Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02332720

Collaborator

(none)

413

Enrollment

Arms

27.1

Actual Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized, three-part, parallel-group, open-label trial of grazoprevir (MK-5172) (100 mg) and uprifosbuvir (MK-3682) (300 mg or 450 mg) with either elbasvir (MK-8742) (50 mg) or ruzasvir (MK-8408) (60 mg), and with or without ribavirin (RBV), in treatment-naive (TN) or treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) genotype (GT) 3, GT4, GT5, or GT6. Part A will consist of 4 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir (MK-3682B) fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of uprifosbuvir (+) grazoprevir (+) ruzasvir with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Grazoprevir Drug: Uprifosbuvir Drug: Elbasvir Drug: Ruzasvir Drug: MK-3682B Drug: Ribavirin (RBV)	Phase 2

Detailed Description

In Part A, study therapy will be administered as separate products, each taken q.d. by mouth. In Part B and Part C, participants will take 2 uprifosbuvir (+) grazoprevir (+) ruzasvir FDC tablets q.d. by mouth; each uprifosbuvir (+) grazoprevir (+) ruzasvir FDC tablet contains grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg.

Study Design

Study Type:

Interventional

Actual Enrollment :

413 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT3, GT4, GT5, and GT6 Infection

Actual Study Start Date :

Jan 28, 2015

Actual Primary Completion Date :

Sep 19, 2016

Actual Study Completion Date :

May 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks) In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	Drug: Grazoprevir Part A: one grazoprevir 100 mg tablet taken q.d. by mouth. Other Names: MK-5172 Drug: Uprifosbuvir Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth. Other Names: MK-3682 Drug: Elbasvir Part A: one elbasvir 50 mg tablet taken q.d. by mouth. Other Names: MK-8742 Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks) In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	Drug: Grazoprevir Part A: one grazoprevir 100 mg tablet taken q.d. by mouth. Other Names: MK-5172 Drug: Uprifosbuvir Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth. Other Names: MK-3682 Drug: Ruzasvir Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth. Other Names: MK-8408 Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 weeks) In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	Drug: Grazoprevir Part A: one grazoprevir 100 mg tablet taken q.d. by mouth. Other Names: MK-5172 Drug: Uprifosbuvir Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth. Other Names: MK-3682 Drug: Elbasvir Part A: one elbasvir 50 mg tablet taken q.d. by mouth. Other Names: MK-8742 Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: A4/B4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 weeks) Participants will be randomized to either Part A or Part B. In Part A, HCV GT3-infected NC TN participants will take grazoprevir (100 mg) + uprifosbuvir (450 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	Drug: Grazoprevir Part A: one grazoprevir 100 mg tablet taken q.d. by mouth. Other Names: MK-5172 Drug: Uprifosbuvir Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth. Other Names: MK-3682 Drug: Ruzasvir Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth. Other Names: MK-8408 Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B5: GT3 NC TN MK-3682B + RBV (8 weeks) In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B6: GT3 NC TN MK-3682B (12 weeks) In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B7: GT3 NC TN MK-3682B + RBV (12 weeks) In Part B, HCV GT3-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B8: GT3 NC TE MK-3682B (8 weeks) In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B9: GT3 NC TE MK-3682B + RBV (8 weeks) In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B10: GT3 NC TE MK-3682B (12 weeks) In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B11: GT3 NC TE MK-3682B + RBV (12 weeks) In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B12: GT3 NC TE MK-3682B (16 weeks) In Part B, HCV GT3-infected NC TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B13: GT3 C TN MK-3682B (12 weeks) In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B14: GT3 C TN MK-3682B + RBV (12 weeks) In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B15: GT3 C TN MK-3682B (16 weeks) In Part B, HCV GT3-infected C TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B16: GT3 C TE MK-3682B (12 weeks) In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B17: GT3 C TE MK-3682B + RBV (12 weeks) In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B18: GT3 C TE MK-3682B (16 weeks) In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B19: GT3 C TE MK-3682B + RBV (16 weeks) In Part B, HCV GT3-infected C TE participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth. Drug: Ribavirin (RBV) Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight. Other Names: Rebetol
Experimental: B20: GT4 NC TN MK-3682B (8 weeks) In Part B, HCV GT4-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B21: GT5 NC TN MK-3682B (12 weeks) In Part B, HCV GT5-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
Experimental: B22: GT6 NC TN MK-3682B (12 weeks) In Part B, HCV GT6-infected NC TN participants will take 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Drug: MK-3682B Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.

Outcome Measures

Primary Outcome Measures

Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) [Up to 20 weeks (Part A), up to 28 weeks (Part B)]
SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (<LLOQ, 15 IU/mL) 12 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.
Number of Participants Experiencing an Adverse Event (AE) [Up to 40 weeks]
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
Number of Participants Who Had Study Drug Discontinued Due to an AE [Up to 16 weeks]
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.

Secondary Outcome Measures

Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24) [Up to 40 weeks]
SVR24 is defined as HCV RNA <LLOQ of 15 IU/mL 24 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has documented chronic HCV GT3, GT4, GT5, or GT6 with no evidence of non-typeable or mixed GT infection
Is otherwise healthy as determined by the medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at the time of screening
Has cirrhosis of the liver (Part B only) or is non-cirrhotic (Part A and B)
Is HCV treatment-naïve or has experienced virologic failure after completing a prior Pegylated Interferon/Ribavirin (Peg-IFN/RBV) regimen
Is of non childbearing potential or agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug and for 14 days after the last dose of study drug if not taking RBV, or for 6 months after the last dose of study drug if taking RBV (or longer if dictated by local regulations). If not abstinent from heterosexual activity, participants in Part A must use 2 acceptable forms of barrier contraception whereas participants in Parts B and C must use 2 acceptable forms of contraception which may include oral contraceptives

Part B only:

If coinfected with human immunodeficiency virus (HIV) is not currently on antiretroviral therapy (ART) and has no plans to initiate ART treatment while participating in this study OR has well-controlled HIV on ART.
Has at least 1 viable antiretroviral regimen alternative beyond their current regimen in the event of HIV virologic failure and the development of anti-retroviral drug resistance.

Exclusion Criteria:

Parts A, B, and C (unless otherwise specified):

Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease.
If cirrhotic (Part B only), is Child-Pugh Class B or C or has a Pugh-Turcotte (CPT) score >5.
Is coinfected with hepatitis B virus (Parts A, B, and C) or is coinfected with HIV (Part A only; HIV coinfected participants are eligible for Parts B and C).
If coinfected with HIV, has a history of opportunistic infection in the preceding 6 months prior to screening.
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
Has clinically-relevant drug or alcohol abuse within 12 months of screening.
Is female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 and 6 months after the last dose of study medication, or longer if dictated by local regulations OR a male participant who is expecting to donate sperm from at least 2 weeks prior to day 1 until 6 months after the last dose of study medication.
Has any of the following conditions:
Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
Poor venous access that precludes routine peripheral blood sampling required for this trial.
History of gastric surgery (e.g., stapling, bypass) or a history of malabsorption disorders (e.g., celiac sprue disease).
Current or history of any clinically significant cardiac abnormalities/dysfunction, including but not limited to: angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia, uncontrolled hypertension, a history of use of antianginal or anti-arrythmic agents for cardiac conditions, prolonged ECG QTc interval (>470 ms for males or >480 ms for females by either the Fridericia formula) at the screening visit, personal or family history of Torsade de pointes.
Chronic pulmonary disease, including but not limited to: clinically significant chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis.
Central nervous system (CNS) trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or cerebral spinal fluid (CSF) leak. Prior brain hemorrhage and/or intracranial aneurysms (whether adequately repaired or not).
Current or history of seizure disorder unless seizure was >10 years ago, a single isolated event, no history of or current use of anti-seizure medications prescribed, and a normal neurological examination is documented in trial files within 6 months of Day 1.
Has a history of stroke or transient ischemic attack.
Has a history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures.
Has medical/surgical conditions that may result in a need for hospitalization during the period of the study.
Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
Has any condition, prestudy laboratory or ECG abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the participant.
Has had a life-threatening serious adverse event (SAE) during the screening period.
Has evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease and autoimmune hepatitis Parts B and C only: is a male whose female partner(s) is/are pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT02332720

Other Study ID Numbers:

3682-012
2014-003347-35

First Posted:

Jan 7, 2015

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details	No participants were randomized to the 'B21: GT5 NC TN MK-3682B (12 weeks)' arm.
Pre-assignment Detail	Participants were enrolled into either Part A or Part B. Part A enrolled non-cirrhotic (NC), treatment-naïve (TN) participants with hepatitis C virus (HCV) genotype (GT) 3; Part B enrolled NC or cirrhotic (C), TN or treatment-experienced (TE) participants with HCV GT3, GT4, GT5 or GT6. Participants who relapsed in Part A were retreated in Part C.

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)	B20: GT4 NC TN MK-3682B (8 Weeks)	B21: GT5 NC TN MK-3682B (12 Weeks)	B22: GT6 NC TN MK-3682B (12 Weeks)
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.	In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
Period Title: Part A and Part B
STARTED	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	21	25	7	0	4
Treated	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	0	4
COMPLETED	20	21	22	22	16	33	36	34	15	14	14	15	16	13	16	13	15	13	20	24	7	0	4
NOT COMPLETED	1	0	0	0	0	3	1	1	0	0	0	0	0	0	0	1	0	1	1	1	0	0	0
Period Title: Part A and Part B
STARTED	2	1	3	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	2	1	3	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)	B20: GT4 NC TN MK-3682B (8 Weeks)	B21: GT5 NC TN MK-3682B (12 Weeks)	B22: GT6 NC TN MK-3682B (12 Weeks)	Total
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks	In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT5-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Total of all reporting groups
Overall Participants	21	21	22	22	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	0	4	412
Age, Customized (Number) [Number]
Less than 18 years	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 NaN	0 0%
18 to 35 years	4 19%	4 19%	3 13.6%	4 18.2%	3 18.8%	8 22.2%	9 24.3%	7 20%	0 0%	1 7.1%	2 14.3%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	2 14.3%	0 0%	0 0%	1 14.3%	0 NaN	49 1225%
36 to 50 years	12 57.1%	9 42.9%	14 63.6%	12 54.5%	4 25%	11 30.6%	14 37.8%	12 34.3%	5 33.3%	5 35.7%	6 42.9%	4 26.7%	6 37.5%	7 53.8%	3 18.8%	3 21.4%	4 26.7%	3 21.4%	6 30%	6 24%	3 42.9%	1 Infinity	150 3750%
51 to 64 years	5 23.8%	8 38.1%	5 22.7%	3 13.6%	6 37.5%	16 44.4%	13 35.1%	16 45.7%	8 53.3%	7 50%	6 42.9%	9 60%	9 56.3%	4 30.8%	13 81.3%	9 64.3%	11 73.3%	9 64.3%	13 65%	18 72%	3 42.9%	3 Infinity	194 4850%
Over 64 years	0 0%	0 0%	0 0%	3 13.6%	3 18.8%	1 2.8%	1 2.7%	0 0%	2 13.3%	1 7.1%	0 0%	1 6.7%	1 6.3%	2 15.4%	0 0%	2 14.3%	0 0%	0 0%	1 5%	1 4%	0 0%	0 NaN	19 475%
Sex: Female, Male (Count of Participants)
Female	9 42.9%	15 71.4%	14 63.6%	11 50%	7 43.8%	19 52.8%	23 62.2%	23 65.7%	7 46.7%	2 14.3%	8 57.1%	6 40%	5 31.3%	3 23.1%	5 31.3%	3 21.4%	8 53.3%	1 7.1%	2 10%	5 20%	1 14.3%	2 Infinity	179 4475%
Male	12 57.1%	6 28.6%	8 36.4%	11 50%	9 56.3%	17 47.2%	14 37.8%	12 34.3%	8 53.3%	12 85.7%	6 42.9%	9 60%	11 68.8%	10 76.9%	11 68.8%	11 78.6%	7 46.7%	13 92.9%	18 90%	20 80%	6 85.7%	2 Infinity	233 5825%

Outcome Measures

1. Primary Outcome

Title	Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)
Description	SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (<LLOQ, 15 IU/mL) 12 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.
Time Frame	Up to 20 weeks (Part A), up to 28 weeks (Part B)

Outcome Measure Data

Analysis Population Description
Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A4+B4: GT3 NC TN MK-3682B (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.	HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.	HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
Measure Participants	21	21	22	22	38	16	35	36	35	15	14	14	15	16	13	16	13	15	14	20	25
Number (95% Confidence Interval) [Percentage of participants]	90.5 431%	95.2 453.3%	86.4 392.7%	90.9 413.2%	92.1 575.6%	93.8 260.6%	100.0 270.3%	97.2 277.7%	100.0 666.7%	100.0 714.3%	92.9 663.6%	100.0 666.7%	93.3 583.1%	93.8 721.5%	92.3 576.9%	100.0 714.3%	100.0 666.7%	100.0 714.3%	100.0 500%	100.0 400%	96.0 1371.4%

2. Primary Outcome

Title	Number of Participants Experiencing an Adverse Event (AE)
Description	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
Time Frame	Up to 40 weeks

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A4+ B4: GT3 NC TN MK-3682B (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)	B20: GT4 NC TN MK-3682B (8 Weeks)	B22: GT6 NC TN MK-3682B (12 Weeks)	Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.	In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Measure Participants	21	21	22	22	38	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4	8
Count of Participants [Participants]	18 85.7%	14 66.7%	16 72.7%	17 77.3%	26 162.5%	9 25%	30 81.1%	25 71.4%	33 220%	12 85.7%	12 85.7%	9 60%	13 81.3%	13 100%	9 56.3%	14 100%	12 80%	12 85.7%	12 60%	16 64%	21 300%	3 Infinity	3 75%	7 1.7%

3. Primary Outcome

Title	Number of Participants Who Had Study Drug Discontinued Due to an AE
Description	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A4+ B4: GT3 NC TN MK-3682B (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)	B20: GT4 NC TN MK-3682B (8 Weeks)	B22: GT6 NC TN MK-3682B (12 Weeks)	Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks during Part A or 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks during Part B.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.	In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.
Measure Participants	21	21	22	22	38	16	36	37	35	15	14	14	15	16	13	16	14	15	14	20	25	7	4	8
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 7.1%	1 6.7%	0 0%	0 0%	1 4%	0 0%	0 NaN	0 0%	0 0%

4. Secondary Outcome

Title	Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)
Description	SVR24 is defined as HCV RNA <LLOQ of 15 IU/mL 24 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.
Time Frame	Up to 40 weeks

Outcome Measure Data

Analysis Population Description
Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.

Arm/Group Title	A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)	A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)	A4+B4: GT3 NC TN MK-3682B (8 Weeks)	B4: GT3 NC TN MK-3682B (8 Weeks)	B5: GT3 NC TN MK-3682B + RBV (8 Weeks)	B6: GT3 NC TN MK-3682B (12 Weeks)	B7: GT3 NC TN MK-3682B + RBV (12 Weeks)	B8: GT3 NC TE MK-3682B (8 Weeks)	B9: GT3 NC TE MK-3682B + RBV (8 Weeks)	B10: GT3 NC TE MK-3682B (12 Weeks)	B11: GT3 NC TE MK-3682B + RBV (12 Weeks)	B12: GT3 NC TE MK-3682B (16 Weeks)	B13: GT3 C TN MK-3682B (12 Weeks)	B14: GT3 C TN MK-3682B + RBV (12 Weeks)	B15: GT3 C TN MK-3682B (16 Weeks)	B16: GT3 C TE MK-3682B (12 Weeks)	B17: GT3 C TE MK-3682B + RBV (12 Weeks)	B18: GT3 C TE MK-3682B (16 Weeks)	B19: GT3 C TE MK-3682B + RBV (16 Weeks)
Arm/Group Description	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy were offered the option of retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part A, HCV GT3-infected NC TN participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. Part A participants who relapsed following completion of therapy received retreatment with 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks during Part C.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.	In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.
Measure Participants	20	21	22	22	38	16	33	36	34	15	14	14	15	16	13	16	13	15	13	20	25
Number (95% Confidence Interval) [Percentage of participants]	90.0 428.6%	95.2 453.3%	86.4 392.7%	90.9 413.2%	92.1 575.6%	93.8 260.6%	100.0 270.3%	97.2 277.7%	100.0 666.7%	100.0 714.3%	92.9 663.6%	100.0 666.7%	93.3 583.1%	93.8 721.5%	92.3 576.9%	100.0 714.3%	100.0 666.7%	100.0 714.3%	100.0 500%	100.0 400%	96.0 1371.4%

Adverse Events

	A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)		A1+C: GT3 NC TN EBR+GZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)		A2+C: GT3 NC TN GZR+RZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)		A3+C: GT3 NC TN EBR+GZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)		A4+C: GT3 NC TN GZR+RZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		B4: GT3 NC TN MK-3682B (8 Wks)		B5: GT3 NC TN MK-3682B + RBV (8 Wks)		B6: GT3 NC TN MK-3682B (12 Wks)		B7: GT3 NC TN MK-3682B + RBV (12 Wks)		B8: GT3 NC TE MK-3682B (8 Wks)		B9: GT3 NC TE MK-3682B + RBV (8 Wks)		B10: GT3 NC TE MK-3682B (12 Wks)		B11: GT3 NC TE MK-3682B + RBV (12 Wks)		B12: GT3 NC TE MK-3682B (16 Wks)		B13: GT3 C TN MK-3682B (12 Wks)		B14: GT3 C TN MK-3682B + RBV (12 Wks)		B15: GT3 C TN MK-3682B (16 Wks)		B16: GT3 C TE MK-3682B (12 Wks)		B17: GT3 C TE MK-3682B + RBV (12 Wks)		B18: GT3 C TE MK-3682B (16 Wks)		B19: GT3 C TE MK-3682B + RBV (16 Wks)		B20: GT4 NC TN MK-3682B (8 Wks)		B22: GT6 NC TN MK-3682B (12 Wks)
Time Frame	Up to 80 weeks (Parts A and B: 8 weeks or up to 16 weeks of treatment, respectively, plus 24-week follow-up; Part C: up to 16 weeks of retreatment plus 24-week follow-up)
Adverse Event Reporting Description

Arm/Group Title	A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)		A1+C: GT3 NC TN EBR+GZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)		A2+C: GT3 NC TN GZR+RZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)		A3+C: GT3 NC TN EBR+GZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)		A4+C: GT3 NC TN GZR+RZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		B4: GT3 NC TN MK-3682B (8 Wks)		B5: GT3 NC TN MK-3682B + RBV (8 Wks)		B6: GT3 NC TN MK-3682B (12 Wks)		B7: GT3 NC TN MK-3682B + RBV (12 Wks)		B8: GT3 NC TE MK-3682B (8 Wks)		B9: GT3 NC TE MK-3682B + RBV (8 Wks)		B10: GT3 NC TE MK-3682B (12 Wks)		B11: GT3 NC TE MK-3682B + RBV (12 Wks)		B12: GT3 NC TE MK-3682B (16 Wks)		B13: GT3 C TN MK-3682B (12 Wks)		B14: GT3 C TN MK-3682B + RBV (12 Wks)		B15: GT3 C TN MK-3682B (16 Wks)		B16: GT3 C TE MK-3682B (12 Wks)		B17: GT3 C TE MK-3682B + RBV (12 Wks)		B18: GT3 C TE MK-3682B (16 Wks)		B19: GT3 C TE MK-3682B + RBV (16 Wks)		B20: GT4 NC TN MK-3682B (8 Wks)		B22: GT6 NC TN MK-3682B (12 Wks)
Arm/Group Description	In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.		In Part A, participants received grazoprevir (100 mg) + uprifosbuvir 300 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.		In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks.		In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (300 mg) + ruzasvir (60 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.		In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks.		In Part A, participants received grazoprevir (100 mg) + uprifosbuvir (450 mg) + elbasvir (50 mg) q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.		In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks.		In Part A, participants received grazoprevir 100 mg + uprifosbuvir 450 mg + ruzasvir 60 mg q.d. by mouth for 8 weeks. After relapsing, participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. and RBV (weight-based dosing) b.i.d. by mouth for 16 weeks in Part C.		In Part B, participants received 2 MK- 3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.		In Part B , participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.		In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.		In Part B, HCV GT3-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.		In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.		In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 8 weeks.		In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.		In Part B, HCV GT3-infected NC TE participants received 2 MK-3682 FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.		In Part B, HCV GT3-infected NC TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.		In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.		In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.		In Part B, HCV GT3-infected C TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.		In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.		In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 12 weeks.		In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 16 weeks.		In Part B, HCV GT3-infected C TE participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d., and RBV (weight-based dosing) b.i.d., by mouth for 16 weeks.		In Part B, HCV GT4-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 8 weeks.		In Part B, HCV GT6-infected NC TN participants received 2 MK-3682B FDC tablets (each containing grazoprevir 50 mg + uprifosbuvir 225 mg + ruzasvir 30 mg) q.d. by mouth for 12 weeks.
All Cause Mortality
	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	0/19 (0%)		0/2 (0%)		0/20 (0%)		0/1 (0%)		0/19 (0%)		0/3 (0%)		0/20 (0%)		0/2 (0%)		0/16 (0%)		0/36 (0%)		0/37 (0%)		0/35 (0%)		0/15 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/16 (0%)		0/13 (0%)		0/16 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/20 (0%)		0/25 (0%)		0/7 (0%)		0/4 (0%)
Serious Adverse Events
	A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)		A1+C: GT3 NC TN EBR+GZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)		A2+C: GT3 NC TN GZR+RZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)		A3+C: GT3 NC TN EBR+GZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)		A4+C: GT3 NC TN GZR+RZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		B4: GT3 NC TN MK-3682B (8 Wks)		B5: GT3 NC TN MK-3682B + RBV (8 Wks)		B6: GT3 NC TN MK-3682B (12 Wks)		B7: GT3 NC TN MK-3682B + RBV (12 Wks)		B8: GT3 NC TE MK-3682B (8 Wks)		B9: GT3 NC TE MK-3682B + RBV (8 Wks)		B10: GT3 NC TE MK-3682B (12 Wks)		B11: GT3 NC TE MK-3682B + RBV (12 Wks)		B12: GT3 NC TE MK-3682B (16 Wks)		B13: GT3 C TN MK-3682B (12 Wks)		B14: GT3 C TN MK-3682B + RBV (12 Wks)		B15: GT3 C TN MK-3682B (16 Wks)		B16: GT3 C TE MK-3682B (12 Wks)		B17: GT3 C TE MK-3682B + RBV (12 Wks)		B18: GT3 C TE MK-3682B (16 Wks)		B19: GT3 C TE MK-3682B + RBV (16 Wks)		B20: GT4 NC TN MK-3682B (8 Wks)		B22: GT6 NC TN MK-3682B (12 Wks)
	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	1/19 (5.3%)		0/2 (0%)		0/20 (0%)		0/1 (0%)		1/19 (5.3%)		0/3 (0%)		0/20 (0%)		1/2 (50%)		0/16 (0%)		1/36 (2.8%)		0/37 (0%)		1/35 (2.9%)		0/15 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/16 (6.3%)		1/13 (7.7%)		0/16 (0%)		2/14 (14.3%)		2/15 (13.3%)		2/14 (14.3%)		2/20 (10%)		1/25 (4%)		0/7 (0%)		0/4 (0%)
Cardiac disorders
Coronary artery disease	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Eye disorders
Keratitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gastrointestinal disorders
Abdominal pain lower	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Hepatobiliary disorders
Biliary colic	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Infections and infestations
Pharyngeal abscess	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Injury, poisoning and procedural complications
Tendon rupture	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Investigations
Blood sodium decreased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	1/2 (50%)	1	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Inflammatory pseudotumour	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lip and/or oral cavity cancer stage 0	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nervous system disorders
Cerebral haemorrhage	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Migraine	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Psychiatric disorders
Alcohol abuse	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Anxiety	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	1/2 (50%)	1	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Mental status changes	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	A1: GT3 NC TN EBR+GZR+UPR300 (8 Wks)		A1+C: GT3 NC TN EBR+GZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A2: GT3 NC TN GZR+RZR+UPR300 (8 Wks)		A2+C: GT3 NC TN GZR+RZR+UPR300 (8 Wks); MK-3682B+RBV (16 Wks)		A3: GT3 NC TN EBR+GZR+UPR450 (8 Wks)		A3+C: GT3 NC TN EBR+GZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		A4: GT3 NC TN GZR+RZR+UPR450 (8 Wks)		A4+C: GT3 NC TN GZR+RZR+UPR450 (8 Wks); MK-3682B+RBV (16 Wks)		B4: GT3 NC TN MK-3682B (8 Wks)		B5: GT3 NC TN MK-3682B + RBV (8 Wks)		B6: GT3 NC TN MK-3682B (12 Wks)		B7: GT3 NC TN MK-3682B + RBV (12 Wks)		B8: GT3 NC TE MK-3682B (8 Wks)		B9: GT3 NC TE MK-3682B + RBV (8 Wks)		B10: GT3 NC TE MK-3682B (12 Wks)		B11: GT3 NC TE MK-3682B + RBV (12 Wks)		B12: GT3 NC TE MK-3682B (16 Wks)		B13: GT3 C TN MK-3682B (12 Wks)		B14: GT3 C TN MK-3682B + RBV (12 Wks)		B15: GT3 C TN MK-3682B (16 Wks)		B16: GT3 C TE MK-3682B (12 Wks)		B17: GT3 C TE MK-3682B + RBV (12 Wks)		B18: GT3 C TE MK-3682B (16 Wks)		B19: GT3 C TE MK-3682B + RBV (16 Wks)		B20: GT4 NC TN MK-3682B (8 Wks)		B22: GT6 NC TN MK-3682B (12 Wks)
	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	17/19 (89.5%)		1/2 (50%)		12/20 (60%)		1/1 (100%)		13/19 (68.4%)		3/3 (100%)		16/20 (80%)		2/2 (100%)		9/16 (56.3%)		30/36 (83.3%)		24/37 (64.9%)		32/35 (91.4%)		12/15 (80%)		12/14 (85.7%)		9/14 (64.3%)		13/15 (86.7%)		13/16 (81.3%)		9/13 (69.2%)		14/16 (87.5%)		12/14 (85.7%)		12/15 (80%)		11/14 (78.6%)		15/20 (75%)		21/25 (84%)		3/7 (42.9%)		3/4 (75%)
Blood and lymphatic system disorders
Anaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Haemolysis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Haemolytic anaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lymph node pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lymphadenopathy	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Cardiac disorders
Arrhythmia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Atrial fibrillation	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Bundle branch block right	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Palpitations	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	1/37 (2.7%)	2	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Sinus tachycardia	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Tachycardia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Ear and labyrinth disorders
Tinnitus	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	1/7 (14.3%)	1	0/4 (0%)	0
Vertigo	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	2	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Eye disorders
Dry eye	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Eye pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Ocular discomfort	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pinguecula	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Vision blurred	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Visual impairment	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	1/14 (7.1%)	2	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Abdominal distension	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	1/14 (7.1%)	1	0/15 (0%)	0	1/16 (6.3%)	2	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	3/25 (12%)	3	0/7 (0%)	0	0/4 (0%)	0
Abdominal pain	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	3/35 (8.6%)	3	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	1/16 (6.3%)	2	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	3/20 (15%)	4	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Abdominal pain upper	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	1/16 (6.3%)	1	2/36 (5.6%)	2	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	2/14 (14.3%)	2	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Aphthous ulcer	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Constipation	0/19 (0%)	0	0/2 (0%)	0	2/20 (10%)	2	0/1 (0%)	0	1/19 (5.3%)	1	2/3 (66.7%)	2	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1	1/14 (7.1%)	1	0/20 (0%)	0	2/25 (8%)	2	1/7 (14.3%)	1	0/4 (0%)	0
Dental caries	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Diarrhoea	2/19 (10.5%)	2	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	0/19 (0%)	0	1/3 (33.3%)	1	3/20 (15%)	3	0/2 (0%)	0	2/16 (12.5%)	2	3/36 (8.3%)	3	5/37 (13.5%)	6	3/35 (8.6%)	4	2/15 (13.3%)	2	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	4/16 (25%)	4	0/13 (0%)	0	1/16 (6.3%)	2	1/14 (7.1%)	2	3/15 (20%)	3	1/14 (7.1%)	1	1/20 (5%)	1	1/25 (4%)	2	0/7 (0%)	0	0/4 (0%)	0
Diverticulum	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dry mouth	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	2/35 (5.7%)	2	2/15 (13.3%)	3	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dyspepsia	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	2/37 (5.4%)	2	3/35 (8.6%)	3	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Faeces soft	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	2/35 (5.7%)	2	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Flatulence	2/19 (10.5%)	2	0/2 (0%)	0	2/20 (10%)	2	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	2	1/13 (7.7%)	1	0/16 (0%)	0	2/14 (14.3%)	2	1/15 (6.7%)	1	2/14 (14.3%)	2	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Frequent bowel movements	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gastritis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gastrooesophageal reflux disease	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	2	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Hiatus hernia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Infrequent bowel movements	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Irritable bowel syndrome	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lip dry	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	1/3 (33.3%)	1	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nausea	2/19 (10.5%)	3	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	5/19 (26.3%)	6	0/3 (0%)	0	6/20 (30%)	6	0/2 (0%)	0	2/16 (12.5%)	2	6/36 (16.7%)	8	4/37 (10.8%)	5	5/35 (14.3%)	6	1/15 (6.7%)	1	3/14 (21.4%)	3	1/14 (7.1%)	1	2/15 (13.3%)	2	3/16 (18.8%)	3	2/13 (15.4%)	2	2/16 (12.5%)	3	3/14 (21.4%)	3	1/15 (6.7%)	1	2/14 (14.3%)	3	2/20 (10%)	2	4/25 (16%)	5	0/7 (0%)	0	0/4 (0%)	0
Oral pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Paraesthesia oral	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Salivary hypersecretion	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Tongue ulceration	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Vomiting	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	1/3 (33.3%)	1	3/20 (15%)	3	0/2 (0%)	0	2/16 (12.5%)	3	1/36 (2.8%)	1	3/37 (8.1%)	3	3/35 (8.6%)	3	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	1/16 (6.3%)	1	3/14 (21.4%)	3	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
General disorders
Asthenia	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	3/36 (8.3%)	3	3/37 (8.1%)	3	3/35 (8.6%)	3	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	2/15 (13.3%)	2	1/16 (6.3%)	1	1/13 (7.7%)	2	1/16 (6.3%)	1	0/14 (0%)	0	1/15 (6.7%)	1	3/14 (21.4%)	3	1/20 (5%)	2	2/25 (8%)	2	1/7 (14.3%)	1	0/4 (0%)	0
Chest discomfort	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Chest pain	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Chills	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	1/36 (2.8%)	1	1/37 (2.7%)	1	1/35 (2.9%)	1	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	1/16 (6.3%)	1	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Energy increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Fatigue	4/19 (21.1%)	4	0/2 (0%)	0	5/20 (25%)	5	0/1 (0%)	0	4/19 (21.1%)	4	1/3 (33.3%)	1	4/20 (20%)	4	1/2 (50%)	2	2/16 (12.5%)	2	10/36 (27.8%)	11	5/37 (13.5%)	5	13/35 (37.1%)	13	3/15 (20%)	3	5/14 (35.7%)	6	4/14 (28.6%)	4	5/15 (33.3%)	5	4/16 (25%)	4	3/13 (23.1%)	3	4/16 (25%)	5	3/14 (21.4%)	3	3/15 (20%)	3	5/14 (35.7%)	7	4/20 (20%)	4	9/25 (36%)	10	0/7 (0%)	0	0/4 (0%)	0
Feeling abnormal	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Feeling cold	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Feeling hot	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Feeling jittery	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Influenza like illness	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	2	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Local swelling	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Malaise	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	2/37 (5.4%)	2	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Pyrexia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	3/37 (8.1%)	3	3/35 (8.6%)	3	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	3/20 (15%)	3	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Vessel puncture site pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Immune system disorders
Seasonal allergy	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Infections and infestations
Acute sinusitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Bronchitis	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Cellulitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Cystitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Ear infection	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gastroenteritis	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Genital herpes	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Gingivitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Herpes simplex	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hordeolum	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Infected dermal cyst	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Influenza	1/19 (5.3%)	1	1/2 (50%)	1	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	1/3 (33.3%)	1	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	2	0/35 (0%)	0	1/15 (6.7%)	1	1/14 (7.1%)	1	0/14 (0%)	0	1/15 (6.7%)	1	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	2/14 (14.3%)	2	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Lower respiratory tract infection	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nasopharyngitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Oral herpes	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Otitis media	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Paronychia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Periodontitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pharyngitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pharyngitis streptococcal	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pneumonia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Respiratory tract infection	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	2	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Rhinitis	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	2/15 (13.3%)	5	0/14 (0%)	0	1/14 (7.1%)	2	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	2/25 (8%)	3	0/7 (0%)	0	0/4 (0%)	0
Sinusitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	3	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Tooth abscess	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Tooth infection	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Upper respiratory tract infection	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	1/16 (6.3%)	1	1/36 (2.8%)	1	0/37 (0%)	0	2/35 (5.7%)	2	1/15 (6.7%)	1	1/14 (7.1%)	2	1/14 (7.1%)	1	0/15 (0%)	0	1/16 (6.3%)	1	1/13 (7.7%)	1	0/16 (0%)	0	2/14 (14.3%)	2	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Urinary tract infection	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	3/36 (8.3%)	3	1/37 (2.7%)	1	2/35 (5.7%)	2	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	1/25 (4%)	1	0/7 (0%)	0	1/4 (25%)	1
Viral infection	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	1/2 (50%)	1	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Viral upper respiratory tract infection	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	2/19 (10.5%)	3	1/3 (33.3%)	2	2/20 (10%)	3	0/2 (0%)	0	2/16 (12.5%)	2	6/36 (16.7%)	7	4/37 (10.8%)	4	1/35 (2.9%)	1	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	3/16 (18.8%)	3	1/13 (7.7%)	1	1/16 (6.3%)	1	3/14 (21.4%)	3	4/15 (26.7%)	4	2/14 (14.3%)	2	1/20 (5%)	1	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Wound infection staphylococcal	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Injury, poisoning and procedural complications
Accidental overdose	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	1/1 (100%)	1	3/19 (15.8%)	3	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	8/36 (22.2%)	8	1/37 (2.7%)	1	5/35 (14.3%)	5	1/15 (6.7%)	1	6/14 (42.9%)	6	1/14 (7.1%)	1	2/15 (13.3%)	2	0/16 (0%)	0	0/13 (0%)	0	4/16 (25%)	4	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	3/25 (12%)	4	0/7 (0%)	0	0/4 (0%)	0
Arthropod bite	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Arthropod sting	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Bone contusion	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Clavicle fracture	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Contusion	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	2	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Fall	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Foot fracture	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Foreign body	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Ligament sprain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Muscle strain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	1/2 (50%)	1	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Rib fracture	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Tendon injury	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Thermal burn	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Investigations
Alanine aminotransferase increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Amylase increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Aspartate aminotransferase increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Bacterial test positive	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Blood bilirubin increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Blood creatine phosphokinase increased	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Blood creatinine increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Blood potassium increased	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Blood urine present	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Haemoglobin decreased	0/19 (0%)	0	1/2 (50%)	1	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Heart rate increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lipase increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Protein urine present	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Transaminases increased	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
White blood cells urine positive	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	1	3/35 (8.6%)	3	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	1/13 (7.7%)	1	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	2/14 (14.3%)	2	1/20 (5%)	1	3/25 (12%)	3	0/7 (0%)	0	0/4 (0%)	0
Gout	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperamylasaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperglycaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperlipasaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperlipidaemia	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hypokalaemia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Increased appetite	2/19 (10.5%)	2	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Vitamin D deficiency	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	2/20 (10%)	2	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Arthralgia	2/19 (10.5%)	2	0/2 (0%)	0	0/20 (0%)	0	1/1 (100%)	1	1/19 (5.3%)	1	0/3 (0%)	0	2/20 (10%)	3	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	2	0/13 (0%)	0	0/16 (0%)	0	2/14 (14.3%)	2	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Back pain	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	2/19 (10.5%)	2	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	2/16 (12.5%)	2	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	2/16 (12.5%)	2	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	1/14 (7.1%)	1	3/20 (15%)	3	0/25 (0%)	0	1/7 (14.3%)	1	1/4 (25%)	1
Fibromyalgia	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Groin pain	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Intervertebral disc degeneration	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Joint swelling	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Muscle spasms	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	4	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Musculoskeletal chest pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Musculoskeletal pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	3/35 (8.6%)	4	1/15 (6.7%)	1	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Musculoskeletal stiffness	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Myalgia	2/19 (10.5%)	2	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	3	2/37 (5.4%)	3	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Neck pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	1/4 (25%)	1
Pain in extremity	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1	0/14 (0%)	0	1/20 (5%)	1	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Plantar fasciitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Rhabdomyolysis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nervous system disorders
Disturbance in attention	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	2/19 (10.5%)	2	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	3/35 (8.6%)	3	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	2/20 (10%)	2	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dizziness	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	1/2 (50%)	1	0/16 (0%)	0	2/36 (5.6%)	2	1/37 (2.7%)	1	3/35 (8.6%)	3	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	3/16 (18.8%)	3	2/13 (15.4%)	2	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	2/14 (14.3%)	2	1/20 (5%)	1	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Dizziness postural	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dysgeusia	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	2/37 (5.4%)	2	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dyskinesia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Headache	4/19 (21.1%)	5	1/2 (50%)	3	5/20 (25%)	6	1/1 (100%)	2	5/19 (26.3%)	8	0/3 (0%)	0	5/20 (25%)	6	1/2 (50%)	1	5/16 (31.3%)	6	12/36 (33.3%)	13	7/37 (18.9%)	7	8/35 (22.9%)	8	2/15 (13.3%)	2	5/14 (35.7%)	5	2/14 (14.3%)	2	5/15 (33.3%)	6	6/16 (37.5%)	6	1/13 (7.7%)	1	4/16 (25%)	4	4/14 (28.6%)	5	1/15 (6.7%)	1	2/14 (14.3%)	3	3/20 (15%)	3	9/25 (36%)	11	1/7 (14.3%)	1	2/4 (50%)	2
Hypersomnia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	2	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Lethargy	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	1/1 (100%)	1	1/19 (5.3%)	1	1/3 (33.3%)	1	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Memory impairment	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	1/1 (100%)	1	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Migraine	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	1/37 (2.7%)	1	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Paraesthesia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Parosmia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Poor quality sleep	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Sciatica	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Somnolence	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Tension headache	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Psychiatric disorders
Affect lability	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	2	0/7 (0%)	0	0/4 (0%)	0
Anxiety	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	2/37 (5.4%)	2	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Depressed mood	1/19 (5.3%)	1	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	2/20 (10%)	2	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Depression	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	3/37 (8.1%)	3	3/35 (8.6%)	3	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Emotional disorder	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Insomnia	2/19 (10.5%)	3	0/2 (0%)	0	1/20 (5%)	2	1/1 (100%)	2	2/19 (10.5%)	2	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	3/36 (8.3%)	3	2/37 (5.4%)	2	3/35 (8.6%)	3	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	2/15 (13.3%)	2	1/16 (6.3%)	1	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	2/14 (14.3%)	2	1/20 (5%)	1	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Irritability	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	1/3 (33.3%)	1	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	3/36 (8.3%)	3	0/37 (0%)	0	3/35 (8.6%)	3	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	2	0/16 (0%)	0	1/13 (7.7%)	1	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Panic attack	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Sleep disorder	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	0/16 (0%)	0	2/36 (5.6%)	2	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	2	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Tearfulness	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nephropathy	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Renal cyst	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Reproductive system and breast disorders
Breast tenderness	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Erectile dysfunction	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Vulval haematoma	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Cough	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	1/1 (100%)	1	2/19 (10.5%)	2	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	3/36 (8.3%)	3	1/37 (2.7%)	1	2/35 (5.7%)	2	3/15 (20%)	3	2/14 (14.3%)	2	1/14 (7.1%)	1	0/15 (0%)	0	1/16 (6.3%)	1	1/13 (7.7%)	1	4/16 (25%)	5	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	3/20 (15%)	3	3/25 (12%)	3	0/7 (0%)	0	0/4 (0%)	0
Dry throat	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dysphonia	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dyspnoea	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	2/14 (14.3%)	2	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Dyspnoea exertional	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	3/36 (8.3%)	3	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	4/15 (26.7%)	4	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Epistaxis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	1/2 (50%)	1	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Haemoptysis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Nasal discomfort	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Oropharyngeal pain	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	0/36 (0%)	0	1/37 (2.7%)	1	2/35 (5.7%)	2	2/15 (13.3%)	2	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	2	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Paranasal sinus discomfort	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Productive cough	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Rhinitis allergic	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Rhinorrhoea	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	2	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Sinus congestion	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	1/35 (2.9%)	1	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Throat irritation	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	1/37 (2.7%)	1	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	1/7 (14.3%)	1	0/4 (0%)	0
Actinic keratosis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Alopecia	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	1/3 (33.3%)	1	1/20 (5%)	1	1/2 (50%)	1	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Dermatitis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dermatitis contact	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Dry skin	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	1/20 (5%)	1	1/2 (50%)	1	0/16 (0%)	0	3/36 (8.3%)	3	0/37 (0%)	0	2/35 (5.7%)	2	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0
Ecchymosis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Eczema	1/19 (5.3%)	1	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Erythema	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperhidrosis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	1/36 (2.8%)	1	0/37 (0%)	0	2/35 (5.7%)	2	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hyperkeratosis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Macule	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Night sweats	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	1/13 (7.7%)	1	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Photosensitivity reaction	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	1/20 (5%)	1	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Pruritus	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	0/1 (0%)	0	1/19 (5.3%)	1	0/3 (0%)	0	1/20 (5%)	1	0/2 (0%)	0	1/16 (6.3%)	1	2/36 (5.6%)	2	0/37 (0%)	0	2/35 (5.7%)	2	2/15 (13.3%)	2	2/14 (14.3%)	2	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1	1/16 (6.3%)	1	0/14 (0%)	0	1/15 (6.7%)	1	1/14 (7.1%)	1	1/20 (5%)	1	5/25 (20%)	5	0/7 (0%)	0	0/4 (0%)	0
Rash	0/19 (0%)	0	0/2 (0%)	0	1/20 (5%)	1	1/1 (100%)	1	0/19 (0%)	0	2/3 (66.7%)	2	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	4/36 (11.1%)	5	0/37 (0%)	0	2/35 (5.7%)	2	1/15 (6.7%)	1	2/14 (14.3%)	2	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	2/14 (14.3%)	3	1/20 (5%)	3	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Rash erythematous	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Rash macular	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	1/4 (25%)	1
Rash maculo-papular	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	1/14 (7.1%)	1	0/14 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	1/25 (4%)	1	0/7 (0%)	0	0/4 (0%)	0
Skin discolouration	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	1/3 (33.3%)	1	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Skin lesion	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	1/16 (6.3%)	1	1/36 (2.8%)	1	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Urticaria	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	1/15 (6.7%)	1	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Vascular disorders
Arteriosclerosis	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Flushing	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	2	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hot flush	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	1/35 (2.9%)	1	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	0/16 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	0/25 (0%)	0	0/7 (0%)	0	0/4 (0%)	0
Hypertension	0/19 (0%)	0	0/2 (0%)	0	0/20 (0%)	0	0/1 (0%)	0	0/19 (0%)	0	0/3 (0%)	0	0/20 (0%)	0	0/2 (0%)	0	0/16 (0%)	0	0/36 (0%)	0	0/37 (0%)	0	0/35 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/14 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0	1/16 (6.3%)	1	0/14 (0%)	0	0/15 (0%)	0	0/14 (0%)	0	0/20 (0%)	0	2/25 (8%)	2	0/7 (0%)	0	0/4 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.

Results Point of Contact

Name/Title	Senior Vice President, Global Clinical Development
Organization	Merck Sharp & Dohme Corp.
Phone	1-800-672-6372
Email	ClinicalTrialsDisclosure@merck.com

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT02332720

Other Study ID Numbers:

3682-012
2014-003347-35

First Posted:

Jan 7, 2015

Last Update Posted:

Jul 30, 2019

Last Verified:

Jul 1, 2019

Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Part B only:

Exclusion Criteria:

Parts A, B, and C (unless otherwise specified):

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact