[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.

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 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.

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.

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.

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.

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.

[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.

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.

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.

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.

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.

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.

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 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.

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] 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.

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.

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.

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.

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.

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.

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] 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.

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.

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] 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.

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.

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] 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.

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.

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] 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.

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 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.

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.

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 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.

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.