Table 3.
Time to retreatmenta
| Treatment cycle duration | Double-blind period | Open-label period | |
|---|---|---|---|
| Cycle 1 (N = 326) | Cycle 2 (N = 465) | Cycle 3 (N = 385) | |
| Median (95% CI) treatment cycle duration, daysb | 140.0 (134.0; 147.0) | 146.0 (140.0; 164.0) | 139.0 (133.0; 140.0) |
aFor each treatment cycle, the duration (time to retreatment) was calculated as the time between injection of current cycle and the first injection into next cycle. For a given cycle, if a patient discontinued with no retreatment, this patient was censored at the date of discontinuation for that cycle. bThe median and 95% CI are presented using Kaplan–Meier estimate. Data are shown for all randomized patients who received aboBoNT-A 50 U in at least one injection site regardless of the amount administered (safety population). Data for cycle 4 have not been included, as this cycle was shorter, reflecting the fact that these patients had completed 15 months of treatment (from the start of the double-blind period), thus completing the study. The duration of cycle 5 was not included since all patients had completed the study by day 85 of cycle 5.
AboBoNT-A = abobotulinumtoxinA; CI = confidence interval; U = unit