Trial Outcomes & Findings for A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (NCT NCT04433585)

Last Updated: 2024-04-23

Results Overview

Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

291 participants

Primary outcome timeframe

Week 24

Results posted on

2024-04-23

Participant Flow

The study consisted of a 24-week treatment period: participants randomly received either high dose LY3471851 or mid dose LY3471851 or low dose LY3471851 or placebo.

Participant milestones

Participant milestones
Measure	LY3471851 High Dose Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo Participants received a subcutaneous injection of placebo dose every 2 weeks from weeks 0 to 24.
Overall Study STARTED	73	70	74	74
Overall Study COMPLETED	44	57	55	65
Overall Study NOT COMPLETED	29	13	19	9

Reasons for withdrawal

Reasons for withdrawal
Measure	LY3471851 High Dose Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo Participants received a subcutaneous injection of placebo dose every 2 weeks from weeks 0 to 24.
Overall Study Withdrawal by Subject	15	3	15	6
Overall Study Adverse Event	10	4	1	0
Overall Study Due to the conflict in Ukraine	2	1	1	2
Overall Study Physician Decision	1	2	0	0
Overall Study Lost to Follow-up	1	1	1	0
Overall Study Lack of Efficacy	0	1	1	1
Overall Study Death	0	1	0	0

Baseline Characteristics

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3471851 High Dose n=73 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=70 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=74 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo n=74 Participants Participants received a subcutaneous injection of placebo dose every 2 weeks from weeks 0 to 24.	Total n=291 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	69 Participants n=7 Participants	74 Participants n=5 Participants	72 Participants n=4 Participants	287 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Age, Continuous	40.0 years STANDARD_DEVIATION 11.4 • n=5 Participants	41.3 years STANDARD_DEVIATION 13.0 • n=7 Participants	39.9 years STANDARD_DEVIATION 12.0 • n=5 Participants	41.6 years STANDARD_DEVIATION 12.0 • n=4 Participants	40.7 years STANDARD_DEVIATION 12.1 • n=21 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	64 Participants n=7 Participants	69 Participants n=5 Participants	67 Participants n=4 Participants	268 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants	35 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	24 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	59 Participants n=5 Participants	56 Participants n=7 Participants	59 Participants n=5 Participants	58 Participants n=4 Participants	232 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	16 Participants n=4 Participants	65 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	45 Participants n=7 Participants	44 Participants n=5 Participants	46 Participants n=4 Participants	184 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Argentina	13 participants n=5 Participants	11 participants n=7 Participants	12 participants n=5 Participants	8 participants n=4 Participants	44 participants n=21 Participants
Region of Enrollment Romania	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	14 participants n=21 Participants
Region of Enrollment Hungary	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	16 participants n=4 Participants	59 participants n=21 Participants
Region of Enrollment Czechia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Japan	6 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	19 participants n=21 Participants
Region of Enrollment Ukraine	10 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	10 participants n=4 Participants	35 participants n=21 Participants
Region of Enrollment India	8 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants	10 participants n=4 Participants	38 participants n=21 Participants
Region of Enrollment Spain	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment Russia	1 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment South Korea	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment Taiwan	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Poland	4 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	0 participants n=4 Participants	16 participants n=21 Participants
Region of Enrollment Mexico	7 participants n=5 Participants	9 participants n=7 Participants	8 participants n=5 Participants	12 participants n=4 Participants	36 participants n=21 Participants
Region of Enrollment Israel	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment Australia	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment Germany	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	LY3471851 High Dose n=73 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=70 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=74 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo n=74 Participants Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24	20 Participants	27 Participants	22 Participants	22 Participants

SECONDARY outcome

Timeframe: Week 24

Population: A subset of modified intent-to-treat (mITT) patients with at least 1 BILAG A score or 2 BILAG B scores at Baseline.

Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K. * No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).

Outcome measures

Outcome measures
Measure	LY3471851 High Dose n=60 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=56 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=59 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo n=60 Participants Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.	12 Participants	26 Participants	18 Participants	18 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K \>= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points \[10 mm\] from baseline.

Outcome measures

Outcome measures
Measure	LY3471851 High Dose n=73 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=70 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=74 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo n=74 Participants Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24	20 Participants	27 Participants	22 Participants	22 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Modified Intent to Treat (mITT) patient population: All randomized patients with at least one dose of study intervention.

Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.

Outcome measures

Outcome measures
Measure	LY3471851 High Dose n=73 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=70 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=74 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo n=74 Participants Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24	12 Participants	18 Participants	11 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 24

Population: PK population at Week 24 is a subset of the mITT population with PK samples collected and available at Week 24.

LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.

Outcome measures

Outcome measures
Measure	LY3471851 High Dose n=39 Participants Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Mid Dose n=53 Participants Participants received a subcutaneous injection of mid dose LY3471851 every 2 weeks from weeks 0 to 24.	LY3471851 Low Dose n=51 Participants Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 24.	Placebo Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 24.
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851	214.4 ng/mL Standard Deviation 96.7	133.3 ng/mL Standard Deviation 50.6	55.9 ng/mL Standard Deviation 30.6	—

Adverse Events

LY3471851 High Dose

Serious events: 3 serious events

Other events: 54 other events

Deaths: 0 deaths

LY3471851 Mid Dose

Serious events: 7 serious events

Other events: 48 other events

Deaths: 1 deaths

LY3471851 Low Dose

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Nektar Therapeutics

Phone: 8554828676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	LY3471851 High Dose n=73 participants at risk LY3471851 administered subcutaneously (SC).	LY3471851 Mid Dose n=70 participants at risk LY3471851 administered subcutaneously (SC).	LY3471851 Low Dose n=74 participants at risk LY3471851 administered subcutaneously (SC).	Placebo n=74 participants at risk Placebo administered subcutaneously (SC).
Infections and infestations COVID-19	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations COVID-19 pneumonia	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Gastroenteritis salmonella	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pneumonia	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pyelonephritis	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Urinary tract infection	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Gastrointestinal disorders Gastric disorder	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Gastrointestinal disorders Vomiting	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
General disorders Chest pain	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
General disorders Injection site reaction	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
General disorders Pyrexia	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Nervous system disorders Headache	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Nervous system disorders Polyneuropathy	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Cardiac disorders Acute myocardial infarction	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Investigations Haemoglobin decreased	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).

Other adverse events
Measure	LY3471851 High Dose n=73 participants at risk LY3471851 administered subcutaneously (SC).	LY3471851 Mid Dose n=70 participants at risk LY3471851 administered subcutaneously (SC).	LY3471851 Low Dose n=74 participants at risk LY3471851 administered subcutaneously (SC).	Placebo n=74 participants at risk Placebo administered subcutaneously (SC).
Infections and infestations COVID-19	4.1% 3/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	11.4% 8/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	5.4% 4/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	6.8% 5/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Urinary tract infection	5.5% 4/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.9% 2/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	5.4% 4/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	6.8% 5/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Upper respiratory tract infection	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	5.7% 4/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	4.1% 3/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.7% 2/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Nasopharyngitis	6.8% 5/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.7% 2/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Bronchitis	4.1% 3/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.9% 2/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Influenza	2.7% 2/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Gastroenteritis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	4.1% 3/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pharyngitis	2.7% 2/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Conjunctivitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.9% 2/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Cystitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Furuncle	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Herpes zoster	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Respiratory tract infection viral	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.9% 2/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Rhinitis	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Sinusitis	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Vaginal infection	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	2.7% 2/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Asymptomatic bacteriuria	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Body tinea	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Bronchitis viral	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Cellulitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Dengue fever	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Escherichia urinary tract infection	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Fungal infection	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Gastroenteritis viral	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Gingivitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Herpes zoster cutaneous disseminated	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Oral candidiasis	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Otitis externa	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Parasitic gastroenteritis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Paronychia	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pharyngitis bacterial	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pharyngitis streptococcal	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Pharyngotonsillitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Sinusitis bacterial	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Skin infection	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Tonsillitis	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Tooth infection	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Viral infection	1.4% 1/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	1.4% 1/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).
General disorders Pyrexia	15.1% 11/73 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	10.0% 7/70 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	4.1% 3/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).	0.00% 0/74 • Adverse events will be reported from the time of the participant signing of the consent until 56 days after the last dose of study drug, up to a maximum of approximately 245 days (8 months). If randomized participants tested positive for antibody to hepatitis B core antigen (anti-HBc) at the screening visit, then the adverse events collection time frame is until 112 days after the last dose of study drug, up to a maximum of approximately 300 days (10 months).