Trial Outcomes & Findings for A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (NCT NCT05763576)

Last Updated: 2026-01-22

Results Overview

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Up to approximately 40 weeks

Results posted on

2026-01-22

Participant Flow

A total of 48 healthy participants (Part 1a) and 12 participants with chronic hepatitis B (CHB) virus infection (Part 2a) took part in the study across 10 investigative sites in Hong Kong, Thailand, New Zealand, Republic of Korea, United States, Spain, and Taiwan from 28 April 2023 to 23 December 2024.

The study consists of 3 parts- Part 1a: single-ascending dose (SAD) and Part 1b: multiple doses in healthy participants, Part 2 (a and b): SAD in participants with CHB, and Part 3: multiple doses in participants with CHB. No participants were enrolled in the Part 1b, Part 2b, and Part 3 as the study was terminated by the sponsor.

Participant milestones

Participant milestones
Measure	Part 1a Placebo Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via subcutaneous (SC) injection or intravenous (IV) infusion on Day 1 of treatment period.	Part 1a Cohort 1 Healthy participants received a single dose of RO7565020, 70 milligrams (mg) as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as an SC injection on Day 1 of treatment period. Cohort 6 was a pharmacokinetic (PK) ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 1 Participants with CHB who were virologically suppressed with stable nucleos(t)ide analogue (NUC) treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
Overall Study STARTED	12	6	6	6	6	6	6	6	6
Overall Study COMPLETED	12	6	6	6	6	5	6	4	0
Overall Study NOT COMPLETED	0	0	0	0	0	1	0	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1a Placebo Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via subcutaneous (SC) injection or intravenous (IV) infusion on Day 1 of treatment period.	Part 1a Cohort 1 Healthy participants received a single dose of RO7565020, 70 milligrams (mg) as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as an SC injection on Day 1 of treatment period. Cohort 6 was a pharmacokinetic (PK) ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 1 Participants with CHB who were virologically suppressed with stable nucleos(t)ide analogue (NUC) treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
Overall Study Study Terminated by Sponsor	0	0	0	0	0	0	0	2	6
Overall Study Withdrawal by Subject	0	0	0	0	0	1	0	0	0

Baseline Characteristics

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1a Placebo n=12 Participants Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 1 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.	Total n=60 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 9.3 • n=270 Participants	39.8 years STANDARD_DEVIATION 7.9 • n=4 Participants	34.8 years STANDARD_DEVIATION 12.4 • n=9 Participants	47.3 years STANDARD_DEVIATION 8.6 • n=220 Participants	39.0 years STANDARD_DEVIATION 13.1 • n=3 Participants	38.5 years STANDARD_DEVIATION 11.2 • n=18 Participants	35.7 years STANDARD_DEVIATION 10.6 • n=2259 Participants	52.8 years STANDARD_DEVIATION 4.4 • n=4 Participants	48.7 years STANDARD_DEVIATION 8.2 • n=1 Participants	40.5 years STANDARD_DEVIATION 11.1 • n=3 Participants
Sex: Female, Male Female	6 Participants n=270 Participants	3 Participants n=4 Participants	5 Participants n=9 Participants	1 Participants n=220 Participants	2 Participants n=3 Participants	4 Participants n=18 Participants	0 Participants n=2259 Participants	1 Participants n=4 Participants	1 Participants n=1 Participants	23 Participants n=3 Participants
Sex: Female, Male Male	6 Participants n=270 Participants	3 Participants n=4 Participants	1 Participants n=9 Participants	5 Participants n=220 Participants	4 Participants n=3 Participants	2 Participants n=18 Participants	6 Participants n=2259 Participants	5 Participants n=4 Participants	5 Participants n=1 Participants	37 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	1 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	1 Participants n=1 Participants	3 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=270 Participants	5 Participants n=4 Participants	6 Participants n=9 Participants	6 Participants n=220 Participants	6 Participants n=3 Participants	5 Participants n=18 Participants	6 Participants n=2259 Participants	6 Participants n=4 Participants	5 Participants n=1 Participants	56 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	4 Participants n=270 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	1 Participants n=220 Participants	2 Participants n=3 Participants	1 Participants n=18 Participants	6 Participants n=2259 Participants	6 Participants n=4 Participants	5 Participants n=1 Participants	26 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=270 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	2 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants
Race (NIH/OMB) White	4 Participants n=270 Participants	5 Participants n=4 Participants	4 Participants n=9 Participants	5 Participants n=220 Participants	3 Participants n=3 Participants	4 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	1 Participants n=1 Participants	26 Participants n=3 Participants
Race (NIH/OMB) More than one race	2 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	1 Participants n=3 Participants	1 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	4 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants	0 Participants n=2259 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to approximately 40 weeks

Population: Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=12 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	6 Participants	6 Participants	4 Participants	5 Participants	4 Participants	6 Participants	1 Participants	—	—
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately 32 weeks

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Number of CHB Participants With AEs and SAEs AEs	—	2 Participants	3 Participants	—	—	—	—	—	—
Part 2a: Number of CHB Participants With AEs and SAEs SAEs	—	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 40 weeks

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=12 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a: Number of Healthy Volunteers With Adverse Events of Special Interest (AESI)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to approximately 32 weeks

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated ALT or AST value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Number of CHB Participants With AESI	—	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=5 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (SC Cohorts) and Part 2a: Time to Maximum Concentration (Tmax) of RO7565020	10.5 day Interval 6.96 to 15.0	14 day Interval 2.0 to 56.0	17 day Interval 6.99 to 21.0	10.5 day Interval 3.0 to 28.0	10.7 day Interval 6.06 to 29.1	7.01 day Interval 3.03 to 21.0	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (IV Cohorts): Tmax of RO7565020	—	2.12 hours Interval 2.12 to 6.3	2.12 hours Interval 2.12 to 2.17	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=5 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Parts 1a and 2a: Maximum Serum Concentration (Cmax) of RO7565020	27.7 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 43.3	4.99 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 52.1	14.4 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 66.0	29.4 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 37.1	165 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 18.6	587 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 27.6	2.96 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 46.5	18.2 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 45.7	—

SECONDARY outcome

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Time of Last Sampling Point or Last Quantifiable Sample, Whichever Comes First (AUC0-last) of RO7565020	2960 day*μg/mL Geometric Coefficient of Variation 33.4	559 day*μg/mL Geometric Coefficient of Variation 42.0	1630 day*μg/mL Geometric Coefficient of Variation 50.0	3390 day*μg/mL Geometric Coefficient of Variation 33.8	6630 day*μg/mL Geometric Coefficient of Variation 19.6	24800 day*μg/mL Geometric Coefficient of Variation 17.0	59.9 day*μg/mL Geometric Coefficient of Variation 575.4	898 day*μg/mL Geometric Coefficient of Variation 121.2	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=3 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=1 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=4 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=2 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=2 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=3 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 n=4 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of RO7565020	2900 day*μg/mL Geometric Coefficient of Variation 25.7	NA day*μg/mL Geometric Coefficient of Variation NA Geometric mean (GM) and Geometric coefficient of variation were not available because, based on Roche internal non-compartmental analysis (NCA) guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.	2180 day*μg/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for one participant.	3660 day*μg/mL Geometric Coefficient of Variation 24.4	8450 day*μg/mL Geometric Coefficient of Variation 10.2	30700 day*μg/mL Geometric Coefficient of Variation 26.7	172 day*μg/mL Geometric Coefficient of Variation 45.3	792 day*μg/mL Geometric Coefficient of Variation 183.9	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=3 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=1 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=4 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=2 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=2 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=3 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 n=4 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Parts 1a and 2a: Terminal Half-life (t1/2) of RO7565020	78.2 day Interval 71.6 to 86.2	NA day Median and full range were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.	88 day Interval 88.0 to 88.0	88.3 day Interval 80.1 to 92.3	83.3 day Interval 80.4 to 86.2	94.8 day Interval 88.9 to 101.0	13.6 day Interval 4.69 to 29.6	19.8 day Interval 4.8 to 51.7	—

SECONDARY outcome

Timeframe: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=2 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=2 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (IV Cohorts): Volume of Distribution (Vss) of RO7565020	—	5.14 liters Geometric Coefficient of Variation 2.5	6.19 liters Geometric Coefficient of Variation 37.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=2 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=2 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (IV Cohorts): Clearance (CL) of RO7565020	—	1.78 milliliter/hour (mL/h) Geometric Coefficient of Variation 10.2	2.03 milliliter/hour (mL/h) Geometric Coefficient of Variation 26.7	—	—	—	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=4 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=1 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=4 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=3 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=3 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (SC Cohorts) and Part 2a: Apparent Clearance (CL/F) of RO7565020	12.1 mL/h Geometric Coefficient of Variation 183.9	NA mL/h Geometric Coefficient of Variation NA GM and Geometric coefficient of variation were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.	4.39 mL/h Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for one participant.	4.1 mL/h Geometric Coefficient of Variation 24.4	5.18 mL/h Geometric Coefficient of Variation 25.7	16.9 mL/h Geometric Coefficient of Variation 45.3	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=4 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=1 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=4 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=3 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=3 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 1a (SC Cohorts) and Part 2a: Apparent Volume of Distribution (Vz/F) at Terminal Phase of RO7565020	7.33 liters Geometric Coefficient of Variation 35.0	NA liters Geometric Coefficient of Variation NA GM and Geometric coefficient of variation were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.	13.4 liters Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for one participant.	12.4 liters Geometric Coefficient of Variation 26.8	14.1 liters Geometric Coefficient of Variation 18.3	7.23 liters Geometric Coefficient of Variation 60.8	—	—	—

SECONDARY outcome

Timeframe: Baseline, 4- and 8-hours post-dose on Day 1; subsequently on Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169

Population: Pharmacodynamic (PD) population included all participants with CHB who received at least one dose of study treatment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

IU/mL= international units per milliliter

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at 8 h Post-dose, Day 1	—	-0.44 log10 IU/mL Standard Deviation 0.24	-0.96 log10 IU/mL Standard Deviation 0.39	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 2	—	-0.88 log10 IU/mL Standard Deviation 0.29	-1.03 log10 IU/mL Standard Deviation 0.33	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 3	—	-0.99 log10 IU/mL Standard Deviation 0.29	-1.12 log10 IU/mL Standard Deviation 0.28	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 4	—	-1.03 log10 IU/mL Standard Deviation 0.29	-1.10 log10 IU/mL Standard Deviation 0.27	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 8	—	-1.38 log10 IU/mL Standard Deviation 0.54	-1.43 log10 IU/mL Standard Deviation 0.29	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 15	—	-1.17 log10 IU/mL Standard Deviation 0.56	-1.29 log10 IU/mL Standard Deviation 0.26	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 22	—	-1.04 log10 IU/mL Standard Deviation 0.58	-1.19 log10 IU/mL Standard Deviation 0.25	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 29	—	-1.01 log10 IU/mL Standard Deviation 0.57	-1.16 log10 IU/mL Standard Deviation 0.27	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 57	—	-0.68 log10 IU/mL Standard Deviation 0.60	-1.06 log10 IU/mL Standard Deviation 0.39	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 85	—	-0.51 log10 IU/mL Standard Deviation 0.57	-0.87 log10 IU/mL Standard Deviation 0.55	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 113	—	-0.58 log10 IU/mL Standard Deviation 0.56	—	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 141	—	-0.54 log10 IU/mL Standard Deviation 0.53	—	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at Day 169	—	-0.29 log10 IU/mL Standard Deviation 0.56	-0.48 log10 IU/mL Standard Deviation 0.67	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Change at 4 h Post-dose, Day 1	—	-0.20 log10 IU/mL Standard Deviation 0.09	-0.63 log10 IU/mL Standard Deviation 0.45	—	—	—	—	—	—
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Baseline	—	2.36 log10 IU/mL Standard Deviation 0.73	2.63 log10 IU/mL Standard Deviation 0.38	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: PD population included all participants with CHB who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Maximum Reduction From Baseline in Serum HBsAg	—	-1.39 log10 IU/mL Standard Deviation 0.471	-1.44 log10 IU/mL Standard Deviation 0.288	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: PD population included all participants with CHB who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Percentage of Participants With HBsAg Loss	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: PD population included all participants with CHB who received at least one dose of study treatment.

HBsAg seroconversion was defined as sustained loss of HBsAg and detection of anti-HBs antibody.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=6 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Percentage of Participants With HBsAg Seroconversion	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169

Population: PD population included all participants with CHB who received at least one dose of study treatment. Overall Number analyzed included participants who were HBeAg-positive at baseline.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=1 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=2 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 2	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 3	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 4	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 8	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 15	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 22	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 29	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 57	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 85	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 113	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 141	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Day 169	—	0 percentage of participants	50.0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 169

Population: PD population included all participants with CHB who received at least one dose of study treatment. Overall number analyzed included participants who were HBeAg-positive at baseline.

HBeAg seroconversion was defined as sustained loss of HBeAg and detection of anti-HBe antibody.

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=1 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=2 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Part 2a: Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline	—	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1a: Baseline and post-baseline (up to approximately 40 weeks); Part 2a: Baseline and post-baseline (up to approximately 32 weeks)

Population: Immunogenicity population included participants who had at least one ADA assessment and analyzed according to the treatment they actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

The number of ADA-positive participants at baseline (baseline prevalence) and after drug administration was determined in participants exposed to RO7565020 (post-baseline). Participants were considered ADA positive if they had ADA negative or have missing data at baseline but develop an ADA response following study treatment administration (treatment-induced ADA response), or if they are ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold (e.g., ≥ 0.60-titer units) greater than the titer of the baseline sample (treatment enhanced ADA response).

Outcome measures

Outcome measures
Measure	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 1a Cohort 1 n=12 Participants Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 Participants Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 Participants Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 Participants Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.	Part 2a Cohort 2 n=6 Participants Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7565020 Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7565020 Post-baseline	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants	4 Participants	1 Participants	0 Participants

Adverse Events

Part 1a Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1a Cohort 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1a Cohort 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1a Cohort 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1a Cohort 4

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1a Cohort 5

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1a Cohort 6

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2a Cohort 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2a Cohort 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1a Placebo n=12 participants at risk Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.	Part 1a Cohort 1 n=6 participants at risk Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 participants at risk Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 participants at risk Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 1 n=6 participants at risk Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.	Part 2a Cohort 2 n=6 participants at risk Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Other adverse events

Other adverse events
Measure	Part 1a Placebo n=12 participants at risk Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.	Part 1a Cohort 1 n=6 participants at risk Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 2 n=6 participants at risk Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 3 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.	Part 1a Cohort 4 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 5 n=6 participants at risk Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.	Part 1a Cohort 6 n=6 participants at risk Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.	Part 2a Cohort 1 n=6 participants at risk Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.	Part 2a Cohort 2 n=6 participants at risk Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
Ear and labyrinth disorders Ear pain	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Palpitations	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Ear and labyrinth disorders Hypoacusis	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Ear and labyrinth disorders Tinnitus	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Cataract	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Infrequent bowel movements	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Nausea	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Catheter site bruise	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Chest pain	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Fatigue	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Influenza like illness	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Bronchitis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19	16.7% 2/12 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 4 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Cellulitis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Conjunctivitis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Gastroenteritis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Influenza	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Oral herpes	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Respiratory tract infection	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 3 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Arthropod bite	16.7% 2/12 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Bone pain	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Headache	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Migraine	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Somnolence	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Syncope	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Endometriosis	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Vaginal discharge	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Vaginal haemorrhage	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin striae	8.3% 1/12 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypertension	0.00% 0/12 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER