Trial Outcomes & Findings for A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines (NCT NCT05248867)

Results Overview

\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

638 participants

Primary outcome timeframe

Baseline, Day 7 (Double-blind period)

Results posted on

2024-05-24

Participant Flow

A total of 638 participants with moderate to severe glabellar lines (GL) at maximum frown were enrolled and randomized in a 3:1 ratio to receive either AGN-151586 or placebo in the Double-blind Period. For those meeting all the retreatment criteria on Day 43, a single open-label treatment with AGN-151586 was administered on the same day.

Participant milestones

Participant milestones
Measure	Placebo Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Double-blind Period STARTED	156	482	0	0	0	0
Double-blind Period COMPLETED	148	454	0	0	0	0
Double-blind Period NOT COMPLETED	8	28	0	0	0	0
Open-label Period STARTED	0	0	3	145	17	437
Open-label Period COMPLETED	0	0	0	143	0	426
Open-label Period NOT COMPLETED	0	0	3	2	17	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Double-blind Period Lost to Follow-up	0	3	0	0	0	0
Double-blind Period Withdrawal by Subject	5	14	0	0	0	0
Double-blind Period Withdrawal by Subject due to Adverse Event	0	3	0	0	0	0
Double-blind Period Other, not specified	3	8	0	0	0	0
Open-label Period Withdrawal by Subject	0	0	3	1	7	9
Open-label Period Withdrawal by Subject due to Adverse Event	0	0	0	1	0	0
Open-label Period Lost to Follow-up	0	0	0	0	5	2
Open-label Period COVID-19 Infection	0	0	0	0	1	0
Open-label Period Other, not specified	0	0	0	0	4	0

Baseline Characteristics

A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Total n=638 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 12.48 • n=5 Participants	47.1 years STANDARD_DEVIATION 12.75 • n=7 Participants	47.2 years STANDARD_DEVIATION 12.68 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	429 Participants n=7 Participants	566 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	53 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	49 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants	433 Participants n=7 Participants	575 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	21 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants	432 Participants n=7 Participants	574 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 0 = None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 1 = Mild	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 2 = Moderate	41 Participants n=5 Participants	149 Participants n=7 Participants	190 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Participant 3 = Severe	114 Participants n=5 Participants	330 Participants n=7 Participants	444 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 0 = None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 1 = Mild	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 2 = Moderate	41 Participants n=5 Participants	149 Participants n=7 Participants	190 Participants n=5 Participants
Facial Wrinkle Scale (FWS) at Maximum Frown - Investigator 3 = Severe	114 Participants n=5 Participants	331 Participants n=7 Participants	445 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 7 (Double-blind period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Primary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]	0.6 percentage of participants Interval 0.0 to 1.9	60.0 percentage of participants Interval 55.5 to 64.4	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 7 (Double-blind period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]	0.8 percentage of participants Interval 0.0 to 2.3	61.0 percentage of participants Interval 55.9 to 66.0	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Primary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Day 7 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]	0.8 percentage of participants Interval 0.0 to 2.3	72.1 percentage of participants Interval 67.5 to 76.7	—	—	—	—

PRIMARY outcome

Timeframe: From time of informed consent to end of study; median time on follow-up was 85 days for Double-blind Placebo, AGN-151586, Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for Placebo/None group, and 53 days for AGN-151586/None group

Population: Safety population: all participants who were treated with at least 1 dose of study drug. All safety analyses were performed with participants analyzed by their actual treatment received in the DB period/OL period.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None n=3 Participants Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 n=145 Participants Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None n=17 Participants Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 n=437 Participants Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Number of Participants With Adverse Events TESAE	1 participants	3 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With Adverse Events Any TEAE	44 participants	118 participants	0 participants	32 participants	0 participants	90 participants

SECONDARY outcome

Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] Percentage of participants achieving a Grade 0 or 1 (none or mild) and a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to both investigator and participant assessments of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 24	0.6 percentage of participants Interval 0.0 to 1.9	30.4 percentage of participants Interval 26.3 to 34.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 36	0.6 percentage of participants Interval 0.0 to 1.9	43.2 percentage of participants Interval 38.7 to 47.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 48	0.6 percentage of participants Interval 0.0 to 1.9	50.1 percentage of participants Interval 45.6 to 54.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 7	0.6 percentage of participants Interval 0.0 to 1.9	60.0 percentage of participants Interval 55.5 to 64.4	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 14	0.0 percentage of participants Interval 0.0 to 0.0	25.3 percentage of participants Interval 21.4 to 29.2	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 21	0.0 percentage of participants Interval 0.0 to 0.0	2.7 percentage of participants Interval 1.3 to 4.2	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 28	0.0 percentage of participants Interval 0.0 to 0.0	0.2 percentage of participants Interval 0.0 to 0.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 8	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 4.8 to 9.3	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 12	0.6 percentage of participants Interval 0.0 to 1.9	15.9 percentage of participants Interval 12.6 to 19.2	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 35	0.0 percentage of participants Interval 0.0 to 0.0	0.4 percentage of participants Interval 0.0 to 1.0	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Participant Assessments of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 43	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 8	1.3 percentage of participants Interval 0.0 to 3.0	11.0 percentage of participants Interval 8.2 to 13.8	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 24	0.6 percentage of participants Interval 0.0 to 1.9	37.4 percentage of participants Interval 33.1 to 41.8	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 7	0.6 percentage of participants Interval 0.0 to 1.9	72.6 percentage of participants Interval 68.6 to 76.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 28	0.0 percentage of participants Interval 0.0 to 0.0	1.3 percentage of participants Interval 0.3 to 2.2	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 35	0.0 percentage of participants Interval 0.0 to 0.0	0.4 percentage of participants Interval 0.0 to 1.0	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 43	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 12	0.7 percentage of participants Interval 0.0 to 2.0	20.2 percentage of participants Interval 16.6 to 23.8	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 36	0.7 percentage of participants Interval 0.0 to 2.0	53.1 percentage of participants Interval 48.6 to 57.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 48	0.6 percentage of participants Interval 0.0 to 1.9	62.2 percentage of participants Interval 57.9 to 66.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 14	0.0 percentage of participants Interval 0.0 to 0.0	32.3 percentage of participants Interval 28.1 to 36.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 21	0.0 percentage of participants Interval 0.0 to 0.0	5.2 percentage of participants Interval 3.2 to 7.3	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] Percentage of participants with a Grade 0 or 1 (none or mild) and at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 8	0.0 percentage of participants Interval 0.0 to 0.0	8.1 percentage of participants Interval 5.7 to 10.5	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 12	0.7 percentage of participants Interval 0.0 to 2.0	18.5 percentage of participants Interval 15.0 to 22.0	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 24	0.6 percentage of participants Interval 0.0 to 1.9	32.1 percentage of participants Interval 27.9 to 36.3	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 36	0.6 percentage of participants Interval 0.0 to 1.9	44.4 percentage of participants Interval 40.0 to 48.9	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Hour 48	1.9 percentage of participants Interval 0.0 to 4.1	51.8 percentage of participants Interval 47.3 to 56.3	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 7	0.6 percentage of participants Interval 0.0 to 1.9	63.3 percentage of participants Interval 58.9 to 67.6	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 14	0.0 percentage of participants Interval 0.0 to 0.0	29.8 percentage of participants Interval 25.6 to 34.0	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 21	0.0 percentage of participants Interval 0.0 to 0.0	4.2 percentage of participants Interval 2.4 to 6.1	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 28	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.7 to 3.1	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 35	1.3 percentage of participants Interval 0.0 to 3.0	1.2 percentage of participants Interval 0.3 to 2.2	—	—	—	—
Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown Over Time [US FDA] Day 43	0.0 percentage of participants Interval 0.0 to 0.0	0.8 percentage of participants Interval 0.0 to 1.7	—	—	—	—

SECONDARY outcome

Timeframe: Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Day 7 [US FDA]	5.1 percentage of participants Interval 1.7 to 8.6	77.6 percentage of participants Interval 73.9 to 81.4	—	—	—	—

SECONDARY outcome

Timeframe: Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [United States FDA]	17.3 percentage of participants Interval 11.4 to 23.2	59.2 percentage of participants Interval 54.8 to 63.6	—	—	—	—

SECONDARY outcome

Timeframe: Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized. Multiple imputation was used for missing data.

\[Secondary endpoint for the United States FDA\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=156 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [US FDA]	9.0 percentage of participants Interval 4.5 to 13.5	78.5 percentage of participants Interval 74.8 to 82.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50 were included. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 20-point Improvement From Baseline in FLO-11 Total Scores for GL at Day 7 [European Union Regulatory Agencies]	8.5 percentage of participants Interval 3.7 to 13.2	66.6 percentage of participants Interval 61.8 to 71.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]	0.8 percentage of participants Interval 0.0 to 2.3	30.9 percentage of participants Interval 26.2 to 35.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 during the Double-Blind Period are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]	0.8 percentage of participants Interval 0.0 to 2.3	36.5 percentage of participants Interval 31.5 to 41.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Participant Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]	11.5 percentage of participants Interval 6.0 to 17.0	64.1 percentage of participants Interval 59.2 to 69.1	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with a ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown at Hour 24 are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 1-grade Improvement From Baseline on FWS According to Investigator Assessment of GL Severity at Maximum Frown at Hour 24 [European Union Regulatory Agencies]	13.8 percentage of participants Interval 7.9 to 19.8	72.5 percentage of participants Interval 67.9 to 77.1	—	—	—	—

SECONDARY outcome

Timeframe: Hour 24 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL at Hour 24 [European Union Regulatory Agencies]	16.2 percentage of participants Interval 9.8 to 22.5	58.7 percentage of participants Interval 53.6 to 63.7	—	—	—	—

SECONDARY outcome

Timeframe: Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their satisfaction with natural look using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 4 (Natural Look) for GL at Day 7 [European Union Regulatory Agencies]	7.7 percentage of participants Interval 3.1 to 12.3	77.7 percentage of participants Interval 73.3 to 82.0	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Day 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50.

\[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥ 1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Time to the First ≥ 1-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]	41.9 days Interval 0.0 to 69.0	1.0 days Interval 0.0 to 45.0	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Day 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50.

\[Secondary endpoint for European Union regulatory agencies\] Time to the first ≥1-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown is reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who did not improve at least 1 grade from Baseline, censoring occurred at the latest visit during the treatment period for which FWS data were available.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Time to the First ≥1-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown [European Union Regulatory Agencies]	41.0 days Interval 0.0 to 69.0	0.7 days Interval 0.0 to 45.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to participant assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 8	0.0 percentage of participants Interval 0.0 to 0.0	7.6 percentage of participants Interval 4.9 to 10.3	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 12	0.8 percentage of participants Interval 0.0 to 2.3	17.7 percentage of participants Interval 13.8 to 21.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 24	0.8 percentage of participants Interval 0.0 to 2.3	30.9 percentage of participants Interval 26.2 to 35.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 36	0.8 percentage of participants Interval 0.0 to 2.3	44.0 percentage of participants Interval 38.9 to 49.1	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 48	2.3 percentage of participants Interval 0.0 to 4.9	50.1 percentage of participants Interval 45.0 to 55.3	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 7	0.8 percentage of participants Interval 0.0 to 2.3	61.0 percentage of participants Interval 55.9 to 66.0	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 14	0.0 percentage of participants Interval 0.0 to 0.0	30.5 percentage of participants Interval 25.6 to 35.3	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 21	0.0 percentage of participants Interval 0.0 to 0.0	4.6 percentage of participants Interval 2.4 to 6.9	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 28	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.5 to 3.3	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 35	1.5 percentage of participants Interval 0.0 to 3.7	1.4 percentage of participants Interval 0.2 to 2.5	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Participant Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 43	0.0 percentage of participants Interval 0.0 to 0.0	0.8 percentage of participants Interval 0.0 to 1.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hours 8, 12, 24, 36, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] Percentage of participants with at least a 2-grade improvement from Baseline on the Facial Wrinkle Scale (FWS) according to investigator assessment of glabellar lines (GL) severity at maximum frown over time are reported. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 21	0.0 percentage of participants Interval 0.0 to 0.0	5.4 percentage of participants Interval 3.0 to 7.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 8	1.5 percentage of participants Interval 0.0 to 3.7	10.9 percentage of participants Interval 7.7 to 14.1	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 12	0.8 percentage of participants Interval 0.0 to 2.3	18.6 percentage of participants Interval 14.5 to 22.6	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 24	0.8 percentage of participants Interval 0.0 to 2.3	36.5 percentage of participants Interval 31.5 to 41.4	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 36	0.8 percentage of participants Interval 0.0 to 2.3	53.3 percentage of participants Interval 48.1 to 58.4	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 48	0.8 percentage of participants Interval 0.0 to 2.3	61.7 percentage of participants Interval 56.6 to 66.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 7	0.8 percentage of participants Interval 0.0 to 2.3	72.1 percentage of participants Interval 67.5 to 76.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 14	0.0 percentage of participants Interval 0.0 to 0.0	32.8 percentage of participants Interval 27.9 to 37.7	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 28	0.0 percentage of participants Interval 0.0 to 0.0	1.1 percentage of participants Interval 0.0 to 2.2	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 35	0.0 percentage of participants Interval 0.0 to 0.0	0.3 percentage of participants Interval 0.0 to 0.8	—	—	—	—
Percentage of Participants With ≥2-grade Improvement From Baseline on the FWS According to Investigator Assessment of GL Severity at Maximum Frown Over Time [European Union Regulatory Agencies] Day 43	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Day 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants who did not meet the responder definition on Day 7 were excluded from the analysis; analysis was limited to those that responded.

\[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to participant assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=251 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Time to Return to Baseline FWS According to Participant Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]	28.0 days Interval 15.0 to 43.0	21.0 days Interval 8.0 to 50.0	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Day 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants who did not meet the responder definition on Day 7 were excluded from the analysis; analysis was limited to those that responded.

\[Secondary endpoint for European Union regulatory agencies\] Time to return to Baseline (Baseline criterion of Moderate or Severe) on the Facial Wrinkle Scale (FWS) according to investigator assessment of FWS at maximum frown after achieving responder definition on Day 7 is reported. Responder definition was a rating of None or Mild on the FWS. Assessments were performed using the 4-grade Facial Wrinkle Scale (FWS), where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. For those who maintained their response, censoring occurred at the latest visit during the treatment period for which FWS was available.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=280 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Time to Return to Baseline FWS According to Investigator Assessment of FWS at Maximum Frown After Achieving Responder Definition on Day 7 [European Union Regulatory Agencies]	15.0 days Interval 15.0 to 15.0	21.0 days Interval 8.0 to 50.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Hours 8, 24, and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The FLSQ is a validated measure that assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the participant perspective. Participants assessed their overall satisfaction with their glabellar lines using a 5-point verbal descriptor scale (VDS): very dissatisfied, mostly dissatisfied, neither dissatisfied nor satisfied, mostly satisfied, and very satisfied. The percentage of participants mostly satisfied or very satisfied is reported. Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Hour 8	14.3 percentage of participants Interval 8.2 to 20.4	33.1 percentage of participants Interval 28.3 to 38.0	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Hour 24	16.2 percentage of participants Interval 9.8 to 22.5	58.7 percentage of participants Interval 53.6 to 63.7	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Hour 48	8.5 percentage of participants Interval 3.7 to 13.2	71.4 percentage of participants Interval 66.7 to 76.0	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 7	4.6 percentage of participants Interval 1.0 to 8.3	76.9 percentage of participants Interval 72.5 to 81.2	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 14	5.8 percentage of participants Interval 1.7 to 10.0	69.9 percentage of participants Interval 65.1 to 74.7	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 21	2.5 percentage of participants Interval 0.0 to 5.2	61.4 percentage of participants Interval 56.3 to 66.5	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 28	4.7 percentage of participants Interval 0.9 to 8.4	56.1 percentage of participants Interval 50.9 to 61.2	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 35	3.8 percentage of participants Interval 0.5 to 7.2	58.3 percentage of participants Interval 53.2 to 63.4	—	—	—	—
Percentage of Participants With Achievement of Mostly Satisfied or Very Satisfied on the Facial Lines Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 (Overall Satisfaction) for GL Over Time [European Union Regulatory Agencies] Day 43	4.8 percentage of participants Interval 1.1 to 8.6	58.1 percentage of participants Interval 52.9 to 63.4	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 10 (Look Angry). Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=124 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=353 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 10 (Look Angry) for GL at Day 7 [European Union Regulatory Agencies]	5.6 percentage of participants Interval 1.6 to 9.7	54.5 percentage of participants Interval 49.2 to 59.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 7 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, and a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Participants with a score that could improve at least 4 points from Baseline were included. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The Facial Lines Outcomes (FLO-11) Questionnaire is an 11-item validated measure that assesses appearance-related psychological impacts of glabellar lines (GL) from the participant's perspective. Items 1-10 are assessed on an 11-point numeric rating scale that ranges from 0 (Not at all) to 10 (Very much), with higher scores indicating negative impact. Item 11 is scored in the reverse direction. Participants answered FLO-11 Item 5 (Look Less Attractive). Percentages are rounded off to nearest single decimal.

Outcome measures

Outcome measures
Measure	Placebo n=128 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=362 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Percentage of Participants With a ≥ 4-point Improvement From Baseline in FLO-11 Item 5 (Look Less Attractive) for GL at Day 7 [European Union Regulatory Agencies]	3.9 percentage of participants Interval 0.5 to 7.3	48.1 percentage of participants Interval 42.9 to 53.3	—	—	—	—

SECONDARY outcome

Timeframe: Hours 24 and 48, Days 7, 14, 21, 28, 35, and 43 (Double-blind Period)

Population: Intent-to-Treat (ITT) Population: all randomized participants, analyzed according to the treatment groups to which they were randomized, with a Baseline Facial Lines Outcome (FLO-11) total score (transformed) of ≤50. Multiple imputation was used for missing data.

\[Secondary endpoint for European Union regulatory agencies\] The GAC-GL Questionnaire assesses the appearance of the participant's GL "now" in comparison with their perspective before treatment. Participants assessed the change in their glabellar lines at maximum frown using a 7-point verbal descriptor scale (VDS): very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse, ranging from 3 to -3. Positive changes indicate improvement, 0 no change, and negative changes indicate worsening.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=368 Participants Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and\] participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 24	0.2 units on a scale Standard Error 0.10	1.4 units on a scale Standard Error 0.07	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Hour 48	0.1 units on a scale Standard Error 0.09	1.9 units on a scale Standard Error 0.06	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 7	0.1 units on a scale Standard Error 0.08	2.2 units on a scale Standard Error 0.06	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 14	0.1 units on a scale Standard Error 0.10	1.5 units on a scale Standard Error 0.07	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 21	0.1 units on a scale Standard Error 0.10	0.5 units on a scale Standard Error 0.07	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 28	0.1 units on a scale Standard Error 0.10	0.2 units on a scale Standard Error 0.07	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 35	0.1 units on a scale Standard Error 0.10	0.0 units on a scale Standard Error 0.07	—	—	—	—
Mean Global Assessment of Change in Glabellar Lines (GAC-GL) at Maximum Frown Over Time [European Union Regulatory Agencies] Day 43	0.1 units on a scale Standard Error 0.09	0.0 units on a scale Standard Error 0.06	—	—	—	—

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

AGN-151586

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo/None

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/AGN-151586

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

AGN-151586/None

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AGN-151586/AGN-151586

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=156 participants at risk Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 participants at risk Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None n=3 participants at risk Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 n=145 participants at risk Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None n=17 participants at risk Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 n=437 participants at risk Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Infections and infestations APPENDICITIS	0.00% 0/156 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.21% 1/482 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/145 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/437 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.
Infections and infestations PNEUMONIA	0.00% 0/156 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.21% 1/482 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/145 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/437 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.
Infections and infestations PYELONEPHRITIS	0.00% 0/156 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/482 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/145 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.23% 1/437 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/156 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.21% 1/482 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/145 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/437 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INVASIVE DUCTAL BREAST CARCINOMA	0.64% 1/156 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/482 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/145 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/437 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.

Other adverse events

Other adverse events
Measure	Placebo n=156 participants at risk Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43.	AGN-151586 n=482 participants at risk Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43.	Placebo/None n=3 participants at risk Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	Placebo/AGN-151586 n=145 participants at risk Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).	AGN-151586/None n=17 participants at risk Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit.	AGN-151586/AGN-151586 n=437 participants at risk Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84).
Nervous system disorders HEADACHE	5.8% 9/156 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	6.4% 31/482 • Number of events 35 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	5.5% 8/145 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	0.00% 0/17 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.	3.2% 14/437 • Number of events 16 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 85 days for the Double-blind Placebo and AGN-151586 groups as well as the Open-label Placebo/AGN-151586 and AGN-151586/AGN-151586 groups, 50 days for the Placebo/None group, and 53 days for the AGN-151586/None group.

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