Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments (NCT NCT04418765)

Last Updated: 2023-09-29

Results Overview

A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

892 participants

Primary outcome timeframe

Baseline, Weeks 1 - 12

Results posted on

2023-09-29

Participant Flow

This study included 2 periods: Placebo-controlled Period - 24-week double-blind treatment period with placebo or eptinezumab and Extension Period - 48-week dose-blinded period with eptinezumab after completion of the Placebo-controlled Period.

Participants assigned to placebo in the Placebo-controlled Period were randomized 1:1 to treatment with either eptinezumab 100 milligrams (mg) or eptinezumab 300 mg. Participants assigned to eptinezumab 100 mg or 300 mg in the Placebo-controlled Period continued their treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Placebo-controlled Period (24 Weeks) STARTED	299	299	294
Placebo-controlled Period (24 Weeks) Received at Least 1 Dose of Study Drug	298	299	294
Placebo-controlled Period (24 Weeks) COMPLETED	293	288	284
Placebo-controlled Period (24 Weeks) NOT COMPLETED	6	11	10
Extension Period (48 Weeks) STARTED	0	433	432
Extension Period (48 Weeks) Received at Least 1 Dose of Study Drug	0	433	432
Extension Period (48 Weeks) COMPLETED	0	392	390
Extension Period (48 Weeks) NOT COMPLETED	0	41	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
Placebo-controlled Period (24 Weeks) Adverse Event	1	1	6
Placebo-controlled Period (24 Weeks) Lack of Efficacy	1	3	0
Placebo-controlled Period (24 Weeks) Protocol Violation	0	1	1
Placebo-controlled Period (24 Weeks) Withdrawal by Subject	1	5	2
Placebo-controlled Period (24 Weeks) Lost to Follow-up	0	1	0
Placebo-controlled Period (24 Weeks) Other than specified	2	0	1
Placebo-controlled Period (24 Weeks) Randomized but not treated	1	0	0
Extension Period (48 Weeks) Adverse Event	0	2	9
Extension Period (48 Weeks) Lack of Efficacy	0	13	13
Extension Period (48 Weeks) Withdrawal by Subject	0	21	14
Extension Period (48 Weeks) Non-compliance with study drug	0	0	2
Extension Period (48 Weeks) Protocol Violation	0	0	2
Extension Period (48 Weeks) Other than specified	0	5	2

Baseline Characteristics

Here, number analyzed = participants evaluable for this baseline measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Total n=890 Participants Total of all reporting groups
MMDs With Use of Acute Medication	12.5 days/month STANDARD_DEVIATION 5.62 • n=298 Participants	12.7 days/month STANDARD_DEVIATION 5.48 • n=299 Participants	12.4 days/month STANDARD_DEVIATION 5.38 • n=293 Participants	12.5 days/month STANDARD_DEVIATION 5.49 • n=890 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 10.83 • n=298 Participants	44.6 years STANDARD_DEVIATION 10.76 • n=299 Participants	43.1 years STANDARD_DEVIATION 10.2 • n=293 Participants	43.8 years STANDARD_DEVIATION 10.61 • n=890 Participants
Sex: Female, Male Female	263 Participants n=298 Participants	277 Participants n=299 Participants	260 Participants n=293 Participants	800 Participants n=890 Participants
Sex: Female, Male Male	35 Participants n=298 Participants	22 Participants n=299 Participants	33 Participants n=293 Participants	90 Participants n=890 Participants
Race/Ethnicity, Customized Race · White	285 Participants n=298 Participants	288 Participants n=299 Participants	281 Participants n=293 Participants	854 Participants n=890 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=298 Participants	0 Participants n=299 Participants	0 Participants n=293 Participants	2 Participants n=890 Participants
Race/Ethnicity, Customized Race · Unknown	11 Participants n=298 Participants	11 Participants n=299 Participants	12 Participants n=293 Participants	34 Participants n=890 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	0 Participants n=298 Participants	0 Participants n=299 Participants	1 Participants n=293 Participants	1 Participants n=890 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	2 Participants n=298 Participants	1 Participants n=299 Participants	2 Participants n=293 Participants	5 Participants n=890 Participants
Race/Ethnicity, Customized Ethnicity · Not collected	296 Participants n=298 Participants	298 Participants n=299 Participants	290 Participants n=293 Participants	884 Participants n=890 Participants
Monthly Migraine Days (MMDs)	13.9 days/month STANDARD_DEVIATION 5.72 • n=298 Participants	13.8 days/month STANDARD_DEVIATION 5.58 • n=299 Participants	13.7 days/month STANDARD_DEVIATION 5.44 • n=293 Participants	13.8 days/month STANDARD_DEVIATION 5.57 • n=890 Participants
Monthly Headache Days (MHDs)	14.5 days/month STANDARD_DEVIATION 5.79 • n=298 Participants	14.5 days/month STANDARD_DEVIATION 5.63 • n=299 Participants	14.4 days/month STANDARD_DEVIATION 5.45 • n=293 Participants	14.5 days/month STANDARD_DEVIATION 5.62 • n=890 Participants
Headache Impact Test (HIT-6) Score	66.2 units on a scale STANDARD_DEVIATION 4.38 • n=288 Participants • Here, number analyzed = participants evaluable for this baseline measure.	66.6 units on a scale STANDARD_DEVIATION 4.7 • n=281 Participants • Here, number analyzed = participants evaluable for this baseline measure.	66.5 units on a scale STANDARD_DEVIATION 4.41 • n=287 Participants • Here, number analyzed = participants evaluable for this baseline measure.	66.4 units on a scale STANDARD_DEVIATION 4.5 • n=856 Participants • Here, number analyzed = participants evaluable for this baseline measure.
Percentage of Migraine Attacks With Severe Pain Intensity	40.4 percentage of migraine attacks STANDARD_DEVIATION 29.74 • n=298 Participants	47.1 percentage of migraine attacks STANDARD_DEVIATION 29.82 • n=299 Participants	43.9 percentage of migraine attacks STANDARD_DEVIATION 28.4 • n=293 Participants	43.8 percentage of migraine attacks STANDARD_DEVIATION 29.43 • n=890 Participants
Percentage of Headache Episodes With Severe Pain Intensity	38.5 percentage of headache episodes STANDARD_DEVIATION 29.29 • n=298 Participants	44.2 percentage of headache episodes STANDARD_DEVIATION 28.56 • n=299 Participants	41 percentage of headache episodes STANDARD_DEVIATION 27.01 • n=293 Participants	41.2 percentage of headache episodes STANDARD_DEVIATION 28.38 • n=890 Participants
Acute Migraine Medication Days	11.2 days STANDARD_DEVIATION 5.93 • n=298 Participants • Here, number analyzed = participants evaluable for this baseline measure.	11.2 days STANDARD_DEVIATION 5.47 • n=299 Participants • Here, number analyzed = participants evaluable for this baseline measure.	11 days STANDARD_DEVIATION 5.29 • n=292 Participants • Here, number analyzed = participants evaluable for this baseline measure.	11.1 days STANDARD_DEVIATION 5.57 • n=889 Participants • Here, number analyzed = participants evaluable for this baseline measure.
Migraine-Specific Quality of Life (MSQ) Subscores MSQ role function-restrictive	35.1 units on a scale STANDARD_DEVIATION 17.14 • n=288 Participants • Here, number analyzed = participants evaluable for this baseline measure.	35.7 units on a scale STANDARD_DEVIATION 17.33 • n=276 Participants • Here, number analyzed = participants evaluable for this baseline measure.	35.7 units on a scale STANDARD_DEVIATION 16.68 • n=287 Participants • Here, number analyzed = participants evaluable for this baseline measure.	35.5 units on a scale STANDARD_DEVIATION 17.03 • n=851 Participants • Here, number analyzed = participants evaluable for this baseline measure.
Migraine-Specific Quality of Life (MSQ) Subscores MSQ role function-preventive	50.5 units on a scale STANDARD_DEVIATION 22.14 • n=288 Participants • Here, number analyzed = participants evaluable for this baseline measure.	50.2 units on a scale STANDARD_DEVIATION 21.39 • n=276 Participants • Here, number analyzed = participants evaluable for this baseline measure.	51 units on a scale STANDARD_DEVIATION 21.47 • n=287 Participants • Here, number analyzed = participants evaluable for this baseline measure.	50.6 units on a scale STANDARD_DEVIATION 21.65 • n=851 Participants • Here, number analyzed = participants evaluable for this baseline measure.
Migraine-Specific Quality of Life (MSQ) Subscores MSQ emotional function	48.4 units on a scale STANDARD_DEVIATION 26.63 • n=288 Participants • Here, number analyzed = participants evaluable for this baseline measure.	50.3 units on a scale STANDARD_DEVIATION 24.7 • n=276 Participants • Here, number analyzed = participants evaluable for this baseline measure.	48.6 units on a scale STANDARD_DEVIATION 23.8 • n=287 Participants • Here, number analyzed = participants evaluable for this baseline measure.	49.1 units on a scale STANDARD_DEVIATION 25.06 • n=851 Participants • Here, number analyzed = participants evaluable for this baseline measure.
Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score	74 units on a scale STANDARD_DEVIATION 20.36 • n=287 Participants • Here, number analyzed = participants evaluable for this baseline measure.	75.9 units on a scale STANDARD_DEVIATION 19.01 • n=276 Participants • Here, number analyzed = participants evaluable for this baseline measure.	74.5 units on a scale STANDARD_DEVIATION 20.72 • n=285 Participants • Here, number analyzed = participants evaluable for this baseline measure.	74.8 units on a scale STANDARD_DEVIATION 20.05 • n=848 Participants • Here, number analyzed = participants evaluable for this baseline measure.
WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment WPAI Absenteeism	12.8 units on a scale STANDARD_DEVIATION 20.7 • n=218 Participants • Here, number analyzed = participants evaluable for this baseline measure.	11.4 units on a scale STANDARD_DEVIATION 19.4 • n=196 Participants • Here, number analyzed = participants evaluable for this baseline measure.	12 units on a scale STANDARD_DEVIATION 19.31 • n=209 Participants • Here, number analyzed = participants evaluable for this baseline measure.	12.1 units on a scale STANDARD_DEVIATION 19.58 • n=623 Participants • Here, number analyzed = participants evaluable for this baseline measure.
WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment WPAI Presenteeism	51.7 units on a scale STANDARD_DEVIATION 24.22 • n=212 Participants • Here, number analyzed = participants evaluable for this baseline measure.	50.8 units on a scale STANDARD_DEVIATION 25.61 • n=191 Participants • Here, number analyzed = participants evaluable for this baseline measure.	53.3 units on a scale STANDARD_DEVIATION 24.01 • n=206 Participants • Here, number analyzed = participants evaluable for this baseline measure.	52 units on a scale STANDARD_DEVIATION 24.58 • n=609 Participants • Here, number analyzed = participants evaluable for this baseline measure.
WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment WPAI Work productivity loss	55.6 units on a scale STANDARD_DEVIATION 24.7 • n=212 Participants • Here, number analyzed = participants evaluable for this baseline measure.	53.7 units on a scale STANDARD_DEVIATION 26.17 • n=191 Participants • Here, number analyzed = participants evaluable for this baseline measure.	57 units on a scale STANDARD_DEVIATION 24.1 • n=206 Participants • Here, number analyzed = participants evaluable for this baseline measure.	55.5 units on a scale STANDARD_DEVIATION 24.97 • n=609 Participants • Here, number analyzed = participants evaluable for this baseline measure.
WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment WPAI Activity impairment	58.7 units on a scale STANDARD_DEVIATION 23.52 • n=286 Participants • Here, number analyzed = participants evaluable for this baseline measure.	58.5 units on a scale STANDARD_DEVIATION 23.47 • n=274 Participants • Here, number analyzed = participants evaluable for this baseline measure.	59.1 units on a scale STANDARD_DEVIATION 23.37 • n=285 Participants • Here, number analyzed = participants evaluable for this baseline measure.	58.7 units on a scale STANDARD_DEVIATION 23.43 • n=845 Participants • Here, number analyzed = participants evaluable for this baseline measure.

PRIMARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12	-2.1 days/month Standard Error 0.38	-4.8 days/month Standard Error 0.37	-5.3 days/month Standard Error 0.37	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	13.1 percentage of participants	42.1 percentage of participants	49.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 13 - 24

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=287 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=286 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24	-2.4 days/month Standard Error 0.39	-5.4 days/month Standard Error 0.39	-6.1 days/month Standard Error 0.39	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	2.0 percentage of participants	15.7 percentage of participants	18.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=277 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=283 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12	-3.1 units on a scale Standard Error 0.61	-6.9 units on a scale Standard Error 0.61	-8.5 units on a scale Standard Error 0.60	—

SECONDARY outcome

Timeframe: Baseline to Weeks 13 - 24

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=287 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=286 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24	23.7 percentage of participants	52.3 percentage of participants	59.1 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 13 - 24

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=287 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24	6.8 percentage of participants	21.3 percentage of participants	27.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	1.1 percentage of participants	5.9 percentage of participants	7.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	12.8 percentage of participants	39.5 percentage of participants	45.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	2.3 percentage of participants	15.1 percentage of participants	16.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	1.1 percentage of participants	4.1 percentage of participants	5.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12	-2.1 days/month Standard Error 0.38	-4.6 days/month Standard Error 0.37	-5.1 days/month Standard Error 0.37	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A migraine attack was defined as a headache that occurred on a single day or lasted \>1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12	-10.2 percentage of migraine attacks Standard Error 1.91	-17.9 percentage of migraine attacks Standard Error 1.87	-21.3 percentage of migraine attacks Standard Error 1.87	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12	-8.8 percentage of headache episodes Standard Error 1.85	-16.2 percentage of headache episodes Standard Error 1.81	-19.5 percentage of headache episodes Standard Error 1.81	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=298 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=290 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12	-1.6 days/month Standard Error 0.34	-4.1 days/month Standard Error 0.33	-4.6 days/month Standard Error 0.34	—

SECONDARY outcome

Timeframe: Baseline, Weeks 13- 24

Outcome measures

Outcome measures
Measure	Placebo n=294 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=287 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=285 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24	-1.7 days/month Standard Error 0.36	-4.6 days/month Standard Error 0.36	-5.2 days/month Standard Error 0.36	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12	-2.0 days/month Standard Error 0.36	-4.6 days/month Standard Error 0.36	-5.2 days/month Standard Error 0.36	—

SECONDARY outcome

Timeframe: Baseline, Weeks 13 - 24

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=287 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=286 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24	-2.1 days/month Standard Error 0.39	-4.9 days/month Standard Error 0.39	-5.8 days/month Standard Error 0.38	—

SECONDARY outcome

Timeframe: Week 12

The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=292 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Patient Global Impression of Change (PGIC) Score at Week 12	3.6 units on a scale Standard Error 0.09	2.6 units on a scale Standard Error 0.09	2.5 units on a scale Standard Error 0.09	—

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo n=286 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=280 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=281 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
PGIC Score at Week 24	3.5 units on a scale Standard Error 0.09	2.5 units on a scale Standard Error 0.09	2.4 units on a scale Standard Error 0.09	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 - 12

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=38 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=35 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12	-2.3 days/month Standard Error 1.12	-5.6 days/month Standard Error 1.07	-7.3 days/month Standard Error 1.18	—

SECONDARY outcome

Timeframe: Day 1

Population: FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.

Outcome measures

Outcome measures
Measure	Placebo n=298 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=299 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=293 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With Migraine on the Day After First Dosing	43.7 percentage of participants	27.2 percentage of participants	24.4 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=293 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=289 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=287 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Most Bothersome Symptom (MBS) Score at Week 12	3.7 units on a scale Standard Error 0.09	2.8 units on a scale Standard Error 0.09	2.7 units on a scale Standard Error 0.09	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=278 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=266 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=276 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the HIT-6 Score at Week 24	-3.9 units on a scale Standard Error 0.63	-8.9 units on a scale Standard Error 0.63	-9.9 units on a scale Standard Error 0.62	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=271 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=283 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 MSQ Role Function-Restrictive	13.7 units on a scale Standard Error 1.75	25.0 units on a scale Standard Error 1.75	28.7 units on a scale Standard Error 1.72	—
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 MSQ Role Function-Preventive	11.6 units on a scale Standard Error 1.63	22.7 units on a scale Standard Error 1.64	25.0 units on a scale Standard Error 1.61	—
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 MSQ Emotional Function	9.6 units on a scale Standard Error 1.83	20.6 units on a scale Standard Error 1.84	23.1 units on a scale Standard Error 1.80	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	Placebo n=287 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=271 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=281 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12	-3.1 units on a scale Standard Error 1.39	2.0 units on a scale Standard Error 1.40	4.4 units on a scale Standard Error 1.38	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=278 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=259 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=275 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 MSQ Role Function-Restrictive	15.0 units on a scale Standard Error 1.76	30.1 units on a scale Standard Error 1.78	30.0 units on a scale Standard Error 1.73	—
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 MSQ Role Function-Preventive	13.1 units on a scale Standard Error 1.63	25.7 units on a scale Standard Error 1.65	26.3 units on a scale Standard Error 1.61	—
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 MSQ Emotional Function	9.9 units on a scale Standard Error 1.84	24.1 units on a scale Standard Error 1.86	24.1 units on a scale Standard Error 1.81	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=276 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=258 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=273 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24	-2.8 units on a scale Standard Error 1.38	2.0 units on a scale Standard Error 1.40	5.2 units on a scale Standard Error 1.37	—

SECONDARY outcome

Timeframe: Baseline, Week 12

The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.

Outcome measures

Outcome measures
Measure	Placebo n=286 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=268 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=280 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Absenteeism	-0.1 units on a scale Standard Error 1.49	-5.8 units on a scale Standard Error 1.53	-3.8 units on a scale Standard Error 1.50	—
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Presenteeism	-9.9 units on a scale Standard Error 2.42	-19.0 units on a scale Standard Error 2.46	-23.3 units on a scale Standard Error 2.40	—
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Work productivity loss	-9.7 units on a scale Standard Error 2.56	-19.5 units on a scale Standard Error 2.61	-24.0 units on a scale Standard Error 2.54	—
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 Activity impairment	-11.2 units on a scale Standard Error 2.07	-21.3 units on a scale Standard Error 2.07	-23.8 units on a scale Standard Error 2.05	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=256 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=273 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Absenteeism	-0.7 units on a scale Standard Error 1.46	-5.2 units on a scale Standard Error 1.53	-5.4 units on a scale Standard Error 1.47	—
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Presenteeism	-7.5 units on a scale Standard Error 2.49	-22.2 units on a scale Standard Error 2.59	-19.3 units on a scale Standard Error 2.46	—
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Work productivity loss	-7.2 units on a scale Standard Error 2.62	-22.6 units on a scale Standard Error 2.73	-20.2 units on a scale Standard Error 2.60	—
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 Activity impairment	-10.1 units on a scale Standard Error 2.07	-24.7 units on a scale Standard Error 2.09	-22.6 units on a scale Standard Error 2.04	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=280 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=284 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score	39.9 percentage of participants	62.1 percentage of participants	62.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	Placebo n=288 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=280 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=285 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score	46.2 percentage of participants	72.1 percentage of participants	71.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Number of participants who visited to a family doctor/general practitioner has been reported.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=291 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 8 Visits	1 Participants	0 Participants	0 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 0 Visit	244 Participants	259 Participants	256 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 1 Visit	35 Participants	22 Participants	22 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 2 Visits	6 Participants	5 Participants	6 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 3 Visits	7 Participants	2 Participants	3 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 4 Visits	1 Participants	1 Participants	1 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 5 Visits	1 Participants	2 Participants	1 Participants	—
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner 6 Visits	2 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 12

Number of participants who visited to a specialist has been reported.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=291 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
HCRU: Visits to a Specialist 0 Visit	249 Participants	256 Participants	257 Participants	—
HCRU: Visits to a Specialist 1 Visit	33 Participants	31 Participants	24 Participants	—
HCRU: Visits to a Specialist 2 Visits	2 Participants	2 Participants	4 Participants	—
HCRU: Visits to a Specialist 3 Visits	7 Participants	2 Participants	4 Participants	—
HCRU: Visits to a Specialist 5 Visits	1 Participants	0 Participants	0 Participants	—
HCRU: Visits to a Specialist 6 Visits	4 Participants	0 Participants	0 Participants	—
HCRU: Visits to a Specialist 8 Visits	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 12

Number of participants who visited to emergency department due to your migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=291 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
HCRU: Number of Emergency Department Visits Due to Your Migraine 2 Visits	0 Participants	1 Participants	1 Participants	—
HCRU: Number of Emergency Department Visits Due to Your Migraine 3 Visits	1 Participants	0 Participants	0 Participants	—
HCRU: Number of Emergency Department Visits Due to Your Migraine 8 Visits	1 Participants	0 Participants	0 Participants	—
HCRU: Number of Emergency Department Visits Due to Your Migraine 0 Visit	289 Participants	289 Participants	285 Participants	—
HCRU: Number of Emergency Department Visits Due to Your Migraine 1 Visit	6 Participants	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 12

Number of participants who admitted in the hospital due to migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=291 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
HCRU: Number of Hospital Admissions Due to Migraine 0 Visit	295 Participants	289 Participants	287 Participants	—
HCRU: Number of Hospital Admissions Due to Migraine 1 Visit	1 Participants	1 Participants	2 Participants	—
HCRU: Number of Hospital Admissions Due to Migraine 2 Visits	0 Participants	1 Participants	0 Participants	—
HCRU: Number of Hospital Admissions Due to Migraine 4 Visits	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 12

Number of participants who had total number of overnight hospital stays due to migraine has been reported.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=291 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=289 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
HCRU: Total Number of Overnight Hospital Stays Due to Migraine 1 Visit	1 Participants	0 Participants	0 Participants	—
HCRU: Total Number of Overnight Hospital Stays Due to Migraine 3 Visits	1 Participants	1 Participants	0 Participants	—
HCRU: Total Number of Overnight Hospital Stays Due to Migraine 0 Visit	295 Participants	290 Participants	289 Participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

Population: Full-analysis-long-term set (FAS\_LT) included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=146 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=282 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg n=282 Participants Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Change at Weeks 37-48	-5.0 days/month Standard Error 0.50	-6.0 days/month Standard Error 0.50	-5.8 days/month Standard Error 0.40	-6.0 days/month Standard Error 0.40
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Change at Weeks 25-36	-4.7 days/month Standard Error 0.49	-6.1 days/month Standard Error 0.49	-5.8 days/month Standard Error 0.39	-5.9 days/month Standard Error 0.39
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Change at Weeks 49-60	-5.6 days/month Standard Error 0.51	-6.6 days/month Standard Error 0.51	-5.8 days/month Standard Error 0.41	-6.0 days/month Standard Error 0.41
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Change at Weeks 61-72	-5.9 days/month Standard Error 0.51	-6.8 days/month Standard Error 0.51	-6.6 days/month Standard Error 0.41	-6.5 days/month Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

Population: FAS\_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=146 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=282 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg n=282 Participants Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 25-36	48.6 percentage of participants	63.0 percentage of participants	59.6 percentage of participants	61.0 percentage of participants
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 49-60	59.7 percentage of participants	68.6 percentage of participants	62.6 percentage of participants	62.3 percentage of participants
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 37-48	49.3 percentage of participants	60.3 percentage of participants	60.6 percentage of participants	61.9 percentage of participants
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 61-72	63.5 percentage of participants	69.9 percentage of participants	68.3 percentage of participants	65.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=146 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=282 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg n=282 Participants Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 25-36	19.4 percentage of participants	28.1 percentage of participants	25.9 percentage of participants	31.2 percentage of participants
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 49-60	32.1 percentage of participants	33.6 percentage of participants	29.3 percentage of participants	38.9 percentage of participants
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 37-48	27.9 percentage of participants	30.8 percentage of participants	31.6 percentage of participants	32.6 percentage of participants
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 Weeks 61-72	36.5 percentage of participants	39.0 percentage of participants	37.7 percentage of participants	44.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 36, 48, 60, and 72

Outcome measures

Outcome measures
Measure	Placebo n=138 Participants Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.	Eptinezumab 100 mg n=139 Participants Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg n=265 Participants Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).	Eptinezumab 300 mg to Eptinezumab 300 mg n=272 Participants Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 Change at Week 60	-12.54 units on a scale Standard Error 0.80	-13.21 units on a scale Standard Error 0.71	-12.57 units on a scale Standard Error 0.56	-13.15 units on a scale Standard Error 0.59
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 Change at Week 36	-10.01 units on a scale Standard Error 0.69	-12.15 units on a scale Standard Error 0.73	-10.99 units on a scale Standard Error 0.57	-12.0 units on a scale Standard Error 0.56
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 Change at Week 48	-10.71 units on a scale Standard Error 0.77	-12.71 units on a scale Standard Error 0.75	-12.55 units on a scale Standard Error 0.59	-12.68 units on a scale Standard Error 0.60
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 Change at Week 72	-12.68 units on a scale Standard Error 0.87	-15.02 units on a scale Standard Error 0.78	-13.28 units on a scale Standard Error 0.63	-14.13 units on a scale Standard Error 0.63

Adverse Events

Placebo-controlled Period: Placebo

Serious events: 3 serious events

Other events: 85 other events

Deaths: 0 deaths

Placebo-controlled Period: Eptinezumab 100 mg

Serious events: 6 serious events

Other events: 95 other events

Deaths: 0 deaths

Placebo-controlled Period: Eptinezumab 300 mg

Serious events: 7 serious events

Other events: 90 other events

Deaths: 0 deaths

Extension Period: Placebo to Eptinezumab 100 mg

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Extension Period: Placebo to Eptinezumab 300 mg

Serious events: 7 serious events

Other events: 62 other events

Deaths: 0 deaths

Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg

Serious events: 9 serious events

Other events: 133 other events

Deaths: 0 deaths

Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg

Serious events: 9 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-controlled Period: Placebo n=298 participants at risk Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.	Placebo-controlled Period: Eptinezumab 100 mg n=299 participants at risk Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.	Placebo-controlled Period: Eptinezumab 300 mg n=294 participants at risk Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.	Extension Period: Placebo to Eptinezumab 100 mg n=145 participants at risk Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.	Extension Period: Placebo to Eptinezumab 300 mg n=148 participants at risk Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.	Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg n=288 participants at risk Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.	Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg n=284 participants at risk Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
Eye disorders Retinal detachment	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Hepatobiliary disorders Cholelithiasis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Immune system disorders Anaphylactic reaction	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations COVID-19	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Concussion	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Hand fracture	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Road traffic accident	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Cervical radiculopathy	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Migraine	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Psychogenic seizure	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Seizure	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Psychiatric disorders Suicidal ideation	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Cardiac disorders Acute myocardial infarction	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Ear and labyrinth disorders Conductive deafness	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Endocrine disorders Hypothyroidism	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Eye disorders Eye pain	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Colitis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Gastritis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Inguinal hernia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Vomiting	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Chronic sinusitis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Gastroenteritis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Peritonitis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Pilonidal disease	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Urinary tract infection	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Intracranial aneurysm	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Radiculopathy	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Renal and urinary disorders Bladder prolapse	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.

Other adverse events

Other adverse events
Measure	Placebo-controlled Period: Placebo n=298 participants at risk Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.	Placebo-controlled Period: Eptinezumab 100 mg n=299 participants at risk Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.	Placebo-controlled Period: Eptinezumab 300 mg n=294 participants at risk Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.	Extension Period: Placebo to Eptinezumab 100 mg n=145 participants at risk Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.	Extension Period: Placebo to Eptinezumab 300 mg n=148 participants at risk Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.	Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg n=288 participants at risk Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.	Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg n=284 participants at risk Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.
General disorders Fatigue	1.3% 4/298 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 6/294 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/288 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations COVID-19	5.4% 16/298 • Number of events 16 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	6.4% 19/299 • Number of events 19 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	5.1% 15/294 • Number of events 15 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	17.2% 25/145 • Number of events 26 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	20.9% 31/148 • Number of events 33 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	21.9% 63/288 • Number of events 69 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	22.2% 63/284 • Number of events 63 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Nasopharyngitis	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/299 • Number of events 7 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	3.1% 9/294 • Number of events 11 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	4.8% 7/145 • Number of events 8 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	8.8% 13/148 • Number of events 15 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	6.6% 19/288 • Number of events 25 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	9.5% 27/284 • Number of events 38 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Abdominal pain	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Abdominal pain upper	0.67% 2/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/299 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 3/148 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Constipation	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Diarrhoea	1.7% 5/298 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Nausea	1.3% 4/298 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	3.4% 5/148 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
General disorders Asthenia	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
General disorders Pyrexia	1.3% 4/298 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/294 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Bronchitis	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 3/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Gastroenteritis	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.8% 5/284 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Sinusitis	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.8% 5/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Upper respiratory tract infection	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.8% 4/145 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	4.1% 6/148 • Number of events 8 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	4.5% 13/288 • Number of events 14 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.8% 8/284 • Number of events 8 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Urinary tract infection	1.7% 5/298 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.1% 3/145 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.7% 4/148 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.8% 5/284 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Investigations Blood creatine phosphokinase increased	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Investigations Blood pressure increased	1.0% 3/298 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Investigations Weight decreased	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 6/299 • Number of events 7 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.1% 6/288 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.1% 6/284 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Back pain	1.3% 4/298 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 6/299 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.8% 8/288 • Number of events 8 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Neck pain	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Dizziness	1.7% 5/298 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.7% 5/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Headache	1.0% 3/298 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Migraine	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.4% 7/288 • Number of events 7 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Sciatica	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Nervous system disorders Somnolence	1.3% 4/298 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Psychiatric disorders Depressive symptom	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Psychiatric disorders Insomnia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.1% 6/284 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Vascular disorders Hypertension	1.0% 3/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.3% 4/299 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/294 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.1% 3/145 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Blood and lymphatic system disorders Anaemia	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Dyspepsia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.8% 5/284 • Number of events 6 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Gastrointestinal disorders Haemorrhoids	0.67% 2/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Immune system disorders Immunisation reaction	0.67% 2/298 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/294 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Cystitis	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	3.4% 5/148 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Herpes zoster	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Influenza	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Oral herpes	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Pharyngitis	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 3/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Rhinitis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Tonsillitis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/284 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Ligament sprain	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Injury, poisoning and procedural complications Procedural pain	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Investigations Blood cholesterol increased	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Investigations Weight increased	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Metabolism and nutrition disorders Dyslipidaemia	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Metabolism and nutrition disorders Hypercholesterolaemia	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 2/294 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 4/288 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Psychiatric disorders Anxiety	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.34% 1/294 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.70% 2/284 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Psychiatric disorders Depression	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/145 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Reproductive system and breast disorders Menstruation irregular	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.68% 1/148 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.0% 3/288 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Cough	0.67% 2/298 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.67% 2/299 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/145 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.4% 2/148 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 5 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/284 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/298 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 2/288 • Number of events 2 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 4 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Skin and subcutaneous tissue disorders Rash	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/299 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/148 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/288 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	1.1% 3/284 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
Social circumstances Menopause	0.34% 1/298 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.33% 1/299 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/294 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.69% 1/145 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	2.0% 3/148 • Number of events 3 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.35% 1/288 • Number of events 1 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.	0.00% 0/284 • Baseline up to Week 72 All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS\_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.

Additional Information

Email contact via

H. Lundbeck A/S

Phone: +4536301311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place