Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants (NCT NCT02952924)

NCT ID: NCT02952924

Last Updated: 2024-10-31

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

192 participants

Primary outcome timeframe

Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c)

Results posted on

2024-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 2: Proof-of-Mechanism (POM) Placebo Participants with chronic hepatitis B virus (CHB) infection received placebo once daily (QD) or twice daily (BID) for 27 days, followed by a single dose on Day 28.	Part 1a: SAD Cohort 1 HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 2: POM Cohort 1 Participants with CHB received 200 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 2 Participants with CHB received 400 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 3 Participants with CHB received 600 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 4 Participants with CHB received 1000 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 5 Participants with CHB received 200 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 3: Cohort A Nucleos(t)ide (NUC)-suppressed CHB participants received 600 mg of RO7049389 QD under fasted conditions in addition to an NUC (administered per local SoC) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort B Treatment-naïve immune-active CHB participants 600 mg of RO7049389 QD under fasted conditions for 4 weeks, followed by RO7049389 + NUC (administered per local SoC) for an additional 44 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort C Treatment-naïve immune-active CHB participants received 600 mg of RO7049389 QD under fasted conditions + NUC + pegylated interferon (Peg-IFN) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.
Overall Study STARTED	11	10	6	3	6	3	6	6	6	6	7	7	6	6	6	6	6	7	6	32	10	30
Overall Study COMPLETED	11	10	6	3	6	3	6	6	6	6	7	7	6	6	6	6	6	6	6	31	10	28
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 2: POM Cohort 4 Participants with CHB received 1000 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 3: Cohort A Nucleos(t)ide (NUC)-suppressed CHB participants received 600 mg of RO7049389 QD under fasted conditions in addition to an NUC (administered per local SoC) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort C Treatment-naïve immune-active CHB participants received 600 mg of RO7049389 QD under fasted conditions + NUC + pegylated interferon (Peg-IFN) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.
Overall Study Protocol Violation	0	1	0
Overall Study Participant refused to adhere to study protocol	1	0	0
Overall Study Participant unable to adhere to study visit schedule	0	0	1
Overall Study Noncompliance with study drug	0	0	1

Baseline Characteristics

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=11 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo n=10 Participants HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 2: Proof-of-Mechanism (POM) Placebo n=6 Participants Participants with chronic hepatitis B virus (CHB) infection received placebo once daily (QD) or twice daily (BID) for 27 days, followed by a single dose on Day 28.	Part 1a: SAD Cohort 1 n=3 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: MAD Cohort 1 n=6 Participants HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 n=7 Participants HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 n=7 Participants HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 n=6 Participants HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 n=6 Participants HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 2: POM Cohort 1 n=6 Participants Participants with CHB received 200 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 2 n=6 Participants Participants with CHB received 400 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 3 n=6 Participants Participants with CHB received 600 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 4 n=7 Participants Participants with CHB received 1000 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 5 n=6 Participants Participants with CHB received 200 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 3: Cohort A n=32 Participants Nucleos(t)ide (NUC)-suppressed CHB participants received 600 mg of RO7049389 QD under fasted conditions in addition to an NUC (administered per local SoC) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort B n=10 Participants Treatment-naïve immune-active CHB participants 600 mg of RO7049389 QD under fasted conditions for 4 weeks, followed by RO7049389 + NUC (administered per local SoC) for an additional 44 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort C n=30 Participants Treatment-naïve immune-active CHB participants received 600 mg of RO7049389 QD under fasted conditions + NUC + pegylated interferon (Peg-IFN) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Total n=192 Participants Total of all reporting groups
Age, Continuous	26.1 years STANDARD_DEVIATION 8.4 • n=5 Participants	25.2 years STANDARD_DEVIATION 4.9 • n=7 Participants	43.5 years STANDARD_DEVIATION 6.4 • n=5 Participants	32.7 years STANDARD_DEVIATION 10.1 • n=4 Participants	27.3 years STANDARD_DEVIATION 7.6 • n=21 Participants	28.7 years STANDARD_DEVIATION 13.6 • n=8 Participants	26.7 years STANDARD_DEVIATION 4.7 • n=8 Participants	26.7 years STANDARD_DEVIATION 13.5 • n=24 Participants	30.5 years STANDARD_DEVIATION 7.0 • n=42 Participants	25.5 years STANDARD_DEVIATION 4.5 • n=42 Participants	23.9 years STANDARD_DEVIATION 2.8 • n=42 Participants	26.7 years STANDARD_DEVIATION 3.8 • n=42 Participants	28.8 years STANDARD_DEVIATION 11.1 • n=36 Participants	28.3 years STANDARD_DEVIATION 5.8 • n=36 Participants	40.2 years STANDARD_DEVIATION 8.3 • n=24 Participants	34.7 years STANDARD_DEVIATION 12.1 • n=135 Participants	41.5 years STANDARD_DEVIATION 11.8 • n=136 Participants	47.0 years STANDARD_DEVIATION 6.1 • n=44 Participants	40.7 years STANDARD_DEVIATION 15.3 • n=667 Participants	47.2 years STANDARD_DEVIATION 8.3 • n=12 Participants	43.8 years STANDARD_DEVIATION 9.8 • n=12 Participants	32.8 years STANDARD_DEVIATION 7.7 • n=12 Participants	34.9 years STANDARD_DEVIATION 11.6 • n=12 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	3 Participants n=135 Participants	2 Participants n=136 Participants	4 Participants n=44 Participants	1 Participants n=667 Participants	13 Participants n=12 Participants	5 Participants n=12 Participants	7 Participants n=12 Participants	40 Participants n=12 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	6 Participants n=36 Participants	6 Participants n=36 Participants	5 Participants n=24 Participants	3 Participants n=135 Participants	4 Participants n=136 Participants	3 Participants n=44 Participants	5 Participants n=667 Participants	19 Participants n=12 Participants	5 Participants n=12 Participants	23 Participants n=12 Participants	152 Participants n=12 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	9 Participants n=12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=36 Participants	5 Participants n=36 Participants	6 Participants n=24 Participants	6 Participants n=135 Participants	6 Participants n=136 Participants	7 Participants n=44 Participants	6 Participants n=667 Participants	30 Participants n=12 Participants	9 Participants n=12 Participants	30 Participants n=12 Participants	180 Participants n=12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	2 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	3 Participants n=12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	5 Participants n=24 Participants	5 Participants n=135 Participants	5 Participants n=136 Participants	7 Participants n=44 Participants	5 Participants n=667 Participants	25 Participants n=12 Participants	5 Participants n=12 Participants	28 Participants n=12 Participants	102 Participants n=12 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	10 Participants n=12 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=36 Participants	4 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants	6 Participants n=12 Participants	4 Participants n=12 Participants	1 Participants n=12 Participants	76 Participants n=12 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=12 Participants

PRIMARY outcome

Timeframe: Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c)

Population: The safety analysis population included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=11 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=3 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo n=10 Participants HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 n=6 Participants HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 n=7 Participants HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 n=7 Participants HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 n=6 Participants HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 n=6 Participants HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1: Percentage of Participants With Adverse Events	27.3 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants	100 Percentage of participants	83.3 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants	60.0 Percentage of participants	83.3 Percentage of participants	57.1 Percentage of participants	28.6 Percentage of participants	16.7 Percentage of participants	16.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: The pharmacokinetic population included all participants unless they significantly violated inclusion/exclusion criteria, deviated significantly from the protocol, or if they had unavailable or incomplete data that could affect analysis.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Time to Reach Maximum Concentration (Tmax) of RO7049389	2.0 Hours Interval 2.0 to 2.0	1.25 Hours Interval 1.0 to 2.0	3.0 Hours Interval 1.5 to 4.0	1.5 Hours Interval 1.5 to 3.0	2.0 Hours Interval 1.5 to 3.0	1.5 Hours Interval 1.5 to 3.0	3.0 Hours Interval 1.5 to 4.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Maximum Observed Plasma Concentration (Cmax) of RO7049389	250 ng/mL Geometric Coefficient of Variation 33.4	1900 ng/mL Geometric Coefficient of Variation 79.7	4610 ng/mL Geometric Coefficient of Variation 75.6	8990 ng/mL Geometric Coefficient of Variation 77.4	14700 ng/mL Geometric Coefficient of Variation 67.6	8990 ng/mL Geometric Coefficient of Variation 77.4	24800 ng/mL Geometric Coefficient of Variation 63.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: AUC From Time Zero to Infinity (AUC0-inf) of RO7049389	879 ng*hr/mL Geometric Coefficient of Variation 7.5	4690 ng*hr/mL Geometric Coefficient of Variation 53.2	10900 ng*hr/mL Geometric Coefficient of Variation 71.9	34400 ng*hr/mL Geometric Coefficient of Variation 71.6	46300 ng*hr/mL Geometric Coefficient of Variation 62.0	34400 ng*hr/mL Geometric Coefficient of Variation 71.6	134000 ng*hr/mL Geometric Coefficient of Variation 91.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of RO7049389	868 ng*hr/mL Geometric Coefficient of Variation 6.6	4660 ng*hr/mL Geometric Coefficient of Variation 53.8	10900 ng*hr/mL Geometric Coefficient of Variation 72.0	34300 ng*hr/mL Geometric Coefficient of Variation 71.6	46200 ng*hr/mL Geometric Coefficient of Variation 62.1	34300 ng*hr/mL Geometric Coefficient of Variation 71.6	134000 ng*hr/mL Geometric Coefficient of Variation 91.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Half-life (T1/2) of RO7049389	3.34 Hours Geometric Coefficient of Variation 35.3	8.80 Hours Geometric Coefficient of Variation 81.1	4.20 Hours Geometric Coefficient of Variation 32.0	7.23 Hours Geometric Coefficient of Variation 39.5	12.1 Hours Geometric Coefficient of Variation 52.1	7.23 Hours Geometric Coefficient of Variation 39.5	12.4 Hours Geometric Coefficient of Variation 44.7	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=3 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Apparent Oral Clearance (CL/F) of RO7049389	171 L/hr Geometric Coefficient of Variation 7.3	128 L/hr Geometric Coefficient of Variation 67.8	61.5 L/hr Geometric Coefficient of Variation 72.1	64.9 L/hr Geometric Coefficient of Variation 130.3	63.3 L/hr Geometric Coefficient of Variation 69.7	64.9 L/hr Geometric Coefficient of Variation 130.3	69.7 L/hr Geometric Coefficient of Variation 122.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Cumulative Amount Excreted Unchanged in Urine (Ae) of RO7049389	—	0.312 mg Geometric Coefficient of Variation 69.6	—	1.88 mg Geometric Coefficient of Variation 83.9	3.56 mg Geometric Coefficient of Variation 92.0	1.88 mg Geometric Coefficient of Variation 83.9	6.89 mg Geometric Coefficient of Variation 101.8	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 Participants HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Parts 1a and 1b: SAD Cohort: Renal Clearance (CLr) of RO7049389	—	1.60 mL/min Geometric Coefficient of Variation 84.8	—	1.55 mL/min Geometric Coefficient of Variation 42.9	1.41 mL/min Geometric Coefficient of Variation 18.7	1.55 mL/min Geometric Coefficient of Variation 42.9	0.82 mL/min Geometric Coefficient of Variation 22.8	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 112

Population: The safety analysis population included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=7 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Percentage of Participants With Adverse Events	50.0 Percentage of participants	66.7 Percentage of participants	66.7 Percentage of participants	83.3 Percentage of participants	57.1 Percentage of participants	33.3 Percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline - Day 112

Population: The efficacy population included all participants who received at least one dose of RO7049389.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=7 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Quantitative Plasma HBV DNA Level Day 112/Follow-up Day 84	5.09 Log10 IU/mL Interval 3.0 to 8.0	5.89 Log10 IU/mL Interval 3.2 to 7.9	6.17 Log10 IU/mL Interval 4.1 to 8.2	4.45 Log10 IU/mL Interval 3.2 to 8.4	4.55 Log10 IU/mL Interval 4.0 to 8.4	7.03 Log10 IU/mL Interval 3.8 to 8.3	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Baseline	5.94 Log10 IU/mL Interval 4.8 to 8.2	4.50 Log10 IU/mL Interval 1.9 to 8.3	7.80 Log10 IU/mL Interval 4.0 to 8.5	4.43 Log10 IU/mL Interval 3.3 to 8.4	5.10 Log10 IU/mL Interval 4.1 to 8.7	7.14 Log10 IU/mL Interval 3.9 to 8.5	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 8	5.25 Log10 IU/mL Interval 4.6 to 7.8	1.40 Log10 IU/mL Interval 1.3 to 4.8	5.27 Log10 IU/mL Interval 1.8 to 6.2	1.75 Log10 IU/mL Interval 1.3 to 5.7	2.25 Log10 IU/mL Interval 1.3 to 6.5	5.21 Log10 IU/mL Interval 2.0 to 6.0	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 15	5.29 Log10 IU/mL Interval 4.3 to 8.1	2.00 Log10 IU/mL Interval 1.3 to 5.4	4.58 Log10 IU/mL Interval 1.4 to 6.0	1.46 Log10 IU/mL Interval 1.3 to 5.5	1.30 Log10 IU/mL Interval 1.3 to 6.0	4.90 Log10 IU/mL Interval 1.3 to 5.6	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 22	5.16 Log10 IU/mL Interval 3.8 to 8.0	1.83 Log10 IU/mL Interval 1.3 to 5.1	4.11 Log10 IU/mL Interval 1.3 to 5.8	1.41 Log10 IU/mL Interval 1.3 to 5.2	1.41 Log10 IU/mL Interval 1.3 to 5.6	4.65 Log10 IU/mL Interval 1.3 to 5.4	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 28	5.29 Log10 IU/mL Interval 3.6 to 8.0	1.65 Log10 IU/mL Interval 1.3 to 4.9	3.64 Log10 IU/mL Interval 1.3 to 5.8	1.30 Log10 IU/mL Interval 1.3 to 4.9	1.30 Log10 IU/mL Interval 1.3 to 5.5	4.43 Log10 IU/mL Interval 1.3 to 5.4	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 35/Follow-up Day 7	5.29 Log10 IU/mL Interval 2.7 to 8.0	3.23 Log10 IU/mL Interval 1.3 to 8.0	5.50 Log10 IU/mL Interval 2.8 to 6.6	2.61 Log10 IU/mL Interval 1.5 to 6.9	2.98 Log10 IU/mL Interval 2.4 to 6.7	6.29 Log10 IU/mL Interval 2.4 to 7.6	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 56/Follow-up Day 28	5.21 Log10 IU/mL Interval 2.7 to 8.1	4.07 Log10 IU/mL Interval 2.4 to 8.3	6.53 Log10 IU/mL Interval 3.3 to 8.2	3.43 Log10 IU/mL Interval 2.8 to 9.1	4.04 Log10 IU/mL Interval 3.1 to 8.3	7.07 Log10 IU/mL Interval 3.9 to 8.3	—	—	—	—	—	—	—
Part 2: Quantitative Plasma HBV DNA Level Day 84/Follow-up Day 56	5.15 Log10 IU/mL Interval 2.6 to 8.2	5.76 Log10 IU/mL Interval 2.4 to 8.0	5.68 Log10 IU/mL Interval 4.4 to 8.1	4.29 Log10 IU/mL Interval 3.5 to 8.2	4.73 Log10 IU/mL Interval 3.7 to 8.5	6.83 Log10 IU/mL Interval 3.8 to 8.4	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Every 2-4 weeks from Baseline through Week 72

Population: The ITT population included all participants who were randomized and received at least one dose of study drug (RO7049389 or placebo). Participants were analyzed according to the treatment group to which they were randomized.

Functional cure is defined as HBV DNA \< lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (\< 0.05 IU/mL) at 24 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Proportion of Patients Achieving Functional Cure Week 2	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 4	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 8	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 12	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 16	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 20	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 24	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 28	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 32	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 36	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 40	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 44	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 50	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 48	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 52	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 54	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 56	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 58	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 60	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 64	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 68	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Week 72	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—
Part 3: Proportion of Patients Achieving Functional Cure Baseline	0 Percentage Interval 0.0 to 0.11	0 Percentage Interval 0.0 to 0.31	0 Percentage Interval 0.0 to 0.12	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 16

This outcome measure evaluated the effect of food on the pharmacokinetics (PK) of RO7049389 after the administration of a single dose. Participants were fed a high-fat, high-calorie breakfast (per FDA food effect bioavailability and bioequivalence study recommendations) 30 minutes prior to dosing after fasting overnight for at least 8 hours. ANOVA (factors fasted/fed state and subject) was performed for measurements available in subjects in both fasted and fed states.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1b: Food Effect on Cmax of RO7049389	2.42 geometric mean ratio Interval 1.48 to 3.95	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 16

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1b: Food Effect on AUCinf of RO7049389	2.17 geometric mean ratio Interval 1.39 to 3.4	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Cmax of Midazolam	0.892 Ratio Interval 0.663 to 1.2	1.01 Ratio Interval 0.846 to 1.21	1.12 Ratio Interval 0.915 to 1.37	0.940 Ratio Interval 0.734 to 1.21	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: AUCinf of Midazolam	1.10 Ratio Interval 0.846 to 1.42	1.18 Ratio Interval 1.06 to 1.31	1.25 Ratio Interval 1.04 to 1.5	1.16 Ratio Interval 0.993 to 1.36	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Tmax of RO7049389 Day 1	2.0 hours Interval 1.5 to 3.0	2.0 hours Interval 1.5 to 3.0	3.0 hours Interval 1.5 to 4.0	3.0 hours Interval 3.0 to 4.0	3.0 hours Interval 2.0 to 3.0	—	—	—	—	—	—	—	—
Part 1c: Tmax of RO7049389 Day 14	1.5 hours Interval 1.0 to 1.5	2.0 hours Interval 1.5 to 4.0	3.0 hours Interval 1.5 to 4.0	—	3.0 hours Interval 3.0 to 4.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Cmax of RO7049389 Day 1	483 ng/mL Geometric Coefficient of Variation 42.5	840 ng/mL Geometric Coefficient of Variation 41.7	4840 ng/mL Geometric Coefficient of Variation 53.7	14500 ng/mL Geometric Coefficient of Variation 39.5	10600 ng/mL Geometric Coefficient of Variation 42.2	—	—	—	—	—	—	—	—
Part 1c: Cmax of RO7049389 Day 14	735 ng/mL Geometric Coefficient of Variation 19.9	583 ng/mL Geometric Coefficient of Variation 41.3	2720 ng/mL Geometric Coefficient of Variation 49.0	—	9960 ng/mL Geometric Coefficient of Variation 32.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: AUC0-12hr of RO7049389 Day 1	1304.09 ng*hr/mL Geometric Coefficient of Variation 31.9	1819.92 ng*hr/mL Geometric Coefficient of Variation 46.1	9760.31 ng*hr/mL Geometric Coefficient of Variation 55.7	32459.87 ng*hr/mL Geometric Coefficient of Variation 42.6	27041.94 ng*hr/mL Geometric Coefficient of Variation 33.6	—	—	—	—	—	—	—	—
Part 1c: AUC0-12hr of RO7049389 Day 14	1806.59 ng*hr/mL Geometric Coefficient of Variation 25.6	1573.32 ng*hr/mL Geometric Coefficient of Variation 27.5	6511.21 ng*hr/mL Geometric Coefficient of Variation 29.0	—	28051.71 ng*hr/mL Geometric Coefficient of Variation 32.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: CLr of RO7049389 Day 1	1.06 mL/min Geometric Coefficient of Variation 74.2	1.08 mL/min Geometric Coefficient of Variation 82.6	1.43 mL/min Geometric Coefficient of Variation 27.0	2.04 mL/min Geometric Coefficient of Variation 54.7	1.19 mL/min Geometric Coefficient of Variation 48.6	—	—	—	—	—	—	—	—
Part 1c: CLr of RO7049389 Day 14	1.96 mL/min Geometric Coefficient of Variation 75.2	1.87 mL/min Geometric Coefficient of Variation 51.7	3.01 mL/min Geometric Coefficient of Variation 46.9	—	2.32 mL/min Geometric Coefficient of Variation 35.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 14

This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 14) within each arm.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Accumulation Ratio of RO7049389	1.45 Geometric mean ratio Geometric Coefficient of Variation 24.3	1.05 Geometric mean ratio Geometric Coefficient of Variation 31.1	0.880 Geometric mean ratio Geometric Coefficient of Variation 35.6	1.09 Geometric mean ratio Geometric Coefficient of Variation 37.4	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: T1/2 of RO7049389 Day 1	2.27 Hours Geometric Coefficient of Variation 24.1	2.44 Hours Geometric Coefficient of Variation 12.6	2.09 Hours Geometric Coefficient of Variation 18.5	1.70 Hours Geometric Coefficient of Variation 30.4	1.53 Hours Geometric Coefficient of Variation 22.5	—	—	—	—	—	—	—	—
Part 1c: T1/2 of RO7049389 Day 14	5.79 Hours Geometric Coefficient of Variation 40.7	5.17 Hours Geometric Coefficient of Variation 26.8	5.08 Hours Geometric Coefficient of Variation 10.5	—	5.73 Hours Geometric Coefficient of Variation 28.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Ae of RO7049389 Day 1	0.0926 mg Geometric Coefficient of Variation 90.7	0.0900 mg Geometric Coefficient of Variation 56.0	0.859 mg Geometric Coefficient of Variation 60.9	3.58 mg Geometric Coefficient of Variation 63.4	1.77 mg Geometric Coefficient of Variation 35.9	—	—	—	—	—	—	—	—
Part 1c: Ae of RO7049389 Day 14	0.243 mg Geometric Coefficient of Variation 89.5	0.189 mg Geometric Coefficient of Variation 60.7	1.26 mg Geometric Coefficient of Variation 53.8	—	3.68 mg Geometric Coefficient of Variation 26.3	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 14

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=7 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=7 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 1c: Ctrough of RO7049389	12.1 ng/mL Geometric Coefficient of Variation 45.1	15.2 ng/mL Geometric Coefficient of Variation 27.8	42.1 ng/mL Geometric Coefficient of Variation 12.8	88.9 ng/mL Geometric Coefficient of Variation 27.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Day 112/Follow-up Day 84

Population: The efficacy population included all participants who received at least one dose of RO7049389.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=7 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 8	0 Percentage of participants	33.3 Percentage of participants	0 Percentage of participants	50.0 Percentage of participants	28.6 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 15	0 Percentage of participants	50.0 Percentage of participants	0 Percentage of participants	50.0 Percentage of participants	57.1 Percentage of participants	16.7 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 22	0 Percentage of participants	50.0 Percentage of participants	0 Percentage of participants	50.0 Percentage of participants	42.9 Percentage of participants	16.7 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 28	0 Percentage of participants	50.0 Percentage of participants	16.7 Percentage of participants	66.7 Percentage of participants	57.1 Percentage of participants	16.7 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 35/Follow-up Day 7	0 Percentage of participants	16.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 56/Follow-up Day 28	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 84/Follow-up Day 56	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—
Part 2: HBV DNA < Lower Limit of Quantification (LLOQ) Day 112/Follow-up Day 84	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=7 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Tmax of RO7049389 Day 1	2.0 Hours Interval 2.0 to 3.0	3.0 Hours Interval 2.0 to 3.0	1.97 Hours Interval 0.92 to 3.0	1.98 Hours Interval 1.92 to 3.03	1.5 Hours Interval 1.0 to 2.87	—	—	—	—	—	—	—	—
Part 2: Tmax of RO7049389 Day 28	2.5 Hours Interval 1.08 to 3.0	2.5 Hours Interval 2.0 to 4.0	2.0 Hours Interval 0.97 to 3.0	2.03 Hours Interval 1.9 to 2.85	1.5 Hours Interval 0.833 to 3.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=7 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Cmax of RO7049389 Day 1	1450 ng/mL Geometric Coefficient of Variation 69.1	8110 ng/mL Geometric Coefficient of Variation 59.7	5030 ng/mL Geometric Coefficient of Variation 42.7	23900 ng/mL Geometric Coefficient of Variation 41.8	910 ng/mL Geometric Coefficient of Variation 89.1	—	—	—	—	—	—	—	—
Part 2: Cmax of RO7049389 Day 28	1500 ng/mL Geometric Coefficient of Variation 60.3	8580 ng/mL Geometric Coefficient of Variation 63.7	4890 ng/mL Geometric Coefficient of Variation 76.9	29800 ng/mL Geometric Coefficient of Variation 15.2	998 ng/mL Geometric Coefficient of Variation 52.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=7 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: AUCtau of RO7049389 Day 1	2870 ng*hr/mL Geometric Coefficient of Variation 50.2	19900 ng*hr/mL Geometric Coefficient of Variation 78.6	11500 ng*hr/mL Geometric Coefficient of Variation 65.5	80000 ng*hr/mL Geometric Coefficient of Variation 71.2	3500 ng*hr/mL Geometric Coefficient of Variation 76.7	—	—	—	—	—	—	—	—
Part 2: AUCtau of RO7049389 Day 28	3350 ng*hr/mL Geometric Coefficient of Variation 47.7	22400 ng*hr/mL Geometric Coefficient of Variation 70.5	14600 ng*hr/mL Geometric Coefficient of Variation 78.0	133000 ng*hr/mL Geometric Coefficient of Variation 50.0	3480 ng*hr/mL Geometric Coefficient of Variation 56.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 28

This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 28) within each arm.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Accumulation Ratio of RO7049389	1.01 Geometric mean ratio Geometric Coefficient of Variation 81.3	0.971 Geometric mean ratio Geometric Coefficient of Variation 58.2	1.65 Geometric mean ratio Geometric Coefficient of Variation 109.8	0.823 Geometric mean ratio Geometric Coefficient of Variation 77.0	0.917 Geometric mean ratio Geometric Coefficient of Variation 40.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=7 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: T1/2 of RO7049389 Day 1	1.68 Hours Geometric Coefficient of Variation 18.0	1.15 Hours Geometric Coefficient of Variation 27.6	1.09 Hours Geometric Coefficient of Variation 22.4	1.40 Hours Geometric Coefficient of Variation 34.5	2.33 Hours Geometric Coefficient of Variation 55.2	—	—	—	—	—	—	—	—
Part 2: T1/2 of RO7049389 Day 28	3.38 Hours Geometric Coefficient of Variation 24.1	3.26 Hours Geometric Coefficient of Variation 28.8	3.70 Hours Geometric Coefficient of Variation 26.1	2.33 Hours Geometric Coefficient of Variation 20.1	3.81 Hours Geometric Coefficient of Variation 24.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 28

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=6 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=6 Participants HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 Participants HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 2: Ctrough of RO7049389	26.7 ng/mL Geometric Coefficient of Variation 72.7	68.2 ng/mL Geometric Coefficient of Variation 89.2	7.94 ng/mL Geometric Coefficient of Variation 60.6	27.0 ng/mL Geometric Coefficient of Variation 42.3	3.37 ng/mL Geometric Coefficient of Variation 88.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 72 weeks

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Percentage of Participants With AEs	68.8 Percentage of Participants	90 Percentage of Participants	100 Percentage of Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Baseline	3.04 Log10 IU/mL Interval 2.48 to 4.3	3.51 Log10 IU/mL Interval 2.44 to 4.63	4.10 Log10 IU/mL Interval 2.5 to 5.49	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 2	3.08 Log10 IU/mL Interval 2.42 to 4.36	3.51 Log10 IU/mL Interval 2.53 to 4.69	4.14 Log10 IU/mL Interval 2.18 to 5.63	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 4	3.08 Log10 IU/mL Interval 2.52 to 4.33	3.47 Log10 IU/mL Interval 2.36 to 4.46	3.98 Log10 IU/mL Interval 1.74 to 5.55	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 8	3.00 Log10 IU/mL Interval 2.41 to 4.33	3.49 Log10 IU/mL Interval 2.3 to 4.25	3.62 Log10 IU/mL Interval 1.34 to 5.06	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 12	3.02 Log10 IU/mL Interval 2.42 to 4.31	3.52 Log10 IU/mL Interval 2.51 to 4.25	3.55 Log10 IU/mL Interval 1.44 to 4.82	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 16	3.03 Log10 IU/mL Interval 2.59 to 4.28	3.22 Log10 IU/mL Interval 2.64 to 4.25	3.44 Log10 IU/mL Interval 1.56 to 4.46	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 20	3.05 Log10 IU/mL Interval 2.54 to 4.3	3.48 Log10 IU/mL Interval 2.79 to 4.26	3.26 Log10 IU/mL Interval 1.47 to 4.37	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 24	2.99 Log10 IU/mL Interval 2.58 to 4.25	3.84 Log10 IU/mL Interval 2.85 to 4.23	3.15 Log10 IU/mL Interval 0.98 to 4.3	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 28	3.04 Log10 IU/mL Interval 2.58 to 4.27	3.39 Log10 IU/mL Interval 2.81 to 4.29	3.10 Log10 IU/mL Interval 1.04 to 4.33	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 32	2.99 Log10 IU/mL Interval 2.54 to 4.28	3.52 Log10 IU/mL Interval 3.12 to 4.32	3.09 Log10 IU/mL Interval 0.82 to 4.27	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 36	2.98 Log10 IU/mL Interval 2.47 to 4.32	3.50 Log10 IU/mL Interval 2.85 to 4.2	2.93 Log10 IU/mL Interval 0.83 to 4.21	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 40	3.03 Log10 IU/mL Interval 2.52 to 4.26	3.81 Log10 IU/mL Interval 2.8 to 4.21	2.91 Log10 IU/mL Interval 0.8 to 4.24	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 44	3.00 Log10 IU/mL Interval 2.5 to 4.23	3.81 Log10 IU/mL Interval 2.84 to 4.24	2.91 Log10 IU/mL Interval 0.38 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 48	2.99 Log10 IU/mL Interval 2.5 to 4.23	3.53 Log10 IU/mL Interval 2.81 to 4.18	2.90 Log10 IU/mL Interval 0.05 to 4.15	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 50	2.96 Log10 IU/mL Interval 2.55 to 4.21	3.21 Log10 IU/mL Interval 3.18 to 3.24	0.83 Log10 IU/mL Interval 0.21 to 1.72	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 52	2.89 Log10 IU/mL Interval 2.55 to 4.24	3.21 Log10 IU/mL Interval 3.2 to 3.23	1.32 Log10 IU/mL Interval 0.37 to 1.78	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 54	2.98 Log10 IU/mL Interval 2.53 to 4.29	3.51 Log10 IU/mL Interval 3.16 to 3.89	1.41 Log10 IU/mL Interval 0.36 to 2.02	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 56	2.97 Log10 IU/mL Interval 2.48 to 4.21	3.75 Log10 IU/mL Interval 2.82 to 4.2	2.86 Log10 IU/mL Interval 0.45 to 4.25	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 58	2.67 Log10 IU/mL Interval 2.52 to 4.23	3.15 Log10 IU/mL Interval 3.15 to 3.15	1.70 Log10 IU/mL Interval 0.48 to 2.19	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 60	3.84 Log10 IU/mL Interval 2.52 to 4.22	3.20 Log10 IU/mL Interval 3.16 to 3.23	1.79 Log10 IU/mL Interval 0.5 to 2.25	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 64	2.98 Log10 IU/mL Interval 2.5 to 4.23	3.53 Log10 IU/mL Interval 2.85 to 4.0	2.83 Log10 IU/mL Interval 0.76 to 4.85	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 68	2.65 Log10 IU/mL Interval 2.56 to 2.74	3.12 Log10 IU/mL Interval 3.12 to 3.12	1.84 Log10 IU/mL Interval 1.0 to 2.46	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B Surface Antigen (HBsAg) Level Week 72	2.95 Log10 IU/mL Interval 2.49 to 4.17	3.71 Log10 IU/mL Interval 2.83 to 4.23	2.75 Log10 IU/mL Interval 0.78 to 4.3	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Population: The population for this endpoint included participants in Part 3 that were HBeAg+ at baseline.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=11 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=6 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=19 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Baseline	0.17 Log10 IU/mL Interval -0.54 to 1.93	1.07 Log10 IU/mL Interval 0.0 to 2.44	2.84 Log10 IU/mL Interval 1.48 to 3.49	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 2	0.16 Log10 IU/mL Interval -0.54 to 2.31	1.01 Log10 IU/mL Interval -0.89 to 2.31	2.79 Log10 IU/mL Interval 1.16 to 3.55	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 4	0.17 Log10 IU/mL Interval -0.54 to 2.01	0.60 Log10 IU/mL Interval -0.89 to 1.96	2.57 Log10 IU/mL Interval 0.65 to 3.36	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 8	0.15 Log10 IU/mL Interval -0.54 to 1.78	0.33 Log10 IU/mL Interval -0.89 to 1.19	2.24 Log10 IU/mL Interval 0.24 to 2.8	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 12	0.12 Log10 IU/mL Interval -0.54 to 1.74	0.17 Log10 IU/mL Interval -0.89 to 0.57	2.02 Log10 IU/mL Interval 0.2 to 2.55	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 16	0.12 Log10 IU/mL Interval -0.54 to 1.71	-0.04 Log10 IU/mL Interval -0.89 to 0.39	1.81 Log10 IU/mL Interval -0.24 to 2.36	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 20	0.06 Log10 IU/mL Interval -0.54 to 1.55	-0.12 Log10 IU/mL Interval -0.89 to 0.37	1.40 Log10 IU/mL Interval -0.89 to 2.25	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 24	0.10 Log10 IU/mL Interval -0.54 to 1.38	-0.24 Log10 IU/mL Interval -0.89 to 0.38	1.31 Log10 IU/mL Interval -0.89 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 28	0.12 Log10 IU/mL Interval -0.54 to 1.39	-0.32 Log10 IU/mL Interval -0.89 to 0.28	1.32 Log10 IU/mL Interval -0.89 to 2.03	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 32	0.14 Log10 IU/mL Interval -0.54 to 1.14	-0.40 Log10 IU/mL Interval -0.89 to 0.38	1.12 Log10 IU/mL Interval -0.89 to 1.97	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 36	0.15 Log10 IU/mL Interval -0.54 to 1.21	-0.43 Log10 IU/mL Interval -0.89 to 0.29	0.96 Log10 IU/mL Interval -0.89 to 1.89	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 40	0.13 Log10 IU/mL Interval -0.54 to 1.16	-0.49 Log10 IU/mL Interval -0.89 to 0.21	0.83 Log10 IU/mL Interval -0.89 to 1.82	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 44	0.16 Log10 IU/mL Interval -0.54 to 1.14	-0.50 Log10 IU/mL Interval -0.89 to 0.34	0.82 Log10 IU/mL Interval -0.89 to 1.75	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 48	0.15 Log10 IU/mL Interval -0.54 to 1.16	-0.52 Log10 IU/mL Interval -0.89 to 0.2	0.69 Log10 IU/mL Interval -0.89 to 1.79	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 50	-0.53 Log10 IU/mL Interval -0.54 to -0.52	-0.71 Log10 IU/mL Interval -0.89 to -0.54	-0.47 Log10 IU/mL Interval -0.47 to -0.47	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 52	-0.54 Log10 IU/mL Interval -0.54 to -0.54	-0.71 Log10 IU/mL Interval -0.89 to -0.54	-0.54 Log10 IU/mL Interval -0.54 to -0.54	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 54	-0.54 Log10 IU/mL Interval -0.54 to -0.54	-0.54 Log10 IU/mL Interval -0.54 to -0.54	-0.49 Log10 IU/mL Interval -0.49 to -0.49	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 56	0.09 Log10 IU/mL Interval -0.54 to 1.22	-0.54 Log10 IU/mL Interval -0.89 to 0.22	0.74 Log10 IU/mL Interval -0.89 to 2.08	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 58	—	-0.54 Log10 IU/mL Interval -0.54 to -0.54	1.23 Log10 IU/mL Interval 1.23 to 1.23	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 60	—	-0.54 Log10 IU/mL Interval -0.54 to -0.54	1.70 Log10 IU/mL Interval 1.7 to 1.7	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 64	0.14 Log10 IU/mL Interval -0.54 to 1.21	-0.54 Log10 IU/mL Interval -0.89 to -0.3	0.36 Log10 IU/mL Interval -0.89 to 2.96	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 68	—	-0.54 Log10 IU/mL Interval -0.54 to -0.54	-0.54 Log10 IU/mL Interval -0.54 to -0.54	—	—	—	—	—	—	—	—	—	—
Part 3: Hepatitis B e-Antigen (HBeAg) Levels Week 72	0.08 Log10 IU/mL Interval -0.54 to 1.16	-0.35 Log10 IU/mL Interval -0.89 to 0.36	-0.23 Log10 IU/mL Interval -0.89 to 1.96	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: HBV RNA Level Baseline	0.99 Log10 copies/mL Interval 0.69 to 4.45	4.02 Log10 copies/mL Interval 0.69 to 6.24	5.30 Log10 copies/mL Interval 0.69 to 7.5	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 2	0.69 Log10 copies/mL Interval 0.69 to 1.79	1.04 Log10 copies/mL Interval 0.69 to 3.93	2.37 Log10 copies/mL Interval 0.69 to 4.53	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 4	0.69 Log10 copies/mL Interval 0.69 to 1.35	0.84 Log10 copies/mL Interval 0.69 to 2.9	1.93 Log10 copies/mL Interval 0.69 to 4.97	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 8	0.69 Log10 copies/mL Interval 0.69 to 2.45	0.69 Log10 copies/mL Interval 0.69 to 1.68	1.54 Log10 copies/mL Interval 0.69 to 7.03	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 12	0.69 Log10 copies/mL Interval 0.69 to 2.64	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 3.37	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 16	0.69 Log10 copies/mL Interval 0.69 to 1.65	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 3.08	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 20	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 3.24	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 24	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 3.09	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 28	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 3.03	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 32	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 2.87	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 36	0.69 Log10 copies/mL Interval 0.69 to 1.22	0.69 Log10 copies/mL Interval 0.69 to 0.69	0.99 Log10 copies/mL Interval 0.69 to 2.92	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 40	0.69 Log10 copies/mL Interval 0.69 to 1.89	0.69 Log10 copies/mL Interval 0.69 to 0.69	0.99 Log10 copies/mL Interval 0.69 to 2.65	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 44	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.69 Log10 copies/mL Interval 0.69 to 0.99	0.99 Log10 copies/mL Interval 0.69 to 2.73	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 48	0.69 Log10 copies/mL Interval 0.69 to 1.83	0.69 Log10 copies/mL Interval 0.69 to 0.69	0.99 Log10 copies/mL Interval 0.69 to 2.7	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 50	0.69 Log10 copies/mL Interval 0.69 to 1.48	1.02 Log10 copies/mL Interval 0.69 to 1.34	0.99 Log10 copies/mL Interval 0.69 to 0.99	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 52	0.69 Log10 copies/mL Interval 0.69 to 1.75	1.46 Log10 copies/mL Interval 1.04 to 1.88	0.99 Log10 copies/mL Interval 0.69 to 0.99	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 54	0.69 Log10 copies/mL Interval 0.69 to 1.64	2.08 Log10 copies/mL Interval 0.69 to 2.76	0.99 Log10 copies/mL Interval 0.69 to 0.99	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 56	0.99 Log10 copies/mL Interval 0.69 to 4.07	1.94 Log10 copies/mL Interval 0.69 to 3.44	1.54 Log10 copies/mL Interval 0.69 to 6.09	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 58	0.69 Log10 copies/mL Interval 0.69 to 1.44	1.75 Log10 copies/mL Interval 1.75 to 1.75	0.99 Log10 copies/mL Interval 0.69 to 2.49	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 60	0.69 Log10 copies/mL Interval 0.69 to 1.89	1.25 Log10 copies/mL Interval 0.69 to 1.82	0.99 Log10 copies/mL Interval 0.69 to 2.65	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 64	0.99 Log10 copies/mL Interval 0.69 to 3.85	1.28 Log10 copies/mL Interval 0.69 to 2.82	0.99 Log10 copies/mL Interval 0.69 to 5.98	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 68	1.28 Log10 copies/mL Interval 0.99 to 1.56	1.99 Log10 copies/mL Interval 1.99 to 1.99	0.99 Log10 copies/mL Interval 0.99 to 1.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV RNA Level Week 72	0.99 Log10 copies/mL Interval 0.69 to 3.87	1.77 Log10 copies/mL Interval 0.69 to 4.52	1.08 Log10 copies/mL Interval 0.69 to 6.04	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Baseline	4.10 Log10 U/mL Interval 1.9 to 6.9	6.15 Log10 U/mL Interval 2.9 to 7.8	7.95 Log10 U/mL Interval 1.9 to 9.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 2	4.10 Log10 U/mL Interval 1.9 to 6.8	5.95 Log10 U/mL Interval 1.9 to 7.6	7.80 Log10 U/mL Interval 1.9 to 9.0	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 4	4.20 Log10 U/mL Interval 1.9 to 6.8	5.55 Log10 U/mL Interval 1.9 to 7.2	7.00 Log10 U/mL Interval 1.9 to 8.7	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 8	4.30 Log10 U/mL Interval 1.9 to 6.8	5.25 Log10 U/mL Interval 1.9 to 6.5	6.70 Log10 U/mL Interval 1.9 to 8.9	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 12	4.30 Log10 U/mL Interval 1.9 to 6.7	5.15 Log10 U/mL Interval 1.9 to 6.2	6.30 Log10 U/mL Interval 1.9 to 8.8	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 16	4.05 Log10 U/mL Interval 1.9 to 6.6	5.50 Log10 U/mL Interval 2.9 to 6.0	6.20 Log10 U/mL Interval 2.5 to 8.7	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 20	4.10 Log10 U/mL Interval 2.5 to 6.7	5.00 Log10 U/mL Interval 2.9 to 6.0	5.90 Log10 U/mL Interval 2.5 to 8.3	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 24	4.20 Log10 U/mL Interval 2.9 to 6.6	5.10 Log10 U/mL Interval 2.5 to 5.9	5.70 Log10 U/mL Interval 1.9 to 8.0	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 28	4.05 Log10 U/mL Interval 2.5 to 6.4	5.00 Log10 U/mL Interval 1.9 to 5.9	5.60 Log10 U/mL Interval 2.5 to 7.7	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 32	4.20 Log10 U/mL Interval 2.5 to 6.5	4.85 Log10 U/mL Interval 2.9 to 6.1	5.40 Log10 U/mL Interval 1.9 to 9.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 36	4.05 Log10 U/mL Interval 2.9 to 6.4	5.10 Log10 U/mL Interval 2.9 to 6.1	5.45 Log10 U/mL Interval 1.9 to 7.8	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 40	4.10 Log10 U/mL Interval 2.9 to 6.5	4.90 Log10 U/mL Interval 2.5 to 6.1	5.45 Log10 U/mL Interval 2.5 to 7.5	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 44	4.35 Log10 U/mL Interval 2.9 to 6.4	4.80 Log10 U/mL Interval 2.5 to 6.1	5.35 Log10 U/mL Interval 1.9 to 7.8	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 48	4.10 Log10 U/mL Interval 2.5 to 6.6	5.10 Log10 U/mL Interval 2.9 to 6.0	5.45 Log10 U/mL Interval 2.5 to 9.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 50	4.00 Log10 U/mL Interval 1.9 to 4.8	5.05 Log10 U/mL Interval 4.8 to 5.3	3.10 Log10 U/mL Interval 2.9 to 4.8	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 52	3.60 Log10 U/mL Interval 1.9 to 4.9	5.05 Log10 U/mL Interval 4.9 to 5.2	3.10 Log10 U/mL Interval 2.9 to 4.8	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 54	3.30 Log10 U/mL Interval 2.5 to 4.8	3.90 Log10 U/mL Interval 2.5 to 5.5	3.10 Log10 U/mL Interval 2.9 to 4.9	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 56	4.15 Log10 U/mL Interval 2.5 to 6.5	5.00 Log10 U/mL Interval 2.9 to 6.1	5.50 Log10 U/mL Interval 1.9 to 9.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 58	2.50 Log10 U/mL Interval 2.5 to 4.6	5.30 Log10 U/mL Interval 5.3 to 5.3	3.20 Log10 U/mL Interval 2.9 to 6.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 60	4.15 Log10 U/mL Interval 2.5 to 4.7	3.60 Log10 U/mL Interval 2.5 to 4.7	2.90 Log10 U/mL Interval 2.5 to 6.5	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 64	4.20 Log10 U/mL Interval 2.5 to 6.5	4.40 Log10 U/mL Interval 2.9 to 5.6	5.15 Log10 U/mL Interval 1.9 to 9.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 68	3.80 Log10 U/mL Interval 2.9 to 4.7	5.30 Log10 U/mL Interval 5.3 to 5.4	3.20 Log10 U/mL Interval 3.0 to 4.4	—	—	—	—	—	—	—	—	—	—
Part 3: HBV Core-Related Antigen (HBcrAg) Levels Week 72	4.20 Log10 U/mL Interval 1.9 to 6.4	4.80 Log10 U/mL Interval 2.5 to 6.5	4.70 Log10 U/mL Interval 1.9 to 9.1	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12 - Week 72

Population: This endpoint includes participants from Part 3 with elevated ALT at baseline.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=9 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=28 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 12	—	66.67 Percentage of participants	35.71 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 24	—	88.89 Percentage of participants	62.96 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 36	—	88.89 Percentage of participants	77.78 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 48	—	88.89 Percentage of participants	85.19 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 56	—	77.78 Percentage of participants	81.48 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 64	—	100 Percentage of participants	92.59 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation Week 72	—	87.5 Percentage of participants	92.59 Percentage of participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 72

Population: This endpoint included participants from Part 3 who were anti-HBc+ at baseline.

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Percentage of Participants With Anti-Hepatitis B Core Antigen (HBc) Antibodies	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: HBV DNA Level Baseline	1.28 Log10 copies/mL Interval 1.28 to 1.28	6.06 Log10 copies/mL Interval 2.61 to 8.84	7.37 Log10 copies/mL Interval 3.43 to 9.36	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 2	1.28 Log10 copies/mL Interval 1.28 to 1.28	3.14 Log10 copies/mL Interval 1.28 to 6.47	3.89 Log10 copies/mL Interval 0.95 to 6.4	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 4	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.99 Log10 copies/mL Interval 1.28 to 5.44	2.76 Log10 copies/mL Interval 0.95 to 5.78	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 8	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.41 Log10 copies/mL Interval 1.28 to 3.73	1.54 Log10 copies/mL Interval 0.95 to 6.15	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 12	1.28 Log10 copies/mL Interval 1.28 to 1.91	1.28 Log10 copies/mL Interval 1.28 to 1.97	1.44 Log10 copies/mL Interval 0.95 to 4.69	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 16	1.28 Log10 copies/mL Interval 1.28 to 1.41	1.28 Log10 copies/mL Interval 1.28 to 2.33	1.28 Log10 copies/mL Interval 0.95 to 3.99	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 20	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 2.01	1.28 Log10 copies/mL Interval 0.95 to 3.28	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 24	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.45	1.28 Log10 copies/mL Interval 0.95 to 2.55	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 28	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 0.95 to 2.55	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 32	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.43	1.28 Log10 copies/mL Interval 0.95 to 4.11	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 36	1.28 Log10 copies/mL Interval 1.28 to 1.32	1.28 Log10 copies/mL Interval 1.28 to 1.41	1.28 Log10 copies/mL Interval 0.95 to 2.21	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 40	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.62	1.28 Log10 copies/mL Interval 0.95 to 2.08	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 44	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 0.95 to 2.39	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 48	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 0.95 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 50	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	0.95 Log10 copies/mL Interval 0.95 to 1.28	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 52	1.28 Log10 copies/mL Interval 1.28 to 1.59	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 0.95 to 2.01	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 54	1.28 Log10 copies/mL Interval 1.28 to 1.3	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 0.95 to 2.89	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 56	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.53	1.28 Log10 copies/mL Interval 0.95 to 5.02	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 58	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	2.09 Log10 copies/mL Interval 0.95 to 4.88	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 60	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	2.52 Log10 copies/mL Interval 0.95 to 5.23	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 64	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 2.94	1.28 Log10 copies/mL Interval 0.95 to 6.65	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 68	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 1.28	2.67 Log10 copies/mL Interval 0.95 to 4.66	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA Level Week 72	1.28 Log10 copies/mL Interval 1.28 to 1.28	1.28 Log10 copies/mL Interval 1.28 to 6.33	1.28 Log10 copies/mL Interval 0.95 to 4.7	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline - Week 72

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Baseline	100 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 2	100 Percentage of participants	10 Percentage of participants	10.3 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 4	100 Percentage of participants	30 Percentage of participants	16.7 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 8	100 Percentage of participants	40 Percentage of participants	41.4 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 12	96.4 Percentage of participants	70 Percentage of participants	43.3 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 16	96.7 Percentage of participants	77.8 Percentage of participants	51.7 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 20	100 Percentage of participants	90 Percentage of participants	55.2 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 24	100 Percentage of participants	88.9 Percentage of participants	51.7 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 28	100 Percentage of participants	100 Percentage of participants	55.2 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 32	100 Percentage of participants	87.5 Percentage of participants	64.3 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 36	96.7 Percentage of participants	90 Percentage of participants	67.9 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 40	100 Percentage of participants	77.8 Percentage of participants	71.4 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 44	100 Percentage of participants	100 Percentage of participants	71.4 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 48	100 Percentage of participants	100 Percentage of participants	81.5 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 50	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 52	90 Percentage of participants	100 Percentage of participants	80 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 54	88.9 Percentage of participants	100 Percentage of participants	80 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 56	100 Percentage of participants	88.9 Percentage of participants	64.3 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 58	100 Percentage of participants	100 Percentage of participants	40 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 60	100 Percentage of participants	100 Percentage of participants	20 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 64	100 Percentage of participants	83.3 Percentage of participants	67.9 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 68	100 Percentage of participants	100 Percentage of participants	40 Percentage of participants	—	—	—	—	—	—	—	—	—	—
Part 3: HBV DNA < Lower Limit of Quantification (LLOQ) Week 72	100 Percentage of participants	77.8 Percentage of participants	78.6 Percentage of participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 - Week 48

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Tmax of RO7049389 Day 1	1.99 Hours Interval 0.98 to 3.03	2.00 Hours Interval 1.0 to 3.02	1.96 Hours Interval 0.95 to 3.02	—	—	—	—	—	—	—	—	—	—
Part 3: Tmax of RO7049389 Week 4	—	2.02 Hours Interval 1.0 to 3.02	—	—	—	—	—	—	—	—	—	—	—
Part 3: Tmax of RO7049389 Week 24	1.94 Hours Interval 0.0 to 3.0	2.00 Hours Interval 1.0 to 3.0	2.00 Hours Interval 0.92 to 4.15	—	—	—	—	—	—	—	—	—	—
Part 3: Tmax of RO7049389 Week 48	1.02 Hours Interval 0.0 to 3.13	2.50 Hours Interval 1.0 to 3.05	2.00 Hours Interval 0.93 to 3.97	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 - Week 48

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: Cmax of RO7049389 Day 1	7140 ng/mL Geometric Coefficient of Variation 107.6	5390 ng/mL Geometric Coefficient of Variation 94.3	5910 ng/mL Geometric Coefficient of Variation 116.8	—	—	—	—	—	—	—	—	—	—
Part 3: Cmax of RO7049389 Week 4	—	4630 ng/mL Geometric Coefficient of Variation 92.8	—	—	—	—	—	—	—	—	—	—	—
Part 3: Cmax of RO7049389 Week 24	2500 ng/mL Geometric Coefficient of Variation 2040.7	3900 ng/mL Geometric Coefficient of Variation 126.9	4260 ng/mL Geometric Coefficient of Variation 89.4	—	—	—	—	—	—	—	—	—	—
Part 3: Cmax of RO7049389 Week 48	5410 ng/mL Geometric Coefficient of Variation 88.4	3510 ng/mL Geometric Coefficient of Variation 246.1	3570 ng/mL Geometric Coefficient of Variation 133.6	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 - Week 48

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: AUCtau of RO7049389 Day 1	18700 h*ng/mL Geometric Coefficient of Variation 105.1	16700 h*ng/mL Geometric Coefficient of Variation 79.3	20900 h*ng/mL Geometric Coefficient of Variation 107.4	—	—	—	—	—	—	—	—	—	—
Part 3: AUCtau of RO7049389 Week 4	—	13600 h*ng/mL Geometric Coefficient of Variation 117.2	—	—	—	—	—	—	—	—	—	—	—
Part 3: AUCtau of RO7049389 Week 24	15400 h*ng/mL Geometric Coefficient of Variation 121.3	10500 h*ng/mL Geometric Coefficient of Variation 241.8	13200 h*ng/mL Geometric Coefficient of Variation 88.2	—	—	—	—	—	—	—	—	—	—
Part 3: AUCtau of RO7049389 Week 48	14100 h*ng/mL Geometric Coefficient of Variation 84.8	16000 h*ng/mL Geometric Coefficient of Variation 121.3	11700 h*ng/mL Geometric Coefficient of Variation 107.6	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 - Week 48

Outcome measures

Outcome measures
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=32 Participants Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1a: SAD Cohort 1 n=10 Participants HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=30 Participants Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 1c: MAD Cohort 1 HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.
Part 3: T1/2 of RO7049389 Day 1	1.16 Hours Interval 0.757 to 1.67	1.13 Hours Interval 0.891 to 1.31	1.31 Hours Interval 0.899 to 1.98	—	—	—	—	—	—	—	—	—	—
Part 3: T1/2 of RO7049389 Week 4	—	1.38 Hours Interval 0.897 to 1.89	—	—	—	—	—	—	—	—	—	—	—
Part 3: T1/2 of RO7049389 Week 24	1.30 Hours Interval 0.832 to 2.19	1.43 Hours Interval 1.17 to 2.38	1.38 Hours Interval 1.06 to 2.25	—	—	—	—	—	—	—	—	—	—
Part 3: T1/2 of RO7049389 Week 48	4.05 Hours Interval 2.62 to 7.59	3.40 Hours Interval 2.63 to 5.85	3.98 Hours Interval 2.54 to 8.33	—	—	—	—	—	—	—	—	—	—

Adverse Events

Parts 1a and 1b: Single Ascending Dose (SAD) Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1c: Multiple Ascending Dose (MAD) Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: Proof-of-Mechanism (POM) Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1a: SAD Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1a and Part 1b: SAD Cohort 2 (Food Effect)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1a: SAD Cohort 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1a: SAD Cohort 4

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1a: SAD Cohort 5

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1a: SAD Cohort 6

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1c: MAD Cohort 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1c: MAD Cohort 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1c: MAD Cohort 3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1c: MAD Cohort 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1c: MAD Cohort 5

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: POM Cohort 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: POM Cohort 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: POM Cohort 3

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: POM Cohort 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: POM Cohort 5

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 3: Cohort A

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Part 3: Cohort B

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Part 3: Cohort C

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=11 participants at risk Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo n=10 participants at risk HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 2: Proof-of-Mechanism (POM) Placebo n=6 participants at risk Participants with chronic hepatitis B virus (CHB) infection received placebo once daily (QD) or twice daily (BID) for 27 days, followed by a single dose on Day 28.	Part 1a: SAD Cohort 1 n=3 participants at risk HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 participants at risk Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 participants at risk HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 participants at risk HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 participants at risk HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 participants at risk HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: MAD Cohort 1 n=6 participants at risk HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 n=7 participants at risk HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 n=7 participants at risk HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 n=6 participants at risk HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 n=6 participants at risk HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 2: POM Cohort 1 n=6 participants at risk Participants with CHB received 200 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 2 n=6 participants at risk Participants with CHB received 400 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 3 n=6 participants at risk Participants with CHB received 600 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 4 n=7 participants at risk Participants with CHB received 1000 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 5 n=6 participants at risk Participants with CHB received 200 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 3: Cohort A n=32 participants at risk Nucleos(t)ide (NUC)-suppressed CHB participants received 600 mg of RO7049389 QD under fasted conditions in addition to an NUC (administered per local SoC) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort B n=10 participants at risk Treatment-naïve immune-active CHB participants 600 mg of RO7049389 QD under fasted conditions for 4 weeks, followed by RO7049389 + NUC (administered per local SoC) for an additional 44 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort C n=30 participants at risk Treatment-naïve immune-active CHB participants received 600 mg of RO7049389 QD under fasted conditions + NUC + pegylated interferon (Peg-IFN) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Immune system disorders Hypersensitivity	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Cellulitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Liver function test increased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Dizziness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)

Other adverse events

Other adverse events
Measure	Parts 1a and 1b: Single Ascending Dose (SAD) Placebo n=11 participants at risk Healthy volunteers (HVs) received a single dose of placebo under fasted (Part 1a) or fed (Part 1b) conditions.	Part 1c: Multiple Ascending Dose (MAD) Placebo n=10 participants at risk HVs received placebo either once-daily (QD) or twice-daily (BID) for 13 days, followed by a single dose on Day 14.	Part 2: Proof-of-Mechanism (POM) Placebo n=6 participants at risk Participants with chronic hepatitis B virus (CHB) infection received placebo once daily (QD) or twice daily (BID) for 27 days, followed by a single dose on Day 28.	Part 1a: SAD Cohort 1 n=3 participants at risk HVs received a single dose of 150 mg of RO7049389 under fasted conditions.	Part 1a and Part 1b: SAD Cohort 2 (Food Effect) n=6 participants at risk Part 1a: Single oral dose of 450 mg of RO7049389 under fasted conditions. Part 1b: Single oral dose of 450 mg of RO7049389 on Day 16 after a standard US FDA-recommended high-fat high-calorie meal.	Part 1a: SAD Cohort 3 n=3 participants at risk HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 4 n=6 participants at risk HVs received a single dose of 2000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 5 n=6 participants at risk HVs received a single dose of 1000 mg of RO7049389 under fasted conditions.	Part 1a: SAD Cohort 6 n=6 participants at risk HVs received a single dose of 2500 mg of RO7049389 under fasted conditions.	Part 1c: MAD Cohort 1 n=6 participants at risk HVs received 200 mg of RO7049389 BID under fasted conditions for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 2 n=7 participants at risk HVs received 200 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 3 n=7 participants at risk HVs received 400 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 4 n=6 participants at risk HVs received 800 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 1c: MAD Cohort 5 n=6 participants at risk HVs received 600 mg of RO7049389 BID after a standard US FDA-recommended high-fat high-calorie meal for 13 days, followed by a single dose on Day 14. Participants also received a single oral dose of midazolam on Day -1 and Day 14.	Part 2: POM Cohort 1 n=6 participants at risk Participants with CHB received 200 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 2 n=6 participants at risk Participants with CHB received 400 mg of RO7049389 BID for 27 days after a standard US FDA recommended high-fat high-calorie meal, followed by a single dose on Day 28.	Part 2: POM Cohort 3 n=6 participants at risk Participants with CHB received 600 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 4 n=7 participants at risk Participants with CHB received 1000 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 2: POM Cohort 5 n=6 participants at risk Participants with CHB received 200 mg of RO7049389 QD for 27 days under fasted conditions, followed by a single dose on Day 28.	Part 3: Cohort A n=32 participants at risk Nucleos(t)ide (NUC)-suppressed CHB participants received 600 mg of RO7049389 QD under fasted conditions in addition to an NUC (administered per local SoC) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort B n=10 participants at risk Treatment-naïve immune-active CHB participants 600 mg of RO7049389 QD under fasted conditions for 4 weeks, followed by RO7049389 + NUC (administered per local SoC) for an additional 44 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.	Part 3: Cohort C n=30 participants at risk Treatment-naïve immune-active CHB participants received 600 mg of RO7049389 QD under fasted conditions + NUC + pegylated interferon (Peg-IFN) for 48 weeks. After the study treatment period, participants either continued NUC for another 24 weeks, or discontinued all treatment.
General disorders Malaise	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Medical device site dermatitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Medical device site rash	9.1% 1/11 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Pyrexia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	60.0% 18/30 • Number of events 35 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	26.7% 8/30 • Number of events 9 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	23.3% 7/30 • Number of events 9 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.2% 2/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Neutropenia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Splenomegaly	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Cardiac disorders Palpitations	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 5 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Ear and labyrinth disorders Deafness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Ear and labyrinth disorders Motion sickness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Ear and labyrinth disorders Vertigo	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Endocrine disorders Thyroid disorder	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Endocrine disorders Thyroid mass	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Blepharitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Blepharospasm	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Conjunctival haemorrhage	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Conjunctivitis allergic	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Orbital oedema	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Eye disorders Visual impairment	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Constipation	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Dental caries	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.2% 2/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 2/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Epigastric discomfort	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Flatulence	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Gastritis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 2/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Gingival bleeding	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Haemorrhoids	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Mouth ulceration	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Nausea	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	28.6% 2/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 5/30 • Number of events 5 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Toothache	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Gastrointestinal disorders Vomiting	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Catheter site bruise	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Catheter site erythema	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Catheter site pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Catheter site swelling	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Chest discomfort	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Fatigue	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	30.0% 9/30 • Number of events 13 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Influenza like illness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	15.6% 5/32 • Number of events 7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 5/30 • Number of events 9 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Injection site erythema	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Swelling face	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
General disorders Vessel puncture site haematoma	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Hepatobiliary disorders Hepatic steatosis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Hepatobiliary disorders Hepatitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 5/30 • Number of events 5 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Immune system disorders Hypersensitivity	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations COVID-19	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Gastroenteritis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Mumps	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Nasopharyngitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 2/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Periorbital cellulitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Respiratory tract infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	9.4% 3/32 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Rhinitis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 2/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 2/6 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	15.6% 5/32 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 5/30 • Number of events 5 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Urinary tract infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	9.4% 3/32 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Vaginal infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Infections and infestations Viral infection	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Injury, poisoning and procedural complications Contusion	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Injury, poisoning and procedural complications Dental restoration failure	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Injury, poisoning and procedural complications Muscle strain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Injury, poisoning and procedural complications Thermal burn	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Alanine aminotransferase increased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 2/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	36.7% 11/30 • Number of events 13 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Aspartate aminotransferase increased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	30.0% 9/30 • Number of events 12 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Blood triglycerides increased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Haemoglobin decreased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 5 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Neutrophil count decreased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 6/30 • Number of events 12 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Platelet count decreased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	40.0% 12/30 • Number of events 17 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations Weight decreased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	23.3% 7/30 • Number of events 7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Investigations White blood cell count decreased	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	23.3% 7/30 • Number of events 11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 10/30 • Number of events 12 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 6/30 • Number of events 10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Metabolism and nutrition disorders Increased appetite	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	28.6% 2/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 2/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 5/30 • Number of events 9 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	23.3% 7/30 • Number of events 11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Dizziness	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	28.6% 2/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 6/30 • Number of events 10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Headache	18.2% 2/11 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 2/10 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	66.7% 4/6 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 2/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	28.6% 2/7 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	9.4% 3/32 • Number of events 7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	20.0% 2/10 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	46.7% 14/30 • Number of events 20 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Hypoaesthesia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.1% 1/32 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Lethargy	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Nervous system disorders Presyncope	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Reproductive system and breast disorders Menstrual disorder	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.2% 2/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	13.3% 4/30 • Number of events 4 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 3/30 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	33.3% 1/3 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	28.6% 2/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.2% 2/32 • Number of events 3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	36.7% 11/30 • Number of events 11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Blister	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.7% 2/30 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Dermatitis contact	9.1% 1/11 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	14.3% 1/7 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/32 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	10.0% 1/10 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	3.3% 1/30 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/11 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/3 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	16.7% 1/6 • Number of events 1 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/7 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/6 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	6.2% 2/32 • Number of events 2 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/10 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)	0.00% 0/30 • Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c), Day 112 (Part 2), and 72 weeks (Part 3)

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

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