Trial Outcomes & Findings for Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B (NCT NCT05770895)

Last Updated: 2026-01-23

Results Overview

Treatment-emergent adverse events (TEAEs) were defined as any AE with a start date on or after the study drug start date; or any AE that led to premature discontinuation of study drug. An SAE is defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

83 participants

Primary outcome timeframe

First dose date to end of study (followed up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2], Day 253 [cohorts 3, 4, 5, 6], and Day 309 [cohorts 7 and 8])

Results posted on

2026-01-23

Participant Flow

Participants were enrolled at study sites in New Zealand and Taiwan.

148 participants (114 in Phase 1a and 34 in Phase 1b) were screened.

Participant milestones

Participant milestones
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) Healthy participants received a single high dose of GS-2829 (0.5 mL of a undiluted ≥ 0.5 x 10\^7 FFU/mL) as IM injection on Day 1 and Day 57; and single high dose of GS-6779 (0.5 ml of a undiluted ≥ 0.5 x 10\^7 FFU/mL) as IM injection on Day 29 and Day 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Overall Study STARTED	8	8	10	8	9	10	8	8	8	6
Overall Study COMPLETED	8	8	8	8	7	10	8	8	8	6
Overall Study NOT COMPLETED	0	0	2	0	2	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) Healthy participants received a single high dose of GS-2829 (0.5 mL of a undiluted ≥ 0.5 x 10\^7 FFU/mL) as IM injection on Day 1 and Day 57; and single high dose of GS-6779 (0.5 ml of a undiluted ≥ 0.5 x 10\^7 FFU/mL) as IM injection on Day 29 and Day 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Overall Study Randomized but never treated	0	0	2	0	0	0	0	0	0	0
Overall Study Withdrew consent	0	0	0	0	2	0	0	0	0	0

Baseline Characteristics

Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=9 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=270 Participants	8 Participants n=4 Participants	8 Participants n=9 Participants	8 Participants n=220 Participants	9 Participants n=3 Participants	10 Participants n=18 Participants	8 Participants n=2259 Participants	8 Participants n=1 Participants	8 Participants n=1 Participants	6 Participants n=1 Participants	81 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=27 Participants
Age, Continuous	35 years STANDARD_DEVIATION 10.7 • n=270 Participants	30 years STANDARD_DEVIATION 5.4 • n=4 Participants	35 years STANDARD_DEVIATION 13.0 • n=9 Participants	34 years STANDARD_DEVIATION 9.8 • n=220 Participants	31 years STANDARD_DEVIATION 8.8 • n=3 Participants	38 years STANDARD_DEVIATION 11.4 • n=18 Participants	55 years STANDARD_DEVIATION 6.1 • n=2259 Participants	46 years STANDARD_DEVIATION 8.9 • n=1 Participants	48 years STANDARD_DEVIATION 9.8 • n=1 Participants	49 years STANDARD_DEVIATION 9.6 • n=1 Participants	40 years STANDARD_DEVIATION 12.1 • n=27 Participants
Sex: Female, Male Female	5 Participants n=270 Participants	2 Participants n=4 Participants	5 Participants n=9 Participants	7 Participants n=220 Participants	3 Participants n=3 Participants	4 Participants n=18 Participants	3 Participants n=2259 Participants	3 Participants n=1 Participants	1 Participants n=1 Participants	4 Participants n=1 Participants	37 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=270 Participants	6 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=220 Participants	6 Participants n=3 Participants	6 Participants n=18 Participants	5 Participants n=2259 Participants	5 Participants n=1 Participants	7 Participants n=1 Participants	2 Participants n=1 Participants	44 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=270 Participants	2 Participants n=4 Participants	1 Participants n=9 Participants	3 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=270 Participants	6 Participants n=4 Participants	7 Participants n=9 Participants	5 Participants n=220 Participants	9 Participants n=3 Participants	10 Participants n=18 Participants	8 Participants n=2259 Participants	8 Participants n=1 Participants	8 Participants n=1 Participants	6 Participants n=1 Participants	74 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=270 Participants	3 Participants n=4 Participants	4 Participants n=9 Participants	4 Participants n=220 Participants	1 Participants n=3 Participants	4 Participants n=18 Participants	8 Participants n=2259 Participants	8 Participants n=1 Participants	8 Participants n=1 Participants	6 Participants n=1 Participants	48 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	5 Participants n=270 Participants	3 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=220 Participants	5 Participants n=3 Participants	4 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	1 Participants n=270 Participants	2 Participants n=4 Participants	1 Participants n=9 Participants	3 Participants n=220 Participants	1 Participants n=3 Participants	1 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	2 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	1 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	1 Participants n=27 Participants
Region of Enrollment New Zealand	8 Participants n=270 Participants	8 Participants n=4 Participants	8 Participants n=9 Participants	8 Participants n=220 Participants	9 Participants n=3 Participants	10 Participants n=18 Participants	3 Participants n=2259 Participants	0 Participants n=1 Participants	2 Participants n=1 Participants	1 Participants n=1 Participants	57 Participants n=27 Participants
Region of Enrollment Taiwan	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	5 Participants n=2259 Participants	8 Participants n=1 Participants	6 Participants n=1 Participants	5 Participants n=1 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: First dose date to end of study (followed up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2], Day 253 [cohorts 3, 4, 5, 6], and Day 309 [cohorts 7 and 8])

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=9 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Any TEAE	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	90.0 percentage of participants	75.0 percentage of participants	62.5 percentage of participants	75.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: First dose date to end of study (followed up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2], Day 253 [cohorts 3, 4, 5, 6], and Day 309 [cohorts 7 and 8])

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time postbaseline. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed postbaseline will be considered treatment emergent.

Outcome measures

Outcome measures
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=9 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities	100.0 percentage of participants	87.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	90.0 percentage of participants	87.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2]) or up to 12 weeks post last dose (up to Day 169 [cohorts 3, 4, 5, 6]; Day 225 [cohorts 7 and 8])

Population: Participants in the Immunogenicity Analysis Set were analyzed. The Immunogenicity Analysis Set included all randomized participants who received at least 1 dose of study drug and have at least 1 value for HBV-specific T-cell total response using the interferon gamma (IFN-γ) enzyme-linked immunospot (EliSpot) assay after administration of the investigational product.

Vaccine-induced HBV-specific T cell responses were measured using an interferon-gamma (IFN-γ), enzyme-linked immunospot (ELISpot) assay with a readout of spot forming cells (SFCs) /10\^6 peripheral blood mononuclear cells (PBMCs). Total response was the sum of the dimethylsulfoxide (DMSO) -adjusted averages for the 4 HBV peptides (HBV core + HBV polymerase (pol) A + HBV pol B + HBV surface antigen (sAg)). Response was defined as a ≥ 3-fold increase over baseline in vaccine-induced HBV-specific total T cell response (measured using the IFN-γ ELISpot assay). A participant's highest fold-increase postbaseline was utilized for analysis of responder/non-responder. Participants with missing values for fold change over baseline were counted as failures (missing = failure).

Outcome measures

Outcome measures
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Percentage of Participants With ≥ 3-Fold Increase in Vaccine-Induced Hepatitis B Virus (HBV) Specific T-Cell Responses	12.5 percentage of participants	0.0 percentage of participants	87.5 percentage of participants	87.5 percentage of participants	100.0 percentage of participants	0.0 percentage of participants	25.0 percentage of participants	0.0 percentage of participants	37.5 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: Up to 24 weeks post last dose (up to Day 225 [cohorts 1, 2]) or up to 12 weeks post last dose (up to Day 169 [cohorts 3, 4, 5, 6]; Day 225 [cohorts 7 and 8])

Population: Participants in the Immunogenicity Analysis Set were analyzed.

Vaccine-induced HBV-specific T cell responses were measured using an IFN-γ ELISpot assay with a readout of SFCs/10\^6 PBMCs. Total response was the sum of the DMSO-adjusted averages for the 4 HBV peptides (HBV Core + HBV Pol A + HBV Pol B + HBV sAg). Peak values were the highest posttreatment value for an individual participant and then means were calculated across the participants in a cohort.

Outcome measures

Outcome measures
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 Participants Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 Participants Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 Participants VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 Participants VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 Participants VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Mean Peak Levels of Vaccine-Induced HBV Specific T-Cell Responses	1154.0 SFC/10^6 PBMCs Standard Deviation 2427.31	196.0 SFC/10^6 PBMCs Standard Deviation 0.00	1677.1 SFC/10^6 PBMCs Standard Deviation 1748.80	2853.7 SFC/10^6 PBMCs Standard Deviation 2273.66	3865.2 SFC/10^6 PBMCs Standard Deviation 2686.77	283.6 SFC/10^6 PBMCs Standard Deviation 127.68	674.4 SFC/10^6 PBMCs Standard Deviation 411.83	401.1 SFC/10^6 PBMCs Standard Deviation 98.49	546.8 SFC/10^6 PBMCs Standard Deviation 227.56	374.7 SFC/10^6 PBMCs Standard Deviation 258.29

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 participants at risk Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 participants at risk Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 participants at risk Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 participants at risk Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=9 participants at risk Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 participants at risk Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 participants at risk VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 participants at risk VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 participants at risk VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 participants at risk VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).

Other adverse events

Other adverse events
Measure	Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 Injections) n=8 participants at risk Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as Intramuscular (IM) injection on Days 1 and 57.	Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 Injections) n=8 participants at risk Healthy participants received a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL)\] as IM injection on Days 1 and 57.	Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 participants at risk Healthy participants received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 participants at risk Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection, on Days 29 and 85.	Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 Cycles) n=9 participants at risk Healthy participants received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1a: Placebo : Healthy Participants n=10 participants at risk Healthy participants who received placebo pooled across Phase 1 a Cohorts 1-4 and 8 (2 participants per cohort were randomized to placebo).	Phase 1b : Cohort 5 (VS Participants With CHB) : GS-2829 and GS-6779 Low Dose (2 Cycles) n=8 participants at risk VS participants with CHB received a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL ) as IM injection on Days 29 and 85.	Phase 1b : Cohort 6 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (2 Cycles) n=8 participants at risk VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29 and 85.	Phase 1b : Cohort 7 (VS Participants With CHB) : GS-2829 and GS-6779 High Dose (3 Cycles) n=8 participants at risk VS participants with CHB received a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) as IM injection on Days 29, 85 and 141.	Phase 1b: Placebo : VS CHB Participants n=6 participants at risk VS CHB participants who received placebo pooled across Phase 1b Cohorts 5-7 (2 participants per cohort were randomized to placebo).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Chills	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Cardiac disorders Tricuspid valve disease	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Eye disorders Conjunctival cyst	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Eye disorders Vision blurred	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	22.2% 2/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Gastrointestinal disorders Nausea	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 3/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Catheter site bruise	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Fatigue	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	62.5% 5/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	75.0% 6/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	44.4% 4/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	30.0% 3/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Feeling cold	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Influenza like illness	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site discomfort	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site erythema	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 3/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site induration	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site pain	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	62.5% 5/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	62.5% 5/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	100.0% 8/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	44.4% 4/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	30.0% 3/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 2/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site pruritus	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Injection site swelling	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 3/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Malaise	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	75.0% 6/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	55.6% 5/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Medical device pain	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Pyrexia	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	50.0% 4/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	22.2% 2/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	20.0% 2/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
General disorders Vessel puncture site bruise	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Immune system disorders Seasonal allergy	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Chlamydial infection	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Covid-19	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	20.0% 2/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 2/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Gastroenteritis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	22.2% 2/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Gastrointestinal viral infection	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Influenza	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Periodontitis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Pneumonia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Post procedural infection	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Rhinitis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Sinusitis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Subcutaneous abscess	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Upper respiratory tract infection	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	22.2% 2/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Infections and infestations Urinary tract infection	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Contusion	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Vascular disorders Hot flush	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Joint injury	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Procedural pain	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Investigations Blood cholesterol increased	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	50.0% 4/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Myalgia	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	62.5% 5/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 3/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Pain in jaw	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Musculoskeletal and connective tissue disorders Temporomandibular pain and dysfunction syndrome	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Dizziness	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Headache	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	87.5% 7/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	44.4% 4/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	40.0% 4/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	33.3% 2/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Hypersomnia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Lethargy	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	25.0% 2/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Migraine	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Parosmia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Nervous system disorders Presyncope	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	37.5% 3/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	16.7% 1/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	10.0% 1/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	22.2% 2/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Acne	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Dandruff	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	11.1% 1/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).
Surgical and medical procedures Tooth extraction	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/9 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/10 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	12.5% 1/8 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).	0.00% 0/6 • Up to Day 225 for Cohorts 1, 2; Up to Day 253 for Cohorts 3, 4, 5, 6; Up to Day 309 for Cohorts 7 and 8 All cause mortality analyzed for All Randomized Analysis Set (participants randomized into study). AEs analyzed for Safety Analysis Set (all participants who received at least 1 dose of study drug).

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
Publication restrictions are in place

Restriction type: OTHER