Trial Outcomes & Findings for A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (NCT NCT00676715)

Last Updated: 2024-12-31

Results Overview

Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

220 participants

Primary outcome timeframe

Week 12 to Week 24

Results posted on

2024-12-31

Participant Flow

A total of 220 participants were randomized, of which 218 received study treatment. Participants took part in the study at 79 investigative sites across 18 countries from July 17, 2008, to November 08, 2023.

The study consisted of a 96-week Treatment Period (TP) followed by a Treatment-free period (TFP). Participants who completed both TP \& TFP (at least Week 120) were invited to participate in the optional Open-label Extension (OLE) period.

Participant milestones

Participant milestones
Measure	Placebo / Ocrelizumab 600 mg In the Treatment Period, participants received placebo as, intravenous (IV) infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 milligrams (mg), IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, every 24 weeks (Q24W).	Ocrelizumab 600 mg / Ocrelizumab 600 mg In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg In the Treatment Period, participants received Avonex 30 micrograms (mcg) as intramuscular (IM) injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Treatment Period (TP) STARTED	54	55	55	54
Treatment Period (TP) COMPLETED	48	46	43	46
Treatment Period (TP) NOT COMPLETED	6	9	12	8
Treatment-free Period (TFP) STARTED	49	48	50	49
Treatment-free Period (TFP) COMPLETED	35	32	30	35
Treatment-free Period (TFP) NOT COMPLETED	14	16	20	14
Open Label Extension (OLE) STARTED	29	32	19	24
Open Label Extension (OLE) COMPLETED	22	21	11	14
Open Label Extension (OLE) NOT COMPLETED	7	11	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo / Ocrelizumab 600 mg In the Treatment Period, participants received placebo as, intravenous (IV) infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 milligrams (mg), IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, every 24 weeks (Q24W).	Ocrelizumab 600 mg / Ocrelizumab 600 mg In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg In the Treatment Period, participants received Avonex 30 micrograms (mcg) as intramuscular (IM) injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Treatment Period (TP) Adverse Event	0	3	2	2
Treatment Period (TP) Death	0	0	1	0
Treatment Period (TP) Failure to return	1	0	0	0
Treatment Period (TP) Violation of selection criteria at entry	0	0	1	0
Treatment Period (TP) Refused treatment/did not cooperate	1	2	3	1
Treatment Period (TP) Withdrew consent	3	3	3	3
Treatment Period (TP) Insufficient therapeutic response	1	1	2	1
Treatment Period (TP) Administrative	0	0	0	1
Treatment-free Period (TFP) Withdrawal by Subject	3	3	4	5
Treatment-free Period (TFP) Reason not provided	8	10	8	7
Treatment-free Period (TFP) Lost to Follow-up	2	2	6	2
Treatment-free Period (TFP) Adverse Event	0	0	1	0
Treatment-free Period (TFP) Death	1	1	1	0
Open Label Extension (OLE) Reason not provided	3	4	1	4
Open Label Extension (OLE) Lost to Follow-up	0	0	1	1
Open Label Extension (OLE) Withdrawal by Subject	2	4	3	3
Open Label Extension (OLE) Adverse Event	0	3	1	0
Open Label Extension (OLE) Death	2	0	2	2

Baseline Characteristics

A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Total n=218 Participants Total of all reporting groups
Age, Continuous	38.0 years STANDARD_DEVIATION 8.8 • n=5 Participants	35.6 years STANDARD_DEVIATION 8.5 • n=7 Participants	38.5 years STANDARD_DEVIATION 8.7 • n=5 Participants	38.1 years STANDARD_DEVIATION 9.3 • n=4 Participants	37.6 years STANDARD_DEVIATION 8.8 • n=21 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	38 Participants n=5 Participants	32 Participants n=4 Participants	141 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	22 Participants n=4 Participants	77 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	26 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	47 Participants n=4 Participants	192 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	51 Participants n=7 Participants	53 Participants n=5 Participants	53 Participants n=4 Participants	209 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12 to Week 24

Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=51 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain	5.6 lesions Standard Deviation 12.53	0.6 lesions Standard Deviation 1.52	0.2 lesions Standard Deviation 0.65	6.9 lesions Standard Deviation 16.01

SECONDARY outcome

Timeframe: Week 24

Population: The intent-to-treat population includes all randomized participants who had received any study drug.

Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Annualized Protocol Defined Relapse Rate at Week 24	0.557 relapses per year Interval 0.37 to 0.839	0.127 relapses per year Interval 0.054 to 0.299	0.213 relapses per year Interval 0.11 to 0.414	0.364 relapses per year Interval 0.22 to 0.602

SECONDARY outcome

Timeframe: Week 24

Population: The intent-to-treat population includes all randomized participants who had received any study drug.

Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=55 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Percentage of Participants Who Remained Relapse Free at Week 24	75.9 percentage of participants Interval 64.5 to 87.3	85.5 percentage of participants Interval 76.1 to 94.8	87.3 percentage of participants Interval 78.5 to 96.1	77.8 percentage of participants Interval 66.7 to 88.9

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The intent-to-treat population includes all randomized participants who had received any study drug. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints.

Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=47 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=51 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=53 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=49 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24 Baseline	8950.84 cubic millimeter (mm^3) Standard Deviation 9776.261	13972.61 cubic millimeter (mm^3) Standard Deviation 19930.158	13178.30 cubic millimeter (mm^3) Standard Deviation 14271.383	13209.11 cubic millimeter (mm^3) Standard Deviation 17206.511
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24 Change at Week 24	-112.31 cubic millimeter (mm^3) Standard Deviation 1464.206	-878.84 cubic millimeter (mm^3) Standard Deviation 2756.839	-600.89 cubic millimeter (mm^3) Standard Deviation 2105.964	1040.06 cubic millimeter (mm^3) Standard Deviation 4510.140

SECONDARY outcome

Timeframe: Weeks 4 to Week 24

Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=51 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain	5.1 lesions Standard Deviation 11.99	0.8 lesions Standard Deviation 1.95	0.8 lesions Standard Deviation 2.16	6.2 lesions Standard Deviation 13.79

SECONDARY outcome

Timeframe: Weeks 4 to Week 24

Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.

Outcome measures

Outcome measures
Measure	Placebo / Ocrelizumab 600 mg n=54 Participants In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 600 mg / Ocrelizumab 600 mg n=51 Participants In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Ocrelizumab 1000 mg/ Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.	Avonex / Ocrelizumab 600 mg n=52 Participants In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Total Number of Gadolinium-Enhancing T1 Lesions	8.7 lesions Standard Deviation 17.54	2.5 lesions Standard Deviation 5.10	1.8 lesions Standard Deviation 5.26	10.3 lesions Standard Deviation 22.15

Adverse Events

Placebo/Ocrelizumab 600mg

Serious events: 11 serious events

Other events: 52 other events

Deaths: 3 deaths

Ocrelizumab 600mg/Ocrelizumab 600mg

Serious events: 17 serious events

Other events: 47 other events

Deaths: 1 deaths

Ocrelizumab 1000mg/Ocrelizumab 600mg

Serious events: 16 serious events

Other events: 45 other events

Deaths: 3 deaths

Avonex/Ocrelizumab 600 mg

Serious events: 16 serious events

Other events: 45 other events

Deaths: 2 deaths

Ocrelizumab 600 mg Open Label Extension (OLE)

Serious events: 28 serious events

Other events: 85 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Placebo/Ocrelizumab 600mg n=54 participants at risk In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Ocrelizumab 600mg/Ocrelizumab 600mg n=55 participants at risk In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W	Ocrelizumab 1000mg/Ocrelizumab 600mg n=55 participants at risk In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Avonex/Ocrelizumab 600 mg n=54 participants at risk In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Ocrelizumab 600 mg Open Label Extension (OLE) n=103 participants at risk Participants who opted to enroll in the OLE received two IV infusions of ocrelizumab, 300mg on Days 1 and 15 of Cycle 5, followed by a single infusion of ocrelizumab, 600mg, once Q24W
Blood and lymphatic system disorders ANAEMIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Blood and lymphatic system disorders IMMUNE THROMBOCYTOPENIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Cardiac disorders CARDIAC ARREST	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Ear and labyrinth disorders VERTIGO	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Endocrine disorders ADRENAL CYST	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Eye disorders RETINAL ARTERY OCCLUSION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders COLITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders INGUINAL HERNIA STRANGULATED	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders SALIVARY DUCT INFLAMMATION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders SUBILEUS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders DEATH	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders DRUG WITHDRAWAL SYNDROME	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders PYREXIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Immune system disorders HYPERSENSITIVITY	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations ANAL ABSCESS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations BRONCHITIS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations CELLULITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations COMPLICATED APPENDICITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations COVID-19	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations COVID-19 PNEUMONIA	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.8% 6/103 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations CYSTITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations DIVERTICULITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations ENCEPHALITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations GASTROENTERITIS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations GINGIVITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders BACK PAIN	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations HEPATITIS A	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations INFECTION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations INFLUENZA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations ORAL HERPES	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations PNEUMONIA	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations SEPSIS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations TRACHEOBRONCHITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations UROSEPSIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications FALL	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications INJURY	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Investigations AMYLASE INCREASED	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Investigations BLOOD POTASSIUM INCREASED	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Investigations SMEAR CERVIX ABNORMAL	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders EPILEPSY	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders MULTIPLE SCLEROSIS PSEUDO RELAPSE	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders MUSCLE SPASTICITY	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders NERVOUS SYSTEM DISORDER	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders SEIZURE	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Pregnancy, puerperium and perinatal conditions PREGNANCY	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders ACUTE PSYCHOSIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders ANXIETY	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders DEPRESSION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders SUSPECTED SUICIDE ATTEMPT	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Renal and urinary disorders URETEROLITHIASIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Reproductive system and breast disorders OVARIAN MASS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Reproductive system and breast disorders UTERINE PROLAPSE	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Vascular disorders HYPERTENSION	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.

Other adverse events

Other adverse events
Measure	Placebo/Ocrelizumab 600mg n=54 participants at risk In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Ocrelizumab 600mg/Ocrelizumab 600mg n=55 participants at risk In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W	Ocrelizumab 1000mg/Ocrelizumab 600mg n=55 participants at risk In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Avonex/Ocrelizumab 600 mg n=54 participants at risk In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.	Ocrelizumab 600 mg Open Label Extension (OLE) n=103 participants at risk Participants who opted to enroll in the OLE received two IV infusions of ocrelizumab, 300mg on Days 1 and 15 of Cycle 5, followed by a single infusion of ocrelizumab, 600mg, once Q24W
Blood and lymphatic system disorders ANAEMIA	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Cardiac disorders PALPITATIONS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Eye disorders VISION BLURRED	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders CONSTIPATION	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders DIARRHOEA	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders HAEMORRHOIDS	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Gastrointestinal disorders NAUSEA	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.7% 7/55 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders ASTHENIA	5.6% 3/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders CHILLS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders FATIGUE	9.3% 5/54 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.7% 7/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	20.0% 11/55 • Number of events 14 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.8% 8/103 • Number of events 12 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders INFLUENZA LIKE ILLNESS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	20.4% 11/54 • Number of events 15 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders OEDEMA PERIPHERAL	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
General disorders PYREXIA	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	14.5% 8/55 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	10.7% 11/103 • Number of events 12 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Immune system disorders HYPOGAMMAGLOBULINAEMIA	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Immune system disorders SEASONAL ALLERGY	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations BRONCHITIS	13.0% 7/54 • Number of events 12 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	10.9% 6/55 • Number of events 11 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.7% 10/103 • Number of events 17 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations COVID-19	22.2% 12/54 • Number of events 13 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.7% 7/55 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	25.2% 26/103 • Number of events 30 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations CYSTITIS	7.4% 4/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations GASTROENTERITIS	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations HERPES ZOSTER	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations INFLUENZA	13.0% 7/54 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.7% 7/55 • Number of events 11 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.7% 10/103 • Number of events 14 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations NASOPHARYNGITIS	18.5% 10/54 • Number of events 15 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	27.3% 15/55 • Number of events 32 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	21.8% 12/55 • Number of events 25 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	16.7% 9/54 • Number of events 25 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	19.4% 20/103 • Number of events 41 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations ORAL HERPES	7.4% 4/54 • Number of events 17 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.8% 6/103 • Number of events 18 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations PHARYNGITIS	11.1% 6/54 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations PNEUMONIA	5.6% 3/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	6.8% 7/103 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations PYELONEPHRITIS	5.6% 3/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations RESPIRATORY TRACT INFECTION	14.8% 8/54 • Number of events 18 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.8% 8/103 • Number of events 9 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations SINUSITIS	9.3% 5/54 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	18.5% 10/54 • Number of events 17 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	25.5% 14/55 • Number of events 25 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	20.0% 11/55 • Number of events 26 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	13.0% 7/54 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	14.6% 15/103 • Number of events 32 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations URINARY TRACT INFECTION	25.9% 14/54 • Number of events 29 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	18.2% 10/55 • Number of events 24 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	27.3% 15/55 • Number of events 39 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	18.5% 10/54 • Number of events 17 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	22.3% 23/103 • Number of events 58 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations VAGINAL INFECTION	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations VIRAL INFECTION	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Infections and infestations VULVOVAGINAL MYCOTIC INFECTION	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications CONTUSION	3.7% 2/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications FALL	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	53.7% 29/54 • Number of events 63 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	45.5% 25/55 • Number of events 60 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	52.7% 29/55 • Number of events 60 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	37.0% 20/54 • Number of events 33 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	22.3% 23/103 • Number of events 39 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications SKIN LACERATION	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Injury, poisoning and procedural complications THERMAL BURN	5.6% 3/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders ARTHRALGIA	14.8% 8/54 • Number of events 15 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	16.4% 9/55 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.3% 5/54 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.6% 13/103 • Number of events 18 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders BACK PAIN	16.7% 9/54 • Number of events 11 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	13.0% 7/54 • Number of events 9 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.8% 6/103 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	13.0% 7/54 • Number of events 11 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	14.5% 8/55 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.8% 8/103 • Number of events 10 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders DIZZINESS	9.3% 5/54 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders HEADACHE	27.8% 15/54 • Number of events 33 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	16.4% 9/55 • Number of events 16 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	18.2% 10/55 • Number of events 14 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	22.2% 12/54 • Number of events 19 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	6.8% 7/103 • Number of events 11 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders HYPOAESTHESIA	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders MIGRAINE	9.3% 5/54 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	48.1% 26/54 • Number of events 70 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	34.5% 19/55 • Number of events 39 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	38.2% 21/55 • Number of events 72 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	53.7% 29/54 • Number of events 58 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	27.2% 28/103 • Number of events 68 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders PARAESTHESIA	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders SCIATICA	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Nervous system disorders SYNCOPE	5.6% 3/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/103 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders ANXIETY	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	11.1% 6/54 • Number of events 6 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders DEPRESSION	3.7% 2/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	12.7% 7/55 • Number of events 8 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	9.1% 5/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Psychiatric disorders INSOMNIA	3.7% 2/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	16.4% 9/55 • Number of events 12 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Renal and urinary disorders RENAL CYST	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Respiratory, thoracic and mediastinal disorders COUGH	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 5 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	4.9% 5/103 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	3.7% 2/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	5.5% 3/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Skin and subcutaneous tissue disorders ALOPECIA	1.9% 1/54 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.97% 1/103 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Skin and subcutaneous tissue disorders RASH	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.6% 2/55 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.3% 4/55 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	7.4% 4/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	2.9% 3/103 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Skin and subcutaneous tissue disorders SKIN LESION	5.6% 3/54 • Number of events 3 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.8% 1/55 • Number of events 1 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/54 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 2/103 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
Vascular disorders HYPERTENSION	7.4% 4/54 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	10.9% 6/55 • Number of events 7 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	0.00% 0/55 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	1.9% 1/54 • Number of events 2 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.	3.9% 4/103 • Number of events 4 • Up to 787 Weeks The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.

Additional Information

Medical Communications

Hoffmann-La Roche

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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 Sponsorâ€™s intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER