER		EFV 600 mg q.d. (Outside THA) INFANT		EFV 600 mg q.d. (Outside THA) MOTHER		EFV 600mg q.d. INFANT		EFV 600mg q.d. MOTHER		EFV 600mg q.d. and at Least One 1st Line TB Drug INFANT		EFV 600mg q.d. and at Least One 1st Line TB Drug MOTHER		EFV 600mg q.d. With 30-35ug EE MOTHER		EFV 600mg q.d. With ENG MOTHER		ETR 200mg b.i.d. INFANT		ETR 200mg b.i.d. MOTHER		EVG/COBI 150/150mg q.d. INFANT		EVG/COBI 150/150mg q.d. MOTHER		FPV/RTV 700/100 b.i.d. INFANT		FPV/RTV 700/100 b.i.d. MOTHER		FTC 200mg q.d. INFANT		FTC 200mg q.d. MOTHER		IDV/RTV 400/100mg q.d. (Only THA) INFANT		IDV/RTV 400/100mg q.d. (Only THA) MOTHER		IDV/RTV 800/100mg b.i.d. MOTHER		LPV/RTV 400/100 b.i.d. With 30-35ug EE MOTHER		LPV/RTV 400/100 b.i.d. With ENG MOTHER		LPV/RTV 400/100mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 533/133mg b.i.d. MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) INFANT		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. (Only African Sites) MOTHER		LPV/RTV 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. MOTHER		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug INFANT		LPV/RTV 800/200mg b.i.d. and at Least One 1st Line TB Drug MOTHER		MVC 150 or 300mg b.i.d. INFANT		MVC 150 or 300mg b.i.d. MOTHER		NFV 1250mg b.i.d. MOTHER		NFV 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. MOTHER		NVP 200mg b.i.d. MOTHER		No ARVs and at Least Two 1st Line TB Drugs INFANT		No ARVs and at Least Two 1st Line TB Drugs MOTHER		RAL 400mg b.i.d. INFANT		RAL 400mg b.i.d. MOTHER		RPV 25mg q.d. INFANT		RPV 25mg q.d. MOTHER		TAF 10mg q.d. w/COBI INFANT		TAF 10mg q.d. w/COBI MOTHER		TAF 25mg q.d. INFANT		TAF 25mg q.d. MOTHER		TAF 25mg q.d. w/COBI or RTV Boosting INFANT		TAF 25mg q.d. w/COBI or RTV Boosting MOTHER		TFV 300mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. MOTHER		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. INFANT		TFV/ATV/RTV 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. MOTHER		TPV/RTV 500/200mg b.i.d. MOTHER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/26 (80.8%)		9/12 (75%)		11/12 (91.7%)		8/22 (36.4%)		21/22 (95.5%)		23/38 (60.5%)		36/38 (94.7%)		27/28 (96.4%)		19/25 (76%)		8/14 (57.1%)		12/13 (92.3%)		2/4 (50%)		14/18 (77.8%)		18/27 (66.7%)		23/28 (82.1%)		1/2 (50%)		4/6 (66.7%)		22/25 (88%)		24/26 (92.3%)		5/9 (55.6%)		28/36 (77.8%)		29/32 (90.6%)		25/30 (83.3%)		29/30 (96.7%)		16/26 (61.5%)		27/27 (100%)		11/21 (52.4%)		24/25 (96%)		14/23 (60.9%)		23/24 (95.8%)		21/29 (72.4%)		21/28 (75%)		4/6 (66.7%)		16/16 (100%)		17/31 (54.8%)		26/31 (83.9%)		8/9 (88.9%)		28/30 (93.3%)		2/5 (40%)		18/21 (85.7%)		11/26 (42.3%)		25/26 (96.2%)		1/1 (100%)		16/27 (59.3%)		17/27 (63%)		13/17 (76.5%)		28/29 (96.6%)		12/25 (48%)		25/25 (100%)		34/35 (97.1%)		2/2 (100%)		2/2 (100%)		3/4 (75%)		9/12 (75%)		21/29 (72.4%)		17/18 (94.4%)		9/12 (75%)		16/27 (59.3%)		27/27 (100%)		3/6 (50%)		40/43 (93%)		24/30 (80%)		30/32 (93.8%)		24/32 (75%)		30/33 (90.9%)		20/27 (74.1%)		23/27 (85.2%)		18/28 (64.3%)		27/29 (93.1%)		21/28 (75%)		11/21 (52.4%)		24/25 (96%)		16/35 (45.7%)		35/35 (100%)		1/1 (100%)
Blood and lymphatic system disorders
Anaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		4/26 (15.4%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Anaemia neonatal	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Anaemia of pregnancy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Haemolytic anaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Iron deficiency anaemia	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		2/36 (5.6%)		2/32 (6.3%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		3/33 (9.1%)		0/27 (0%)		4/27 (14.8%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neutrophilia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Splenomegaly	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cardiac disorders
Atrial septal defect acquired	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Extrasystoles	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		1/5 (20%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tachycardia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		2/29 (6.9%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital, familial and genetic disorders
ABO haemolytic disease of newborn	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Atrial septal defect	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital HIV infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital central nervous system anomaly	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital choroid plexus cyst	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital genital malformation female	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital musculoskeletal anomaly	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital naevus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		2/30 (6.7%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital toxoplasmosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Congenital umbilical hernia	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Craniotabes	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cryptorchism	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hydrocele	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Patent ductus arteriosus	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sickle cell trait	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		2/30 (6.7%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Trisomy 21	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Ear and labyrinth disorders
Deafness	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Ear pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Eye disorders
Conjunctival discolouration	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Conjunctival pallor	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Eye discharge	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		2/23 (8.7%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Photophobia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Abdominal distension	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		1/4 (25%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Abdominal hernia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Abdominal pain	0/26 (0%)		0/12 (0%)		3/12 (25%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		3/28 (10.7%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		3/32 (9.4%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		4/24 (16.7%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		6/29 (20.7%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		3/18 (16.7%)		0/12 (0%)		0/27 (0%)		3/27 (11.1%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		3/29 (10.3%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Abdominal pain lower	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		6/27 (22.2%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		3/24 (12.5%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		1/27 (3.7%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Abdominal pain upper	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Abdominal tenderness	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Constipation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Diarrhoea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		2/22 (9.1%)		3/38 (7.9%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		1/30 (3.3%)		1/30 (3.3%)		2/26 (7.7%)		1/27 (3.7%)		1/21 (4.8%)		1/25 (4%)		3/23 (13%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		5/29 (17.2%)		0/25 (0%)		3/25 (12%)		3/35 (8.6%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		1/12 (8.3%)		2/29 (6.9%)		3/18 (16.7%)		1/12 (8.3%)		1/27 (3.7%)		2/27 (7.4%)		0/6 (0%)		1/43 (2.3%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		2/25 (8%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Dyspepsia	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Gastrooesophageal reflux disease	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		3/30 (10%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		1/43 (2.3%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		1/33 (3%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Infantile colic	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nausea	1/26 (3.8%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		2/22 (9.1%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		2/18 (11.1%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		5/26 (19.2%)		0/9 (0%)		1/36 (2.8%)		3/32 (9.4%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		1/29 (3.4%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Umbilical hernia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		3/32 (9.4%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vomiting	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		1/22 (4.5%)		2/22 (9.1%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		1/14 (7.1%)		1/13 (7.7%)		0/4 (0%)		1/18 (5.6%)		6/27 (22.2%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		4/26 (15.4%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		1/30 (3.3%)		3/30 (10%)		1/26 (3.8%)		4/27 (14.8%)		0/21 (0%)		1/25 (4%)		2/23 (8.7%)		2/24 (8.3%)		2/29 (6.9%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		1/31 (3.2%)		1/9 (11.1%)		1/30 (3.3%)		0/5 (0%)		2/21 (9.5%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		1/29 (3.4%)		1/18 (5.6%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		1/30 (3.3%)		1/32 (3.1%)		3/32 (9.4%)		1/33 (3%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		2/29 (6.9%)		1/28 (3.6%)		0/21 (0%)		4/25 (16%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
General disorders
Adverse event	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Asthenia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		2/27 (7.4%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Chest pain	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Chills	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Face oedema	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Fatigue	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		2/22 (9.1%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		2/21 (9.5%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Inflammation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Influenza like illness	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		2/27 (7.4%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		3/25 (12%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Oedema peripheral	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		2/22 (9.1%)		0/38 (0%)		3/38 (7.9%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		3/29 (10.3%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Peripheral swelling	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pyrexia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		3/38 (7.9%)		1/28 (3.6%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		2/26 (7.7%)		1/9 (11.1%)		3/36 (8.3%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		3/26 (11.5%)		3/27 (11.1%)		1/21 (4.8%)		4/25 (16%)		2/23 (8.7%)		2/24 (8.3%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		2/16 (12.5%)		0/31 (0%)		2/31 (6.5%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		1/27 (3.7%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		2/32 (6.3%)		1/32 (3.1%)		1/33 (3%)		2/27 (7.4%)		0/27 (0%)		1/28 (3.6%)		2/29 (6.9%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		4/35 (11.4%)		0/1 (0%)
Hepatobiliary disorders
Cholelithiasis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cholestasis of pregnancy	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Drug-induced liver injury	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hepatomegaly	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hyperbilirubinaemia	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		2/38 (5.3%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hyperbilirubinaemia neonatal	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Jaundice	0/26 (0%)		0/12 (0%)		0/12 (0%)		1/22 (4.5%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		2/9 (22.2%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		2/21 (9.5%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Ocular icterus	0/26 (0%)		0/12 (0%)		0/12 (0%)		1/22 (4.5%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		2/35 (5.7%)		2/35 (5.7%)		0/1 (0%)
Immune system disorders
Immunisation reaction	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Infections and infestations
Amniotic cavity infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bacterial disease carrier	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bacterial sepsis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bacterial vaginosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		2/36 (5.6%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		4/31 (12.9%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		4/35 (11.4%)		0/1 (0%)
Beta haemolytic streptococcal infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		6/33 (18.2%)		0/27 (0%)		3/27 (11.1%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Body tinea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		2/13 (15.4%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bronchiolitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		3/30 (10%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		2/23 (8.7%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		1/4 (25%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		3/30 (10%)		0/32 (0%)		4/32 (12.5%)		0/33 (0%)		2/27 (7.4%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bronchitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		1/9 (11.1%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Candida sepsis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cervicitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Cervicitis human papilloma virus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Cervicitis streptococcal	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Conjunctivitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Endometritis decidual	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Escherichia pyelonephritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Escherichia urinary tract infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		3/35 (8.6%)		0/1 (0%)
Gastroenteritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		3/26 (11.5%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		1/27 (3.7%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Genital candidiasis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		3/38 (7.9%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		3/9 (33.3%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Genital herpes	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Genital herpes simplex	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Herpes simplex	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Impetigo	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Mastitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nasopharyngitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		4/21 (19%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		3/26 (11.5%)		3/26 (11.5%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Onychomycosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		2/18 (11.1%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Oral candidiasis	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		4/38 (10.5%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		4/27 (14.8%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		4/25 (16%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		6/30 (20%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		1/23 (4.3%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		5/31 (16.1%)		0/31 (0%)		2/9 (22.2%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		1/6 (16.7%)		1/43 (2.3%)		3/30 (10%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		4/28 (14.3%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Otitis externa	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Otitis media acute	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pharyngitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		3/26 (11.5%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Pyelonephritis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Rhinitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sepsis neonatal	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sinusitis bacterial	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Skin candida	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		3/38 (7.9%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		0/26 (0%)		2/9 (22.2%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		1/9 (11.1%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Staphylococcal abscess	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Subcutaneous abscess	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tinea cruris	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tinea infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tinea versicolour	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Upper respiratory tract infection	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		2/30 (6.7%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		2/23 (8.7%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Urinary tract infection	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		3/24 (12.5%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Vaginitis gardnerella	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Varicella	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Viral rash	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Viral upper respiratory tract infection	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		1/4 (25%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vulvovaginal candidiasis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		3/38 (7.9%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		2/36 (5.6%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		2/26 (7.7%)		2/27 (7.4%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		3/24 (12.5%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		2/16 (12.5%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		4/32 (12.5%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		3/27 (11.1%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		4/35 (11.4%)		0/1 (0%)
Vulvovaginitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		3/30 (10%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Vulvovaginitis streptococcal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		1/1 (100%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Vulvovaginitis trichomonal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Injury, poisoning and procedural complications
Anaesthetic complication	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		4/25 (16%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Animal bite	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		1/2 (50%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Incision site pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		3/26 (11.5%)		0/9 (0%)		4/36 (11.1%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Procedural pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Wound complication	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Investigations
Alanine aminotransferase increased	0/26 (0%)		0/12 (0%)		2/12 (16.7%)		0/22 (0%)		5/22 (22.7%)		0/38 (0%)		3/38 (7.9%)		4/28 (14.3%)		2/25 (8%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		2/18 (11.1%)		0/27 (0%)		2/28 (7.1%)		1/2 (50%)		1/6 (16.7%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		4/36 (11.1%)		8/32 (25%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		5/27 (18.5%)		0/21 (0%)		4/25 (16%)		0/23 (0%)		5/24 (20.8%)		5/29 (17.2%)		6/28 (21.4%)		0/6 (0%)		4/16 (25%)		1/31 (3.2%)		3/31 (9.7%)		1/9 (11.1%)		8/30 (26.7%)		0/5 (0%)		3/21 (14.3%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		1/27 (3.7%)		2/27 (7.4%)		1/17 (5.9%)		4/29 (13.8%)		0/25 (0%)		2/25 (8%)		5/35 (14.3%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		3/12 (25%)		2/29 (6.9%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		6/27 (22.2%)		0/6 (0%)		8/43 (18.6%)		0/30 (0%)		7/32 (21.9%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		1/27 (3.7%)		0/28 (0%)		3/29 (10.3%)		4/28 (14.3%)		0/21 (0%)		4/25 (16%)		0/35 (0%)		6/35 (17.1%)		0/1 (0%)
Amylase increased	3/26 (11.5%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		9/22 (40.9%)		0/38 (0%)		13/38 (34.2%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		2/21 (9.5%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		1/27 (3.7%)		1/27 (3.7%)		1/17 (5.9%)		6/29 (20.7%)		0/25 (0%)		3/25 (12%)		4/35 (11.4%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		3/18 (16.7%)		2/12 (16.7%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		2/28 (7.1%)		0/21 (0%)		5/25 (20%)		0/35 (0%)		6/35 (17.1%)		0/1 (0%)
Aspartate aminotransferase increased	2/26 (7.7%)		0/12 (0%)		2/12 (16.7%)		1/22 (4.5%)		2/22 (9.1%)		5/38 (13.2%)		4/38 (10.5%)		5/28 (17.9%)		1/25 (4%)		0/14 (0%)		3/13 (23.1%)		0/4 (0%)		3/18 (16.7%)		3/27 (11.1%)		1/28 (3.6%)		1/2 (50%)		0/6 (0%)		0/25 (0%)		5/26 (19.2%)		0/9 (0%)		4/36 (11.1%)		8/32 (25%)		4/30 (13.3%)		7/30 (23.3%)		0/26 (0%)		4/27 (14.8%)		0/21 (0%)		5/25 (20%)		1/23 (4.3%)		7/24 (29.2%)		3/29 (10.3%)		5/28 (17.9%)		0/6 (0%)		3/16 (18.8%)		2/31 (6.5%)		5/31 (16.1%)		2/9 (22.2%)		10/30 (33.3%)		0/5 (0%)		4/21 (19%)		1/26 (3.8%)		3/26 (11.5%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		2/17 (11.8%)		4/29 (13.8%)		0/25 (0%)		2/25 (8%)		10/35 (28.6%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		3/29 (10.3%)		1/18 (5.6%)		2/12 (16.7%)		1/27 (3.7%)		8/27 (29.6%)		1/6 (16.7%)		7/43 (16.3%)		0/30 (0%)		9/32 (28.1%)		1/32 (3.1%)		2/33 (6.1%)		1/27 (3.7%)		4/27 (14.8%)		2/28 (7.1%)		2/29 (6.9%)		5/28 (17.9%)		1/21 (4.8%)		4/25 (16%)		2/35 (5.7%)		5/35 (14.3%)		0/1 (0%)
Bilirubin conjugated increased	1/26 (3.8%)		1/12 (8.3%)		0/12 (0%)		2/22 (9.1%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		1/5 (20%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		4/21 (19%)		1/25 (4%)		1/35 (2.9%)		1/35 (2.9%)		0/1 (0%)
Blood albumin decreased	0/26 (0%)		0/12 (0%)		6/12 (50%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		9/13 (69.2%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		15/28 (53.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		7/26 (26.9%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		21/30 (70%)		0/26 (0%)		17/27 (63%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		20/24 (83.3%)		1/29 (3.4%)		0/28 (0%)		1/6 (16.7%)		6/16 (37.5%)		1/31 (3.2%)		11/31 (35.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		10/25 (40%)		0/35 (0%)		0/2 (0%)		2/2 (100%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		16/27 (59.3%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		15/32 (46.9%)		0/32 (0%)		13/33 (39.4%)		0/27 (0%)		12/27 (44.4%)		0/28 (0%)		13/29 (44.8%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood alkaline phosphatase increased	6/26 (23.1%)		0/12 (0%)		2/12 (16.7%)		0/22 (0%)		10/22 (45.5%)		0/38 (0%)		2/38 (5.3%)		1/28 (3.6%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		7/18 (38.9%)		0/27 (0%)		4/28 (14.3%)		0/2 (0%)		2/6 (33.3%)		2/25 (8%)		9/26 (34.6%)		0/9 (0%)		4/36 (11.1%)		8/32 (25%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		4/25 (16%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		3/16 (18.8%)		0/31 (0%)		4/31 (12.9%)		0/9 (0%)		9/30 (30%)		0/5 (0%)		10/21 (47.6%)		0/26 (0%)		3/26 (11.5%)		1/1 (100%)		0/27 (0%)		0/27 (0%)		2/17 (11.8%)		12/29 (41.4%)		0/25 (0%)		0/25 (0%)		18/35 (51.4%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		3/29 (10.3%)		10/18 (55.6%)		2/12 (16.7%)		1/27 (3.7%)		2/27 (7.4%)		0/6 (0%)		12/43 (27.9%)		1/30 (3.3%)		10/32 (31.3%)		1/32 (3.1%)		1/33 (3%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		5/29 (17.2%)		11/28 (39.3%)		0/21 (0%)		12/25 (48%)		0/35 (0%)		17/35 (48.6%)		0/1 (0%)
Blood bicarbonate decreased	0/26 (0%)		0/12 (0%)		4/12 (33.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		7/28 (25%)		3/25 (12%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		9/28 (32.1%)		0/2 (0%)		1/6 (16.7%)		4/25 (16%)		15/26 (57.7%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		3/30 (10%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		5/29 (17.2%)		9/28 (32.1%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		7/31 (22.6%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		9/27 (33.3%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		2/30 (6.7%)		10/32 (31.3%)		0/32 (0%)		3/33 (9.1%)		0/27 (0%)		4/27 (14.8%)		0/28 (0%)		5/29 (17.2%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood bilirubin increased	4/26 (15.4%)		3/12 (25%)		4/12 (33.3%)		3/22 (13.6%)		18/22 (81.8%)		2/38 (5.3%)		33/38 (86.8%)		17/28 (60.7%)		13/25 (52%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		2/18 (11.1%)		5/27 (18.5%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		1/30 (3.3%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		8/21 (38.1%)		1/26 (3.8%)		12/26 (46.2%)		0/1 (0%)		1/27 (3.7%)		2/27 (7.4%)		3/17 (17.6%)		8/29 (27.6%)		0/25 (0%)		0/25 (0%)		5/35 (14.3%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		1/33 (3%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		3/29 (10.3%)		2/28 (7.1%)		2/21 (9.5%)		18/25 (72%)		2/35 (5.7%)		27/35 (77.1%)		0/1 (0%)
Blood calcium decreased	9/26 (34.6%)		0/12 (0%)		2/12 (16.7%)		0/22 (0%)		6/22 (27.3%)		0/38 (0%)		4/38 (10.5%)		1/28 (3.6%)		2/25 (8%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		1/27 (3.7%)		5/28 (17.9%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		2/36 (5.6%)		3/32 (9.4%)		1/30 (3.3%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		3/25 (12%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		3/16 (18.8%)		0/31 (0%)		3/31 (9.7%)		0/9 (0%)		7/30 (23.3%)		0/5 (0%)		5/21 (23.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		5/17 (29.4%)		15/29 (51.7%)		0/25 (0%)		0/25 (0%)		13/35 (37.1%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		4/29 (13.8%)		4/18 (22.2%)		5/12 (41.7%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		4/43 (9.3%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		3/27 (11.1%)		0/28 (0%)		0/29 (0%)		9/28 (32.1%)		0/21 (0%)		12/25 (48%)		0/35 (0%)		12/35 (34.3%)		1/1 (100%)
Blood calcium increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood cholesterol increased	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		2/29 (6.9%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		2/25 (8%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Blood creatine phosphokinase increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood creatinine increased	0/26 (0%)		1/12 (8.3%)		2/12 (16.7%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		1/30 (3.3%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		1/1 (100%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		2/30 (6.7%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Blood glucose abnormal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		3/22 (13.6%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		7/25 (28%)		0/35 (0%)		5/35 (14.3%)		1/1 (100%)
Blood glucose decreased	3/26 (11.5%)		3/12 (25%)		0/12 (0%)		0/22 (0%)		10/22 (45.5%)		4/38 (10.5%)		16/38 (42.1%)		2/28 (7.1%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		2/18 (11.1%)		2/27 (7.4%)		6/28 (21.4%)		0/2 (0%)		0/6 (0%)		5/25 (20%)		8/26 (30.8%)		0/9 (0%)		3/36 (8.3%)		2/32 (6.3%)		10/30 (33.3%)		1/30 (3.3%)		2/26 (7.7%)		2/27 (7.4%)		3/21 (14.3%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		2/16 (12.5%)		3/31 (9.7%)		3/31 (9.7%)		0/9 (0%)		3/30 (10%)		0/5 (0%)		6/21 (28.6%)		2/26 (7.7%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		2/27 (7.4%)		1/17 (5.9%)		13/29 (44.8%)		0/25 (0%)		13/25 (52%)		13/35 (37.1%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		7/29 (24.1%)		10/18 (55.6%)		1/12 (8.3%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		6/43 (14%)		4/30 (13.3%)		3/32 (9.4%)		4/32 (12.5%)		0/33 (0%)		7/27 (25.9%)		4/27 (14.8%)		2/28 (7.1%)		3/29 (10.3%)		6/28 (21.4%)		0/21 (0%)		8/25 (32%)		3/35 (8.6%)		16/35 (45.7%)		0/1 (0%)
Blood glucose increased	3/26 (11.5%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		7/22 (31.8%)		0/38 (0%)		9/38 (23.7%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		4/26 (15.4%)		0/9 (0%)		2/36 (5.6%)		1/32 (3.1%)		2/30 (6.7%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		5/29 (17.2%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		4/21 (19%)		0/26 (0%)		1/26 (3.8%)		1/1 (100%)		2/27 (7.4%)		1/27 (3.7%)		1/17 (5.9%)		9/29 (31%)		0/25 (0%)		6/25 (24%)		15/35 (42.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		2/29 (6.9%)		4/18 (22.2%)		2/12 (16.7%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		4/32 (12.5%)		0/32 (0%)		2/33 (6.1%)		1/27 (3.7%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		3/28 (10.7%)		0/21 (0%)		5/25 (20%)		0/35 (0%)		6/35 (17.1%)		0/1 (0%)
Blood magnesium decreased	2/26 (7.7%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood phosphorus decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood potassium decreased	3/26 (11.5%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		2/22 (9.1%)		1/38 (2.6%)		11/38 (28.9%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		6/26 (23.1%)		0/9 (0%)		2/36 (5.6%)		4/32 (12.5%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		5/29 (17.2%)		2/28 (7.1%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		3/31 (9.7%)		0/9 (0%)		4/30 (13.3%)		0/5 (0%)		4/21 (19%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		2/27 (7.4%)		0/27 (0%)		2/17 (11.8%)		8/29 (27.6%)		0/25 (0%)		9/25 (36%)		11/35 (31.4%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		3/29 (10.3%)		2/18 (11.1%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		7/43 (16.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		5/28 (17.9%)		0/21 (0%)		8/25 (32%)		0/35 (0%)		12/35 (34.3%)		1/1 (100%)
Blood potassium increased	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		1/22 (4.5%)		0/22 (0%)		2/38 (5.3%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		3/27 (11.1%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		4/25 (16%)		0/26 (0%)		2/9 (22.2%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		6/30 (20%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		2/27 (7.4%)		0/27 (0%)		1/28 (3.6%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		3/35 (8.6%)		0/35 (0%)		0/1 (0%)
Blood pressure increased	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		5/27 (18.5%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood sodium decreased	10/26 (38.5%)		0/12 (0%)		2/12 (16.7%)		0/22 (0%)		12/22 (54.5%)		0/38 (0%)		20/38 (52.6%)		3/28 (10.7%)		1/25 (4%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		5/18 (27.8%)		2/27 (7.4%)		5/28 (17.9%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		14/26 (53.8%)		1/9 (11.1%)		12/36 (33.3%)		10/32 (31.3%)		2/30 (6.7%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		3/24 (12.5%)		3/29 (10.3%)		7/28 (25%)		0/6 (0%)		3/16 (18.8%)		1/31 (3.2%)		2/31 (6.5%)		0/9 (0%)		14/30 (46.7%)		0/5 (0%)		11/21 (52.4%)		1/26 (3.8%)		2/26 (7.7%)		1/1 (100%)		0/27 (0%)		3/27 (11.1%)		7/17 (41.2%)		23/29 (79.3%)		0/25 (0%)		22/25 (88%)		30/35 (85.7%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		1/12 (8.3%)		12/29 (41.4%)		10/18 (55.6%)		4/12 (33.3%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		12/43 (27.9%)		2/30 (6.7%)		8/32 (25%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		2/29 (6.9%)		16/28 (57.1%)		0/21 (0%)		18/25 (72%)		1/35 (2.9%)		25/35 (71.4%)		1/1 (100%)
Blood sodium increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blood triglycerides increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cardiac murmur	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		1/5 (20%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		1/21 (4.8%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gamma-glutamyltransferase increased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Glucose tolerance test abnormal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Haemoglobin decreased	6/26 (23.1%)		2/12 (16.7%)		3/12 (25%)		0/22 (0%)		5/22 (22.7%)		9/38 (23.7%)		7/38 (18.4%)		2/28 (7.1%)		5/25 (20%)		0/14 (0%)		8/13 (61.5%)		0/4 (0%)		1/18 (5.6%)		3/27 (11.1%)		14/28 (50%)		0/2 (0%)		0/6 (0%)		6/25 (24%)		8/26 (30.8%)		1/9 (11.1%)		9/36 (25%)		9/32 (28.1%)		3/30 (10%)		11/30 (36.7%)		1/26 (3.8%)		15/27 (55.6%)		4/21 (19%)		7/25 (28%)		0/23 (0%)		15/24 (62.5%)		3/29 (10.3%)		2/28 (7.1%)		2/6 (33.3%)		7/16 (43.8%)		2/31 (6.5%)		11/31 (35.5%)		1/9 (11.1%)		5/30 (16.7%)		0/5 (0%)		2/21 (9.5%)		3/26 (11.5%)		8/26 (30.8%)		0/1 (0%)		2/27 (7.4%)		0/27 (0%)		2/17 (11.8%)		4/29 (13.8%)		5/25 (20%)		11/25 (44%)		6/35 (17.1%)		0/2 (0%)		1/2 (50%)		1/4 (25%)		6/12 (50%)		1/29 (3.4%)		4/18 (22.2%)		3/12 (25%)		0/27 (0%)		10/27 (37%)		2/6 (33.3%)		11/43 (25.6%)		5/30 (16.7%)		12/32 (37.5%)		2/32 (6.3%)		12/33 (36.4%)		0/27 (0%)		13/27 (48.1%)		1/28 (3.6%)		15/29 (51.7%)		6/28 (21.4%)		0/21 (0%)		4/25 (16%)		1/35 (2.9%)		5/35 (14.3%)		0/1 (0%)
Lipase increased	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		3/22 (13.6%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		3/29 (10.3%)		0/25 (0%)		0/25 (0%)		3/35 (8.6%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		2/12 (16.7%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		2/25 (8%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Neutrophil count decreased	2/26 (7.7%)		1/12 (8.3%)		0/12 (0%)		2/22 (9.1%)		2/22 (9.1%)		4/38 (10.5%)		4/38 (10.5%)		3/28 (10.7%)		2/25 (8%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		2/27 (7.4%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		5/25 (20%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		3/30 (10%)		1/30 (3.3%)		1/26 (3.8%)		1/27 (3.7%)		2/21 (9.5%)		1/25 (4%)		1/23 (4.3%)		0/24 (0%)		2/29 (6.9%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		4/31 (12.9%)		2/31 (6.5%)		1/9 (11.1%)		2/30 (6.7%)		0/5 (0%)		0/21 (0%)		4/26 (15.4%)		3/26 (11.5%)		0/1 (0%)		4/27 (14.8%)		2/27 (7.4%)		1/17 (5.9%)		2/29 (6.9%)		3/25 (12%)		6/25 (24%)		5/35 (14.3%)		0/2 (0%)		0/2 (0%)		1/4 (25%)		1/12 (8.3%)		4/29 (13.8%)		1/18 (5.6%)		4/12 (33.3%)		1/27 (3.7%)		1/27 (3.7%)		0/6 (0%)		1/43 (2.3%)		8/30 (26.7%)		1/32 (3.1%)		2/32 (6.3%)		0/33 (0%)		3/27 (11.1%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		2/28 (7.1%)		0/21 (0%)		2/25 (8%)		2/35 (5.7%)		7/35 (20%)		0/1 (0%)
Platelet count decreased	0/26 (0%)		2/12 (16.7%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		1/26 (3.8%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		3/25 (12%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Streptococcus test positive	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Weight decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
White blood cell count decreased	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dyslipidaemia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Failure to thrive	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Feeding disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypoglycaemia	0/26 (0%)		2/12 (16.7%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		4/23 (17.4%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypoglycaemia neonatal	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Lactose intolerance	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Late metabolic acidosis of newborn	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Poor feeding infant	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Underweight	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Arthralgia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		2/36 (5.6%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		5/43 (11.6%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Back pain	1/26 (3.8%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		3/22 (13.6%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		2/36 (5.6%)		3/32 (9.4%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		2/27 (7.4%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		2/29 (6.9%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		3/31 (9.7%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		1/29 (3.4%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		3/32 (9.4%)		0/32 (0%)		2/33 (6.1%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		3/35 (8.6%)		0/1 (0%)
Cranial sutures widening	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Diastasis recti abdominis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypotonia neonatal	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Joint swelling	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Osteopenia	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pain in extremity	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Torticollis	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		4/38 (10.5%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vulvovaginal warts	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nervous system disorders
Carpal tunnel syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		2/26 (7.7%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dizziness	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		2/13 (15.4%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		3/32 (9.4%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Headache	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		3/22 (13.6%)		0/38 (0%)		6/38 (15.8%)		2/28 (7.1%)		1/25 (4%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		4/18 (22.2%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		3/26 (11.5%)		0/9 (0%)		3/36 (8.3%)		6/32 (18.8%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		5/27 (18.5%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		2/24 (8.3%)		1/29 (3.4%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		3/31 (9.7%)		0/9 (0%)		4/30 (13.3%)		0/5 (0%)		2/21 (9.5%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		2/27 (7.4%)		1/27 (3.7%)		0/17 (0%)		3/29 (10.3%)		0/25 (0%)		2/25 (8%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		1/29 (3.4%)		2/18 (11.1%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		5/43 (11.6%)		0/30 (0%)		3/32 (9.4%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		2/29 (6.9%)		1/28 (3.6%)		0/21 (0%)		6/25 (24%)		0/35 (0%)		8/35 (22.9%)		0/1 (0%)
Hemiparesis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Hypoaesthesia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Intraventricular haemorrhage	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Migraine	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		1/27 (3.7%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Neonatal seizure	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nervous system cyst	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neuropathy peripheral	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		2/13 (15.4%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Paraesthesia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Sciatica	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Seizure	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Syncope	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		1/17 (5.9%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pregnancy, puerperium and perinatal conditions
Caput succedaneum	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Foetal growth restriction	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		1/13 (7.7%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		0/36 (0%)		3/32 (9.4%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Gestational diabetes	0/26 (0%)		0/12 (0%)		2/12 (16.7%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Gestational hypertension	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Haemorrhage in pregnancy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Jaundice neonatal	0/26 (0%)		2/12 (16.7%)		0/12 (0%)		1/22 (4.5%)		0/22 (0%)		14/38 (36.8%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		2/26 (7.7%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		2/21 (9.5%)		0/25 (0%)		6/35 (17.1%)		0/35 (0%)		0/1 (0%)
Labour pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Low birth weight baby	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		4/27 (14.8%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Maternal condition affecting foetus	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Morning sickness	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		3/24 (12.5%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Oligohydramnios	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		1/36 (2.8%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Polyhydramnios	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		2/29 (6.9%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Postpartum haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		2/29 (6.9%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pre-eclampsia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		3/18 (16.7%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		3/36 (8.3%)		1/32 (3.1%)		0/30 (0%)		4/30 (13.3%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		2/16 (12.5%)		0/31 (0%)		4/31 (12.9%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pregnancy	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Premature baby	0/26 (0%)		3/12 (25%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		2/23 (8.7%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		4/27 (14.8%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		3/28 (10.7%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Premature delivery	0/26 (0%)		0/12 (0%)		3/12 (25%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		1/13 (7.7%)		1/4 (25%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		3/27 (11.1%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		2/25 (8%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		3/27 (11.1%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		6/33 (18.2%)		0/27 (0%)		3/27 (11.1%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Premature labour	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		2/18 (11.1%)		2/12 (16.7%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		2/27 (7.4%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Premature rupture of membranes	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		2/32 (6.3%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Preterm premature rupture of membranes	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Small for dates baby	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Umbilical granuloma	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		2/21 (9.5%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine atony	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Uterine contractions during pregnancy	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		2/36 (5.6%)		2/32 (6.3%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		1/12 (8.3%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine hypertonus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		2/27 (7.4%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Weight decrease neonatal	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		3/14 (21.4%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Psychiatric disorders
Anxiety	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Depressed mood	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Depression	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		2/22 (9.1%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Generalised anxiety disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Mental disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Perinatal depression	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Renal and urinary disorders
Dysuria	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		4/32 (12.5%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Pollakiuria	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		3/24 (12.5%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Proteinuria	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		3/30 (10%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		1/2 (50%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Renal pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Urinary incontinence	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vesicoureteric reflux	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Reproductive system and breast disorders
Adenomyosis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Breast engorgement	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		5/38 (13.2%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Breast mass	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Cervical dysplasia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		2/28 (7.1%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		2/36 (5.6%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		5/25 (20%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		4/26 (15.4%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		3/32 (9.4%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		4/35 (11.4%)		0/1 (0%)
Cervix inflammation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Genital prolapse	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Heavy menstrual bleeding	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		4/28 (14.3%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pelvic discomfort	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pelvic pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Shortened cervix	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		1/18 (5.6%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Uterine pain	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vaginal discharge	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		4/38 (10.5%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		4/28 (14.3%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		5/26 (19.2%)		0/9 (0%)		4/36 (11.1%)		6/32 (18.8%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		3/27 (11.1%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		5/31 (16.1%)		0/9 (0%)		2/30 (6.7%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		4/32 (12.5%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		6/35 (17.1%)		0/1 (0%)
Vaginal haemorrhage	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		1/25 (4%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		2/27 (7.4%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		2/25 (8%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		1/12 (8.3%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		3/33 (9.1%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		1/29 (3.4%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Vulval disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		1/28 (3.6%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Vulval ulceration	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Vulvovaginal burning sensation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vulvovaginal pain	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Vulvovaginal pruritus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		2/30 (6.7%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		3/31 (9.7%)		0/9 (0%)		3/30 (10%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		4/32 (12.5%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Bronchospasm	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		1/4 (25%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Cough	1/26 (3.8%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		1/22 (4.5%)		2/38 (5.3%)		4/38 (10.5%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		4/25 (16%)		3/26 (11.5%)		1/9 (11.1%)		2/36 (5.6%)		1/32 (3.1%)		4/30 (13.3%)		0/30 (0%)		5/26 (19.2%)		2/27 (7.4%)		0/21 (0%)		2/25 (8%)		4/23 (17.4%)		4/24 (16.7%)		0/29 (0%)		1/28 (3.6%)		1/6 (16.7%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		3/9 (33.3%)		3/30 (10%)		0/5 (0%)		1/21 (4.8%)		3/26 (11.5%)		1/26 (3.8%)		0/1 (0%)		2/27 (7.4%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		1/25 (4%)		3/35 (8.6%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		3/30 (10%)		4/32 (12.5%)		4/32 (12.5%)		3/33 (9.1%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		2/29 (6.9%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Dyspnoea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		1/22 (4.5%)		2/38 (5.3%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		1/4 (25%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		1/26 (3.8%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		5/30 (16.7%)		1/30 (3.3%)		1/26 (3.8%)		1/27 (3.7%)		0/21 (0%)		2/25 (8%)		1/23 (4.3%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		1/6 (16.7%)		0/16 (0%)		1/31 (3.2%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		2/35 (5.7%)		1/2 (50%)		0/2 (0%)		2/4 (50%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		3/27 (11.1%)		0/27 (0%)		0/6 (0%)		2/43 (4.7%)		0/30 (0%)		1/32 (3.1%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		2/35 (5.7%)		0/35 (0%)		0/1 (0%)
Grunting	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		3/32 (9.4%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Infantile apnoea	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Lung disorder	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Meconium aspiration syndrome	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Nasal congestion	0/26 (0%)		0/12 (0%)		1/12 (8.3%)		0/22 (0%)		1/22 (4.5%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		3/25 (12%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		2/30 (6.7%)		1/30 (3.3%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		1/24 (4.2%)		0/29 (0%)		2/28 (7.1%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		1/27 (3.7%)		1/27 (3.7%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		2/25 (8%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		2/30 (6.7%)		1/32 (3.1%)		3/32 (9.4%)		2/33 (6.1%)		1/27 (3.7%)		0/27 (0%)		3/28 (10.7%)		2/29 (6.9%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Nasal flaring	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Neonatal respiratory distress	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		1/26 (3.8%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		1/2 (50%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal respiratory distress syndrome	0/26 (0%)		3/12 (25%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		1/4 (25%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		3/32 (9.4%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Neonatal tachypnoea	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		2/26 (7.7%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Oropharyngeal pain	1/26 (3.8%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		1/26 (3.8%)		1/9 (11.1%)		0/36 (0%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		2/29 (6.9%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		1/27 (3.7%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		3/32 (9.4%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		1/27 (3.7%)		0/28 (0%)		1/29 (3.4%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		4/35 (11.4%)		0/1 (0%)
Oropharyngeal plaque	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		2/25 (8%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pharyngeal ulceration	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Productive cough	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Respiratory distress	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Respiratory failure	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Rhinorrhoea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		3/38 (7.9%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		2/25 (8%)		3/23 (13%)		1/24 (4.2%)		0/29 (0%)		1/28 (3.6%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		2/9 (22.2%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		3/26 (11.5%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Sneezing	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		1/30 (3.3%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Tachypnoea	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Transient tachypnoea of the newborn	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		1/4 (25%)		0/18 (0%)		4/27 (14.8%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		1/35 (2.9%)		0/35 (0%)		0/1 (0%)
Use of accessory respiratory muscles	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		1/21 (4.8%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		1/25 (4%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Wheezing	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		1/26 (3.8%)		0/9 (0%)		2/36 (5.6%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		1/43 (2.3%)		2/30 (6.7%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Alopecia	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		2/28 (7.1%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		1/26 (3.8%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Blister	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		1/25 (4%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dermatitis atopic	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		1/23 (4.3%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		2/30 (6.7%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dermatitis diaper	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		2/14 (14.3%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		1/27 (3.7%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		1/9 (11.1%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		2/23 (8.7%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		2/32 (6.3%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Dry skin	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Eczema infantile	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		3/27 (11.1%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		0/30 (0%)		1/26 (3.8%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		2/27 (7.4%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		2/30 (6.7%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		2/27 (7.4%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Erythema	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		2/38 (5.3%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		2/32 (6.3%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Erythema toxicum neonatorum	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		1/38 (2.6%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		2/30 (6.7%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Exfoliative rash	0/26 (0%)		1/12 (8.3%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		1/2 (50%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Pruritus	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		2/28 (7.1%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		2/26 (7.7%)		0/9 (0%)		1/36 (2.8%)		1/32 (3.1%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		1/30 (3.3%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		1/35 (2.9%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		2/12 (16.7%)		0/29 (0%)		3/18 (16.7%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		1/32 (3.1%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		1/28 (3.6%)		0/21 (0%)		1/25 (4%)		0/35 (0%)		1/35 (2.9%)		0/1 (0%)
Rash	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		1/18 (5.6%)		0/27 (0%)		1/28 (3.6%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		1/26 (3.8%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		1/30 (3.3%)		0/30 (0%)		0/26 (0%)		1/27 (3.7%)		0/21 (0%)		1/25 (4%)		1/23 (4.3%)		1/24 (4.2%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		1/31 (3.2%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		1/21 (4.8%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		2/35 (5.7%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		2/18 (11.1%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		1/32 (3.1%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		1/28 (3.6%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Rash papular	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		2/24 (8.3%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		1/29 (3.4%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Rash pruritic	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		1/6 (16.7%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		1/24 (4.2%)		1/29 (3.4%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Seborrhoeic dermatitis	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		2/27 (7.4%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		1/25 (4%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		5/30 (16.7%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		2/31 (6.5%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		1/6 (16.7%)		0/43 (0%)		1/30 (3.3%)		0/32 (0%)		4/32 (12.5%)		0/33 (0%)		1/27 (3.7%)		0/27 (0%)		2/28 (7.1%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Skin hyperpigmentation	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		1/13 (7.7%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		1/31 (3.2%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Skin induration	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		1/38 (2.6%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		1/36 (2.8%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)
Vascular disorders
Hypertension	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		2/38 (5.3%)		0/28 (0%)		0/25 (0%)		0/14 (0%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		2/32 (6.3%)		0/30 (0%)		1/30 (3.3%)		0/26 (0%)		4/27 (14.8%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		1/16 (6.3%)		0/31 (0%)		2/31 (6.5%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		1/25 (4%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		1/12 (8.3%)		1/29 (3.4%)		0/18 (0%)		0/12 (0%)		0/27 (0%)		0/27 (0%)		0/6 (0%)		3/43 (7%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		1/33 (3%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		2/35 (5.7%)		0/1 (0%)
Neonatal hypotension	0/26 (0%)		0/12 (0%)		0/12 (0%)		0/22 (0%)		0/22 (0%)		0/38 (0%)		0/38 (0%)		0/28 (0%)		0/25 (0%)		1/14 (7.1%)		0/13 (0%)		0/4 (0%)		0/18 (0%)		0/27 (0%)		0/28 (0%)		0/2 (0%)		0/6 (0%)		0/25 (0%)		0/26 (0%)		0/9 (0%)		0/36 (0%)		0/32 (0%)		0/30 (0%)		0/30 (0%)		0/26 (0%)		0/27 (0%)		0/21 (0%)		0/25 (0%)		0/23 (0%)		0/24 (0%)		0/29 (0%)		0/28 (0%)		0/6 (0%)		0/16 (0%)		0/31 (0%)		0/31 (0%)		0/9 (0%)		0/30 (0%)		0/5 (0%)		0/21 (0%)		0/26 (0%)		0/26 (0%)		0/1 (0%)		0/27 (0%)		0/27 (0%)		0/17 (0%)		0/29 (0%)		0/25 (0%)		0/25 (0%)		0/35 (0%)		0/2 (0%)		0/2 (0%)		0/4 (0%)		0/12 (0%)		0/29 (0%)		0/18 (0%)		0/12 (0%)		1/27 (3.7%)		0/27 (0%)		0/6 (0%)		0/43 (0%)		0/30 (0%)		0/32 (0%)		0/32 (0%)		0/33 (0%)		0/27 (0%)		0/27 (0%)		0/28 (0%)		0/29 (0%)		0/28 (0%)		0/21 (0%)		0/25 (0%)		0/35 (0%)		0/35 (0%)		0/1 (0%)

Limitations/Caveats

Over the course of the study, some study arms were discontinued or closed for reasons such as there being sufficient pharmacokinetic data from other studies or lack of enrollment (as specified in Protocol Section 8.42), leading to a low number of participants in those arms. In addition, due to the COVID-19 pandemic there was a delay in running assays for certain arms and/or analyzing PK results; the results for those arms will be reported when available.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.