Trial Outcomes & Findings for Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis (NCT NCT00906399)

Last Updated: 2014-09-19

Results Overview

A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (\< 4 versus ≥ 4), baseline age (\< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1516 participants

Primary outcome timeframe

1 Year

Results posted on

2014-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Year 1: Placebo Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.	Year 2: Placebo Followed by Peginterferon Beta-1a Q4W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Placebo Followed by Peginterferon Beta-1a Q2W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.	Year 2: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Year 1 STARTED	500	501	515	0	0	0	0
Year 1 Completed Year 1 Study Treatment	456	438	438	0	0	0	0
Year 1 COMPLETED	456	438	439	0	0	0	0
Year 1 NOT COMPLETED	44	63	76	0	0	0	0
Year 2 STARTED	0	0	0	228	228	438	438
Year 2 Completed Year 2 Study Treatment	0	0	0	200	196	391	411
Year 2 COMPLETED	0	0	0	198	193	391	409
Year 2 NOT COMPLETED	0	0	0	30	35	47	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Year 1: Placebo Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.	Year 2: Placebo Followed by Peginterferon Beta-1a Q4W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Placebo Followed by Peginterferon Beta-1a Q2W Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.	Year 2: Peginterferon Beta-1a Q4W 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Peginterferon Beta-1a Q2W 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Year 1 Randomized But Not Treated	0	1	3	0	0	0	0
Year 1 Adverse Event	4	22	24	0	0	0	0
Year 1 Lost to Follow-up	4	4	2	0	0	0	0
Year 1 Withdrawal by Subject	30	32	36	0	0	0	0
Year 1 Physician Decision	0	1	3	0	0	0	0
Year 1 Death	2	1	1	0	0	0	0
Year 1 Other	4	2	7	0	0	0	0
Year 2 Adverse Event	0	0	0	9	8	11	6
Year 2 Lost to Follow-up	0	0	0	1	4	2	4
Year 2 Withdrawal by Subject	0	0	0	17	18	27	13
Year 2 Physician Decision	0	0	0	0	2	6	3
Year 2 Death	0	0	0	1	0	0	3
Year 2 Other	0	0	0	2	3	1	0

Baseline Characteristics

Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=500 Participants Placebo every 2 weeks for 48 weeks	Peginterferon Beta-1a Q4W n=500 Participants 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Peginterferon Beta-1a Q2W n=512 Participants 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks	Total n=1512 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 9.74 • n=5 Participants	36.4 years STANDARD_DEVIATION 9.87 • n=7 Participants	36.9 years STANDARD_DEVIATION 9.79 • n=5 Participants	36.5 years STANDARD_DEVIATION 9.80 • n=4 Participants
Sex: Female, Male Female	358 Participants n=5 Participants	352 Participants n=7 Participants	361 Participants n=5 Participants	1071 Participants n=4 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	148 Participants n=7 Participants	151 Participants n=5 Participants	441 Participants n=4 Participants
Expanded Disability Status Scale (EDSS)	2.44 units on a scale STANDARD_DEVIATION 1.180 • n=5 Participants	2.48 units on a scale STANDARD_DEVIATION 1.244 • n=7 Participants	2.47 units on a scale STANDARD_DEVIATION 1.255 • n=5 Participants	2.46 units on a scale STANDARD_DEVIATION 1.226 • n=4 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).

Outcome measures

Outcome measures
Measure	Year 1: Placebo n=500 Participants Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=500 Participants 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=512 Participants 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Annualized Relapse Rate (ARR) at 1 Year	0.397 relapses per person-years Interval 0.328 to 0.481	0.288 relapses per person-years Interval 0.234 to 0.355	0.256 relapses per person-years Interval 0.206 to 0.318

SECONDARY outcome

Timeframe: 1 Year

Population: ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.

Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.

Outcome measures

Outcome measures
Measure	Year 1: Placebo n=476 Participants Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=462 Participants 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=457 Participants 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year	10.9 lesions 95% Confidence Interval 19.51 • Interval 9.6 to 12.5	7.9 lesions 95% Confidence Interval 15.84 • Interval 6.9 to 9.0	3.6 lesions 95% Confidence Interval 8.55 • Interval 3.1 to 4.2

SECONDARY outcome

Timeframe: Year 1

Population: ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.

A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.

Outcome measures

Outcome measures
Measure	Year 1: Placebo n=500 Participants Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=500 Participants 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=512 Participants 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Proportion of Participants Relapsed at 1 Year	0.291 proportion of participants	0.222 proportion of participants	0.187 proportion of participants

SECONDARY outcome

Timeframe: 1 Year

Population: ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.

Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.

Outcome measures

Outcome measures
Measure	Year 1: Placebo n=500 Participants Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=500 Participants 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=512 Participants 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year	0.105 proportion of participants	0.068 proportion of participants	0.068 proportion of participants

Adverse Events

Year 1: Placebo

Serious events: 76 serious events

Other events: 378 other events

Deaths: 0 deaths

Year 1: Peginterferon Beta-1a Q4W

Serious events: 70 serious events

Other events: 466 other events

Deaths: 0 deaths

Year 1: Peginterferon Beta-1a Q2W

Serious events: 55 serious events

Other events: 472 other events

Deaths: 0 deaths

Year 2: Placebo Followed by Peginterferon Beta-1a Q4W

Serious events: 42 serious events

Other events: 190 other events

Deaths: 0 deaths

Year 2: Placebo Followed by Peginterferon Beta-1a Q2W

Serious events: 36 serious events

Other events: 206 other events

Deaths: 0 deaths

Year 2: Peginterferon Beta-1a Q4W

Serious events: 67 serious events

Other events: 373 other events

Deaths: 0 deaths

Year 2: Peginterferon Beta-1a Q2W

Serious events: 39 serious events

Other events: 367 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Year 1: Placebo n=499 participants at risk Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=500 participants at risk 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=513 participants at risk 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.	Year 2: Placebo Followed by Peginterferon Beta-1a Q4W n=227 participants at risk Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Placebo Followed by Peginterferon Beta-1a Q2W n=228 participants at risk Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.	Year 2: Peginterferon Beta-1a Q4W n=439 participants at risk 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Peginterferon Beta-1a Q2W n=438 participants at risk 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Abdominal Distension	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Constipation	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Haemorrhoids	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Intestinal Strangulation	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Proctalgia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Cholelithiasis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Drug-Induced Liver Injury	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Hepatic Function Abnormal	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Hepatitis Toxic	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Sacroilitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Cervical Dysplasia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Ectropion Of Cervix	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Endometriosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Epididymal Cyst	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Pelvic Adhesions	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Uterine Cervical Erosion	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Congenital, familial and genetic disorders Congenital Cystic Kidney Disease	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Hyperpyrexia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Investigations Alanine Aminotransferase Increased	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Investigations Haemoglobin Decreased	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Suicidal Ideation	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Concussion	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Conversion Disorder	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Meniscus Lesion	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Multiple Injuries	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Dengue Fever	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Pneumonia	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.40% 2/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Urinary Tract Infection	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.40% 2/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	1.3% 3/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Erysipelas	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Sepsis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Septic Shock	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Urosepsis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Acute Sinusitis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Appendicitis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Cervicitis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Gastroenteritis Viral	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Subcutaneous Abscess	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Tonsillitis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Vulval Neoplasm	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Blood and lymphatic system disorders Leukopenia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Immune system disorders Anaphylactic Reaction	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Immune system disorders Hypersensitivity	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Metabolism and nutrition disorders Malnutrition	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Depression	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Personality Disorder	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Multiple Sclerosis Relapse	11.4% 57/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.4% 47/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.6% 34/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.9% 27/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.2% 21/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.3% 45/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.7% 25/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Multiple Sclerosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Cerebral Ischaemia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Cerebrovascular Insufficiency	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Monoparesis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Neuritis Cranial	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Neuromyelitis Optica	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Paraesthesia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Partial Seizures	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Partial Seizures With Secondary Generalization	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Sciatica	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Uhthoff's Phenomenon	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Ataxia	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Neuralgia	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Subarachnoid Haemorrhage	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Eye disorders Retinal Detachment	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Vascular disorders Deep Vein Thrombosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Vascular disorders Venous Thrombosis Limb	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Acute Hepatic Failure	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Patellofemoral Pain Syndrome	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Osteoporosis	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Renal and urinary disorders Hydronephrosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Renal and urinary disorders Micturition Disorder	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Renal and urinary disorders Urinary Incontinence	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Pregnancy, puerperium and perinatal conditions Abortion Incomplete	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Death	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Injection Site Reaction	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Irritability	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Chest Pain	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Gait Disturbance	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Investigations Transaminases Increased	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.19% 1/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Facial Bones Fracture	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.20% 1/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Avulsion Fracture	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Fall	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.46% 2/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Tibia Fracture	0.20% 1/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Cystitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Infected Skin Ulcer	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Bacterial Diarrhoea	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Cellulitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Cellulitis Gangrenous	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Chronic Sinusitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Endometritis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Myometritis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Pelvic Inflammatory Disease	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Pyelonephritis Chronic	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Salpingo-Oophoritis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Typhoid Fever	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Viral Pharyngitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Viral Tracheitis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip And/Or Oral Cavity Cancer	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Immune system disorders Sarcoidosis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Endocrine disorders Basedow's Disease	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Schizophrenia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Bulbar Palsy	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Complex Partial Seizures	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Extrapyramidal Disorder	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Grand Mal Convulsion	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Paraparesis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Syncope	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Trigeminal Neuralgia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Cardiac disorders Cardiopulmonary Failure	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Cardiac disorders Myocardial Infarction	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Vascular disorders Hypertensive Crisis	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Vascular disorders Shock	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Respiratory, thoracic and mediastinal disorders Organising Pneumonia	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.23% 1/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.44% 1/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.

Other adverse events

Other adverse events
Measure	Year 1: Placebo n=499 participants at risk Placebo every 2 weeks for 48 weeks	Year 1: Peginterferon Beta-1a Q4W n=500 participants at risk 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 1: Peginterferon Beta-1a Q2W n=513 participants at risk 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.	Year 2: Placebo Followed by Peginterferon Beta-1a Q4W n=227 participants at risk Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Placebo Followed by Peginterferon Beta-1a Q2W n=228 participants at risk Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.	Year 2: Peginterferon Beta-1a Q4W n=439 participants at risk 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).	Year 2: Peginterferon Beta-1a Q2W n=438 participants at risk 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Psychiatric disorders Depression	4.2% 21/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.0% 25/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.3% 22/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	2.6% 6/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.7% 13/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.1% 18/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.9% 17/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Nasopharyngitis	15.4% 77/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.8% 69/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.5% 54/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.7% 22/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.5% 17/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.3% 45/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.7% 47/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Urinary Tract Infection	4.0% 20/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.6% 28/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.5% 28/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 10/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.8% 11/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.1% 31/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.6% 29/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Infections and infestations Upper Respiratory Tract Infection	5.4% 27/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.2% 16/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.5% 28/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Psychiatric disorders Insomnia	3.8% 19/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.6% 18/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.5% 28/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Headache	33.1% 165/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	41.2% 206/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	43.9% 225/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	30.8% 70/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	28.1% 64/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	27.8% 122/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	28.8% 126/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Multiple Sclerosis Relapse	30.9% 154/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	22.2% 111/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	17.5% 90/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	22.0% 50/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	22.8% 52/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	21.6% 95/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	14.4% 63/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Dizziness	6.0% 30/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 22/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.8% 35/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Paraesthesia	4.6% 23/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 22/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.1% 26/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Nervous system disorders Hypoaesthesia	6.0% 30/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.8% 29/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.3% 17/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.7% 13/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.8% 11/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	2.3% 10/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	2.5% 11/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Ear and labyrinth disorders Vertigo	8.6% 43/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.4% 32/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.3% 27/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.0% 9/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.8% 11/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.9% 17/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.2% 14/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.2% 31/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.2% 26/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.6% 34/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 28/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.2% 26/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.1% 21/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Nausea	6.2% 31/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	8.6% 43/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	8.8% 45/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.0% 9/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.1% 14/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.6% 16/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.2% 27/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Vomiting	2.2% 11/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.4% 37/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.1% 26/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Gastrointestinal disorders Diarrhoea	4.6% 23/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 22/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.5% 18/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 30/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	19.4% 97/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	19.3% 99/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.9% 27/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.8% 27/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.7% 60/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.2% 58/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Back Pain	11.4% 57/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	12.8% 64/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	12.1% 62/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.8% 11/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	8.3% 19/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.1% 31/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.3% 32/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 35/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.8% 54/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.3% 58/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.1% 23/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.1% 14/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.5% 33/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.5% 33/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Pain In Extremity	9.6% 48/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.6% 53/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	8.6% 44/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 10/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.1% 14/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.2% 23/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.1% 31/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Musculoskeletal and connective tissue disorders Muscular Weakness	3.6% 18/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.6% 23/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.3% 22/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.3% 12/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.3% 12/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.1% 18/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.0% 13/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Injection Site Erythema	6.6% 33/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	56.4% 282/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	61.4% 315/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	52.4% 119/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	59.2% 135/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	48.1% 211/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	48.4% 212/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Influenza Like Illness	12.6% 63/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	46.8% 234/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	46.4% 238/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	41.9% 95/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	46.5% 106/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	45.3% 199/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	43.8% 192/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Pyrexia	15.0% 75/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	43.6% 218/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	44.2% 227/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	29.1% 66/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	28.9% 66/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	31.4% 138/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	31.1% 136/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Chills	4.6% 23/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	18.4% 92/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	17.2% 88/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	12.3% 28/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	12.7% 29/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.8% 52/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.4% 41/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Injection Site Pain	3.0% 15/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.4% 67/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	15.2% 78/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.0% 25/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.0% 25/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.3% 32/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.3% 45/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Asthenia	7.6% 38/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	14.0% 70/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.3% 68/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.6% 24/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 10/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	8.9% 39/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.1% 40/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Injection Site Pruritus	1.2% 6/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.2% 56/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	13.6% 70/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.5% 17/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.4% 26/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.5% 24/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.7% 47/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Fatigue	9.8% 49/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	11.0% 55/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	10.1% 52/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 10/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	9.2% 21/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.9% 26/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	7.3% 32/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Pain	3.2% 16/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.8% 29/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.9% 25/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
General disorders Hyperthermia	1.0% 5/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.2% 26/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.3% 22/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	0.00% 0/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Investigations Body Temperature Increased	2.8% 14/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.6% 33/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.0% 31/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	2.2% 5/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.4% 10/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	4.3% 19/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.5% 24/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
Investigations Alanine Aminotransferase Increased	2.6% 13/499 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.8% 19/500 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.7% 29/513 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	5.7% 13/227 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	6.1% 14/228 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.9% 17/439 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.	3.0% 13/438 • Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up One participant, randomized to placebo-\>Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.

Additional Information

Biogen Idec Study Medical Director

Biogen Idec

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER