Trial Outcomes & Findings for A Study of Galcanezumab in Participants With Chronic Cluster Headache (NCT NCT02438826)

Last Updated: 2020-08-25

Results Overview

Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

Baseline, Week 1 through Week 12

Results posted on

2020-08-25

Participant Flow

Study consists of a 12-week double-blind treatment phase; an optional 1-year open-label treatment phase; and a 16-week post-treatment phase (washout).

Participant milestones

Participant milestones
Measure	Placebo/Galcanezumab (GMB) 300 mg Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants from placebo group received 300 milligrams (mg) of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations. Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.	GMB 300 mg/GMB 300 mg Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations. Post-Treatment Phase: Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.	Placebo (Post-Treatment Phase) Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.	Galcanezumab 300 mg (Post-Treatment Phase) Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
Double-Blind Treatment Phase STARTED	123	117	0	0
Double-Blind Treatment Phase Received at Least 1 Dose of Study Drug	120	117	0	0
Double-Blind Treatment Phase COMPLETED	117	113	0	0
Double-Blind Treatment Phase NOT COMPLETED	6	4	0	0
Open-Label Treatment Phase STARTED	116	113	0	0
Open-Label Treatment Phase COMPLETED	72	80	0	0
Open-Label Treatment Phase NOT COMPLETED	44	33	0	0
Post-Treatment Phase STARTED	93	93	2	4
Post-Treatment Phase COMPLETED	84	92	2	4
Post-Treatment Phase NOT COMPLETED	9	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Galcanezumab (GMB) 300 mg Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants from placebo group received 300 milligrams (mg) of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations. Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.	GMB 300 mg/GMB 300 mg Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations. Post-Treatment Phase: Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
Double-Blind Treatment Phase Adverse Event	1	1
Double-Blind Treatment Phase Lack of Efficacy	1	0
Double-Blind Treatment Phase Withdrawal by Subject	1	1
Double-Blind Treatment Phase Protocol Violation	1	2
Double-Blind Treatment Phase Screen Failure	2	0
Open-Label Treatment Phase Adverse Event	11	6
Open-Label Treatment Phase Lack of Efficacy	27	18
Open-Label Treatment Phase Lost to Follow-up	0	2
Open-Label Treatment Phase Withdrawal by Subject	6	7
Post-Treatment Phase Adverse Event	3	0
Post-Treatment Phase Lack of Efficacy	4	0
Post-Treatment Phase Physician Decision	1	0
Post-Treatment Phase Withdrawal by Subject	1	1

Baseline Characteristics

All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=120 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=117 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.	Total n=237 Participants Total of all reporting groups
Age, Continuous	44.38 years STANDARD_DEVIATION 10.81 • n=120 Participants	45.62 years STANDARD_DEVIATION 11.03 • n=117 Participants	45.00 years STANDARD_DEVIATION 10.92 • n=237 Participants
Sex: Female, Male Female	34 Participants n=120 Participants	31 Participants n=117 Participants	65 Participants n=237 Participants
Sex: Female, Male Male	86 Participants n=120 Participants	86 Participants n=117 Participants	172 Participants n=237 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=120 Participants	18 Participants n=117 Participants	33 Participants n=237 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=120 Participants	81 Participants n=117 Participants	168 Participants n=237 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=120 Participants	18 Participants n=117 Participants	36 Participants n=237 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=120 Participants	0 Participants n=117 Participants	0 Participants n=237 Participants
Race (NIH/OMB) Asian	0 Participants n=120 Participants	0 Participants n=117 Participants	0 Participants n=237 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=120 Participants	0 Participants n=117 Participants	0 Participants n=237 Participants
Race (NIH/OMB) Black or African American	1 Participants n=120 Participants	1 Participants n=117 Participants	2 Participants n=237 Participants
Race (NIH/OMB) White	101 Participants n=120 Participants	99 Participants n=117 Participants	200 Participants n=237 Participants
Race (NIH/OMB) More than one race	18 Participants n=120 Participants	17 Participants n=117 Participants	35 Participants n=237 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=120 Participants	0 Participants n=117 Participants	0 Participants n=237 Participants
Region of Enrollment Greece	0 Participants n=120 Participants	1 Participants n=117 Participants	1 Participants n=237 Participants
Region of Enrollment Canada	4 Participants n=120 Participants	4 Participants n=117 Participants	8 Participants n=237 Participants
Region of Enrollment Netherlands	5 Participants n=120 Participants	5 Participants n=117 Participants	10 Participants n=237 Participants
Region of Enrollment Belgium	16 Participants n=120 Participants	16 Participants n=117 Participants	32 Participants n=237 Participants
Region of Enrollment United States	15 Participants n=120 Participants	18 Participants n=117 Participants	33 Participants n=237 Participants
Region of Enrollment Finland	2 Participants n=120 Participants	2 Participants n=117 Participants	4 Participants n=237 Participants
Region of Enrollment Denmark	5 Participants n=120 Participants	4 Participants n=117 Participants	9 Participants n=237 Participants
Region of Enrollment Italy	17 Participants n=120 Participants	14 Participants n=117 Participants	31 Participants n=237 Participants
Region of Enrollment United Kingdom	8 Participants n=120 Participants	8 Participants n=117 Participants	16 Participants n=237 Participants
Region of Enrollment France	20 Participants n=120 Participants	20 Participants n=117 Participants	40 Participants n=237 Participants
Region of Enrollment Germany	22 Participants n=120 Participants	20 Participants n=117 Participants	42 Participants n=237 Participants
Region of Enrollment Spain	6 Participants n=120 Participants	5 Participants n=117 Participants	11 Participants n=237 Participants
Weekly Cluster Headache Attacks	18.47 cluster headache attacks per week STANDARD_DEVIATION 10.66 • n=120 Participants	19.18 cluster headache attacks per week STANDARD_DEVIATION 9.82 • n=117 Participants	18.82 cluster headache attacks per week STANDARD_DEVIATION 10.24 • n=237 Participants
Lifetime Suicidal Ideation Prior to Screening	30 Participants n=120 Participants	25 Participants n=117 Participants	55 Participants n=237 Participants
Lifetime Suicidal Behavior Prior to Screening	5 Participants n=119 Participants • All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.	4 Participants n=117 Participants • All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.	9 Participants n=236 Participants • All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.
Verapamil Use at Baseline	63 Participants n=120 Participants	55 Participants n=117 Participants	118 Participants n=237 Participants

PRIMARY outcome

Timeframe: Baseline, Week 1 through Week 12

Population: All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=117 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency	-4.59 cluster headache attacks per week Standard Error 0.79	-5.38 cluster headache attacks per week Standard Error 0.81

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 12

Population: All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.

A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=117 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks	27.1 percentage of participants Standard Error 3.5	32.6 percentage of participants Standard Error 3.8

SECONDARY outcome

Timeframe: Baseline, Week 3 through Week 12

Population: All randomized participants who received at least 1 dose of study drug, had a baseline, and at least one post baseline value.

Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=117 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks	17.50 percentage of participants	16.24 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 12

Population: All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.

A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=117 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks	39.0 percentage of participants Standard Error 3.9	49.1 percentage of participants Standard Error 4.1

SECONDARY outcome

Timeframe: Week 4

Population: All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 4.

PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=88 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)	19.4 percentage of participants	21.5 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 8.

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=86 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)	32.0 percentage of participants	32.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 12.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=95 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)	35.6 percentage of participants	30.4 percentage of participants

SECONDARY outcome

Timeframe: Week 1 through Week 12

Population: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.

C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.

Outcome measures

Outcome measures
Measure	Placebo n=119 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=116 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)	5.04 percentage of participants	4.31 percentage of participants

SECONDARY outcome

Timeframe: Week 1 through Week 12

Population: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.

C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.

Outcome measures

Outcome measures
Measure	Placebo n=119 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=116 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 1 through Week 12

Population: All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.

Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer \>= 1: 20.

Outcome measures

Outcome measures
Measure	Placebo n=115 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg n=113 Participants Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)	0 percentage of participants	0.88 percentage of participants

SECONDARY outcome

Timeframe: Week 2

Population: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 2.

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Outcome measures

Outcome measures
Measure	Placebo n=90 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	30,600 nanogram per milliliter Standard Deviation 10,700	—

SECONDARY outcome

Timeframe: Week 4

Population: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 4.

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	20,200 nanogram per milliliter Standard Deviation 6780	—

SECONDARY outcome

Timeframe: Week 8

Population: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 8.

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	29,700 nanogram per milliliter Standard Deviation 11,500	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 12.

Pharmacokinetics (PK): Serum Concentration of Galcanezumab

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	31,100 nanogram per milliliter Standard Deviation 11,900	—

Adverse Events

Placebo (Double-Blind Treatment Phase)

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Galcanezumab 300 mg (Double-Blind Treatment Phase)

Serious events: 2 serious events

Other events: 68 other events

Deaths: 0 deaths

Placebo/GMB 300 mg (Open-Label Treatment Phase)

Serious events: 11 serious events

Other events: 69 other events

Deaths: 0 deaths

GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)

Serious events: 10 serious events

Other events: 72 other events

Deaths: 0 deaths

Placebo (Post-Treatment Phase)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Galcanezumab 300 mg (Post-Treatment Phase)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo/GMB 300 mg (Post-Treatment Phase)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

GMB 300 mg/GMB 300 Mg-Post-Treatment Phase

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Double-Blind Treatment Phase) n=120 participants at risk Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg (Double-Blind Treatment Phase) n=117 participants at risk Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months	Placebo/GMB 300 mg (Open-Label Treatment Phase) n=116 participants at risk Participants from placebo group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.	GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase) n=113 participants at risk Participants from galcanezumab of double-blind group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.	Placebo (Post-Treatment Phase) n=2 participants at risk Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.	Galcanezumab 300 mg (Post-Treatment Phase) n=4 participants at risk Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.	Placebo/GMB 300 mg (Post-Treatment Phase) n=93 participants at risk Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.	GMB 300 mg/GMB 300 Mg-Post-Treatment Phase n=93 participants at risk Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
Cardiac disorders Atrial fibrillation	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Amaurosis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Melaena	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site urticaria	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Helicobacter gastritis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Rectal abscess	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection bacterial	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Kidney rupture	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage iii	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral ischaemia	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cluster headache	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Reversible cerebral vasoconstriction syndrome	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Social circumstances Pregnancy of partner	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Arthrodesis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Placebo (Double-Blind Treatment Phase) n=120 participants at risk Participants received placebo once a month by subcutaneous (SC) injection for 3 months.	Galcanezumab 300 mg (Double-Blind Treatment Phase) n=117 participants at risk Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months	Placebo/GMB 300 mg (Open-Label Treatment Phase) n=116 participants at risk Participants from placebo group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.	GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase) n=113 participants at risk Participants from galcanezumab of double-blind group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.	Placebo (Post-Treatment Phase) n=2 participants at risk Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.	Galcanezumab 300 mg (Post-Treatment Phase) n=4 participants at risk Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.	Placebo/GMB 300 mg (Post-Treatment Phase) n=93 participants at risk Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.	GMB 300 mg/GMB 300 Mg-Post-Treatment Phase n=93 participants at risk Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
Renal and urinary disorders Nephrolithiasis	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/34 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/34 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 1/31 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/34 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/34 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	2.5% 3/120 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Palpitations	2.5% 3/120 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	2.5% 3/120 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Thyroid mass	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Visual impairment	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	2.5% 3/120 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	1.7% 2/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.2% 6/116 • Number of events 8 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	5.0% 6/120 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/116 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	5.0% 6/120 • Number of events 8 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.1% 6/117 • Number of events 7 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	2.5% 3/120 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	1.7% 2/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	5.8% 7/120 • Number of events 9 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/117 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.2% 6/116 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Influenza like illness	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/117 • Number of events 8 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/116 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site erythema	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.8% 8/117 • Number of events 11 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/116 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 7 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site pain	9.2% 11/120 • Number of events 15 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 14/117 • Number of events 32 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.8% 16/116 • Number of events 32 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 8/113 • Number of events 14 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site pruritus	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.0% 7/117 • Number of events 10 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/116 • Number of events 7 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 10 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site reaction	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 8/116 • Number of events 20 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site swelling	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 7 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/116 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	2.5% 3/120 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.9% 8/116 • Number of events 8 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.4% 5/113 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 4/93 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	12.5% 15/120 • Number of events 16 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.3% 12/117 • Number of events 13 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.1% 14/116 • Number of events 19 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.0% 17/113 • Number of events 24 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 3/93 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	1.7% 2/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 6/113 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tracheitis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	1.7% 2/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.4% 5/113 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/34 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/31 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/29 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	1.7% 2/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight increased	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 4/120 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/116 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 6/113 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/117 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/116 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.8% 10/113 • Number of events 12 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 3/120 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/116 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.83% 1/120 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/117 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 3/116 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	5.0% 6/120 • Number of events 7 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/117 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.4% 4/116 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	3.3% 4/120 • Number of events 5 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/117 • Number of events 3 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 3/113 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.83% 1/120 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.86% 1/116 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.3% 5/116 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 2/93 • Number of events 2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	3.3% 4/120 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 1/117 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.7% 2/116 • Number of events 4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 6/113 • Number of events 6 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 1/93 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/120 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/117 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/116 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/113 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/93 • Up to 1 Year 7 Months All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60