A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03529773
• Collaborator: (none)
• Enrollment: 1,235
• Locations: 40
• Arms: 20
• Actual Duration (Months): 32.4
• Patients Per Site: 30.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Infections	Biological: Formulation A; Biological: Formulation B; Biological: Placebo	Phase 2

Detailed Description

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: ParallelParallel
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Observer blind
• Primary Purpose: Prevention
• Official Title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY ADULTS
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sentinel Arm 1 Low dose formulation A	Biological: Formulation A; RSV vaccine
Experimental: Sentinel Arm 2 Mid dose formulation A	Biological: Formulation A; RSV vaccine
Experimental: Sentinel Arm 3 High dose formulation A	Biological: Formulation A; RSV vaccine
Experimental: Sentinel Arm 4 Low dose formulation B	Biological: Formulation B; RSV vaccine
Experimental: Sentinel Arm 5 Mid dose formulation B	Biological: Formulation B; RSV vaccine
Experimental: Sentinel Arm 6 High dose formulation B	Biological: Formulation B; RSV vaccine
Placebo Comparator: Sentinel Arm 7 Placebo	Biological: Placebo; Placebo
Experimental: Expanded Arm 8 Low dose formulation A and SIIV	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 9 Mid dose formulation A and SIIV	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 10 High dose formulation A and SIIV	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 11 Low dose formulation B and SIIV	Biological: Formulation B; RSV vaccine
Experimental: Expanded Arm 12 Mid dose formulation B and SIIV	Biological: Formulation B; RSV vaccine
Experimental: Expanded Arm 13 High dose formulation B and SIIV	Biological: Formulation B; RSV vaccine
Experimental: Expanded Arm 14 Low dose formulation A and placebo	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 15 Mid dose formulation A and placebo	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 16 High dose formulation A and placebo	Biological: Formulation A; RSV vaccine
Experimental: Expanded Arm 17 Low dose formulation B and placebo	Biological: Formulation B; RSV vaccine
Experimental: Expanded Arm 18 Mid dose formulation B and placebo	Biological: Formulation B; RSV vaccine
Experimental: Expanded Arm 19 High dose formulation B and placebo	Biological: Formulation B; RSV vaccine
Placebo Comparator: Expanded Arm 20 placebo and placebo	Biological: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination [Within 14 days after vaccination]

   Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

2. Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination [Within 14 days after vaccination]

   Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.

3. Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1 [Within 14 days after vaccination 1 on Day 1]

   Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

4. Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1 [Within 14 days after vaccination 1 on Day 1]

   Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.

5. Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination [Within 14 days after vaccination]

   Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

6. Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination [Within 14 days after vaccination]

   Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

7. Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1 [Within 14 days after vaccination 1 on Day 1]

   Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

8. Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1 [Within 14 days after vaccination 1 on Day 1]

   Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

9. Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination [Within 1 month after vaccination (up to 35 days)]

   An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

10. Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination [Within 1 month after vaccination (up to 35 days)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

11. Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1 [Within 1 month after vaccination 1 (up to 35 days)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

12. Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination [Within 1 month after vaccination 1 (up to 35 days)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

13. Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination [Upto 12 months after vaccination (up to 378 days)]

    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

14. Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination [Upto 12 months after vaccination (upto 378 days)]

    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

15. Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1 [Upto 12 months after vaccination 1 (upto 378 days)]

    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

16. Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1 [Upto 12 months after vaccination 1 (upto 378 days)]

    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

17. Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2 [Within 1 month after vaccination 2 (upto Day 70)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

18. Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2 [Within 1 month after vaccination 2 (upto Day 70)]

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

Secondary Outcome Measures

1. Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) [Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination]

   GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.

2. Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years) [Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination]

   GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.

3. Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years) [Before vaccination, 1, 2, 3, 6 and 12 months after vaccination]

   GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.

4. Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years) [Before vaccination, 1, 2, 3, 6 and 12 months after vaccination]

   GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.

5. Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years) [Before vaccination and 1 Month after SIIV vaccination]

   The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.

6. Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years) [Before vaccination and 1 Month after SIIV vaccination]

   The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.

2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.

3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.

4. Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.

5. Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).

6. Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).

Exclusion Criteria:

1. Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.

2. Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.

3. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

4. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.

5. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).

6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.

7. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).

8. Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

9. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

10. Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).

11. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.

12. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

14. Women who are pregnant or breastfeeding.

15. Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.

16. Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	Anaheim Clinical Trials	Anaheim	California	United States	92801
3	Paradigm Clinical Research Centers, Inc.	La Mesa	California	United States	91942
4	Paradigm Clinical Research Center	Redding	California	United States	96001
5	Clinical Research of South Florida	Coral Gables	Florida	United States	33134
6	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
7	Meridian Clinical Research	Savannah	Georgia	United States	31406
8	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
9	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
10	Meridian Clinical Research Dakota Dunes	Sioux City	Iowa	United States	51106
11	Augusta Family Practice	Augusta	Kansas	United States	67010
12	Heartland Research Associates, LLC	Augusta	Kansas	United States	67010
13	Axtell Clinic, P.A.	Newton	Kansas	United States	67114
14	Heartland Research Associates, LLC	Newton	Kansas	United States	67114
15	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
16	Sundance Clinical Research, LLC	Saint Louis	Missouri	United States	63141
17	Meridian Clinical Research, LLC	Norfolk	Nebraska	United States	68701
18	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
19	United Medical Associates	Binghamton	New York	United States	13901
20	Regional Clinical Research, Inc.	Endwell	New York	United States	13760
21	Rochester Regional Health/Rochester General Hospital	Rochester	New York	United States	14621
22	University of Rochester Medical Center	Rochester	New York	United States	14642
23	PMG Research of Charlotte, LLC	Charlotte	North Carolina	United States	28209
24	PMG Research of Raleigh	Raleigh	North Carolina	United States	27609
25	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
26	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
27	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45219
28	Aventiv Research Inc.	Columbus	Ohio	United States	43213
29	PriMed Clinical Research	Dayton	Ohio	United States	45419
30	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
31	Benchmark Research	Austin	Texas	United States	78705
32	Texas Health Care, PLLC	Fort Worth	Texas	United States	76104
33	Ventavia Research Group, LLC	Fort Worth	Texas	United States	76104
34	Benchmark Research	Fort Worth	Texas	United States	76135
35	HealthFirst Medical Group	Fort Worth	Texas	United States	76135
36	Clinical Trials of Texas, LLC	San Antonio	Texas	United States	78229
37	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	United States	84109
38	J. Lewis Research, Inc. /Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
39	J.Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah	United States	84095
40	Advanced Clinical Research	West Jordan	Utah	United States	84088

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Jun 11, 2019
• Statistical Analysis Plan - Jun 15, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03529773
• Other Study ID Numbers: C3671001; RSV FIH
• First Posted: May 18, 2018
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Respiratory tract infections, RSV, vaccine
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

Participant Flow

Pre-assignment Detail	Total 1446 participants signed the Informed Consent Form (ICF). Out of which 211 participants were screen failures,1235 actually enrolled into the study and assigned to a study treatment. Only 1233 participants were vaccinated.

Arm/Group Title	Sentinel Cohort: Respiratory Syncytial Virus (RSV) Vaccine 60 Microgram (mcg) Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 milliliter (mL) seasonal inactivated influenza vaccine (SIIV) intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Period Title: Overall Study
STARTED	12	12	12	12	12	12	12	12	12	12	12	12	12	12	41	42	41	41	41	41	41	41	41	41	41	41	41	41	41	40	42	40	40	41	41	40	41	42	43	41
COMPLETED	12	12	11	12	11	11	12	11	12	11	11	12	10	11	35	38	40	35	37	37	34	36	34	35	33	30	32	39	40	40	39	40	40	39	37	36	39	36	39	37
NOT COMPLETED	0	0	1	0	1	1	0	1	0	1	1	0	2	1	6	4	1	6	4	4	7	5	7	6	8	11	9	2	1	0	3	0	0	2	4	4	2	6	4	4

Baseline Characteristics

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years	Total
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Total of all reporting groups
Overall Participants	12	12	12	12	12	12	12	12	12	12	12	12	12	12	41	42	41	40	41	41	41	41	41	41	41	41	41	40	41	40	42	40	40	41	41	40	41	42	43	41	1233
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	32.2 (9.5)	34.0 (9.0)	34.8 (8.0)	34.2 (8.7)	43.3 (4.8)	36.3 (8.4)	35.2 (9.4)	65.4 (9.9)	66.3 (9.7)	63.7 (7.4)	62.6 (8.6)	62.1 (9.8)	61.3 (7.7)	61.3 (9.8)	33.4 (8.2)	32.6 (9.1)	33.0 (8.6)	34.1 (9.3)	34.1 (8.5)	36.8 (8.8)	34.1 (8.7)	33.1 (9.4)	36.2 (8.9)	34.7 (8.9)	33.9 (8.5)	34.6 (7.7)	33.6 (8.5)	72.6 (5.9)	71.9 (4.8)	72.4 (5.6)	72.8 (5.1)	70.9 (5.5)	71.7 (5.4)	72.2 (4.7)	71.3 (4.8)	72.3 (5.0)	71.6 (5.2)	71.4 (5.1)	70.7 (4.9)	70.9 (4.7)	52.47 (19.68)
Sex: Female, Male (Count of Participants)
Female	7 58.3%	10 83.3%	6 50%	10 83.3%	9 75%	9 75%	5 41.7%	7 58.3%	8 66.7%	7 58.3%	5 41.7%	10 83.3%	9 75%	6 50%	27 65.9%	28 66.7%	27 65.9%	25 62.5%	29 70.7%	29 70.7%	26 63.4%	25 61%	29 70.7%	29 70.7%	28 68.3%	29 70.7%	29 70.7%	17 42.5%	23 56.1%	20 50%	25 59.5%	24 60%	22 55%	22 53.7%	23 56.1%	26 65%	26 63.4%	26 61.9%	20 46.5%	29 70.7%	771 62.5%
Male	5 41.7%	2 16.7%	6 50%	2 16.7%	3 25%	3 25%	7 58.3%	5 41.7%	4 33.3%	5 41.7%	7 58.3%	2 16.7%	3 25%	6 50%	14 34.1%	14 33.3%	14 34.1%	15 37.5%	12 29.3%	12 29.3%	15 36.6%	16 39%	12 29.3%	12 29.3%	13 31.7%	12 29.3%	12 29.3%	23 57.5%	18 43.9%	20 50%	17 40.5%	16 40%	18 45%	19 46.3%	18 43.9%	14 35%	15 36.6%	16 38.1%	23 53.5%	12 29.3%	462 37.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 8.3%	2 16.7%	1 8.3%	1 8.3%	1 8.3%	2 16.7%	0 0%	2 16.7%	1 8.3%	1 8.3%	2 16.7%	1 8.3%	0 0%	4 9.8%	5 11.9%	7 17.1%	5 12.5%	4 9.8%	7 17.1%	6 14.6%	5 12.2%	3 7.3%	5 12.2%	6 14.6%	4 9.8%	3 7.3%	2 5%	1 2.4%	2 5%	1 2.4%	3 7.5%	3 7.5%	4 9.8%	3 7.3%	1 2.5%	5 12.2%	2 4.8%	1 2.3%	5 12.2%	112 9.1%
Not Hispanic or Latino	12 100%	10 83.3%	10 83.3%	11 91.7%	11 91.7%	11 91.7%	8 66.7%	12 100%	10 83.3%	11 91.7%	11 91.7%	10 83.3%	10 83.3%	12 100%	37 90.2%	37 88.1%	34 82.9%	35 87.5%	37 90.2%	34 82.9%	35 85.4%	36 87.8%	38 92.7%	36 87.8%	35 85.4%	36 87.8%	38 92.7%	38 95%	39 95.1%	38 95%	41 97.6%	37 92.5%	37 92.5%	37 90.2%	37 90.2%	39 97.5%	36 87.8%	40 95.2%	40 93%	36 87.8%	1112 90.2%
Unknown or Not Reported	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	2 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	0 0%	0 0%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	0 0%	0 0%	0 0%	2 4.7%	0 0%	9 0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	1 8.3%	0 0%	1 2.4%	0 0%	1 2.5%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.5%	0 0%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	10 0.8%
Asian	0 0%	0 0%	0 0%	1 8.3%	0 0%	1 8.3%	2 16.7%	0 0%	1 8.3%	1 8.3%	0 0%	0 0%	0 0%	1 8.3%	1 2.4%	1 2.4%	0 0%	2 5%	1 2.4%	0 0%	0 0%	3 7.3%	1 2.4%	0 0%	0 0%	1 2.4%	1 2.4%	1 2.5%	1 2.4%	0 0%	0 0%	1 2.5%	0 0%	0 0%	1 2.4%	0 0%	0 0%	0 0%	1 2.3%	0 0%	23 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	1 2.4%	0 0%	0 0%	0 0%	0 0%	1 2.5%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 0.3%
Black or African American	2 16.7%	4 33.3%	2 16.7%	2 16.7%	1 8.3%	4 33.3%	0 0%	2 16.7%	0 0%	1 8.3%	4 33.3%	3 25%	1 8.3%	2 16.7%	10 24.4%	7 16.7%	8 19.5%	8 20%	6 14.6%	8 19.5%	9 22%	8 19.5%	13 31.7%	7 17.1%	7 17.1%	9 22%	9 22%	4 10%	6 14.6%	1 2.5%	5 11.9%	3 7.5%	3 7.5%	2 4.9%	6 14.6%	5 12.5%	3 7.3%	3 7.1%	6 14%	4 9.8%	188 15.2%
White	10 83.3%	7 58.3%	10 83.3%	8 66.7%	10 83.3%	7 58.3%	9 75%	9 75%	11 91.7%	9 75%	7 58.3%	8 66.7%	9 75%	8 66.7%	30 73.2%	32 76.2%	32 78%	28 70%	31 75.6%	31 75.6%	30 73.2%	29 70.7%	27 65.9%	32 78%	30 73.2%	28 68.3%	29 70.7%	35 87.5%	34 82.9%	38 95%	36 85.7%	34 85%	37 92.5%	37 90.2%	33 80.5%	35 87.5%	37 90.2%	39 92.9%	36 83.7%	36 87.8%	978 79.3%
More than one race	0 0%	1 8.3%	0 0%	1 8.3%	0 0%	0 0%	0 0%	1 8.3%	0 0%	1 8.3%	0 0%	1 8.3%	2 16.7%	0 0%	0 0%	1 2.4%	0 0%	1 2.5%	2 4.9%	1 2.4%	0 0%	1 2.4%	0 0%	1 2.4%	1 2.4%	1 2.4%	2 4.9%	0 0%	0 0%	0 0%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	0 0%	0 0%	0 0%	20 1.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%	0 0%	0 0%	1 2.4%	2 4.9%	0 0%	0 0%	0 0%	1 2.4%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.5%	0 0%	1 2.4%	1 2.4%	0 0%	0 0%	0 0%	0 0%	0 0%	10 0.8%

Outcome Measures

1. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Description	Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Time Frame	Within 14 days after vaccination

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination
Measure Participants	12	12	12	12	11	12	12
Pain at injection site: mild	50.0 416.7%	58.3 485.8%	25.0 208.3%	75.0 625%	0 0%	58.3 485.8%	16.7 139.2%
Pain at injection site: moderate	0 0%	16.7 139.2%	0 0%	8.3 69.2%	18.2 151.7%	8.3 69.2%	0 0%
Pain at injection site: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Redness: mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Redness: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Redness: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Swelling: mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Swelling: moderate	0 0%	8.3 69.2%	0 0%	8.3 69.2%	0 0%	8.3 69.2%	0 0%
Swelling: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Description	Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Time Frame	Within 14 days after vaccination

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years
Arm/Group Description	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
Pain at injection site: mild	16.7 139.2%	16.7 139.2%	8.3 69.2%	16.7 139.2%	8.3 69.2%	8.3 69.2%	0 0%
Pain at injection site: moderate	0 0%	8.3 69.2%	0 0%	25.0 208.3%	0 0%	8.3 69.2%	0 0%
Pain at injection site: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Redness: mild	16.7 139.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Redness: moderate	0 0%	0 0%	0 0%	0 0%	8.3 69.2%	0 0%	0 0%
Redness: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Swelling: mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Swelling: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Swelling: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Description	Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Time Frame	Within 14 days after vaccination 1 on Day 1

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	41	42	41	40	41	41	41	40	41	41	41	41	41
Pain at injection site: mild	34.1 284.2%	31.0 258.3%	41.5 345.8%	32.5 270.8%	36.6 305%	43.9 365.8%	48.8 406.7%	55.0 458.3%	24.4 203.3%	34.1 284.2%	51.2 426.7%	48.8 406.7%	14.6 121.7%
Pain at injection site: moderate	12.2 101.7%	7.1 59.2%	26.8 223.3%	20.0 166.7%	9.8 81.7%	7.3 60.8%	12.2 101.7%	12.5 104.2%	14.6 121.7%	7.3 60.8%	9.8 81.7%	17.1 142.5%	2.4 20%
Pain at injection site: severe	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%
Redness: mild	2.4 20%	4.8 40%	0 0%	2.5 20.8%	0 0%	2.4 20%	2.4 20%	7.5 62.5%	2.4 20%	0 0%	7.3 60.8%	4.9 40.8%	2.4 20%
Redness: moderate	0 0%	2.4 20%	0 0%	0 0%	2.4 20%	2.4 20%	2.4 20%	0 0%	4.9 40.8%	2.4 20%	0 0%	9.8 81.7%	0 0%
Redness: severe	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%
Swelling: mild	2.4 20%	4.8 40%	0 0%	0 0%	2.4 20%	9.8 81.7%	2.4 20%	5.0 41.7%	4.9 40.8%	0 0%	4.9 40.8%	9.8 81.7%	0 0%
Swelling: moderate	2.4 20%	4.8 40%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%	7.3 60.8%	4.9 40.8%	2.4 20%	9.8 81.7%	0 0%
Swelling: severe	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%

4. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Description	Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Time Frame	Within 14 days after vaccination 1 on Day 1

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3). Participants received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	40	40	40	42	40	40	41	41	40	41	42	43	40
Pain at injection site: mild	25.0 208.3%	10.0 83.3%	22.5 187.5%	23.8 198.3%	22.5 187.5%	10.0 83.3%	26.8 223.3%	19.5 162.5%	32.5 270.8%	19.5 162.5%	19.0 158.3%	14.0 116.7%	5.0 41.7%
Pain at injection site: moderate	2.5 20.8%	0 0%	5.0 41.7%	0 0%	0 0%	2.5 20.8%	2.4 20%	0 0%	0 0%	0 0%	4.8 40%	4.7 39.2%	0 0%
Pain at injection site: severe	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%
Redness: mild	2.5 20.8%	2.5 20.8%	0 0%	7.1 59.2%	2.5 20.8%	7.5 62.5%	2.4 20%	2.4 20%	0 0%	7.3 60.8%	0 0%	4.7 39.2%	0 0%
Redness: moderate	5.0 41.7%	2.5 20.8%	2.5 20.8%	2.4 20%	5.0 41.7%	0 0%	2.4 20%	0 0%	2.5 20.8%	2.4 20%	2.4 20%	2.3 19.2%	0 0%
Redness: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%
Swelling: mild	7.5 62.5%	5.0 41.7%	0 0%	4.8 40%	2.5 20.8%	5.0 41.7%	2.4 20%	2.4 20%	5.0 41.7%	0 0%	2.4 20%	2.3 19.2%	2.5 20.8%
Swelling: moderate	0 0%	0 0%	0 0%	0 0%	5.0 41.7%	0 0%	0 0%	0 0%	0 0%	2.4 20%	2.4 20%	2.3 19.2%	0 0%
Swelling: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	2.3 19.2%	0 0%

5. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Description	Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Time Frame	Within 14 days after vaccination

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	11	12	12
Fever: >=38.0 degree C	0 0%	8.3 69.2%	0 0%	0 0%	0 0%	8.3 69.2%	0 0%
Fever: mild	0 0%	8.3 69.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	8.3 69.2%	0 0%
Fever: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fatigue: mild	8.3 69.2%	41.7 347.5%	16.7 139.2%	33.3 277.5%	9.1 75.8%	16.7 139.2%	25.0 208.3%
Fatigue: moderate	25.0 208.3%	8.3 69.2%	25.0 208.3%	25.0 208.3%	36.4 303.3%	33.3 277.5%	0 0%
Fatigue: severe	8.3 69.2%	0 0%	0 0%	0 0%	9.1 75.8%	8.3 69.2%	0 0%
Headache: mild	16.7 139.2%	16.7 139.2%	8.3 69.2%	33.3 277.5%	27.3 227.5%	8.3 69.2%	8.3 69.2%
Headache: moderate	25.0 208.3%	25.0 208.3%	16.7 139.2%	8.3 69.2%	27.3 227.5%	33.3 277.5%	0 0%
Headache: severe	0 0%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%
Nausea: mild	8.3 69.2%	0 0%	8.3 69.2%	16.7 139.2%	0 0%	16.7 139.2%	0 0%
Nausea: moderate	16.7 139.2%	0 0%	8.3 69.2%	0 0%	18.2 151.7%	8.3 69.2%	0 0%
Nausea: severe	8.3 69.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Muscle pain: mild	50.0 416.7%	25.0 208.3%	25.0 208.3%	33.3 277.5%	0 0%	41.7 347.5%	8.3 69.2%
Muscle pain: moderate	0 0%	8.3 69.2%	8.3 69.2%	16.7 139.2%	9.1 75.8%	16.7 139.2%	0 0%
Muscle pain: severe	0 0%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%
Joint pain: mild	8.3 69.2%	0 0%	0 0%	16.7 139.2%	0 0%	16.7 139.2%	8.3 69.2%
Joint pain: moderate	0 0%	8.3 69.2%	16.7 139.2%	0 0%	9.1 75.8%	0 0%	0 0%
Joint pain: severe	0 0%	0 0%	0 0%	0 0%	9.1 75.8%	0 0%	0 0%
Vomiting: mild	8.3 69.2%	0 0%	0 0%	0 0%	18.2 151.7%	0 0%	0 0%
Vomiting: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Vomiting: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Diarrhea: mild	0 0%	16.7 139.2%	16.7 139.2%	8.3 69.2%	27.3 227.5%	8.3 69.2%	0 0%
Diarrhea: moderate	8.3 69.2%	8.3 69.2%	0.0 0%	8.3 69.2%	0 0%	0 0%	8.3 69.2%
Diarrhea: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Description	Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Time Frame	Within 14 days after vaccination

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years
Arm/Group Description	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
Fever: >=38.0 degree C	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fatigue: mild	41.7 347.5%	16.7 139.2%	33.3 277.5%	8.3 69.2%	0 0%	16.7 139.2%	16.7 139.2%
Fatigue: moderate	0 0%	33.3 277.5%	0 0%	25.0 208.3%	8.3 69.2%	8.3 69.2%	16.7 139.2%
Fatigue: severe	0 0%	8.3 69.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Headache: mild	0 0%	8.3 69.2%	8.3 69.2%	25.0 208.3%	16.7 139.2%	8.3 69.2%	0 0%
Headache: moderate	8.3 69.2%	16.7 139.2%	0 0%	0 0%	8.3 69.2%	0 0%	8.3 69.2%
Headache: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Nausea: mild	16.7 139.2%	8.3 69.2%	16.7 139.2%	0 0%	8.3 69.2%	8.3 69.2%	0 0%
Nausea: moderate	0 0%	0 0%	0 0%	8.3 69.2%	0 0%	8.3 69.2%	0 0%
Nausea: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Muscle pain: mild	33.3 277.5%	33.3 277.5%	8.3 69.2%	25.0 208.3%	8.3 69.2%	25.0 208.3%	0 0%
Muscle pain:moderate	0 0%	0 0%	0 0%	25.0 208.3%	8.3 69.2%	8.3 69.2%	8.3 69.2%
Muscle pain: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Joint pain: mild	8.3 69.2%	16.7 139.2%	0 0%	16.7 139.2%	8.3 69.2%	8.3 69.2%	0 0%
Joint pain: moderate	8.3 69.2%	16.7 139.2%	0 0%	16.7 139.2%	0 0%	8.3 69.2%	8.3 69.2%
Joint pain: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Vomiting: mild	0 0%	0 0%	8.3 69.2%	0 0%	0 0%	0 0%	0 0%
Vomiting: moderate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Vomiting: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Diarrhea: mild	0 0%	0 0%	16.7 139.2%	0 0%	25.0 208.3%	8.3 69.2%	8.3 69.2%
Diarrhea: moderate	0 0%	0 0%	0 0%	8.3 69.2%	8.3 69.2%	8.3 69.2%	0 0%
Diarrhea: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Description	Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Time Frame	Within 14 days after vaccination 1 on Day 1

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	41	42	41	40	41	41	41	40	41	41	41	41	41
Fever: >=38.0 degree C	0 0%	0 0%	2.4 20%	2.5 20.8%	12.2 101.7%	4.9 40.8%	0 0%	0 0%	2.4 20%	2.4 20%	0 0%	2.4 20%	0 0%
Fever: mild	0 0%	0 0%	0 0%	2.5 20.8%	4.9 40.8%	2.4 20%	0 0%	0 0%	2.4 20%	2.4 20%	0 0%	2.4 20%	0 0%
Fever: moderate	0 0%	0 0%	2.4 20%	0 0%	2.4 20%	2.4 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: severe	0 0%	0 0%	0 0%	0 0%	4.9 40.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fever: Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fatigue: mild	14.6 121.7%	16.7 139.2%	17.1 142.5%	17.5 145.8%	17.1 142.5%	9.8 81.7%	29.3 244.2%	27.5 229.2%	14.6 121.7%	14.6 121.7%	29.3 244.2%	19.5 162.5%	12.2 101.7%
Fatigue: moderate	31.7 264.2%	28.6 238.3%	24.4 203.3%	22.5 187.5%	19.5 162.5%	26.8 223.3%	14.6 121.7%	22.5 187.5%	29.3 244.2%	39.0 325%	19.5 162.5%	22.0 183.3%	19.5 162.5%
Fatigue: severe	2.4 20%	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	2.4 20%	0 0%
Headache: mild	12.2 101.7%	28.6 238.3%	19.5 162.5%	32.5 270.8%	29.3 244.2%	17.1 142.5%	29.3 244.2%	27.5 229.2%	19.5 162.5%	7.3 60.8%	26.8 223.3%	24.4 203.3%	19.5 162.5%
Headache: moderate	29.3 244.2%	21.4 178.3%	19.5 162.5%	10.0 83.3%	19.5 162.5%	24.4 203.3%	17.1 142.5%	20.0 166.7%	29.3 244.2%	29.3 244.2%	17.1 142.5%	14.6 121.7%	12.2 101.7%
Headache: severe	2.4 20%	4.8 40%	0 0%	2.5 20.8%	2.4 20%	7.3 60.8%	0 0%	0 0%	2.4 20%	2.4 20%	2.4 20%	2.4 20%	0 0%
Nausea: mild	4.9 40.8%	7.1 59.2%	12.2 101.7%	12.5 104.2%	9.8 81.7%	19.5 162.5%	7.3 60.8%	7.5 62.5%	14.6 121.7%	14.6 121.7%	2.4 20%	9.8 81.7%	9.8 81.7%
Nausea: moderate	9.8 81.7%	7.1 59.2%	7.3 60.8%	2.5 20.8%	4.9 40.8%	7.3 60.8%	4.9 40.8%	12.5 104.2%	4.9 40.8%	0 0%	7.3 60.8%	7.3 60.8%	4.9 40.8%
Nausea: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	2.4 20%	0 0%	2.4 20%	0 0%
Muscle pain: mild	24.4 203.3%	16.7 139.2%	34.1 284.2%	27.5 229.2%	29.3 244.2%	22.0 183.3%	43.9 365.8%	37.5 312.5%	19.5 162.5%	24.4 203.3%	36.6 305%	26.8 223.3%	12.2 101.7%
Muscle pain: moderate	14.6 121.7%	14.3 119.2%	22.0 183.3%	10.0 83.3%	4.9 40.8%	19.5 162.5%	17.1 142.5%	12.5 104.2%	19.5 162.5%	12.2 101.7%	7.3 60.8%	19.5 162.5%	0 0%
Muscle pain: severe	2.4 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.5 20.8%	2.4 20%	0 0%	4.9 40.8%	4.9 40.8%	0 0%
Joint pain: mild	12.2 101.7%	4.8 40%	14.6 121.7%	2.5 20.8%	12.2 101.7%	4.9 40.8%	14.6 121.7%	12.5 104.2%	7.3 60.8%	4.9 40.8%	9.8 81.7%	7.3 60.8%	4.9 40.8%
Joint pain: moderate	7.3 60.8%	7.1 59.2%	9.8 81.7%	2.5 20.8%	7.3 60.8%	7.3 60.8%	9.8 81.7%	17.5 145.8%	9.8 81.7%	12.2 101.7%	7.3 60.8%	9.8 81.7%	0 0%
Joint pain: severe	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%
Vomiting: mild	2.4 20%	0 0%	0 0%	2.5 20.8%	2.4 20%	2.4 20%	0 0%	0 0%	2.4 20%	0 0%	2.4 20%	2.4 20%	2.4 20%
Vomiting: moderate	0 0%	0 0%	2.4 20%	0 0%	4.9 40.8%	0 0%	2.4 20%	0 0%	0 0%	2.4 20%	2.4 20%	4.9 40.8%	0 0%
Vomiting: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%
Diarrhea: mild	7.3 60.8%	11.9 99.2%	19.5 162.5%	12.5 104.2%	22.0 183.3%	17.1 142.5%	19.5 162.5%	22.5 187.5%	12.2 101.7%	19.5 162.5%	7.3 60.8%	17.1 142.5%	9.8 81.7%
Diarrhea: moderate	7.3 60.8%	11.9 99.2%	4.9 40.8%	2.5 20.8%	2.4 20%	7.3 60.8%	0 0%	2.5 20.8%	2.4 20%	2.4 20%	4.9 40.8%	7.3 60.8%	2.4 20%
Diarrhea: severe	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

8. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Description	Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Time Frame	Within 14 days after vaccination 1 on Day 1

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1 and with e-dairy data available.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	40	40	40	42	40	40	41	41	40	41	42	43	40
Fever: >=38.0 degree C	0 0%	2.5 20.8%	2.5 20.8%	0 0%	0 0%	0 0%	2.4 20%	2.4 20%	2.5 20.8%	2.4 20%	4.8 40%	4.7 39.2%	0 0%
Fever: mild	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	2.4 20%	0 0%	0 0%	4.8 40%	2.3 19.2%	0 0%
Fever: moderate	0 0%	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	0 0%	2.3 19.2%	0 0%
Fever: severe	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%
Fever: Grade 4	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%
Fatigue: mild	7.5 62.5%	12.5 104.2%	12.5 104.2%	26.2 218.3%	10.0 83.3%	7.5 62.5%	14.6 121.7%	14.6 121.7%	22.5 187.5%	19.5 162.5%	23.8 198.3%	20.9 174.2%	7.5 62.5%
Fatigue: moderate	12.5 104.2%	10.0 83.3%	15.0 125%	11.9 99.2%	12.5 104.2%	10.0 83.3%	19.5 162.5%	14.6 121.7%	20.0 166.7%	4.9 40.8%	21.4 178.3%	4.7 39.2%	7.5 62.5%
Fatigue: severe	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	2.5 20.8%	0 0%	2.4 20%	0 0%	2.4 20%	2.4 20%	0 0%	0 0%
Headache: mild	17.5 145.8%	7.5 62.5%	7.5 62.5%	14.3 119.2%	15.0 125%	12.5 104.2%	7.3 60.8%	22.0 183.3%	10.0 83.3%	24.4 203.3%	21.4 178.3%	9.3 77.5%	20.0 166.7%
Headache: moderate	7.5 62.5%	5.0 41.7%	5.0 41.7%	2.4 20%	2.5 20.8%	5.0 41.7%	2.4 20%	2.4 20%	5.0 41.7%	2.4 20%	11.9 99.2%	11.6 96.7%	2.5 20.8%
Headache: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%
Nausea: mild	5.0 41.7%	7.5 62.5%	2.5 20.8%	0 0%	5.0 41.7%	5.0 41.7%	7.3 60.8%	4.9 40.8%	7.5 62.5%	9.8 81.7%	2.4 20%	2.3 19.2%	5.0 41.7%
Nausea: moderate	0 0%	2.5 20.8%	0 0%	2.4 20%	0 0%	0 0%	2.4 20%	14.6 121.7%	5.0 41.7%	0 0%	4.8 40%	2.3 19.2%	0 0%
Nausea: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%
Muscle pain: mild	15.0 125%	7.5 62.5%	10.0 83.3%	14.3 119.2%	15.0 125%	5.0 41.7%	14.6 121.7%	19.5 162.5%	17.5 145.8%	17.1 142.5%	19.0 158.3%	4.7 39.2%	7.5 62.5%
Muscle pain: moderate	2.5 20.8%	7.5 62.5%	5.0 41.7%	2.4 20%	7.5 62.5%	7.5 62.5%	4.9 40.8%	4.9 40.8%	15.0 125%	9.8 81.7%	16.7 139.2%	16.3 135.8%	0 0%
Muscle pain: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	2.4 20%	0 0%	0 0%	2.5 20.8%
Joint pain: mild	12.5 104.2%	10.0 83.3%	5.0 41.7%	9.5 79.2%	10.0 83.3%	7.5 62.5%	7.3 60.8%	7.3 60.8%	12.5 104.2%	7.3 60.8%	21.4 178.3%	2.3 19.2%	7.5 62.5%
Joint pain: moderate	7.5 62.5%	5.0 41.7%	5.0 41.7%	9.5 79.2%	5.0 41.7%	7.5 62.5%	4.9 40.8%	7.3 60.8%	0 0%	9.8 81.7%	7.1 59.2%	4.7 39.2%	7.5 62.5%
Joint pain: severe	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	4.9 40.8%	0 0%	0 0%	0 0%	0 0%	0 0%
Vomiting: mild	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	2.5 20.8%	0 0%	0 0%	2.3 19.2%	0 0%
Vomiting: moderate	0 0%	2.5 20.8%	0 0%	0 0%	0 0%	0 0%	0 0%	4.9 40.8%	2.5 20.8%	2.4 20%	0 0%	0 0%	0 0%
Vomiting: severe	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%
Diarrhea: mild	5.0 41.7%	15.0 125%	20.0 166.7%	7.1 59.2%	5.0 41.7%	2.5 20.8%	7.3 60.8%	7.3 60.8%	17.5 145.8%	7.3 60.8%	14.3 119.2%	2.3 19.2%	5.0 41.7%
Diarrhea: moderate	2.5 20.8%	2.5 20.8%	2.5 20.8%	2.4 20%	5.0 41.7%	2.5 20.8%	2.4 20%	7.3 60.8%	7.5 62.5%	2.4 20%	0 0%	4.7 39.2%	0 0%
Diarrhea: severe	0 0%	0 0%	0 0%	2.4 20%	0 0%	0 0%	0 0%	0 0%	0 0%	2.4 20%	0 0%	2.3 19.2%	2.5 20.8%

9. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 1 month after vaccination (up to 35 days)

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
Number (95% Confidence Interval) [Percentage of participants]	16.7 139.2%	16.7 139.2%	0 0%	0 0%	8.3 69.2%	16.7 139.2%	8.3 69.2%

10. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 1 month after vaccination (up to 35 days)

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years
Arm/Group Description	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
Number (95% Confidence Interval) [Percentage of participants]	25.0 208.3%	25.0 208.3%	8.3 69.2%	0 0%	0 0%	8.3 69.2%	0.0 0%

11. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 1 month after vaccination 1 (up to 35 days)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	41	42	41	40	41	41	41	41	41	41	41	41	41
Number (95% Confidence Interval) [Percentage of participants]	17.1 142.5%	16.7 139.2%	14.6 121.7%	22.5 187.5%	24.4 203.3%	22.0 183.3%	7.3 60.8%	22.0 183.3%	9.8 81.7%	12.2 101.7%	12.2 101.7%	17.1 142.5%	9.8 81.7%

12. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 1 month after vaccination 1 (up to 35 days)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	40	41	40	42	40	40	41	41	40	41	42	43	41
Number (95% Confidence Interval) [Percentage of participants]	10.0 83.3%	14.6 121.7%	5.0 41.7%	26.2 218.3%	22.5 187.5%	20.0 166.7%	14.6 121.7%	14.6 121.7%	15.0 125%	9.8 81.7%	11.9 99.2%	16.3 135.8%	12.2 101.7%

13. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
Description	MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Upto 12 months after vaccination (up to 378 days)

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
MAEs	33.3 277.5%	0 0%	25.0 208.3%	16.7 139.2%	8.3 69.2%	25.0 208.3%	16.7 139.2%
SAEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

14. Primary Outcome

Title	Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
Description	MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Upto 12 months after vaccination (upto 378 days)

Outcome Measure Data

Analysis Population Description

All participants in sentinel cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years:	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years
Arm/Group Description	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	12
MAEs	25.0 208.3%	50.0 416.7%	25.0 208.3%	25.0 208.3%	25.0 208.3%	16.7 139.2%	16.7 139.2%
SAEs	0 0%	0 0%	0 0%	0 0%	8.3 69.2%	16.7 139.2%	0 0%

15. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
Description	MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Upto 12 months after vaccination 1 (upto 378 days)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	41	42	41	40	41	41	41	41	41	41	41	41	41
MAEs	22.0 183.3%	14.3 119.2%	9.8 81.7%	17.5 145.8%	22.0 183.3%	19.5 162.5%	12.2 101.7%	24.4 203.3%	24.4 203.3%	22.0 183.3%	24.4 203.3%	22.0 183.3%	22.0 183.3%
SAEs	2.4 20%	0 0%	0 0%	2.5 20.8%	2.4 20%	4.9 40.8%	0 0%	4.9 40.8%	4.9 40.8%	2.4 20%	2.4 20%	7.3 60.8%	2.4 20%

16. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
Description	MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Upto 12 months after vaccination 1 (upto 378 days)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	40	41	40	42	40	40	41	41	40	41	42	43	41
MAEs	15.0 125%	24.4 203.3%	30.0 250%	31.0 258.3%	22.5 187.5%	22.5 187.5%	17.1 142.5%	34.1 284.2%	47.5 395.8%	43.9 365.8%	28.6 238.3%	25.6 213.3%	14.6 121.7%
SAEs	5.0 41.7%	17.1 142.5%	10.0 83.3%	19.0 158.3%	10.0 83.3%	5.0 41.7%	17.1 142.5%	4.9 40.8%	10.0 83.3%	7.3 60.8%	7.1 59.2%	7.0 58.3%	7.3 60.8%

17. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Time Frame	Within 1 month after vaccination 2 (upto Day 70)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	41	42	41	40	41	41	41	41	41	41	41	41	41
Number (95% Confidence Interval) [Percentage of participants]	19.5 162.5%	14.3 119.2%	19.5 162.5%	10.0 83.3%	7.3 60.8%	17.1 142.5%	22.0 183.3%	14.6 121.7%	26.8 223.3%	26.8 223.3%	19.5 162.5%	17.1 142.5%	9.8 81.7%

18. Primary Outcome

Title	Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
Description	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Time Frame	Within 1 month after vaccination 2 (upto Day 70)

Outcome Measure Data

Analysis Population Description

All participants in expanded cohort who received at least 1 dose of the investigational products at Visit 1.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	40	41	40	42	40	40	41	41	40	41	42	43	41
Number (95% Confidence Interval) [Percentage of participants]	10.0 83.3%	7.3 60.8%	20.0 166.7%	21.4 178.3%	25.0 208.3%	30.0 250%	12.2 101.7%	9.8 81.7%	32.5 270.8%	24.4 203.3%	11.9 99.2%	18.6 155%	17.1 142.5%

19. Secondary Outcome

Title	Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Description	GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population (EIP): participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 120 mcg Age 18-49 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: RSV 240 mcg Age 18-49 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years	Sentinel Cohort: Placebo Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	11	11	12
RSV A: before vaccination 1	1319	1754	1090	1531	2029	1553	1229
RSV A: 2 Weeks after vaccination 1	20936	24970	31584	31193	44866	52339	2817
RSV A: 1 Month after vaccination 1	16730	20512	10021	16521	27892	28453	2430
RSV A: 2 Months after vaccination 1	12702	28577	11171	15529	23033	18883	1851
RSV A:3 Months after vaccination 1	8258	15276	10800	12421	19654	12922	1560
RSV A:6 Months after vaccination 1	11466	22737	12034	9707	13672	8237	2658
RSV A: 12 Months after vaccination 1	4430	11052	6147	5849	9851	8707	2043
RSV B: before vaccination 1	1427	2077	995	1670	1600	1492	1393
RSV B: 2 Weeks after vaccination 1	23974	22491	32104	42222	59752	59955	2817
RSV B: 1 Month after vaccination 1	18932	19197	8510	18080	26759	29668	1861
RSV B: 2 Months after vaccination 1	13959	28374	8760	16167	19534	18280	1604
RSV B: 3 Months after vaccination 1	9688	12697	8833	11986	16706	11588	1613
RSV B: 6 Months after vaccination 1	15235	16492	10918	11658	11857	7435	2865
RSV B: 12 Months after vaccination 1	4674	9274	4127	5392	8565	7373	1970

20. Secondary Outcome

Title	Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
Description	GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination

Outcome Measure Data

Analysis Population Description

EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.

Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years	Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 120 mcg Age 50-85 Years	Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: RSV 240 mcg Age 50-85 Years	Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years	Sentinel Cohort: Placebo Age 50-85 Years
Arm/Group Description	Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.	Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.
Measure Participants	12	12	12	12	12	12	11
RSV A: before vaccination 1	1904	1672	2056	1923	1923	1564	2359
RSV A: 2 Weeks after vaccination 1	17464	22594	31946	30618	29812	40272	2233
RSV A: 1 Month after vaccination 1	21116	21788	23161	20499	24481	36197	2675
RSV A: 2 Months after vaccination 1	15025	10949	16441	10493	12659	13723	1502
RSV A:3 Months after vaccination 1	9792	12202	11476	11561	11195	12747	1543
RSV A:6 Months after vaccination 1	12290	10213	12795	12172	7083	9417	1945
RSV A: 12 Months after vaccination 1	9446	7507	8484	10709	2705	4145	2341
RSV B: before vaccination 1	2573	1139	1190	1568	2144	1417	2285
RSV B: 2 Weeks after vaccination 1	27923	19751	25820	33779	47514	41776	2441
RSV B: 1 Month after vaccination 1	27789	21429	16610	19632	32668	37852	3104
RSV B: 2 Months after vaccination 1	19061	10713	11284	9247	15567	12441	1461
RSV B: 3 Months after vaccination 1	12225	10364	7190	11138	12998	11726	1436
RSV B: 6 Months after vaccination 1	16998	11281	8636	12541	6949	8066	1920
RSV B: 12 Months after vaccination 1	9721	5801	6174	8589	3230	2918	2188

21. Secondary Outcome

Title	Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Description	GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination, 1, 2, 3, 6 and 12 months after vaccination

Outcome Measure Data

Analysis Population Description

EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	39	39	40	38	40	40	39	38	40	39	41	40	41
RSV A: before vaccination 1	1998	1471	1518	1768	1297	1713	1862	1933	1733	1640	1522	1625	1750
RSV A: 1 Month after vaccination 1	17482	21728	17460	18064	17760	22628	26465	25860	23783	29332	21196	26938	1883
RSV A: 2 Months after vaccination 1	10247	11976	10326	12522	9595	14140	15754	13518	13790	14999	11533	12812	1252
RSV A:3 Months after vaccination 1	11164	12664	12042	12773	9205	13801	15360	13663	11805	14570	12273	10764	1718
RSV A:6 Months after vaccination 1	8403	8118	9568	9533	6492	10324	10005	10237	7768	10343	8823	8210	2031
RSV A: 12 Months after vaccination 1	7679	7050	7640	9062	4889	8435	9174	8231	6919	6983	6769	5658	1994
RSV B: before vaccination 1	1847	1475	1516	1586	1460	1502	1739	1733	1480	1520	1363	1584	1783
RSV B: 1 Month after vaccination 1	17583	19561	18762	16835	18929	24395	23560	22928	23481	31571	21150	28166	1748
RSV B: 2 Months after vaccination 1	10259	11771	11441	11253	10486	14223	15173	11716	12850	16485	11148	14024	1447
RSV B: 3 Months after vaccination 1	11694	12016	12852	11719	9953	13011	13364	11333	10567	14638	10322	11146	1839
RSV B: 6 Months after vaccination 1	8102	8411	9954	8667	6640	9482	9702	8836	7244	11073	8235	8856	2171
RSV B: 12 Months after vaccination 1	7539	7413	7651	7629	5778	7747	8492	7177	6078	7086	6133	5494	2017

22. Secondary Outcome

Title	Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
Description	GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination, 1, 2, 3, 6 and 12 months after vaccination

Outcome Measure Data

Analysis Population Description

EIP: participants who were eligible, received all RSV vaccine or placebo to which they were randomized, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations. Here, "number analyzed" signifies participants evaluable at specific rows.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	38	40	40	40	38	40	40	40	40	38	41	43	39
RSV A: before vaccination 1	2129	2096	2064	2461	2269	2269	2578	2089	2203	1965	1793	2734	1585
RSV A: 1 Month after vaccination 1	16007	20417	14905	19625	25065	22318	23566	27600	22184	21601	23510	25815	1697
RSV A: 2 Months after vaccination 1	9452	13199	9922	15484	16288	12740	11939	15840	14438	14542	16797	17410	1414
RSV A:3 Months after vaccination 1	12010	14230	10362	15345	16637	14957	13675	16424	16089	12200	15291	16265	1772
RSV A:6 Months after vaccination 1	8452	11903	8444	10827	11871	10202	10226	13148	10769	9495	10578	11268	2057
RSV A: 12 Months after vaccination 1	7732	7891	6518	9143	7942	8639	7731	9340	9738	5872	6946	8919	1931
RSV B: before vaccination 1	2198	1862	1999	2423	2314	2194	2685	2032	2586	2241	1635	2390	1766
RSV B: 1 Month after vaccination 1	15172	20553	15169	20421	24257	18648	24158	30071	27996	25080	24320	25719	1664
RSV B: 2 Months after vaccination 1	9162	14085	9928	16107	14496	10893	11605	17024	17255	16376	17706	17268	1413
RSV B: 3 Months after vaccination 1	12578	13735	9741	15856	14163	11927	13631	16675	18557	13452	15031	14645	1995
RSV B: 6 Months after vaccination 1	8429	11417	7869	11739	10606	9270	10384	13562	11710	10597	10645	10875	2374
RSV B: 12 Months after vaccination 1	7467	7969	6445	9200	7573	6634	7449	9256	9855	6809	7001	8500	2058

23. Secondary Outcome

Title	Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
Description	The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination and 1 Month after SIIV vaccination

Outcome Measure Data

Analysis Population Description

Evaluable influenza immunogenicity population (EIIP) : participants who were eligible, received all RSV vaccine or placebo to which they were randomized, received influenza vaccine, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years
Arm/Group Description	Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	39	33	40	32	40	33	39	33	40	36	41	31	34
A-H1N1: before SIIV	44.5	25.0	38.0	33.7	18.9	27.0	29.6	26.1	20.5	28.7	32.1	22.7	33.5
A-H1N1: 1 month after SIIV	77.2	95.3	85.8	114.0	62.4	113.5	70.2	128.8	57.2	83.6	72.3	114.4	126.9
A-H3N2: before SIIV	35.1	25.4	32.7	35.7	23.9	28.8	30.3	25.7	20.9	22.4	32.3	20.3	34.4
A-H3N2: 1 month after SIIV	77.7	129.6	81.4	158.8	85.2	120.0	74.5	130.6	81.4	82.1	95.8	134.8	152.5
B1: before SIIV	13.2	10.3	10.8	13.3	7.3	13.0	8.7	9.5	8.3	9.4	12.6	9.2	10.5
B1: 1 month after SIIV	23.5	41.7	29.3	47.2	18.4	38.4	19.1	32.7	15.5	22.3	23.8	25.6	31.8
B2: before SIIV	16.3	11.7	12.5	18.4	9.3	12.8	11.5	10.6	10.4	12.3	11.6	11.2	13.1
B2: 1 month after SIIV	29.0	39.4	27.8	46.9	22.6	28.4	22.3	39.7	20.1	28.7	25.9	37.5	36.2

24. Secondary Outcome

Title	Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
Description	The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Time Frame	Before vaccination and 1 Month after SIIV vaccination

Outcome Measure Data

Analysis Population Description

EIIP : participants who were eligible, received all RSV vaccine or placebo to which they were randomized, received influenza vaccine, had blood drawn for assay testing within 27 to 42 days after Visit 1, had at least 1 valid and determinate assay result at 1-month-postvaccination visit and no major protocol violations.

Arm/Group Title	Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years	Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years	Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.	Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.	Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
Measure Participants	38	35	40	36	38	37	40	37	40	33	41	35	34
A-H1N1: before SIIV	13.8	14.8	11.0	13.4	16.6	12.3	17.5	14.4	17.8	15.2	15.6	22.5	17.6
A-H1N1: 1 month after SIIV	43.6	54.5	44.4	61.9	52.9	51.1	56.6	71.0	45.7	58.4	52.4	72.0	75.8
A-H3N2: before SIIV	29.7	24.7	26.2	22.9	34.6	23.5	30.5	35.7	22.5	32.6	34.7	44.5	28.7
A-H3N2: 1 month after SIIV	94.3	105.6	78.2	118.3	140.0	109.3	131.5	185.0	79.0	153.4	103.1	130.4	106.4
B1: before SIIV	9.4	8.6	12.9	8.5	11.1	10.4	11.5	8.7	8.7	8.5	9.5	8.6	9.1
B1: 1 month after SIIV	19.5	26.4	22.9	31.7	24.7	23.4	26.2	21.6	18.9	29.4	21.2	23.1	26.8
B2: before SIIV	7.7	7.7	9.6	8.0	10.6	8.2	9.9	6.9	7.9	8.3	8.6	8.4	7.3
B2: 1 month after SIIV	10.4	11.0	13.0	12.4	16.6	13.2	13.3	10.0	9.7	15.3	10.9	13.2	13.2

Adverse Events

Time Frame	Local reactions and systemic events collected as Non-SAEs: within 14 days after Vaccination (Vax) 1 and Vax 3 (for revaccination); Other Non-SAEs: Vax 1 up to 1 month after Vax 1, Vax 3 up to 1 month after Vax 3 for revaccination; SAEs: Vax 1 up to 12 months after Vax 1 (approximately up to 378 days), Vax 1 up to 12 months after Vax 3 for revaccination (approximately up to 798 days)
Adverse Event Reporting Description	Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Arm/Group Title	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years		Sentinel Cohort: RSV 120 mcg Age 18-49 Years		Sentinel Cohort: RSV 240 mcg Age 18-49 Years		Sentinel Cohort: Placebo Age 18-49 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years		Sentinel Cohort: RSV 120 mcg Age 50-85 Years		Sentinel Cohort: RSV 240 mcg Age 50-85 Years		Sentinel Cohort: Placebo Age 50-85 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
Arm/Group Description	Participants aged 18-49 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received single 60-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received single 120-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received single 240-mcg dose with aluminum hydroxide intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 60-mcg dose of RSV vaccine, intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 120-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received single 240-mcg dose intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 50-85 years received placebo matched to RSV vaccine intramuscularly. Participants were followed up to 12 months after vaccination.		Participants aged 18-49 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 18-49 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 65-85 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 18-49 years received RSV vaccine 60 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 120 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 120 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 18-49 years received RSV vaccine 240 mcg along with placebo (saline control) at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3		Participants aged 18-49 years received RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV Intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 65-85 years received RSV vaccine 60 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 60 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 120 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 120 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.		Participants aged 65-85 years received RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 65-85 years received RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly at Day 1 (Vaccination 1). Participants received placebo (saline control) intramuscularly at Day 35 (Vaccination 2). Participants were followed up to 12 months after vaccination 1. Participants who consented were revaccinated with RSV vaccine 240 mcg along with aluminum hydroxide and 0.5 mL SIIV intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received placebo (saline control) intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.		Participants aged 65-85 years received placebo (saline control) and placebo (saline control) intramuscularly at Day 1 (Vaccination 1). Participants received 0.5 mL SIIV intramuscularly at Day 35 (Vaccination 2). Participants who consented were revaccinated with placebo (saline control) and placebo (saline control) intramuscularly after 12 months of Vaccination 1 (Vaccination 3) and received 0.5 mL SIIV intramuscularly at 35 days post Vaccination 3 (Vaccination 4). Participants were followed up to 12 months after Vaccination 3.
All Cause Mortality
	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years		Sentinel Cohort: RSV 120 mcg Age 18-49 Years		Sentinel Cohort: RSV 240 mcg Age 18-49 Years		Sentinel Cohort: Placebo Age 18-49 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years		Sentinel Cohort: RSV 120 mcg Age 50-85 Years		Sentinel Cohort: RSV 240 mcg Age 50-85 Years		Sentinel Cohort: Placebo Age 50-85 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Serious Adverse Events
	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years		Sentinel Cohort: RSV 120 mcg Age 18-49 Years		Sentinel Cohort: RSV 240 mcg Age 18-49 Years		Sentinel Cohort: Placebo Age 18-49 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years		Sentinel Cohort: RSV 120 mcg Age 50-85 Years		Sentinel Cohort: RSV 240 mcg Age 50-85 Years		Sentinel Cohort: Placebo Age 50-85 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		2/12 (16.7%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		2/41 (4.9%)		1/41 (2.4%)		2/41 (4.9%)		7/41 (17.1%)		8/42 (19%)		2/40 (5%)		2/41 (4.9%)		5/41 (12.2%)		3/43 (7%)		0/42 (0%)		1/40 (2.5%)		2/41 (4.9%)		2/41 (4.9%)		3/41 (7.3%)		3/41 (7.3%)		2/40 (5%)		4/40 (10%)		4/40 (10%)		7/41 (17.1%)		5/40 (12.5%)		4/42 (9.5%)		3/41 (7.3%)
Blood and lymphatic system disorders
Anaemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Cardiac disorders
Atrial fibrillation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		2/40 (5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Cardiac failure congestive	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Coronary artery disease	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Myocardial infarction	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Sinus node dysfunction	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastrointestinal disorders
Abdominal pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Colitis ischaemic	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastrointestinal haemorrhage	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Ileus	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Proctitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Upper gastrointestinal haemorrhage	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Diverticular perforation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
General disorders
Chest pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Pyrexia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hepatobiliary disorders
Cholecystitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Infections and infestations
Abscess limb	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cellulitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Escherichia bacteraemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastroenteritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Influenza	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Osteomyelitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pneumonia bacterial	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rhinovirus infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Viral sepsis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
COVID-19	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Pneumonia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		1/41 (2.4%)
Injury, poisoning and procedural complications
Contusion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Gun shot wound	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Maisonneuve fracture	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rib fracture	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Subdural haematoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Toxicity to various agents	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Metabolism and nutrition disorders
Fluid retention	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Lactic acidosis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hyperkalaemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Musculoskeletal and connective tissue disorders
Neck pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Osteoarthritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rotator cuff syndrome	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Invasive breast carcinoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Lung carcinoma cell type unspecified stage IV	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Lung neoplasm malignant	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Oesophageal cancer metastatic	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Prostate cancer	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Sarcoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Tonsil cancer	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rectal adenocarcinoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nervous system disorders
Autonomic failure syndrome	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Brain injury	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cerebrovascular accident	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		1/41 (2.4%)
Seizure	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Syncope	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Ectopic pregnancy	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pregnancy	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Psychiatric disorders
Completed suicide	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Depression suicidal	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Mental status changes	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Suicide attempt	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Renal and urinary disorders
Acute kidney injury	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Reproductive system and breast disorders
Dysmenorrhoea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Asthma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Chronic obstructive pulmonary disease	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hypoxia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pulmonary embolism	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Social circumstances
Pregnancy of partner	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Surgical and medical procedures
Hip arthroplasty	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vascular disorders
Deep vein thrombosis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Sentinel Cohort: RSV Vaccine 60 mcg Age 18-49 Years		Sentinel Cohort: RSV 120 mcg Age 18-49 Years		Sentinel Cohort: RSV 240 mcg Age 18-49 Years		Sentinel Cohort: Placebo Age 18-49 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 50-85 Years		Sentinel Cohort: RSV 60 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 120 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV 240 mcg With Aluminum Hydroxide Age 18-49 Years		Sentinel Cohort: RSV Vaccine 60 mcg Age 50-85 Years		Sentinel Cohort: RSV 120 mcg Age 50-85 Years		Sentinel Cohort: RSV 240 mcg Age 50-85 Years		Sentinel Cohort: Placebo Age 50-85 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 18-49 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 18-49 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and Placebo and SIIV Age 18-49 Years		Expanded Cohort: RSV 60 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 60 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 120 mcg With SIIV and Placebo Age 65-85 Years:		Expanded Cohort: RSV 120 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With SIIV and Placebo Age 65-85 Years		Expanded Cohort: RSV 240 mcg With Aluminum Hydroxide and SIIV and Placebo Age 65-85 Years		Expanded Cohort: Placebo and Placebo and SIIV Age 65-85 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	9/12 (75%)		6/12 (50%)		7/12 (58.3%)		6/12 (50%)		7/12 (58.3%)		7/12 (58.3%)		8/12 (66.7%)		10/12 (83.3%)		11/12 (91.7%)		9/12 (75%)		8/12 (66.7%)		5/12 (41.7%)		5/12 (41.7%)		4/12 (33.3%)		31/41 (75.6%)		36/41 (87.8%)		33/41 (80.5%)		35/41 (85.4%)		35/41 (85.4%)		35/41 (85.4%)		31/41 (75.6%)		24/41 (58.5%)		27/42 (64.3%)		22/40 (55%)		25/41 (61%)		28/41 (68.3%)		33/43 (76.7%)		32/42 (76.2%)		30/40 (75%)		33/41 (80.5%)		35/41 (85.4%)		32/41 (78%)		38/41 (92.7%)		22/40 (55%)		20/40 (50%)		21/40 (52.5%)		21/41 (51.2%)		32/40 (80%)		29/42 (69%)		21/41 (51.2%)
Blood and lymphatic system disorders
Anaemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Lymphadenitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Lymphadenopathy	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Thrombocytopenia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cardiac disorders
Atrial fibrillation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Ear and labyrinth disorders
Ear pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vertigo	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vertigo positional	1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Eye disorders
Eye irritation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Diarrhoea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		2/41 (4.9%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		1/42 (2.4%)		1/41 (2.4%)
Diarrhoea (DIARRHEA)	1/12 (8.3%)		2/12 (16.7%)		3/11 (27.3%)		1/12 (8.3%)		0/12 (0%)		1/12 (8.3%)		2/12 (16.7%)		3/12 (25%)		2/12 (16.7%)		1/12 (8.3%)		0/12 (0%)		2/12 (16.7%)		4/12 (33.3%)		1/12 (8.3%)		6/41 (14.6%)		10/41 (24.4%)		10/41 (24.4%)		8/41 (19.5%)		11/41 (26.8%)		9/41 (22%)		6/41 (14.6%)		7/40 (17.5%)		5/42 (11.9%)		2/40 (5%)		6/41 (14.6%)		5/41 (12.2%)		7/43 (16.3%)		10/42 (23.8%)		7/40 (17.5%)		10/41 (24.4%)		10/40 (25%)		11/41 (26.8%)		14/41 (34.1%)		3/40 (7.5%)		9/40 (22.5%)		4/40 (10%)		4/41 (9.8%)		10/40 (25%)		8/42 (19%)		6/40 (15%)
Food poisoning	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastrooesophageal reflux disease	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Glossodynia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nausea	1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Paraesthesia oral	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Toothache	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Vomiting	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		3/41 (7.3%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		1/42 (2.4%)		0/41 (0%)
Nausea (NAUSEA)	4/12 (33.3%)		2/12 (16.7%)		2/11 (18.2%)		0/12 (0%)		1/12 (8.3%)		1/12 (8.3%)		2/12 (16.7%)		0/12 (0%)		2/12 (16.7%)		3/12 (25%)		2/12 (16.7%)		2/12 (16.7%)		1/12 (8.3%)		0/12 (0%)		6/41 (14.6%)		8/41 (19.5%)		6/41 (14.6%)		5/41 (12.2%)		12/41 (29.3%)		4/41 (9.8%)		8/41 (19.5%)		4/40 (10%)		1/42 (2.4%)		2/40 (5%)		8/41 (19.5%)		6/41 (14.6%)		3/43 (7%)		6/42 (14.3%)		6/40 (15%)		11/41 (26.8%)		9/40 (22.5%)		7/41 (17.1%)		10/41 (24.4%)		2/40 (5%)		1/40 (2.5%)		2/40 (5%)		4/41 (9.8%)		7/40 (17.5%)		5/42 (11.9%)		3/40 (7.5%)
Vomiting (VOMITING)	1/12 (8.3%)		0/12 (0%)		2/11 (18.2%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		1/41 (2.4%)		3/41 (7.3%)		1/41 (2.4%)		2/41 (4.9%)		3/41 (7.3%)		1/41 (2.4%)		2/40 (5%)		0/42 (0%)		0/40 (0%)		3/41 (7.3%)		1/41 (2.4%)		1/43 (2.3%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		1/40 (2.5%)		1/41 (2.4%)		4/41 (9.8%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		2/40 (5%)		0/42 (0%)		1/40 (2.5%)
General disorders
Chest pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Chills	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Fatigue	1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		2/41 (4.9%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site bruising	1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site erythema	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site erythema (REDNESS)	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		2/12 (16.7%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		2/41 (4.9%)		3/41 (7.3%)		4/41 (9.8%)		1/41 (2.4%)		2/40 (5%)		4/42 (9.5%)		3/40 (7.5%)		1/41 (2.4%)		6/41 (14.6%)		3/43 (7%)		3/42 (7.1%)		1/40 (2.5%)		2/41 (4.9%)		3/40 (7.5%)		2/41 (4.9%)		6/41 (14.6%)		3/40 (7.5%)		1/40 (2.5%)		3/40 (7.5%)		2/41 (4.9%)		2/40 (5%)		1/42 (2.4%)		0/40 (0%)
Injection site haemorrhage	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Injection site pain (PAIN AT INJECTION SITE)	6/12 (50%)		3/12 (25%)		2/11 (18.2%)		2/12 (16.7%)		3/12 (25%)		5/12 (41.7%)		2/12 (16.7%)		9/12 (75%)		10/12 (83.3%)		8/12 (66.7%)		2/12 (16.7%)		1/12 (8.3%)		1/12 (8.3%)		0/12 (0%)		19/41 (46.3%)		28/41 (68.3%)		19/41 (46.3%)		25/41 (61%)		27/41 (65.9%)		30/41 (73.2%)		10/41 (24.4%)		4/40 (10%)		10/42 (23.8%)		5/40 (12.5%)		8/41 (19.5%)		16/41 (39%)		16/43 (37.2%)		16/42 (38.1%)		21/40 (52.5%)		21/41 (51.2%)		27/40 (67.5%)		24/41 (58.5%)		30/41 (73.2%)		11/40 (27.5%)		11/40 (27.5%)		9/40 (22.5%)		12/41 (29.3%)		17/40 (42.5%)		17/42 (40.5%)		2/40 (5%)
Injection site pruritus	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site swelling	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Injection site swelling (SWELLING)	0/12 (0%)		0/12 (0%)		0/11 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		1/12 (8.3%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		2/41 (4.9%)		0/41 (0%)		2/41 (4.9%)		1/41 (2.4%)		5/41 (12.2%)		4/41 (9.8%)		0/41 (0%)		2/40 (5%)		2/42 (4.8%)		2/40 (5%)		1/41 (2.4%)		4/41 (9.8%)		5/43 (11.6%)		4/42 (9.5%)		1/40 (2.5%)		4/41 (9.8%)		2/40 (5%)		2/41 (4.9%)		10/41 (24.4%)		3/40 (7.5%)		0/40 (0%)		3/40 (7.5%)		1/41 (2.4%)		4/40 (10%)		5/42 (11.9%)		1/40 (2.5%)
Malaise	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Oedema peripheral	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Pyrexia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pyrexia (FEVER)	0/12 (0%)		0/12 (0%)		0/11 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		5/41 (12.2%)		0/41 (0%)		2/41 (4.9%)		0/41 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		1/41 (2.4%)		3/43 (7%)		0/42 (0%)		1/40 (2.5%)		2/41 (4.9%)		0/40 (0%)		2/41 (4.9%)		1/41 (2.4%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		1/41 (2.4%)		2/40 (5%)		2/42 (4.8%)		0/40 (0%)
Sensation of foreign body	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Fatigue (FATIGUE)	5/12 (41.7%)		5/12 (41.7%)		6/11 (54.5%)		3/12 (25%)		7/12 (58.3%)		4/12 (33.3%)		3/12 (25%)		6/12 (50%)		7/12 (58.3%)		7/12 (58.3%)		5/12 (41.7%)		4/12 (33.3%)		1/12 (8.3%)		4/12 (33.3%)		20/41 (48.8%)		17/41 (41.5%)		16/41 (39%)		18/41 (43.9%)		21/41 (51.2%)		24/41 (58.5%)		18/41 (43.9%)		10/40 (25%)		16/42 (38.1%)		8/40 (20%)		13/41 (31.7%)		12/41 (29.3%)		16/43 (37.2%)		19/42 (45.2%)		16/40 (40%)		15/41 (36.6%)		20/40 (50%)		25/41 (61%)		20/41 (48.8%)		8/40 (20%)		11/40 (27.5%)		9/40 (22.5%)		14/41 (34.1%)		20/40 (50%)		21/42 (50%)		8/40 (20%)
Hepatobiliary disorders
Cholelithiasis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hyperbilirubinaemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Immune system disorders
Seasonal allergy	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Infections and infestations
Bronchitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Bronchitis viral	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cellulitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Conjunctivitis bacterial	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cystitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Ear infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Folliculitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Furuncle	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastroenteritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gastroenteritis viral	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Herpes zoster	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		2/40 (5%)		0/42 (0%)		0/41 (0%)
Infected cyst	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Influenza	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nasopharyngitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Oral herpes	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Otitis externa	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Otitis media	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pharyngitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Pneumonia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Respiratory tract infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		2/41 (4.9%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		2/41 (4.9%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		2/41 (4.9%)
Respiratory tract infection viral	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Sinusitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Tooth abscess	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Upper respiratory tract infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		3/41 (7.3%)		3/41 (7.3%)		0/41 (0%)		0/41 (0%)		3/41 (7.3%)		1/41 (2.4%)		0/41 (0%)		1/42 (2.4%)		1/40 (2.5%)		0/41 (0%)		1/41 (2.4%)		1/43 (2.3%)		2/42 (4.8%)		3/40 (7.5%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		2/41 (4.9%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Urinary tract infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		2/40 (5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vaginal infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vestibular neuronitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Viral infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Viral pharyngitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Viral upper respiratory tract infection	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Sinusitis bacterial	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Osteomyelitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Concussion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Contusion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Epicondylitis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Face injury	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Fall	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		2/41 (4.9%)		1/41 (2.4%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		1/41 (2.4%)		1/40 (2.5%)		1/42 (2.4%)		0/41 (0%)
Jaw fracture	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Joint injury	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Limb injury	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Procedural pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Skin laceration	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Investigations
Alanine aminotransferase increased	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Aspartate aminotransferase increased	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Blood pressure systolic decreased	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Diabetes mellitus inadequate control	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Gout	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hyperglycaemia	0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hypokalaemia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Type 2 diabetes mellitus	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		2/40 (5%)		1/41 (2.4%)		2/40 (5%)		0/42 (0%)		1/41 (2.4%)
Arthralgia (JOINT PAIN)	1/12 (8.3%)		2/12 (16.7%)		2/11 (18.2%)		1/12 (8.3%)		4/12 (33.3%)		4/12 (33.3%)		2/12 (16.7%)		1/12 (8.3%)		2/12 (16.7%)		2/12 (16.7%)		2/12 (16.7%)		0/12 (0%)		1/12 (8.3%)		1/12 (8.3%)		8/41 (19.5%)		11/41 (26.8%)		8/41 (19.5%)		10/41 (24.4%)		11/41 (26.8%)		9/41 (22%)		5/41 (12.2%)		7/40 (17.5%)		8/42 (19%)		6/40 (15%)		8/41 (19.5%)		7/41 (17.1%)		6/43 (14%)		5/42 (11.9%)		2/40 (5%)		5/41 (12.2%)		12/40 (30%)		11/41 (26.8%)		9/41 (22%)		8/40 (20%)		4/40 (10%)		6/40 (15%)		5/41 (12.2%)		6/40 (15%)		14/42 (33.3%)		7/40 (17.5%)
Arthritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Back pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Haemarthrosis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Intervertebral disc degeneration	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Intervertebral disc protrusion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Limb discomfort	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Muscle spasms	0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Musculoskeletal chest pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Myalgia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Myalgia (MUSCLE PAIN)	6/12 (50%)		4/12 (33.3%)		2/11 (18.2%)		1/12 (8.3%)		4/12 (33.3%)		6/12 (50%)		4/12 (33.3%)		4/12 (33.3%)		6/12 (50%)		7/12 (58.3%)		4/12 (33.3%)		1/12 (8.3%)		2/12 (16.7%)		1/12 (8.3%)		17/41 (41.5%)		23/41 (56.1%)		14/41 (34.1%)		25/41 (61%)		19/41 (46.3%)		23/41 (56.1%)		9/41 (22%)		6/40 (15%)		7/42 (16.7%)		5/40 (12.5%)		11/41 (26.8%)		16/41 (39%)		11/43 (25.6%)		13/42 (31%)		15/40 (37.5%)		17/41 (41.5%)		21/40 (52.5%)		19/41 (46.3%)		26/41 (63.4%)		7/40 (17.5%)		6/40 (15%)		9/40 (22.5%)		8/41 (19.5%)		18/40 (45%)		18/42 (42.9%)		5/40 (12.5%)
Neck mass	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Osteoarthritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Pain in extremity	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Polyarthritis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Trigger finger	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Squamous cell carcinoma	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nervous system disorders
Dizziness	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Headache	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		2/41 (4.9%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		1/41 (2.4%)
Migraine	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Paraesthesia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Sinus headache	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Syncope	0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Tension headache	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Headache (HEADACHE)	5/12 (41.7%)		3/12 (25%)		7/11 (63.6%)		1/12 (8.3%)		3/12 (25%)		3/12 (25%)		1/12 (8.3%)		5/12 (41.7%)		5/12 (41.7%)		5/12 (41.7%)		1/12 (8.3%)		1/12 (8.3%)		3/12 (25%)		1/12 (8.3%)		18/41 (43.9%)		16/41 (39%)		21/41 (51.2%)		19/41 (46.3%)		26/41 (63.4%)		21/41 (51.2%)		17/41 (41.5%)		5/40 (12.5%)		7/42 (16.7%)		7/40 (17.5%)		10/41 (24.4%)		12/41 (29.3%)		16/43 (37.2%)		23/42 (54.8%)		18/40 (45%)		20/41 (48.8%)		19/40 (47.5%)		19/41 (46.3%)		20/41 (48.8%)		10/40 (25%)		5/40 (12.5%)		7/40 (17.5%)		4/41 (9.8%)		11/40 (27.5%)		15/42 (35.7%)		10/40 (25%)
Hypoaesthesia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Psychiatric disorders
Anxiety	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Insomnia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Renal and urinary disorders
Nephrolithiasis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nephropathy	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Reproductive system and breast disorders
Galactorrhoea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vulvovaginal pruritus	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Cough	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/12 (8.3%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		1/42 (2.4%)		0/41 (0%)
Dyspnoea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		2/40 (5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nasal congestion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		1/42 (2.4%)		0/40 (0%)		2/41 (4.9%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Nasal septum deviation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Oropharyngeal pain	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		1/40 (2.5%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Respiratory disorder	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		2/41 (4.9%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/43 (2.3%)		3/42 (7.1%)		2/40 (5%)		3/41 (7.3%)		1/41 (2.4%)		0/41 (0%)		2/41 (4.9%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		2/41 (4.9%)		1/40 (2.5%)		0/42 (0%)		1/41 (2.4%)
Respiratory symptom	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rhinalgia	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rhinitis allergic	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rhinorrhoea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		1/40 (2.5%)		2/41 (4.9%)		0/41 (0%)		1/43 (2.3%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		1/40 (2.5%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		2/42 (4.8%)		0/41 (0%)
Skin and subcutaneous tissue disorders
Dermal cyst	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		1/41 (2.4%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Dermatitis contact	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		1/41 (2.4%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Dermatitis exfoliative	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Diabetic foot	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)
Hyperhidrosis	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Pityriasis rosea	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		1/40 (2.5%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rash	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		1/41 (2.4%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Rash macular	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		1/40 (2.5%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Skin exfoliation	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		1/40 (2.5%)		0/42 (0%)		0/41 (0%)
Skin lesion	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/42 (2.4%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Urticaria	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Vascular disorders
Flushing	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		0/41 (0%)
Hypertension	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/41 (2.4%)		0/41 (0%)		0/41 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/43 (0%)		0/42 (0%)		0/40 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		0/41 (0%)		1/40 (2.5%)		0/40 (0%)		0/40 (0%)		0/41 (0%)		0/40 (0%)		0/42 (0%)		1/41 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.