TABLE 1.
Change From Baseline in Lip Fullness* at 8 Weeks After Last Injection
| HARK (N = 183†/176‡) | Control (N = 87†/85‡) | |
| Upper lip | ||
| Mean (SD) | 1.8 (0.98)† | 1.7 (0.90)† |
| 1.8 (0.96)‡ | 1.7 (0.91)‡ | |
| 95% CI mean of (control—HARK) | (−0.31, 0.18)† | |
| (−0.32, 0.17)‡ | ||
| Lower lip | ||
| Mean (SD) | 1.8 (0.98)† | 1.8 (0.85)† |
| 1.8 (0.98)‡ | 1.8 (0.86)‡ | |
| 95% CI mean of (control—HARK) | (−0.32, 0.16)† | |
| (−0.30, 0.19)‡ |
Blinded Evaluator live assessment of upper and lower lip MLFS score.
ITT.
PP.
CI, confidence interval; ITT, intention-to-treat population; MLFS, medicis lip fullness scale; PP, per protocol population.