Trial Outcomes & Findings for A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. (NCT NCT03580356)

Last Updated: 2025-01-07

Results Overview

The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. Possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (\>12 hives/12 hours). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate). Negative change from baseline indicates improvement

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1078 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-01-07

Participant Flow

1,078 participants enrolled in 27 countries at 185 sites.

There were 1,023 adult subjects and 55 adolescent subjects. Out of these 3 adults were mis-randomized and hence did not enter treatment period. 901 adults and 52 adolescent subjects entered the post treatment follow-up period. The number entering post-treatment follow up is higher than the number completing treatment since this also included subjects who entered the follow up period after early treatment discontinuation.

Participant milestones

Participant milestones
Measure	Ligelizumab 72 mg - Adults Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72 mg - Adolescents Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg - Adults Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg - Adolescents Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg - Adults Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300 mg - Adolescents Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo - Ligelizumab 120mg - Adults 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48	Placebo - Ligelizumab 120mg - Adolescents 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48
Treatment Period STARTED	307	16	304	19	309	14	103	6
Treatment Period Randomized Set (RAN)	307	16	304	19	309	14	103	6
Treatment Period Safety Set (SAF)	304	16	306	19	307	14	103	6
Treatment Period Full Analysis Set (FAS)	307	16	303	19	307	14	103	6
Treatment Period COMPLETED	269	15	259	17	263	13	82	6
Treatment Period NOT COMPLETED	38	1	45	2	46	1	21	0
Post-treatment Follow Up Period STARTED	272	15	275	18	265	13	89	6
Post-treatment Follow Up Period COMPLETED	260	15	256	17	259	13	82	5
Post-treatment Follow Up Period NOT COMPLETED	12	0	19	1	6	0	7	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ligelizumab 72 mg - Adults Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72 mg - Adolescents Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg - Adults Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg - Adolescents Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg - Adults Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300 mg - Adolescents Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo - Ligelizumab 120mg - Adults 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48	Placebo - Ligelizumab 120mg - Adolescents 2 injections of 1.0 mL of ligelizumab placebo q4w from Week 0 to Week 20; 1.0 mL of ligelizumab 120 mg + 1.0 mL of ligelizumab placebo q4w from Week 24 through Week 48
Treatment Period Withdrawal by Subject	13	0	13	1	17	0	5	0
Treatment Period Adverse Event	10	0	13	0	5	0	8	0
Treatment Period Protocol Violation	5	0	6	1	9	1	1	0
Treatment Period Lack of Efficacy	6	0	2	0	3	0	3	0
Treatment Period Pregnancy	1	0	7	0	2	0	1	0
Treatment Period Physician Decision	2	0	1	0	4	0	2	0
Treatment Period Lost to Follow-up	1	1	1	0	3	0	1	0
Treatment Period Death	0	0	1	0	0	0	0	0
Treatment Period Technical problems	0	0	0	0	1	0	0	0
Treatment Period Misrandomized, no treatment	0	0	1	0	2	0	0	0
Post-treatment Follow Up Period Withdrawal by Subject	6	0	12	1	4	0	6	1
Post-treatment Follow Up Period Lost to Follow-up	3	0	2	0	1	0	0	0
Post-treatment Follow Up Period Adverse Event	1	0	3	0	0	0	0	0
Post-treatment Follow Up Period Lack of Efficacy	0	0	1	0	1	0	0	0
Post-treatment Follow Up Period Protocol Violation	1	0	1	0	0	0	0	0
Post-treatment Follow Up Period Physician Decision	0	0	0	0	0	0	1	0
Post-treatment Follow Up Period Pregnancy	1	0	0	0	0	0	0	0

Baseline Characteristics

Randomized Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ligelizumab 72 mg n=323 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=323 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=323 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=109 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20	Total n=1078 Participants Total of all reporting groups
Age, Categorical Adults · <=18 years	0 Participants n=307 Participants • Randomized Set	0 Participants n=304 Participants • Randomized Set	0 Participants n=309 Participants • Randomized Set	0 Participants n=103 Participants • Randomized Set	0 Participants n=1023 Participants • Randomized Set
Age, Categorical Adults · Between 18 and 65 years	288 Participants n=307 Participants • Randomized Set	278 Participants n=304 Participants • Randomized Set	286 Participants n=309 Participants • Randomized Set	96 Participants n=103 Participants • Randomized Set	948 Participants n=1023 Participants • Randomized Set
Age, Categorical Adults · >=65 years	19 Participants n=307 Participants • Randomized Set	26 Participants n=304 Participants • Randomized Set	23 Participants n=309 Participants • Randomized Set	7 Participants n=103 Participants • Randomized Set	75 Participants n=1023 Participants • Randomized Set
Age, Categorical Adolescents · <=18 years	16 Participants n=16 Participants • Randomized Set	19 Participants n=19 Participants • Randomized Set	14 Participants n=14 Participants • Randomized Set	6 Participants n=6 Participants • Randomized Set	55 Participants n=55 Participants • Randomized Set
Age, Categorical Adolescents · Between 18 and 65 years	0 Participants n=16 Participants • Randomized Set	0 Participants n=19 Participants • Randomized Set	0 Participants n=14 Participants • Randomized Set	0 Participants n=6 Participants • Randomized Set	0 Participants n=55 Participants • Randomized Set
Age, Categorical Adolescents · >=65 years	0 Participants n=16 Participants • Randomized Set	0 Participants n=19 Participants • Randomized Set	0 Participants n=14 Participants • Randomized Set	0 Participants n=6 Participants • Randomized Set	0 Participants n=55 Participants • Randomized Set
Age, Continuous Adults	41.7 Years STANDARD_DEVIATION 13.42 • n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	43.0 Years STANDARD_DEVIATION 14.11 • n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	44.1 Years STANDARD_DEVIATION 14.11 • n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	42.9 Years STANDARD_DEVIATION 13.01 • n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	42.9 Years STANDARD_DEVIATION 13.81 • n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Age, Continuous Adolescents	14.3 Years STANDARD_DEVIATION 1.39 • n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	15.1 Years STANDARD_DEVIATION 1.56 • n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	15.9 Years STANDARD_DEVIATION 1.17 • n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	14.8 Years STANDARD_DEVIATION 1.47 • n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	15.0 Years STANDARD_DEVIATION 1.50 • n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Sex: Female, Male Adult · Female	227 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	211 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	225 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	80 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	743 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Sex: Female, Male Adult · Male	80 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	93 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	84 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	23 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	280 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Sex: Female, Male Adolescent · Female	10 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	12 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	10 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	4 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	36 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Sex: Female, Male Adolescent · Male	6 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	7 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	4 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	2 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	19 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult White	227 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	218 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	228 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	79 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	752 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent White	9 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	15 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	10 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	5 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	39 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Black or African American	5 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	12 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	9 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	1 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	27 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent Black or African American	1 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	1 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Asian	66 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	67 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	63 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	19 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	215 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent Asian	2 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	2 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	4 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	8 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Native Hawaiian or Other Pacific Islander	0 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent Native Hawaiian or Pacific Islander	0 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Native American	7 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	4 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	6 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	3 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	20 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescents Native American	4 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	2 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	1 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	7 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Multi-racial	2 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	3 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	3 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	1 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	9 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent Multi-racial	0 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adult Race Not Reported	0 Participants n=307 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=304 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=309 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=103 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=1023 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
Race/Ethnicity, Customized Adolescent Race Not Reported	0 Participants n=16 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=19 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=14 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=6 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.	0 Participants n=55 Participants • Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS) included all randomized Adult subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=307 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=303 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=307 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=103 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects	-19.218 Scores on a scale Standard Error 0.651	-20.312 Scores on a scale Standard Error 0.654	-19.632 Scores on a scale Standard Error 0.652	-9.221 Scores on a scale Standard Error 1.135

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS) included all randomized adolescent subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=16 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=19 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=14 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=6 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)	-14.92 scores on a scale Standard Deviation 13.479	-24.83 scores on a scale Standard Deviation 12.640	-18.16 scores on a scale Standard Deviation 10.246	-11.94 scores on a scale Standard Deviation 14.278

SECONDARY outcome

Timeframe: Week 12

Population: FAS: Adults + Adolescents = Total

The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. Data is presented as percentage of patients with a UAS7=0 score. No Statistical analysis was planned for adolescent group.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=322 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=320 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=321 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=109 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) Adults	88 Participants	103 Participants	94 Participants	4 Participants
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) Adolescents	4 Participants	8 Participants	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS: Adults

Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at Week 12 Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate) Negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=307 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=303 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=307 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=103 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)	-8.632 scores on a scale Standard Error 0.298	-9.023 scores on a scale Standard Error 0.300	-8.733 scores on a scale Standard Error 0.300	-4.527 scores on a scale Standard Error 0.522

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS: Adolescents

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=16 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=19 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=14 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=6 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)	-6.38 scores on a scale Standard Deviation 6.994	-12.04 scores on a scale Standard Deviation 6.264	-8.56 scores on a scale Standard Deviation 4.935	-6.97 scores on a scale Standard Deviation 7.904

SECONDARY outcome

Timeframe: Week 12

Population: FAS: Adults + Adolescents = Total

Assessed as percentage of subjects achieving DLQI = 0-1, which means No impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis was planned for adolescent group.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=322 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=319 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=319 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=109 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) Adults	134 Participants	153 Participants	147 Participants	18 Participants
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) Adolescents	4 Participants	9 Participants	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS: Adults

Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity.

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=307 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=303 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=307 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=103 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)	8.668 Weeks Standard Error 0.241	8.897 Weeks Standard Error 0.246	8.427 Weeks Standard Error 0.237	6.242 Weeks Standard Error 0.331

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS: Adolescents

Outcome measures

Outcome measures
Measure	Ligelizumab 72 mg n=16 Participants Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg n=19 Participants Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300 mg n=14 Participants Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w	Placebo n=6 Participants Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)	6.8 Weeks Standard Error 4.90	8.6 Weeks Standard Error 4.60	10.2 Weeks Standard Error 3.01	9.2 Weeks Standard Error 4.92

Adverse Events

Ligelizumab 72mg (Adults)

Serious events: 3 serious events

Other events: 177 other events

Deaths: 0 deaths

Ligelizumab 72mg (Adolescents)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Ligelizumab 72mg (Adults+Adolescents)

Serious events: 3 serious events

Other events: 184 other events

Deaths: 0 deaths

Ligelizumab 120 mg (Adults)

Serious events: 3 serious events

Other events: 182 other events

Deaths: 1 deaths

Ligelizumab 120 mg (Adolescents)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ligelizumab 120 mg (Adults+Adolescents)

Serious events: 3 serious events

Other events: 192 other events

Deaths: 1 deaths

Omalizumab 300mg (Adults)

Serious events: 2 serious events

Other events: 165 other events

Deaths: 0 deaths

Omalizumab 300mg (Adolescents)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Omalizumab 300mg (Adults+Adolescents)

Serious events: 2 serious events

Other events: 175 other events

Deaths: 0 deaths

Placebo Only (Adults)

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo Only (Adolescents)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Only (Adults+Adolescents)

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Transitioned to Ligelizumab 120mg (Adults)

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Transitioned to Ligelizumab 120mg (Adolescents)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Transitioned to Ligelizumab 120mg (Adults+Adolescents)

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ligelizumab 72mg (Adults) n=304 participants at risk Ligelizumab 72mg (Adults): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72mg (Adolescents) n=16 participants at risk Ligelizumab 72mg (Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72mg (Adults+Adolescents) n=320 participants at risk Ligelizumab 72mg (Adults+Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adults) n=306 participants at risk Ligelizumab 120 mg (Adults): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adolescents) n=19 participants at risk Ligelizumab 120 mg (Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adults+Adolescents) n=325 participants at risk Ligelizumab 120 mg (Adults+Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300mg (Adults) n=307 participants at risk Omalizumab 300mg (Adults): 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300mg (Adolescents) n=14 participants at risk Omalizumab 300mg (Adolescents): 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300mg (Adults+Adolescents) n=321 participants at risk Omalizumab 300mg (Adults+Adolescents): 2 injections of 1.2 mL omalizumab q4w	Placebo Only (Adults) n=103 participants at risk Placebo only (Adults): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Placebo Only (Adolescents) n=6 participants at risk Placebo only (Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Placebo Only (Adults+Adolescents) n=109 participants at risk Placebo only (Adults+Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Transitioned to Ligelizumab 120mg (Adults) n=90 participants at risk Placebo Adults patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.	Transitioned to Ligelizumab 120mg (Adolescents) n=6 participants at risk Placebo Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.	Transitioned to Ligelizumab 120mg (Adults+Adolescents) n=96 participants at risk Placebo Adults+Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.
Infections and infestations COVID-19	0.33% 1/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.65% 2/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Angioedema	0.66% 2/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Vascular disorders Hypertension	0.00% 0/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.

Other adverse events

Other adverse events
Measure	Ligelizumab 72mg (Adults) n=304 participants at risk Ligelizumab 72mg (Adults): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72mg (Adolescents) n=16 participants at risk Ligelizumab 72mg (Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 72mg (Adults+Adolescents) n=320 participants at risk Ligelizumab 72mg (Adults+Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adults) n=306 participants at risk Ligelizumab 120 mg (Adults): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adolescents) n=19 participants at risk Ligelizumab 120 mg (Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Ligelizumab 120 mg (Adults+Adolescents) n=325 participants at risk Ligelizumab 120 mg (Adults+Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w	Omalizumab 300mg (Adults) n=307 participants at risk Omalizumab 300mg (Adults): 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300mg (Adolescents) n=14 participants at risk Omalizumab 300mg (Adolescents): 2 injections of 1.2 mL omalizumab q4w	Omalizumab 300mg (Adults+Adolescents) n=321 participants at risk Omalizumab 300mg (Adults+Adolescents): 2 injections of 1.2 mL omalizumab q4w	Placebo Only (Adults) n=103 participants at risk Placebo only (Adults): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Placebo Only (Adolescents) n=6 participants at risk Placebo only (Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Placebo Only (Adults+Adolescents) n=109 participants at risk Placebo only (Adults+Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented	Transitioned to Ligelizumab 120mg (Adults) n=90 participants at risk Placebo Adults patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.	Transitioned to Ligelizumab 120mg (Adolescents) n=6 participants at risk Placebo Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.	Transitioned to Ligelizumab 120mg (Adults+Adolescents) n=96 participants at risk Placebo Adults+Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented.
Skin and subcutaneous tissue disorders Urticaria	4.3% 13/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.1% 13/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.6% 17/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.2% 17/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.6% 11/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 4/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 4/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	16.7% 1/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Vascular disorders Hypertension	3.6% 11/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Blood and lymphatic system disorders Anaemia	0.99% 3/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.5% 5/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Abdominal pain	3.6% 11/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.0% 6/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 4/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 4/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Abdominal pain upper	3.0% 9/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Diarrhoea	3.6% 11/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.8% 12/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.6% 11/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 3/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 3/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Gastritis	1.3% 4/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.3% 7/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.65% 2/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Nausea	4.3% 13/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.7% 15/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Toothache	1.3% 4/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.5% 5/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 4/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 4/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Gastrointestinal disorders Vomiting	3.3% 10/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Fatigue	2.6% 8/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Injection site erythema	2.3% 7/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 12/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Injection site pain	2.0% 6/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 6/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Injection site reaction	1.6% 5/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Injection site swelling	2.0% 6/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 6/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 6/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 3/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 3/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Injection site urticaria	0.00% 0/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
General disorders Pyrexia	2.0% 6/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Bronchitis	2.6% 8/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations COVID-19	5.6% 17/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 17/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.2% 16/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	10.5% 2/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.5% 18/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.3% 2/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.4% 4/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.2% 4/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Gastroenteritis	3.0% 9/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.0% 6/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 6/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Influenza	4.6% 14/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.0% 16/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.6% 11/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	10.5% 2/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.0% 13/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 3/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 3/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Nasopharyngitis	13.8% 42/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 2/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	13.8% 44/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	11.8% 36/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	15.8% 3/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.0% 39/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	11.7% 36/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	28.6% 4/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.5% 40/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.8% 6/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	16.7% 1/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.4% 7/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.8% 7/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.3% 7/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Oral herpes	0.33% 1/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.5% 5/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 3/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 3/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Pharyngitis	1.3% 4/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	16.7% 1/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Sinusitis	0.66% 2/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.94% 3/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.5% 5/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Tonsillitis	0.66% 2/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Upper respiratory tract infection	5.6% 17/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 17/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.6% 17/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	10.5% 2/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.8% 19/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.9% 15/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.7% 15/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Infections and infestations Urinary tract infection	1.3% 4/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.6% 11/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.4% 11/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.9% 18/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.6% 18/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Investigations Blood creatinine increased	0.99% 3/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 3/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Investigations SARS-CoV-2 test negative	2.3% 7/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.62% 2/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 8/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.9% 15/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.6% 15/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.6% 14/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.4% 14/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 3/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 3/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Musculoskeletal and connective tissue disorders Back pain	6.2% 19/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.9% 19/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.5% 20/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.5% 21/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.9% 15/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.7% 15/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 5/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 6/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Nervous system disorders Dizziness	2.0% 6/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 3/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.3% 7/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Nervous system disorders Headache	11.5% 35/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	25.0% 4/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.2% 39/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.4% 44/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	10.5% 2/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.2% 46/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.1% 37/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.3% 2/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	12.1% 39/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.8% 7/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.4% 7/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.7% 6/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 6/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Nervous system disorders Migraine	0.33% 1/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 3/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 3/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Nervous system disorders Somnolence	0.99% 3/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.94% 3/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.33% 1/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.3% 2/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 3/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 3/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Reproductive system and breast disorders Dysmenorrhoea	0.33% 1/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.31% 1/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 7/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 7/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 12/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 6/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.9% 12/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.1% 13/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 2/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 2/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Acne	0.99% 3/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.94% 3/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	5.3% 1/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.1% 10/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	7.1% 1/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.9% 6/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Angioedema	4.3% 13/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	4.4% 14/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.0% 6/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.8% 6/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	2.6% 8/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	6.2% 1/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.6% 8/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.5% 8/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.3% 4/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.2% 4/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.2% 2/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.1% 2/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Dermatitis contact	1.6% 5/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.6% 5/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.9% 9/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	2.8% 9/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.98% 3/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.93% 3/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.1% 1/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	1.0% 1/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Skin and subcutaneous tissue disorders Eczema	3.9% 12/304 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/16 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.8% 12/320 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.9% 12/306 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/19 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/325 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.3% 10/307 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	14.3% 2/14 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	3.7% 12/321 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.97% 1/103 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.92% 1/109 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/90 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/6 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.	0.00% 0/96 • Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 1 (862) 778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER