136 Chapter 6 The primary endpoint is change in MMD from baseline to the last 4 weeks of treatment (weeks 9-12). Group differences (ethinylestradiol/levonorgestrel 30/150 μg versus vitamin E 400IU) will be analysed using a mixed-effects model of repeated measures with patients’ baseline value and treatment as fixed effects and patients as random effects. Secondary continuous efficacy endpoints will be analysed using a linear mixed-effects model including appropriate terms and covariates. The adjusted mean change from baseline for each treatment group, associated 95% confidence intervals, and p-values will be reported. Dichotomous endpoints derived from corresponding continuous endpoints will be analysed with stratified Cochran-Mantel-Haenszel tests. For dichotomous efficacy endpoints, adjusted odds ratios for ethinylestradiol/ levonorgestrel compared with vitamin E, associated 95% confidence intervals, and p-values will be reported. The primary end point and continuous secondary end points will be analyzed without any imputation of missing data. Sensitivity analyses will be conducted with imputation under missing-at-random or missing-not-atrandom assumptions. The data analyst will be blinded. Safety analysis will include all participants who received at least one dose of study drug. AEs and SAEs will be coded and summarized by Medical Dictionary for Regulatory Activities. All adverse events will be documented.
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