Trial Outcomes & Findings for AMG 334 20160172 Pediatric Migraine PK Study. (NCT NCT03499119)

NCT ID: NCT03499119

Last Updated: 2024-05-28

Results Overview

Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 53 participants
• Primary outcome timeframe: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
• Results posted on: 2024-05-28

Participant Flow

Of the 63 participants screened, 53 participants were enrolled at 9 centers in the United States between 04 May 2018 and 23 November 2021. Enrollment was staggered by age category with adolescents 12 to < 18 years of age starting enrollment first, followed by children 6 to < 12 years of age.

Participants weighing < 40 kg (Cohort 1) received a dose of either 35 mg or 70 mg erenumab. Participants weighing ≥ 40 kg (Cohort 2) received a dose of either 70 mg or 140 mg erenumab. All participants participated in the initial treatment phase for a total of 12 weeks of treatment. Adolescents 12 to < 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase.

Participant milestones

Measure	Cohort 1: Erenumab 35 mg Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Initial Treatment Phase STARTED	4	9	8	32
Initial Treatment Phase COMPLETED	3	9	7	29
Initial Treatment Phase NOT COMPLETED	1	0	1	3
Optional Extension Phase STARTED	1	3	5	27
Optional Extension Phase COMPLETED	1	2	5	21
Optional Extension Phase NOT COMPLETED	0	1	0	6

Reasons for withdrawal

Measure	Cohort 1: Erenumab 35 mg Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Initial Treatment Phase Protocol Specified Criteria	0	0	0	1
Initial Treatment Phase Withdrawal by Subject	0	0	0	1
Initial Treatment Phase Decision by Sponsor	1	0	1	1
Optional Extension Phase Lost to Follow-up	0	0	0	1
Optional Extension Phase Withdrawal by Subject	0	0	0	5
Optional Extension Phase Protocol Specified Criteria	0	1	0	0

Baseline Characteristics

AMG 334 20160172 Pediatric Migraine PK Study.

Baseline characteristics by cohort

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Total n=53 Participants Total of all reporting groups
Age, Continuous	10.8 years STANDARD_DEVIATION 1.7 • n=5 Participants	10.4 years STANDARD_DEVIATION 1.0 • n=7 Participants	14.6 years STANDARD_DEVIATION 1.3 • n=5 Participants	15.4 years STANDARD_DEVIATION 1.5 • n=4 Participants	14.1 years STANDARD_DEVIATION 2.5 • n=21 Participants
Age, Customized Children (6 to < 12 years)	3 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Age, Customized Adolescents (12 to < 18 years)	1 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants	31 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants	49 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Black (or African American)	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants	43 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Population: The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if: * participants missed the previous dose or the actual time deviated by \> 30% from the nominal sample collection time * PK profile was missing \> 2 samples * PK values at the beginning or end of PK profile were missing, or * predose PK sample concentration was \> 5% of maximum concentration value.

Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=3 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=30 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Time to Maximum Concentration (Tmax) of Erenumab First Dose	7.0 days Interval 2.9 to 7.2	7.0 days Interval 2.9 to 14.0	9.0 days Interval 2.9 to 15.0	7.0 days Interval 2.9 to 16.0
Time to Maximum Concentration (Tmax) of Erenumab Third Dose	7.2 days Interval 7.0 to 8.0	10.0 days Interval 7.0 to 21.0	9.0 days Interval 6.0 to 26.0	7.2 days Interval 4.0 to 15.0

PRIMARY outcome

Timeframe: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Population: The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if: * participants missed the previous dose or the actual time deviated by \> 30% from the nominal sample collection time * PK profile was missing \> 2 samples * PK values at the beginning or end of PK profile were missing, or * predose PK sample concentration was \> 5% of maximum concentration value.

Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=3 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=30 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Maximum Observed Concentration (Cmax) of Erenumab First Dose	7.92 μg/mL Standard Deviation 0.947	13.3 μg/mL Standard Deviation 4.85	7.16 μg/mL Standard Deviation 1.76	13.4 μg/mL Standard Deviation 4.53
Maximum Observed Concentration (Cmax) of Erenumab Third Dose	11.3 μg/mL Standard Deviation 3.14	18.9 μg/mL Standard Deviation 7.29	14.1 μg/mL Standard Deviation 5.54	23.7 μg/mL Standard Deviation 8.83

PRIMARY outcome

Timeframe: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Population: The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if: * participants missed the previous dose or the actual time deviated by \> 30% from the nominal sample collection time * PK profile was missing \> 2 samples * PK values at the beginning or end of PK profile were missing, or * predose PK sample concentration was \> 5% of maximum concentration value.

Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=3 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=31 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Trough Concentration (Ctrough) of Erenumab Third Dose	5.43 μg/mL Standard Deviation 0.861	10.3 μg/mL Standard Deviation 5.47	9.81 μg/mL Standard Deviation 2.37	14.9 μg/mL Standard Deviation 5.87
Trough Concentration (Ctrough) of Erenumab First Dose	3.92 μg/mL Standard Deviation 0.626	7.02 μg/mL Standard Deviation 2.85	4.23 μg/mL Standard Deviation 1.05	7.77 μg/mL Standard Deviation 2.79

PRIMARY outcome

Timeframe: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85

Population: The PK analysis set contained all randomized participants who received at least 1 dose of erenumab and had at least 1 PK concentration result. Data were excluded from the NCA if: * participants missed the previous dose or the actual time deviated by \> 30% from the nominal sample collection time * PK profile was missing \> 2 samples * PK values at the beginning or end of PK profile were missing, or * predose PK sample concentration was \> 5% of maximum concentration value.

Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=3 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=6 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=6 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=21 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab Third Dose	243 day*μg/mL Interval 176.0 to 269.0	465 day*μg/mL Interval 336.0 to 667.0	329 day*μg/mL Interval 180.0 to 437.0	475 day*μg/mL Interval 259.0 to 1000.0
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab First Dose	175 day*μg/mL Interval 165.0 to 185.0	282 day*μg/mL Interval 65.8 to 357.0	151 day*μg/mL Interval 112.0 to 192.0	277 day*μg/mL Interval 175.0 to 551.0

PRIMARY outcome

Timeframe: Up to Week 52 + 16-week safety follow-up

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	2 Participants	6 Participants	6 Participants	28 Participants

PRIMARY outcome

Timeframe: Up to Week 52 + 16-week safety follow-up

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Number of Participants With Clinically Significant Changes in Vital Signs Measurements	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52 + 16-week safety follow-up

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 52 + 16-week safety follow-up

Population: The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

The neurological examinations were completed as per standard of care.

Outcome measures

Measure	Cohort 1: Erenumab 35 mg n=4 Participants Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 1: Erenumab 70 mg n=9 Participants Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 70 mg n=8 Participants Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.	Cohort 2: Erenumab 140 mg n=32 Participants Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase. Adolescents 12 to \< 18 years of age at time of consent had the option of continuing treatment with the same dose they received in the initial treatment phase in a 40-week extension phase, for a total of 52 weeks of treatment.
Number of Participants With Clinically Significant Changes in Neurological Assessments	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Initial Treatment Phase Cohort 1: Erenumab 35 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Initial Treatment Phase Cohort 1: Erenumab 70 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Initial Treatment Phase Cohort 2: Erenumab 70 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Initial Treatment Phase Cohort 2: Erenumab 140 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Optional Extension Phase Cohort 1: Erenumab 35 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Optional Extension Phase Cohort 1: Erenumab 70 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Optional Extension Phase Cohort 2: Erenumab 70 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Optional Extension Phase Cohort 2: Erenumab 140 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Initial Treatment Phase Cohort 1: Erenumab 35 mg n=4 participants at risk Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 1: Erenumab 70 mg n=9 participants at risk Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 2: Erenumab 70 mg n=8 participants at risk Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 2: Erenumab 140 mg n=32 participants at risk Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Optional Extension Phase Cohort 1: Erenumab 35 mg n=1 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing \< 40 kg continued to receive a dose of 35 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 1: Erenumab 70 mg n=3 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing \< 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 2: Erenumab 70 mg n=5 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 2: Erenumab 140 mg n=27 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 140 mg erenumab Q4W via SC injection in the 40-week extension phase.
Gastrointestinal disorders Gastritis	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Appendicitis	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Suicidal ideation	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	33.3% 1/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Suicide attempt	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

Other adverse events

Measure	Initial Treatment Phase Cohort 1: Erenumab 35 mg n=4 participants at risk Participants weighing \< 40 kg received a dose of 35 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 1: Erenumab 70 mg n=9 participants at risk Participants weighing \< 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 2: Erenumab 70 mg n=8 participants at risk Participants weighing ≥ 40 kg received a dose of 70 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Initial Treatment Phase Cohort 2: Erenumab 140 mg n=32 participants at risk Participants weighing ≥ 40 kg received a dose of 140 mg erenumab Q4W via SC injection in the initial 12-week treatment phase.	Optional Extension Phase Cohort 1: Erenumab 35 mg n=1 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing \< 40 kg continued to receive a dose of 35 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 1: Erenumab 70 mg n=3 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing \< 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 2: Erenumab 70 mg n=5 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 70 mg erenumab Q4W via SC injection in the 40-week extension phase.	Optional Extension Phase Cohort 2: Erenumab 140 mg n=27 participants at risk Adolescents 12 to \< 18 years of age at time of consent weighing ≥ 40 kg continued to receive a dose of 140 mg erenumab Q4W via SC injection in the 40-week extension phase.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	18.5% 5/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 3/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Ear and labyrinth disorders Vertigo	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Constipation	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Nausea	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 3/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	40.0% 2/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	14.8% 4/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Fatigue	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Injection site erythema	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Injection site induration	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Injection site pain	25.0% 1/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Injection site swelling	25.0% 1/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Injection site warmth	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
General disorders Pyrexia	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Immune system disorders Seasonal allergy	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Ear infection	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Hordeolum	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	33.3% 1/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Influenza	25.0% 1/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Pharyngitis streptococcal	25.0% 1/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Rhinitis	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	40.0% 2/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	25.9% 7/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Infections and infestations Viral infection	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Investigations QRS axis abnormal	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.7% 1/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Posture abnormal	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Nervous system disorders Balance disorder	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Nervous system disorders Dizziness	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 3/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Nervous system disorders Headache	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	18.8% 6/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Nervous system disorders Migraine	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Adjustment disorder with mixed anxiety and depressed mood	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Anxiety	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Panic attack	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Psychiatric disorders Suicidal ideation	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	22.2% 2/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	7.4% 2/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	12.5% 1/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	6.2% 2/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	20.0% 1/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	11.1% 1/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	3.1% 1/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/4 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/9 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/8 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/32 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/1 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	33.3% 1/3 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/5 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.	0.00% 0/27 • Initial treatment phase: up to Week 12 + 16-week safety follow-up; optional extension phase: Week 12 to Week 52 + 16-week safety follow-up The safety analysis set consisted of all randomized participants who received at least 1 dose of erenumab during the initial treatment phase.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

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