Efficacy Analyses. Efficacy analyses will be performed on the Efficacy Analysis Set. The primary endpoint, the incidence rate of laboratory confirmed influenza using RT-PCR on nasal swab samples, will be compared between vaccine groups using Xxxxxx’x Exact Test. Secondary efficacy endpoints assessing the incidence and severity of influenza-like symptoms will be performed by comparing the incidence of ILI (using the regulatory definition of ILI defined as feeling feverish or having a fever (temperature ≥37.8 C) and at least one of the following symptoms: a cough, and/or sore throat) by Xxxxxx’x test exact and symptom severity as an area-under-the- curve (AUC) using a Xxxx-Xxxxxxx U Test.
Efficacy Analyses. This study defines one primary endpointevaluations will use the FAS as the prima All efficacy ry analysis set. For all planned inferential analyses, alternative models/methods may be considered if convergence cannot be achieved.
Efficacy Analyses. Similar to those methods described for the primary endpoint in Section 14.5, MMRM will be used for the analysis of the following variables: changes from baseline in MADRS total score, HAM-A total score, , and select individual item and subscale scores. For each model, the comparison of interest will be between SAGE-217 capsule and placebo at the 15-day time point. Model-based point estimates (ie, LS means), 95% confidence intervals, and p-values will be reported. Generalized estimating equation (GEE) methods will be used for the analysis of the following binary variables: HAM-D response (define as ≥50% reduction from baseline in HAM-D total score), HAM-D remission (defined as ≤7.0 HAM-D total score), and CGI-I response. Generalized estimating equation models will include terms for center, treatment, baseline score, assessment time point, and time point-by-treatment as explanatory variables. The comparison of interest will be the difference between SAGE-217 Capsules and placebo at the 15-day time point. Model-based point estimates (ie, odds ratios), 95% confidence intervals, and p-values will be reported. For the CGI-I response analysis, baseline CGI-S score will be included in the model. Descriptive statistics for all scores, change from baseline values, and response variables will be presented by treatment and assessment time point. Summaries will include n, mean, SD, median, minimum, and maximum.
Efficacy Analyses. Unless stated otherwise, all efficacy analyses will compare post-treatment assessment values to the subject’s corresponding baseline assessment value.
Efficacy Analyses. Statistical analysis of efficacy endpoints will be for descriptive purposes only. Nominal p-values will be based on statistical tests will be 2-sided hypothesis tests performed at the 10% level of significance for main effects. All confidence intervals will be 2-sided 90% confidence intervals, unless stated otherwise. When summarizing diary data by visit, including weekly response endpoints, only the data from the 7 days prior to the subject’s clinic visit will be included.
