Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache (NCT NCT03971071)

Last Updated: 2025-09-19

Results Overview

Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) \< 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days \< 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

620 participants

Primary outcome timeframe

Months 4, 5, and 6 (weeks 13 through 24) of the DBTP

Results posted on

2025-09-19

Participant Flow

Participants were enrolled at 67 study centers in North America, Europe, and Australia, and participated from 07 October 2019 to 13 June 2023.

Adult participants with a history of chronic migraine and medication overuse headaches according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria were randomized 1:1:1 to receive erenumab 70 mg or 140 mg subcutaneously (SC) once every 4 weeks (QM) or matching placebo. Prior to randomization, participants completed a 4-week baseline period to evaluate eligibility.

Participant milestones

Participant milestones
Measure	Placebo (DBTP) Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the Open-label Treatment Period (OLTP) and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Double-blind Treatment Period (DBTP) STARTED	206	207	207	0	0
Double-blind Treatment Period (DBTP) Opioid-treated Cohort	12	12	12	0	0
Double-blind Treatment Period (DBTP) Nonopioid-treated Cohort	194	195	195	0	0
Double-blind Treatment Period (DBTP) COMPLETED	197	193	201	0	0
Double-blind Treatment Period (DBTP) NOT COMPLETED	9	14	6	0	0
Open-label Treatment Period STARTED	0	0	0	291	296
Open-label Treatment Period COMPLETED	0	0	0	281	281
Open-label Treatment Period NOT COMPLETED	0	0	0	10	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (DBTP) Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the Open-label Treatment Period (OLTP) and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Double-blind Treatment Period (DBTP) Sponsor decision	0	1	0	0	0
Double-blind Treatment Period (DBTP) Withdrawal by Subject	7	11	6	0	0
Double-blind Treatment Period (DBTP) Other	2	2	0	0	0
Open-label Treatment Period Sponsor decision	0	0	0	0	1
Open-label Treatment Period Withdrawal by Subject	0	0	0	10	13
Open-label Treatment Period Lost to Follow-up	0	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (DBTP) n=206 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=207 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=207 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Total n=620 Participants Total of all reporting groups
Age, Continuous	44.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	43.1 years STANDARD_DEVIATION 11.6 • n=7 Participants	43.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	43.6 years STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	170 Participants n=7 Participants	174 Participants n=5 Participants	510 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	110 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	196 Participants n=5 Participants	197 Participants n=7 Participants	194 Participants n=5 Participants	587 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	196 Participants n=5 Participants	187 Participants n=7 Participants	187 Participants n=5 Participants	570 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	38 Participants n=4 Participants

PRIMARY outcome

Timeframe: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP

Population: Efficacy analysis set (nonopioid-treated cohort): randomized participants with an opioid medication use of ≤ 4 days per month during the baseline period and who received at least 1 dose of IP during DBTP.

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=194 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6	102 Participants	117 Participants	134 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications.

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=194 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=193 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6	-6.61 days per month Standard Error 0.41	-7.83 days per month Standard Error 0.41	-9.35 days per month Standard Error 0.41	—	—

SECONDARY outcome

Timeframe: Month 3 (week 12) to month 6 (week 24) of the DBTP

Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD \< 10 days or mean monthly headache days \< 14 days over the 3-month period (weeks 12 to 24).

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=194 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Number of Participants With Sustained MOH Remission at Month 6	73 Participants	96 Participants	119 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=194 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=193 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)	-8.50 Scores on a scale Standard Error 0.86	-11.75 Scores on a scale Standard Error 0.87	-10.63 Scores on a scale Standard Error 0.86	—	—

SECONDARY outcome

Timeframe: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP

The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=194 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=193 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=194 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID	-10.91 Scores on a scale Standard Error 0.84	-13.52 Scores on a scale Standard Error 0.85	-13.29 Scores on a scale Standard Error 0.84	—	—

SECONDARY outcome

Timeframe: Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)

Population: Safety analysis set: randomized participants who received at least 1 dose of IP.

TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks). Any clinically significant changes in vital signs were included as TEAEs.

Outcome measures

Outcome measures
Measure	Placebo (DBTP) n=206 Participants Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=206 Participants Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=206 Participants Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) n=291 Participants Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) n=296 Participants Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	130 Participants	139 Participants	142 Participants	178 Participants	182 Participants

Adverse Events

Placebo (DBTP)

Serious events: 8 serious events

Other events: 29 other events

Deaths: 0 deaths

Erenumab 70 mg (DBTP)

Serious events: 3 serious events

Other events: 67 other events

Deaths: 0 deaths

Erenumab 140 mg (DBTP)

Serious events: 3 serious events

Other events: 72 other events

Deaths: 0 deaths

Erenumab 70 mg (OLTP)

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

Erenumab 140 mg (OLTP)

Serious events: 12 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (DBTP) n=206 participants at risk Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=206 participants at risk Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=206 participants at risk Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) n=291 participants at risk Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) n=296 participants at risk Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Injury, poisoning and procedural complications Multiple fractures	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendicitis	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.68% 2/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Embolic pneumonia	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Mastoiditis	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Periorbital cellulitis	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Migraine	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.49% 1/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular arrhythmia	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal prolapse	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Volvulus	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Uterine polyp	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo (DBTP) n=206 participants at risk Participants were randomized to receive matching placebo SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (DBTP) n=206 participants at risk Participants were randomized to receive 1 mL of erenumab 70 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 140 mg (DBTP) n=206 participants at risk Participants were randomized to receive 1 mL of erenumab 140 mg/mL SC QM for 24 weeks in the DBTP.	Erenumab 70 mg (OLTP) n=291 participants at risk Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 70 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 70 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 70 mg in the OLTP.	Erenumab 140 mg (OLTP) n=296 participants at risk Eligible participants who successfully completed the DBTP continued to the OLTP and received erenumab 140 mg SC QM for up to 28 weeks (up to Week 52). Eligible participants included participants randomized to erenumab 140 mg in the DBTP and participants randomized to placebo in the DBTP, re-randomized to erenumab 140 mg in the OLTP.
Gastrointestinal disorders Constipation	4.4% 9/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.0% 31/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.5% 34/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.6% 22/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.1% 24/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	6.8% 14/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	12.1% 25/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	16.0% 33/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	10.7% 31/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	13.2% 39/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	1.9% 4/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 12/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.4% 9/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 15/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.7% 14/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	1.9% 4/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.9% 8/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 12/206 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 1/291 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.0% 3/296 • Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP). All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER