Statistical analysis
CERVICAL INTRAEPITHELIAL NEOPLASIA, CIN 1, HSIL, REGRESSION, EVENTS, HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION
The study was designed to have 80% power to detect a 30%, 20%, and 10% difference in the rates of pathological complete regression or complete regression plus partial regression between high-, intermediate-, low-dose, and placebo groups, respectively. Because spontaneous regression to normal or CIN 1 with placebo was estimated at 10%, at least 12 outcome events were required in the high-dose group for the study to be conclusive; we aimed to include 40 patients for each group (Baseline demographics and other characteristics in patients of full analysis setCIN = cervical intraepithelial neoplasia; HPV = human papillomavirus; HSIL = high-grade squamous intraepithelial lesion; IQR = interquartile range.