AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines

Primary outcomes

1. Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7

   Time frame: Baseline (Day 1) through Day 7

   Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.

2. Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.

3. Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.

4. Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.

5. Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention

   Time frame: From first dose of study drug until the end of study (up to 42 days)

   Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: > 500 msec or change from baseline value: increase of > 60 msec; QTcF observed value: > 500 msec or change from baseline value: increase of > 60 msec.

6. Number of Participants With Anti-drug Antibodies (ADAs)

   Time frame: Up to Day 42

   Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.