Trial Outcomes & Findings for Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy (NCT NCT03039686)

Last Updated: 2020-12-21

Results Overview

The NSAA is a functional scale specifically designed for ambulant boys with Duchenne muscular dystrophy (DMD) that can provide information about motor function. The NSAA is a 17-item test of standing, ability to transition from lying to sitting, sitting to standing, and other mobility assessments. Each of the 17 items is evaluated on an ordinal scale of 0-2: 0 = unable to achieve independently, 1 = modified method but achieves goal independent of physical assistance from another, or 2 = normal with no obvious modification of activity. Total score range is 0 to 34. Higher scores reflect better performance.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

166 participants

Primary outcome timeframe

Baseline

Results posted on

2020-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Double-blind Period STARTED	56	55	55
Double-blind Period COMPLETED	29	26	32
Double-blind Period NOT COMPLETED	27	29	23
Open Label Period STARTED	0	38	42
Open Label Period Completed DB, Did Not Start OL	2	2	3
Open Label Period COMPLETED	0	0	0
Open Label Period NOT COMPLETED	0	38	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Double-blind Period Administrative Reason by Sponsor	24	25	21
Double-blind Period Subject Request to Discontinue Study Treatment	1	2	0
Double-blind Period Withdrawal by Subject	2	2	1
Double-blind Period Death	0	0	1
Open Label Period Administrative Reason by Sponsor	0	34	41
Open Label Period Subject Request to Discontinue Study Treatment	0	1	0
Open Label Period Withdrawal by Subject	0	3	1

Baseline Characteristics

Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	Total n=166 Participants Total of all reporting groups
Age, Continuous	8.4 years STANDARD_DEVIATION 1.7 • n=5 Participants	8.5 years STANDARD_DEVIATION 1.8 • n=7 Participants	8.4 years STANDARD_DEVIATION 1.5 • n=5 Participants	8.5 years STANDARD_DEVIATION 1.7 • n=4 Participants
Age, Customized Children (6-11 years)	56 participants n=5 Participants	55 participants n=7 Participants	55 participants n=5 Participants	166 participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	55 Participants n=7 Participants	55 Participants n=5 Participants	166 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	41 Participants n=7 Participants	43 Participants n=5 Participants	127 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Asian	9 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	23 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized White	42 participants n=5 Participants	45 participants n=7 Participants	45 participants n=5 Participants	132 participants n=4 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline for the North Star Ambulatory Assessment (NSAA) Total Score	23.1 score on a scale Standard Deviation 6.4	24.5 score on a scale Standard Deviation 5.5	22.7 score on a scale Standard Deviation 6.7	—	—

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. MMRM analysis included all participants at baseline and the following number of participants by Week 48: Placebo n=30, Low Dose n=29, High Dose n=33.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline in the North Star Ambulatory Assessment (NSAA) Total Score at Week 48	-2.99 score on a scale Standard Error 0.65	-3.44 score on a scale Standard Error 0.67	-2.41 score on a scale Standard Error 0.64	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

The time to complete the 4 stair climb was measured at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline Time for 4 Stair Climb	3.81 seconds (secs) Standard Deviation 1.55	3.85 seconds (secs) Standard Deviation 1.61	3.92 seconds (secs) Standard Deviation 1.91	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

4SCV was calculated as the ratio of the number of stairs climbed (4) divided by the number of seconds taken to complete the 4-stair climb. The results were converted into velocity (distance/time). A positive change from baseline indicates an improvement. Based on the mixed-effect model of repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in 4 Stair Climb Velocity (4SCV)	-0.15 stairs/sec Standard Error 0.07	-0.15 stairs/sec Standard Error 0.07	-0.07 stairs/sec Standard Error 0.07	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

The time required for a participant to stand from supine position. A longer time reflects a worse outcome.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline for the Time to Stand From Supine	6.28 secs Standard Deviation 4.75	6.15 secs Standard Deviation 4.07	7.24 secs Standard Deviation 9.22	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

The time required for a participant to stand from supine position. A longer time reflects a worse outcome. A negative change from baseline indicates an improvement. Based on the mixed-effect model of repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in Stand From Supine Velocity	-0.05 1/sec Standard Error 0.01	-0.02 1/sec Standard Error 0.01	-0.02 1/sec Standard Error 0.01	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

The time required for a participant to run or walk a distance of 10 meters as quickly as possible. A longer time reflects a worse outcome.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline Time for 10 Meter Walk/Run	5.38 secs Standard Deviation 1.48	5.51 secs Standard Deviation 1.68	5.68 secs Standard Deviation 2.30	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

The time required for a participant to run or walk a distance of 10 meters as quickly as possible calculated as velocity (distance/time). A positive change from baseline indicates an improvement. Based on the mixed-effect model of repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in 10 M Walk/Run Velocity	-0.23 m/sec Standard Error 0.06	-0.14 m/sec Standard Error 0.07	-0.23 m/sec Standard Error 0.06	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

The PODCI is designed to be completed by the parent/guardian of a child who has knowledge of the child's conditions. The Transfer and Basic Mobility scale is one of the subscales of the PODCI. The results are standardized into a scale of 0-100 with a higher score reflecting better performance.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline for the Pediatric Outcome Data Collection Instrument (PODCI) Transfer and Basic Mobility Subscale	85.59 score on a scale Standard Deviation 10.21	86.54 score on a scale Standard Deviation 9.52	84.47 score on a scale Standard Deviation 14.76	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in Pediatric Outcome Data Collection Instrument (PODCI) Transfer and Basic Mobility Subscale	-5.47 score on a scale Standard Error 1.79	-7.47 score on a scale Standard Error 1.83	-4.51 score on a scale Standard Error 1.77	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. Number analyzed is the number of participants with data available for analyses at the given timepoint.

Proximal lower extremity flexor (knee extension and knee flexion) strength was measured using manual myometry. A higher score reflects a better outcome. A positive change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in Proximal Lower Extremity Flexor Strength Baseline: Knee Extenders	5.58 kilogram (kg) Standard Deviation 2.87	6.25 kilogram (kg) Standard Deviation 3.63	5.76 kilogram (kg) Standard Deviation 3.53	—	—
Change From Baseline at Week 48 in Proximal Lower Extremity Flexor Strength Change from Baseline at Week 48: Knee Extenders	-1.19 kilogram (kg) Standard Deviation 2.13	-0.47 kilogram (kg) Standard Deviation 2.43	-0.88 kilogram (kg) Standard Deviation 2.97	—	—
Change From Baseline at Week 48 in Proximal Lower Extremity Flexor Strength Baseline: Knee Flexors	5.04 kilogram (kg) Standard Deviation 2.58	5.70 kilogram (kg) Standard Deviation 3.08	5.04 kilogram (kg) Standard Deviation 2.72	—	—
Change From Baseline at Week 48 in Proximal Lower Extremity Flexor Strength Change from Baseline at Week 48: Knee Flexors	0.15 kilogram (kg) Standard Deviation 2.24	0.08 kilogram (kg) Standard Deviation 2.53	-0.13 kilogram (kg) Standard Deviation 2.29	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

The 6MWD measured the distance a participant was able to traverse while walking for 6 minutes. A longer distance reflects a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Baseline for the 6 Minute Walk Distance (6MWD)	388.33 meters (m) Standard Deviation 69.59	399.73 meters (m) Standard Deviation 68.35	370.73 meters (m) Standard Deviation 93.35	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

The 6MWD measured the distance a participant was able to traverse while walking for 6 minutes. A longer distance reflects a better outcome. A positive change from baseline indicates an improvement. Based on the mixed-effect model of repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in 6 Minute Walk Distance (6MWD)	-41.3 meters (m) Standard Error 8.7	-39.6 meters (m) Standard Error 9.0	-30.0 meters (m) Standard Error 8.7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment. Included in the analysis are only those subjects for whom an efficacy assessment was completed at Week 48.

The CGI-C was used to assess the participant's overall condition on a 7-point scale, using the status markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse" at Week 48 as compared to baseline.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=37 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=31 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Very much improved	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Much improved	5.6 percentage of participants	2.7 percentage of participants	3.2 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Minimally improved	13.9 percentage of participants	13.5 percentage of participants	19.4 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 No change	58.3 percentage of participants	54.1 percentage of participants	51.6 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Minimally worse	16.7 percentage of participants	18.9 percentage of participants	22.6 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Much worse	5.6 percentage of participants	10.8 percentage of participants	3.2 percentage of participants	—	—
Percentage of Participants for Each Clinical Global Impression of Change (CGI-C) Assessment Status at Week 48 Very much worse	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Intent-to-Treat (ITT) population included all enrolled participants who received a randomization treatment assignment.

Stride velocity was recorded with the ActiMyo device in a subset of the overall study population. The ActiMyo device measures the daily movement and activity levels of the participant. The device consists of two sensors worn on each ankle. A higher velocity reflects a better outcome. A positive change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=19 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=15 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Change From Baseline at Week 48 in 95th Percentile Stride Velocity Baseline	1.69 m/sec Standard Deviation 0.33	1.54 m/sec Standard Deviation 0.35	1.57 m/sec Standard Deviation 0.46	—	—
Change From Baseline at Week 48 in 95th Percentile Stride Velocity Change from Baseline at Week 48	-0.25 m/sec Standard Deviation 0.39	-0.22 m/sec Standard Deviation 0.22	-0.28 m/sec Standard Deviation 0.29	—	—

SECONDARY outcome

Timeframe: During DB period (48 weeks) and Whole study (up to approximately 34 months)

Population: Safety population included all enrolled participants who received at least 1 dose of study therapy. Data are presented for the arms in the DB period as well as for all RO7239361-treated participants in the whole study.

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=69 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study n=68 Participants Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Number of Participants With Adverse Events (AEs) Double-Blind Period	46 participants	48 participants	49 participants	—	—
Number of Participants With Adverse Events (AEs) Whole Study	—	—	—	57 participants	56 participants

SECONDARY outcome

Timeframe: During DB period (48 weeks) and Whole study (up to approximately 34 months)

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period. Following the DB period participants received low dose or high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=55 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose n=55 Participants Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose n=69 Participants Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose Whole Study n=68 Participants Participants received high dose SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.
Number of Participants With AEs Leading to Discontinuation Double-Blind Period	0 participants	0 participants	0 participants	—	—
Number of Participants With AEs Leading to Discontinuation Whole Study	—	—	—	0 participants	0 participants

Adverse Events

Placebo DB

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

RO7239361 Low Dose DB

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

RO7239361 High Dose DB

Serious events: 4 serious events

Other events: 47 other events

Deaths: 1 deaths

Placebo, Then RO7239361 Low Dose OL

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo, Then RO7239361 High Dose OL

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

RO7239361 Low Dose, Then RO7239361 Low Dose OL

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

RO7239361 High Dose, Then RO7239361 High Dose OL

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo DB n=56 participants at risk Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period.	RO7239361 Low Dose DB n=55 participants at risk Participants received low dose RO7239361 SC on specified days of the 48-week DB period.	RO7239361 High Dose DB n=55 participants at risk Participants received high dose RO7239361 SC on specified days of the 48-week DB period.	Placebo, Then RO7239361 Low Dose OL n=14 participants at risk Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label (OL) period followed by 24 weeks of follow-up.	Placebo, Then RO7239361 High Dose OL n=13 participants at risk Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose, Then RO7239361 Low Dose OL n=24 participants at risk Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose, Then RO7239361 High Dose OL n=29 participants at risk Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up
Cardiac disorders Cardiac arrest	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Cardiac disorders Myocarditis	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Cardiac disorders Supraventricular tachycardia	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Influenza like illness	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Gastrointestinal viral infection	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Viral infection	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Overdose	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Metabolism and nutrition disorders Hypocalcaemia	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.

Other adverse events

Other adverse events
Measure	Placebo DB n=56 participants at risk Participants received matching placebo solution subcutaneously (SC) on specified days of the 48-week double-blind (DB) period.	RO7239361 Low Dose DB n=55 participants at risk Participants received low dose RO7239361 SC on specified days of the 48-week DB period.	RO7239361 High Dose DB n=55 participants at risk Participants received high dose RO7239361 SC on specified days of the 48-week DB period.	Placebo, Then RO7239361 Low Dose OL n=14 participants at risk Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label (OL) period followed by 24 weeks of follow-up.	Placebo, Then RO7239361 High Dose OL n=13 participants at risk Participants received matching placebo solution SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 Low Dose, Then RO7239361 Low Dose OL n=24 participants at risk Participants received low dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received low dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up.	RO7239361 High Dose, Then RO7239361 High Dose OL n=29 participants at risk Participants received high dose RO7239361 SC on specified days of the 48-week DB period. Following the DB period participants received high dose RO7239361 on specified days for up to 192 weeks during the open-label period followed by 24 weeks of follow-up
General disorders Gait inability	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site bruising	3.6% 2/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Gadolinium deposition disease	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Ligament sprain	7.1% 4/56 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.3% 2/14 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.5% 3/24 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Ear and labyrinth disorders Ear pain	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Abdominal discomfort	1.8% 1/56 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Abdominal pain	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Abdominal pain upper	5.4% 3/56 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 12 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Constipation	7.1% 4/56 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	18.2% 10/55 • Number of events 13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 8 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Dyspepsia	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Nausea	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	9.1% 5/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	13.8% 4/29 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Gastrointestinal disorders Vomiting	10.7% 6/56 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.5% 8/55 • Number of events 14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	10.9% 6/55 • Number of events 11 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.5% 3/24 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Fatigue	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site erythema	14.3% 8/56 • Number of events 25 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	20.0% 11/55 • Number of events 43 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	21.8% 12/55 • Number of events 38 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	23.1% 3/13 • Number of events 17 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	8.3% 2/24 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site induration	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site oedema	5.4% 3/56 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site pruritus	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 12 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site reaction	3.6% 2/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 33 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Injection site swelling	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 31 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Localised oedema	5.4% 3/56 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
General disorders Pyrexia	14.3% 8/56 • Number of events 8 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	16.4% 9/55 • Number of events 13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.5% 8/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.3% 2/14 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.5% 3/24 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Ear infection	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Gastroenteritis	1.8% 1/56 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Gastroenteritis viral	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Hordeolum	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Influenza	5.4% 3/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	10.9% 6/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	8.3% 2/24 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Nasopharyngitis	23.2% 13/56 • Number of events 17 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	23.6% 13/55 • Number of events 17 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	23.6% 13/55 • Number of events 16 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.3% 2/14 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Pharyngitis	3.6% 2/56 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Rhinitis	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Sinusitis	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Infections and infestations Upper respiratory tract infection	10.7% 6/56 • Number of events 8 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 16 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Contusion	3.6% 2/56 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	9.1% 5/55 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Fall	8.9% 5/56 • Number of events 11 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	9.1% 5/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Skin abrasion	3.6% 2/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 12 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Investigations Bone density decreased	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Investigations Glutamate dehydrogenase increased	3.6% 2/56 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 6/56 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 8 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	9.1% 5/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Musculoskeletal and connective tissue disorders Back pain	7.1% 4/56 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Musculoskeletal and connective tissue disorders Muscle spasms	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	15.4% 2/13 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 2/56 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 6 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.5% 8/55 • Number of events 11 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Nervous system disorders Headache	16.1% 9/56 • Number of events 28 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	25.5% 14/55 • Number of events 60 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	18.2% 10/55 • Number of events 42 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	8.3% 2/24 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Nervous system disorders Migraine	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 10 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Respiratory, thoracic and mediastinal disorders Cough	17.9% 10/56 • Number of events 10 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	14.5% 8/55 • Number of events 11 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 3/56 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 15 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	10.9% 6/55 • Number of events 17 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.7% 1/13 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	6.9% 2/29 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.8% 1/56 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 7 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 3 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Skin and subcutaneous tissue disorders Erythema	5.4% 3/56 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	1.8% 1/55 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Skin and subcutaneous tissue disorders Rash	7.1% 4/56 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.3% 4/55 • Number of events 5 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	12.7% 7/55 • Number of events 9 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	4.2% 1/24 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.4% 1/29 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/56 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/55 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	7.1% 1/14 • Number of events 1 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.
Skin and subcutaneous tissue disorders Urticaria	5.4% 3/56 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	3.6% 2/55 • Number of events 2 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	5.5% 3/55 • Number of events 4 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/14 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/13 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/24 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.	0.00% 0/29 • Up to approximately 34 months Safety population included all enrolled participants who received at least 1 dose of study therapy.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER