Trial Outcomes & Findings for Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study (NCT NCT02614196)

NCT ID: NCT02614196

Last Updated: 2020-06-17

Results Overview

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 986 participants
• Primary outcome timeframe: Baseline, Month 1 through Month 6
• Results posted on: 2020-06-17

Participant Flow

Participant milestones

Measure	Placebo Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Placebo Maximum Extended Enrollment Cohort Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg Maximum Extended Enrollment Cohort Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg Maximum Extended Enrollment Cohort Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
Double Blind Treatment Phase STARTED	463	233	226	30	15	19
Double Blind Treatment Phase Received at Least One Dose of Study Drug	461	231	223	30	14	19
Double Blind Treatment Phase COMPLETED	387	203	195	26	14	19
Double Blind Treatment Phase NOT COMPLETED	76	30	31	4	1	0
Post Treatment Follow-up Phase STARTED	410	213	207	25	15	19
Post Treatment Follow-up Phase COMPLETED	390	208	199	24	13	19
Post Treatment Follow-up Phase NOT COMPLETED	20	5	8	1	2	0

Reasons for withdrawal

Measure	Placebo Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Placebo Maximum Extended Enrollment Cohort Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg Maximum Extended Enrollment Cohort Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg Maximum Extended Enrollment Cohort Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.
Double Blind Treatment Phase Adverse Event	8	5	9	0	0	0
Double Blind Treatment Phase Lack of Efficacy	6	1	1	0	0	0
Double Blind Treatment Phase Lost to Follow-up	10	7	1	0	0	0
Double Blind Treatment Phase Physician Decision	4	0	2	0	0	0
Double Blind Treatment Phase Pregnancy	1	2	0	0	0	0
Double Blind Treatment Phase Protocol Violation	5	2	1	0	1	0
Double Blind Treatment Phase Terminated by sponsor	1	0	0	0	0	0
Double Blind Treatment Phase Withdrawal by Subject	39	11	14	4	0	0
Double Blind Treatment Phase Did not receive study drug	2	2	3	0	0	0
Post Treatment Follow-up Phase Lost to Follow-up	8	3	3	0	1	0
Post Treatment Follow-up Phase Pregnancy	2	0	0	0	0	0
Post Treatment Follow-up Phase Protocol Violation	0	1	0	0	1	0
Post Treatment Follow-up Phase Withdrawal by Subject	10	1	5	1	0	0

Baseline Characteristics

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

Baseline characteristics by cohort

Measure	Placebo n=461 Participants Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg n=231 Participants Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg n=223 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Placebo Maximum Extended Enrollment Cohort n=30 Participants Participants received placebo by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 120mg Maximum Extended Enrollment Cohort n=15 Participants Participants received loading dose of 240mg galcanezumab at 1st dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Galcanezumab 240mg Maximum Extended Enrollment Cohort n=19 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months during double blind treatment phase. Participants did not receive any intervention during post-treatment follow-up phase.	Total n=979 Participants Total of all reporting groups
Age, Continuous	42.33 years STANDARD_DEVIATION 11.30 • n=5 Participants	40.91 years STANDARD_DEVIATION 11.15 • n=7 Participants	41.91 years STANDARD_DEVIATION 10.77 • n=5 Participants	45.37 years STANDARD_DEVIATION 10.30 • n=4 Participants	39.40 years STANDARD_DEVIATION 11.58 • n=21 Participants	42.58 years STANDARD_DEVIATION 11.13 • n=10 Participants	41.95 years STANDARD_DEVIATION 11.12 • n=115 Participants
Sex: Female, Male Female	393 Participants n=5 Participants	197 Participants n=7 Participants	191 Participants n=5 Participants	22 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=10 Participants	830 Participants n=115 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	149 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	118 Participants n=5 Participants	58 Participants n=7 Participants	61 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	246 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	318 Participants n=5 Participants	162 Participants n=7 Participants	151 Participants n=5 Participants	21 Participants n=4 Participants	10 Participants n=21 Participants	12 Participants n=10 Participants	674 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	59 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	20 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	41 Participants n=115 Participants
Race (NIH/OMB) Asian	50 Participants n=5 Participants	28 Participants n=7 Participants	24 Participants n=5 Participants	30 Participants n=4 Participants	15 Participants n=21 Participants	19 Participants n=10 Participants	166 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	63 Participants n=115 Participants
Race (NIH/OMB) White	325 Participants n=5 Participants	166 Participants n=7 Participants	152 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	643 Participants n=115 Participants
Race (NIH/OMB) More than one race	30 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	64 Participants n=115 Participants
Race (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	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Argentina	22 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	44 Participants n=115 Participants
Region of Enrollment South Korea	34 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=10 Participants	98 Participants n=115 Participants
Region of Enrollment Netherlands	24 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	46 Participants n=115 Participants
Region of Enrollment United States	224 Participants n=5 Participants	112 Participants n=7 Participants	110 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	446 Participants n=115 Participants
Region of Enrollment Czechia	39 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	77 Participants n=115 Participants
Region of Enrollment Taiwan	12 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants	8 Participants n=21 Participants	10 Participants n=10 Participants	58 Participants n=115 Participants
Region of Enrollment Mexico	36 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	71 Participants n=115 Participants
Region of Enrollment United Kingdom	8 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	15 Participants n=115 Participants
Region of Enrollment Israel	11 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	21 Participants n=115 Participants
Region of Enrollment Germany	37 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	75 Participants n=115 Participants
Region of Enrollment Spain	14 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	28 Participants n=115 Participants
Migraine Headache Days (MHD) per month	9.19 Days per Month STANDARD_DEVIATION 2.99 • n=5 Participants	9.07 Days per Month STANDARD_DEVIATION 2.87 • n=7 Participants	9.06 Days per Month STANDARD_DEVIATION 2.92 • n=5 Participants	9.16 Days per Month STANDARD_DEVIATION 2.98 • n=4 Participants	9.06 Days per Month STANDARD_DEVIATION 2.86 • n=21 Participants	9.01 Days per Month STANDARD_DEVIATION 2.90 • n=10 Participants	9.10 Days per Month STANDARD_DEVIATION 2.93 • n=115 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.

Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):

A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia;

Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.

Outcome measures

Measure	Placebo n=450 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=220 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days	-2.28 Migraine Headache Days per Month Standard Error 0.20	-4.29 Migraine Headache Days per Month Standard Error 0.25	-4.18 Migraine Headache Days per Month Standard Error 0.26

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.

Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline.

Outcome measures

Measure	Placebo n=450 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=220 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days ≥50%	36 percentage of participants Standard Error 1.7	59.3 percentage of participants Standard Error 2.4	56.5 percentage of participants Standard Error 2.5
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days ≥75%	17.8 percentage of participants Standard Error 1.3	33.5 percentage of participants Standard Error 2.3	34.3 percentage of participants Standard Error 2.3
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days 100%	5.7 percentage of participants Standard Error 0.7	11.5 percentage of participants Standard Error 1.4	13.8 percentage of participants Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline, Month 4 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine.

It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors.

Outcome measures

Measure	Placebo n=443 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=219 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain	19.65 units on a scale Standard Error 0.92	28.47 units on a scale Standard Error 1.15	27.04 units on a scale Standard Error 1.17

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.

Overall mean is derived from the average of months 1 to 6 from MMRM model.LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.

Outcome measures

Measure	Placebo n=450 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=220 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache	-1.85 Days per Month Standard Error 0.18	-3.67 Days per Month Standard Error 0.22	-3.63 Days per Month Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline, Month 4 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

The PGI-S scale is a participant-rated instrument that measures patients own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

Outcome measures

Measure	Placebo n=443 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=219 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating	-0.94 units on a scale Standard Error 0.07	-1.22 units on a scale Standard Error 0.08	-1.17 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline, Month 1 through Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.

Outcome measures

Measure	Placebo n=450 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=226 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=220 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Overall Mean Change From Baseline in Headache Hours	-10.89 Headache Hours per Month Standard Error 1.92	-26.07 Headache Hours per Month Standard Error 2.41	-24.44 Headache Hours per Month Standard Error 2.44

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.

LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.

Outcome measures

Measure	Placebo n=409 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=216 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=215 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score	-12.02 units on a scale Standard Error 1.27	-21.17 units on a scale Standard Error 1.58	-20.24 units on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Month 1 through Month 6

Population: All randomized participants who received at least one dose of study drug \& had least one non-missing test result for ADA for each of the baseline period and the post-baseline period. As pre-specified in the analysis plan, outcome measures will not be reported for the ME2 arms/groups but only for the main global study arms/groups.

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

Outcome measures

Measure	Placebo n=443 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=222 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=214 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab	0.45 percentage of participants	8.56 percentage of participants	5.14 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: All randomized participants who received at least one dose of study drug and had measurable serum concentrations. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

Outcome measures

Measure	Placebo n=194 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=193 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab	17400 Nanogram per milliliter (ng/mL) Standard Deviation 8820	32200 Nanogram per milliliter (ng/mL) Standard Deviation 12600	—

SECONDARY outcome

Timeframe: Month 6

Population: All randomized participants who had received at least one dose of study drug and had measurable plasma concentration. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

Outcome measures

Measure	Placebo n=29 Participants Participants received placebo by subcutaneous injection once a month for 6 months.	Galcanezumab 120mg n=187 Participants Participants received loading dose of 240mg galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.	Galcanezumab 240mg n=185 Participants Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	0.541 ng/mL Standard Deviation 1.11	3.93 ng/mL Standard Deviation 1.83	4.98 ng/mL Standard Deviation 1.60

Adverse Events

Placebo - Treatment Phase

Serious events: 5 serious events

Other events: 150 other events

Deaths: 0 deaths

Galcanezumab 120mg - Treatment Phase

Serious events: 5 serious events

Other events: 78 other events

Deaths: 0 deaths

Galcanezumab 240mg - Treatment Phase

Serious events: 7 serious events

Other events: 87 other events

Deaths: 0 deaths

Placebo - Post-treatment Phase

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Galcanezumab 120mg - Post-treatment Phase

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Galcanezumab 240mg - Post-treatment Phase

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo - Treatment Phase ME2

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Galcanezumab 120mg - Treatment Phase ME2

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Galcanezumab 240mg - Treatment Phase ME2

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo - Post-treatment Phase ME2

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Galcanezumab 120mg - Post-treatment Phase ME2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Galcanezumab 240mg - Post-treatment Phase ME2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo - Treatment Phase n=461 participants at risk Participants received placebo subcutaneously once a month for 6 months.	Galcanezumab 120mg - Treatment Phase n=226 participants at risk Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.	Galcanezumab 240mg - Treatment Phase n=228 participants at risk Participants received 240mg galcanezumab subcutaneously once a month for 6 months.	Placebo - Post-treatment Phase n=410 participants at risk Participants didn't receive any intervention.	Galcanezumab 120mg - Post-treatment Phase n=212 participants at risk Participants didn't receive any intervention.	Galcanezumab 240mg - Post-treatment Phase n=208 participants at risk Participants didn't receive any intervention.	Placebo - Treatment Phase ME2 n=30 participants at risk Participants received placebo subcutaneously once a month for 6 months.	Galcanezumab 120mg - Treatment Phase ME2 n=14 participants at risk Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.	Galcanezumab 240mg - Treatment Phase ME2 n=20 participants at risk Participants received 240mg galcanezumab subcutaneously once a month for 6 months.	Placebo - Post-treatment Phase ME2 n=25 participants at risk Participants didn't receive any intervention.	Galcanezumab 120mg - Post-treatment Phase ME2 n=14 participants at risk Participants didn't receive any intervention.	Galcanezumab 240mg - Post-treatment Phase ME2 n=20 participants at risk Participants didn't receive any intervention.
Cardiac disorders Acute myocardial infarction	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Endocrine disorders Goitre	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Gastritis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Haemorrhoids	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Rectal polyp	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Pyrexia	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Hepatobiliary disorders Gallbladder polyp	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Appendicitis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Influenza	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Pyelonephritis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Urosepsis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Foot fracture	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Rib fracture	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Road traffic accident	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.3% 1/30 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the cervix	0.00% 0/393 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.52% 1/192 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/196 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/349 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/179 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/181 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/18 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/393 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/192 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/196 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/349 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.56% 1/179 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/181 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/18 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Headache	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Migraine	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Transient ischaemic attack	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Psychiatric disorders Disorientation	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Psychiatric disorders Panic attack	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Psychiatric disorders Suicide attempt	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Renal and urinary disorders Bladder dysfunction	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.

Other adverse events

Measure	Placebo - Treatment Phase n=461 participants at risk Participants received placebo subcutaneously once a month for 6 months.	Galcanezumab 120mg - Treatment Phase n=226 participants at risk Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.	Galcanezumab 240mg - Treatment Phase n=228 participants at risk Participants received 240mg galcanezumab subcutaneously once a month for 6 months.	Placebo - Post-treatment Phase n=410 participants at risk Participants didn't receive any intervention.	Galcanezumab 120mg - Post-treatment Phase n=212 participants at risk Participants didn't receive any intervention.	Galcanezumab 240mg - Post-treatment Phase n=208 participants at risk Participants didn't receive any intervention.	Placebo - Treatment Phase ME2 n=30 participants at risk Participants received placebo subcutaneously once a month for 6 months.	Galcanezumab 120mg - Treatment Phase ME2 n=14 participants at risk Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months subcutaneously.	Galcanezumab 240mg - Treatment Phase ME2 n=20 participants at risk Participants received 240mg galcanezumab subcutaneously once a month for 6 months.	Placebo - Post-treatment Phase ME2 n=25 participants at risk Participants didn't receive any intervention.	Galcanezumab 120mg - Post-treatment Phase ME2 n=14 participants at risk Participants didn't receive any intervention.	Galcanezumab 240mg - Post-treatment Phase ME2 n=20 participants at risk Participants didn't receive any intervention.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 5/461 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.8% 4/226 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/228 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.94% 2/212 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	6.7% 2/30 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Abdominal pain upper	0.65% 3/461 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.8% 4/226 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/228 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Nausea	3.3% 15/461 • Number of events 15 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.8% 4/226 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/228 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Gastrointestinal disorders Vomiting	0.87% 4/461 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/228 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site pain	8.5% 39/461 • Number of events 142 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	9.3% 21/226 • Number of events 100 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	8.8% 20/228 • Number of events 61 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
General disorders Injection site reaction	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.1% 7/226 • Number of events 17 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.9% 18/228 • Number of events 25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	15.0% 3/20 • Number of events 12 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Cystitis	1.1% 5/461 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/226 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/228 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Hordeolum	0.43% 2/461 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Influenza	3.0% 14/461 • Number of events 16 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/226 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.9% 9/228 • Number of events 9 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.2% 5/410 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.47% 1/212 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	6.7% 2/30 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Nasopharyngitis	8.9% 41/461 • Number of events 49 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	8.4% 19/226 • Number of events 23 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.0% 16/228 • Number of events 21 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.4% 18/410 • Number of events 19 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	2.4% 5/212 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.9% 4/208 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.3% 1/30 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	14.3% 2/14 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	10.0% 2/20 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Pharyngitis	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.49% 2/410 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.47% 1/212 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	6.7% 2/30 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Rhinitis	0.87% 4/461 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/226 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.47% 1/212 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Upper respiratory tract infection	3.5% 16/461 • Number of events 19 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	5.8% 13/226 • Number of events 14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	5.3% 12/228 • Number of events 12 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.73% 3/410 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.9% 4/212 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.96% 2/208 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	6.7% 2/30 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	21.4% 3/14 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	5.0% 1/20 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Vaginal infection	0.00% 0/393 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.0% 2/192 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.51% 1/196 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.57% 2/349 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/179 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/181 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/18 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Infections and infestations Vulvovaginitis	0.25% 1/393 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/192 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/196 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/349 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/179 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/181 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/18 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Contusion	0.65% 3/461 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/228 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	10.0% 2/20 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Injury, poisoning and procedural complications Muscle strain	0.22% 1/461 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/226 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Back pain	4.3% 20/461 • Number of events 24 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/226 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	2.2% 5/228 • Number of events 5 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.98% 4/410 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.94% 2/212 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.3% 1/30 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	14.3% 2/14 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/461 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.44% 1/228 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.24% 1/410 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Dizziness	2.2% 10/461 • Number of events 12 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.5% 8/226 • Number of events 10 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	3.1% 7/228 • Number of events 7 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Nervous system disorders Hypoaesthesia	0.43% 2/461 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/226 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.88% 2/228 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/410 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	4.0% 1/25 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Psychiatric disorders Insomnia	1.7% 8/461 • Number of events 9 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/226 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/228 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.73% 3/410 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/208 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/30 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.1% 1/14 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	5.0% 1/20 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/393 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/192 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/196 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/349 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.56% 1/179 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/181 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/22 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	7.7% 1/13 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/18 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/13 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 9/461 • Number of events 9 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.8% 4/226 • Number of events 4 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	1.3% 3/228 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.49% 2/410 • Number of events 2 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/212 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.48% 1/208 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	6.7% 2/30 • Number of events 3 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	5.0% 1/20 • Number of events 1 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/25 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/14 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.	0.00% 0/20 • Up to 10 Months There were 5 participants in Galcanezumab 120mg treatment phase, 1 participant in Galcanezumab 120mg post- treatment , 1 participant in Galcanezumab 120 mg treatment phase ME2 \& 1 participant in Galcanezumab 120mg post-treatment ME2 arms who discontinued after receiving loading dose of 240mg, these participants were included in Galcanezumab 240mg Treatment, Post Treatment \& equivalent ME2 arms for adverse event reporting. Per protocol, AE analysis was planned per treatment regimen received.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place