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Adverse Events Occurring ≥5% of Subjects in Any Treatment Group
| MedDRA Preferred Term | TOL-463 Vaginal Gel (n = 55) | TOL-463 Vaginal Insert (n = 49) | All Subjects (n = 104) | Treatment Related Only |
|---|---|---|---|---|
| Headache | 1 (2) | 4 (8) | 5 (5) | 2 (2) |
| Vulvovaginal burning sensation | 5 (9) | 5 (10) | 10 (10) | 10 (10) |
| Vulvovaginal pruritus | 4 (7) | 3 (6) | 7 (7) | 7 (7) |
Data are presented as No. (%).
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.
