Endpoints and Assessments
treatment-emergent adverse
SECONDARY
The primary efficacy endpoints were the proportion of responders treated with aboBoNT-A at cycle 1, day 29 at maximum frown, as measured by the ILA and SSA to test for superiority compared with placebo, and measured by the ILA to test for non-inferiority compared to active comparator. A responder was defined as having a severity grade of none (0) or mild (1) at maximum frown.The secondary efficacy endpoints included the proportion of responders treated with aboBoNT-A compared with placebo, as evaluated by an independent reviewer’s assessment (IRA) of photographs of the patient’s glabellar lines at maximum frown at cycle 1, day 29 (using a four-point photographic scale, where 0 = none and 3 = severe). The mean subject’s global assessment (SGA) score (nine-point scale from  + 4 [100% improvement] to 0 [no change] to −4 [100% worsening]) at cycle 1, day 29 and the proportion of responders at cycle 1, day 29 with respect to the SGA score (a responder based on the SGA scale was defined as having a grade of at least  + 2 [50% improvement]) were also assessed.Further endpoints in cycle 1 were the proportion of responders measured by the ILA and SSA at maximum frown and by the ILA at rest, and the proportion of responders measured by the SGA score, measured at all study visits except day 29. Additional assessments were the proportion of responders according to the IRA of photographs at day 85; the correlation between the ILA and SSA of glabellar lines at maximum frown at baseline and day 29; the mean change from baseline in the patient’s self-perception of age (categories: ‘Safety endpoints included treatment-emergent adverse events (TEAEs), vital signs, clinical laboratory evaluations, and the presence of BoNT-A antibodies.Results from both the double-blind and open-label phases are presented for patients who received aboBoNT-A, and results from patients who received the active or placebo comparator are limited to baseline, primary endpoint, and safety data.