Statistical considerations
(EP)/Late
REGRESSION, RECRUITMENT
Previous studies in menopausal women found a VMS Score of 3 points less than placebo to be a Because no previously powered perimenopausal VMS RCT provided guidance, we performed a pre-planned, blinded, mid-recruitment evaluation of the final VMS Score SD during the 3rd m; we adjusted this SD for its correlation with baseline VMS Score SD. This showed an adjusted SD of 8.0. In consultation with the DSMC, the completing women’s target recruitment increased to 228. We secured funds to extend recruitment for an additional year.Statistical analysis was per Statistical Plan by T Lee under J Singer’s direction. We compared VMS Scores at 1-m intervals between experimental groups using regression analysis adjusted for Early/Late perimenopause (EP/LP) status and average daily baseline VMS Score. The data remained skewed despite transformation; based on normality assumptions, we could not employ linear regression. Due to overly dispersed data, we utilized log-linear negative binomial regression adjusted for EP/LP phases and the log of the average daily baseline VMS Score.We assessed the treatment effect by VMS Score as the ratio of the mean Score between the two experimental groups (Primary analysis was by Intention­to­Treat (ITT). We imputed missing data points using multiple imputation (100 imputations) by a fully conditional specification method with the predictive mean matching option (5 closest observations) to avoid imputing negative values. Variables included in the imputation model were: average baseline and study treatment VMS Score, experimental group, Early (EP)/Late (LP) Perimenopause status“Women’s Perceived Change