Trial Outcomes & Findings for Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults (NCT NCT03483961)

Last Updated: 2023-07-03

Results Overview

To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

445 participants

Primary outcome timeframe

Day 57 (from Day 1 vaccination), 28 days after the last injection.

Results posted on

2023-07-03

Participant Flow

Participants were recruited at 3 U.S. sites.

Participant milestones

Participant milestones
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 9: 20 mcg/Adjuvant (Day 1 & 29) 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel	Group 10: 40 mcg/Adjuvant (Day 1) 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Overall Study STARTED	53	52	51	50	53	53	51	52	20	10
Overall Study Exposed / Safety	53	52	50	51	53	53	51	52	20	10
Overall Study Immunogenicity-evaluable	47	44	44	45	48	48	47	50	20	10
Overall Study COMPLETED	42	42	39	41	43	47	46	39	18	10
Overall Study NOT COMPLETED	11	10	12	9	10	6	5	13	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 9: 20 mcg/Adjuvant (Day 1 & 29) 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Overall Study Lost to Follow-up	7	6	6	6	6	4	4	11	1
Overall Study Withdrawal by Subject	3	4	5	3	4	2	1	2	1
Overall Study Other than AE, death, PI decision, LTFU, noncompliance, study terminated, or withdrawal of consent	1	0	0	0	0	0	0	0	0
Overall Study Adverse Event	0	0	1	0	0	0	0	0	0

Baseline Characteristics

Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=53 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=52 Participants 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=51 Participants 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=50 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=53 Participants Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=53 Participants Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=51 Participants Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=52 Participants Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 9: 20 mcg/Adjuvant (Day 1 & 29) n=20 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel	Group 10: 40 mcg/Adjuvant (Day 1) n=10 Participants 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel	Total n=445 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=53 Participants	1 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=53 Participants	1 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	5 Participants n=445 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=53 Participants	51 Participants n=52 Participants	51 Participants n=51 Participants	50 Participants n=50 Participants	53 Participants n=53 Participants	52 Participants n=53 Participants	51 Participants n=51 Participants	52 Participants n=52 Participants	20 Participants n=20 Participants	10 Participants n=10 Participants	440 Participants n=445 Participants
Age, Categorical >=65 years	0 Participants n=53 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	0 Participants n=445 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 8.22 • n=53 Participants	31.2 years STANDARD_DEVIATION 8.26 • n=52 Participants	31.2 years STANDARD_DEVIATION 7.64 • n=51 Participants	33.7 years STANDARD_DEVIATION 7.53 • n=50 Participants	30.6 years STANDARD_DEVIATION 7.72 • n=53 Participants	32.9 years STANDARD_DEVIATION 7.53 • n=53 Participants	32.4 years STANDARD_DEVIATION 7.78 • n=51 Participants	31.6 years STANDARD_DEVIATION 7.82 • n=52 Participants	27.1 years STANDARD_DEVIATION 7.58 • n=20 Participants	29.6 years STANDARD_DEVIATION 7.65 • n=10 Participants	31.5 years STANDARD_DEVIATION 7.86 • n=445 Participants
Sex: Female, Male Female	30 Participants n=53 Participants	30 Participants n=52 Participants	37 Participants n=51 Participants	32 Participants n=50 Participants	38 Participants n=53 Participants	29 Participants n=53 Participants	27 Participants n=51 Participants	26 Participants n=52 Participants	7 Participants n=20 Participants	3 Participants n=10 Participants	259 Participants n=445 Participants
Sex: Female, Male Male	23 Participants n=53 Participants	22 Participants n=52 Participants	14 Participants n=51 Participants	18 Participants n=50 Participants	15 Participants n=53 Participants	24 Participants n=53 Participants	24 Participants n=51 Participants	26 Participants n=52 Participants	13 Participants n=20 Participants	7 Participants n=10 Participants	186 Participants n=445 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=53 Participants	4 Participants n=52 Participants	4 Participants n=51 Participants	3 Participants n=50 Participants	4 Participants n=53 Participants	8 Participants n=53 Participants	2 Participants n=51 Participants	4 Participants n=52 Participants	2 Participants n=20 Participants	1 Participants n=10 Participants	35 Participants n=445 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=53 Participants	48 Participants n=52 Participants	47 Participants n=51 Participants	47 Participants n=50 Participants	49 Participants n=53 Participants	45 Participants n=53 Participants	49 Participants n=51 Participants	48 Participants n=52 Participants	18 Participants n=20 Participants	9 Participants n=10 Participants	410 Participants n=445 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=53 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	0 Participants n=445 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=53 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=53 Participants	1 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	1 Participants n=20 Participants	0 Participants n=10 Participants	2 Participants n=445 Participants
Race (NIH/OMB) Asian	0 Participants n=53 Participants	2 Participants n=52 Participants	1 Participants n=51 Participants	2 Participants n=50 Participants	0 Participants n=53 Participants	1 Participants n=53 Participants	0 Participants n=51 Participants	2 Participants n=52 Participants	1 Participants n=20 Participants	0 Participants n=10 Participants	9 Participants n=445 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=53 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	1 Participants n=53 Participants	0 Participants n=53 Participants	1 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	2 Participants n=445 Participants
Race (NIH/OMB) Black or African American	10 Participants n=53 Participants	9 Participants n=52 Participants	14 Participants n=51 Participants	13 Participants n=50 Participants	14 Participants n=53 Participants	9 Participants n=53 Participants	15 Participants n=51 Participants	7 Participants n=52 Participants	7 Participants n=20 Participants	6 Participants n=10 Participants	104 Participants n=445 Participants
Race (NIH/OMB) White	43 Participants n=53 Participants	40 Participants n=52 Participants	36 Participants n=51 Participants	35 Participants n=50 Participants	36 Participants n=53 Participants	40 Participants n=53 Participants	34 Participants n=51 Participants	41 Participants n=52 Participants	11 Participants n=20 Participants	4 Participants n=10 Participants	320 Participants n=445 Participants
Race (NIH/OMB) More than one race	0 Participants n=53 Participants	1 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	2 Participants n=53 Participants	2 Participants n=53 Participants	1 Participants n=51 Participants	2 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	8 Participants n=445 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=53 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=50 Participants	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=20 Participants	0 Participants n=10 Participants	0 Participants n=445 Participants
Region of Enrollment United States	53 participants n=53 Participants	52 participants n=52 Participants	51 participants n=51 Participants	50 participants n=50 Participants	53 participants n=53 Participants	53 participants n=53 Participants	51 participants n=51 Participants	52 participants n=52 Participants	20 participants n=20 Participants	10 participants n=10 Participants	445 participants n=445 Participants
Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer.	7.5 titer n=47 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=44 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=44 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=45 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.8 titer n=48 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=48 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=47 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.5 titer n=50 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	8.6 titer n=20 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	9.0 titer n=10 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).	7.6 titer n=403 Participants • Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).

PRIMARY outcome

Timeframe: Day 57 (from Day 1 vaccination), 28 days after the last injection.

Population: Immunogenicity-evaluable: Exposed participants as treated per protocol (no major protocol deviation or exclusion reason prior to unblinding, all doses received, no prohibited medication, and evaluable serum samples within required time frames).

Outcome measures

Outcome measures
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=47 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=44 Participants 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=44 Participants 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=45 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=47 Participants Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=50 Participants Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone
Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.	2057.0 titer Interval 1584.8 to 2670.0	1116.2 titer Interval 852.5 to 1461.4	1465.3 titer Interval 1119.1 to 1918.4	2023.8 titer Interval 1550.5 to 2641.7	920.1 titer Interval 710.9 to 1190.9	1206.9 titer Interval 932.4 to 1562.2	1562.8 titer Interval 1204.1 to 2028.3	1712.5 titer Interval 1330.0 to 2205.0

SECONDARY outcome

Timeframe: At Days 8, 15, 22, 29, 36, and 57.

To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.

Outcome measures

Outcome measures
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=47 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=44 Participants 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=44 Participants 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=45 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=47 Participants Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=50 Participants Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 8	70.6 titer Interval 53.2 to 93.7	34.3 titer Interval 25.6 to 46.1	72.6 titer Interval 54.2 to 97.2	117.6 titer Interval 87.8 to 157.4	8.4 titer Interval 6.3 to 11.1	7.5 titer Interval 5.7 to 10.0	7.5 titer Interval 5.7 to 10.0	7.5 titer Interval 5.7 to 9.9
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 15	419.3 titer Interval 323.6 to 543.4	189.4 titer Interval 144.9 to 247.6	530.2 titer Interval 405.6 to 693.0	912.7 titer Interval 700.4 to 1189.5	7.7 titer Interval 6.0 to 10.0	7.5 titer Interval 5.8 to 9.7	7.7 titer Interval 5.9 to 9.9	7.5 titer Interval 5.8 to 9.6
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 22	691.5 titer Interval 499.2 to 957.9	351.3 titer Interval 250.9 to 492.0	1400.2 titer Interval 999.9 to 1960.8	2198.1 titer Interval 1575.6 to 3066.5	46.4 titer Interval 33.6 to 64.1	63.1 titer Interval 45.7 to 87.1	119.0 titer Interval 85.9 to 164.9	7.5 titer Interval 5.5 to 10.3
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 29	417.2 titer Interval 305.4 to 570.0	277.3 titer Interval 200.9 to 382.8	890.5 titer Interval 645.1 to 1229.2	1238.1 titer Interval 900.2 to 1702.9	258.0 titer Interval 189.5 to 351.3	328.8 titer Interval 241.5 to 447.6	886.2 titer Interval 648.7 to 1210.5	8.2 titer Interval 6.0 to 11.0
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 36	3442.8 titer Interval 2533.9 to 4677.8	1675.8 titer Interval 1220.9 to 2300.2	2772.4 titer Interval 2019.8 to 3805.4	3435.0 titer Interval 2511.4 to 4698.1	1327.7 titer Interval 980.4 to 1797.9	2155.4 titer Interval 1591.6 to 2919.0	3609.0 titer Interval 2647.7 to 4919.3	157.9 titer Interval 117.3 to 212.6
Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 57	2057.0 titer Interval 1584.8 to 2670.0	1116.2 titer Interval 852.5 to 1461.4	1465.3 titer Interval 1119.1 to 1918.4	2023.8 titer Interval 1550.5 to 2641.7	920.1 titer Interval 710.9 to 1190.9	1206.9 titer Interval 932.4 to 1562.2	1562.8 titer Interval 1204.1 to 2028.3	1712.5 titer Interval 1330.0 to 2205.0

SECONDARY outcome

Timeframe: At Days 182, 365, 547, and 760.

To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.

Outcome measures

Outcome measures
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=47 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=44 Participants 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=44 Participants 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=45 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=47 Participants Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=50 Participants Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 182	345.1 titer Interval 258.1 to 461.3	209.0 titer Interval 153.1 to 285.2	358.4 titer Interval 261.6 to 491.2	486.6 titer Interval 360.5 to 656.9	253.4 titer Interval 188.4 to 340.9	303 titer Interval 226.7 to 405.0	388.1 titer Interval 291.3 to 517.1	505.7 titer Interval 380.7 to 671.8
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 365	243.4 titer Interval 176.8 to 334.9	137.5 titer Interval 98.3 to 192.3	226.7 titer Interval 160.6 to 320.0	336.6 titer Interval 244.6 to 463.2	195.2 titer Interval 141.3 to 269.6	246.9 titer Interval 180.1 to 338.4	302.0 titer Interval 220.3 to 414.0	491.7 titer Interval 362.5 to 667.0
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 547	169.2 titer Interval 126.2 to 226.8	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	215.7 titer Interval 160.9 to 289.1	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	297.9 titer Interval 221.4 to 400.8
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. Day 760	169.8 titer Interval 122.4 to 235.5	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	5365.1 titer Interval 3853.2 to 7470.1	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	NA titer Follow-up to Day 365 in this group.	279.7 titer Interval 200.1 to 391.1

SECONDARY outcome

Timeframe: Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.

To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.

Outcome measures

Outcome measures
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=47 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. Day 547 (pre-boost)	223.6 titer Interval 166.7 to 299.9	—	—	—	—	—	—	—
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. Day 575 (post-boost)	12325.8 titer Interval 8951.4 to 16972.4	—	—	—	—	—	—	—
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. Day 760 (post-boost)	5874.2 titer Interval 4269.4 to 8082.3	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 57 (from Day 1 vaccination), 28 days after the last injection.

Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline.

Outcome measures

Outcome measures
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=47 Participants 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=44 Participants 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=44 Participants 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=45 Participants 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=48 Participants Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=47 Participants Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=50 Participants Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. Titer at or above 15	47 Participants	44 Participants	44 Participants	45 Participants	48 Participants	48 Participants	47 Participants	50 Participants
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. Titer at or above 40	47 Participants	44 Participants	43 Participants	45 Participants	48 Participants	48 Participants	47 Participants	50 Participants
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. Titer at or above 160	47 Participants	42 Participants	43 Participants	45 Participants	47 Participants	48 Participants	46 Participants	50 Participants
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. Titer at or above 640	43 Participants	32 Participants	41 Participants	43 Participants	29 Participants	40 Participants	41 Participants	44 Participants
Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. Titer at or above 4-fold rise over baseline	47 Participants	44 Participants	43 Participants	45 Participants	48 Participants	48 Participants	47 Participants	50 Participants

Adverse Events

Group 1: 20 mcg/Unadjuvant (Day 1 & 29)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 2: 6 mcg/Adjuvant (Day 1 & 29)

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Group 3: 10 mcg/Adjuvant (Day 1 & 29)

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547)

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Group 5: 6 mcg/Adjuvant (Day 15 & 29)

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Group 6: 10 mcg/Adjuvant (Day 15 & 29)

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Group 7: 20 mcg/Adjuvant (Day 15 & 29)

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Group 8: 40 mcg/Adjuvant (Day 29)

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Group 9: 20 mcg/Adjuvant (Day 1 & 29)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Group 10: 40 mcg/Adjuvant (Day 1)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=53 participants at risk 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=52 participants at risk 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=50 participants at risk 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=51 participants at risk 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=53 participants at risk Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=53 participants at risk Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=51 participants at risk Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=52 participants at risk Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 9: 20 mcg/Adjuvant (Day 1 & 29) n=20 participants at risk 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel	Group 10: 40 mcg/Adjuvant (Day 1) n=10 participants at risk 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Immune system disorders Anaphylactic reaction	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/50 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Infections and infestations Appendicitis	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Infections and infestations Gastroenteritis	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Infections and infestations Pneumonia	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Injury, poisoning and procedural complications Induced abortion haemorrhage	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Injury, poisoning and procedural complications Laryngeal injury	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/50 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Pregnancy, puerperium and perinatal conditions Threatened labour	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.

Other adverse events

Other adverse events
Measure	Group 1: 20 mcg/Unadjuvant (Day 1 & 29) n=53 participants at risk 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) CHIKV VLP/unadjuvanted: Vaccine consists of virus-like particles of chikungunya virus antigens Placebo: Placebo is vaccine diluent alone	Group 2: 6 mcg/Adjuvant (Day 1 & 29) n=52 participants at risk 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 3: 10 mcg/Adjuvant (Day 1 & 29) n=50 participants at risk 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 4: 20mcg/Adjuvant(Day 1 & 29);40mcg/Adjuvant (Day 547) n=51 participants at risk 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 5: 6 mcg/Adjuvant (Day 15 & 29) n=53 participants at risk Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 6: 10 mcg/Adjuvant (Day 15 & 29) n=53 participants at risk Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 7: 20 mcg/Adjuvant (Day 15 & 29) n=51 participants at risk Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 8: 40 mcg/Adjuvant (Day 29) n=52 participants at risk Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel Placebo: Placebo is vaccine diluent alone	Group 9: 20 mcg/Adjuvant (Day 1 & 29) n=20 participants at risk 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel	Group 10: 40 mcg/Adjuvant (Day 1) n=10 participants at risk 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. CHIKV VLP/adjuvanted: Adjuvanted formulation includes Alhydrogel
Infections and infestations Upper respiratory tract infection	7.5% 4/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	3.8% 2/52 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/50 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	3.9% 2/51 • Number of events 3 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.5% 4/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	3.9% 2/51 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.7% 4/52 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Infections and infestations Gastroenteritis	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/50 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.8% 4/51 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/52 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Gastrointestinal disorders Toothache	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/53 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	1.9% 1/53 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	2.0% 1/51 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Hangover	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	3.9% 2/51 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 1/10 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Nervous system disorders Presyncope	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/50 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Gastrointestinal disorders Nausea, solicited	15.1% 8/53 • Number of events 9 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	11.5% 6/52 • Number of events 10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	16.0% 8/50 • Number of events 8 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	27.5% 14/51 • Number of events 17 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.5% 4/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	9.4% 5/53 • Number of events 7 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	11.8% 6/51 • Number of events 6 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	11.5% 6/52 • Number of events 8 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Injection site pain, solicited	35.8% 19/53 • Number of events 25 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	51.9% 27/52 • Number of events 41 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	46.0% 23/50 • Number of events 35 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	56.9% 29/51 • Number of events 63 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	34.0% 18/53 • Number of events 25 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	34.0% 18/53 • Number of events 27 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	35.3% 18/51 • Number of events 30 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	50.0% 26/52 • Number of events 32 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	50.0% 10/20 • Number of events 16 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.0% 2/10 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Fatigue, solicited	20.8% 11/53 • Number of events 16 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	23.1% 12/52 • Number of events 18 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	24.0% 12/50 • Number of events 14 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	37.3% 19/51 • Number of events 27 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	13.2% 7/53 • Number of events 7 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	13.2% 7/53 • Number of events 10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	21.6% 11/51 • Number of events 17 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	19.2% 10/52 • Number of events 15 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 2/20 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.0% 2/10 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Malaise, solicited	13.2% 7/53 • Number of events 8 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	13.5% 7/52 • Number of events 10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	12.0% 6/50 • Number of events 7 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	27.5% 14/51 • Number of events 15 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.5% 4/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	13.2% 7/53 • Number of events 10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	19.6% 10/51 • Number of events 13 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	17.3% 9/52 • Number of events 11 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 2/20 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 1/10 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Chills, solicited	1.9% 1/53 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.8% 3/52 • Number of events 3 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 5/50 • Number of events 5 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	15.7% 8/51 • Number of events 9 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.7% 3/53 • Number of events 3 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.5% 4/53 • Number of events 6 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.8% 4/51 • Number of events 5 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.8% 3/52 • Number of events 3 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Musculoskeletal and connective tissue disorders Myalgia, solicited	20.8% 11/53 • Number of events 12 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	23.1% 12/52 • Number of events 15 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	24.0% 12/50 • Number of events 18 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	41.2% 21/51 • Number of events 35 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.8% 11/53 • Number of events 14 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	18.9% 10/53 • Number of events 18 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	21.6% 11/51 • Number of events 19 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	21.2% 11/52 • Number of events 11 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.0% 2/10 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia, solicited	5.7% 3/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	17.3% 9/52 • Number of events 11 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	8.0% 4/50 • Number of events 6 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	23.5% 12/51 • Number of events 16 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.7% 3/53 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.5% 4/53 • Number of events 7 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.8% 4/51 • Number of events 8 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	11.5% 6/52 • Number of events 6 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	5.0% 1/20 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 1/10 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
Nervous system disorders Headache, solicited	20.8% 11/53 • Number of events 14 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	26.9% 14/52 • Number of events 23 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	36.0% 18/50 • Number of events 21 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	39.2% 20/51 • Number of events 31 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.8% 11/53 • Number of events 12 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	20.8% 11/53 • Number of events 17 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	27.5% 14/51 • Number of events 19 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	36.5% 19/52 • Number of events 26 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	15.0% 3/20 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	10.0% 1/10 • Number of events 1 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.
General disorders Pyrexia, solicited	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	3.8% 2/52 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	4.0% 2/50 • Number of events 2 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	7.8% 4/51 • Number of events 4 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/53 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/51 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/52 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/20 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.	0.00% 0/10 • Unsolicited adverse events were monitored through Day 760 (Groups 1, 4, and 8), Day 365 (Groups 2, 3, 5, 6, and 7), Day 182 (Group 9), and Day 29 (Group 10), but only unsolicited adverse events occurring through Day 57 (end of treatment and observation period, 28 days after last dose for Groups 1-8) are reported. One subject was randomized to Group 3 but treated in Group 4 due to a dispensing error. This participant was counted in Group 3 in the Participant Flow Number Started but was counted in Group 4 for the safety population for all safety analyses.

Additional Information

Sharmila Rajendran

Emergent BioSolutions

Phone: 650-486-0244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI may publish or release study data after the earlier of (a) the date of publication of a multi-center publication coordinated by Sponsor on the study data, or (b) the date of submission of the study data by Sponsor to regulatory authorities for regulatory approval; provided that PI furnishes Sponsor with a copy of any proposed publication or release at least ninety days in advance of the proposed submission or presentation date for review. PI must acknowledge Sponsor on any publication.
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