MMRM longitudinal analysis.
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SENSITIVITY
Results of the non-weighted and weighted MMRM analyses with the estimation of the effect sizes. The LS mean (± standard error) of the longitudinal HAMD-17 total score changes from baseline are presented by treatment.A sensitivity analysis was conducted to evaluate the impact of the excessively high and excessively low propensity to a PE on the estimated TE with and without the use of a propensity weight in the MMRM analysis. Three analyses were conducted with and without propensity weight by (i) removing the subjects with high probability of a PE (Prob > 0.8), (ii) removing the subjects with very low probability of a PE (Prob < 0.1), and (iii) including all subjects. The results of the analyses are presented in Table Sensitivity analysis results to evaluate the impact of the excessively high and excessively low propensity to a placebo effect on the estimated TE with and without a propensity weigh in the MMRM analysis.The analysis with and without propensity weight indicated that the weighted analysis provided an estimate of TE and an effect-size about twice larger than the non-weighted analysis. In this analysis: (i) the TE increased when the subject with high probability of a PE were removed, and (ii) the TE decreased when the subject with low probability of a PE were removed. These findings are consistent with the expected effect of low/high placebo response on the estimated/estimable TE.The % absolute deviation from the TE (i.e., bias) estimated in the total population (all data) and in population without subjects with high (Prob > 0.8) and with low (Prob < 0.2) probability of a PE was estimated and compared in the propensity weighted and non-weighted analyses (Fig. 