Figure 3.

Primary endpoint ITT analysis

(A) Whole group ITT analysis (n=37) irrespective of treatment assignment order using adjusted means from crossover analysis with 95% CIs: percentage change in hot flush frequency (total number of hot flushes) during the final week of the 4 week treatment period with MLE4901 and placebo compared with hot flush frequency (total number of hot flushes) during the final week of the 2 week baseline period. Statistical analysis incorporated a total of seven daily counts for each of the study weeks analysed, and is based on a crossover model including treatment and period as fixed effects, subject as a random effect (within sequence), and baseline flush count as a covariate. All other possible demographic covariates were tested in the model but none were significant and therefore all were excluded from the final model. The model used is a generalised linear model with gamma error structure. Tests for sequence (order), and period, effect across all our models confirmed neither were significant. (B) Subgroup ITT analysis (n=37) by treatment assignment group using participants' unadjusted (raw) data with 95% CIs: percentage change in hot flush frequency (total number of hot flushes) during the final week of the 4 week treatment period with MLE4901 and placebo compared with hot flush frequency (total number of hot flushes) during the final week of the 2 week baseline period depending on whether the participant received MLE4901 or placebo as the first or second intervention. ITT=intention to treat.