Statistical analysis plan
SECONDARY
Analyses will be conducted using an intention-to-treat (ITT) approach, including all participants originally allocated to one of the treatment conditions. To estimate the intervention effect across time, linear mixed models (LMM) will be used for both primary and secondary continuous outcomes, with outcome score at different time-points as the dependent variable and time point indicators and treatment-by-time point indicator interaction terms as independent variables. For dichotomous outcomes, generalized estimating equation (GEE) will be used in order to favor population averaged above subject specific results. The significance threshold will be set at alpha = 0.05 and treatment effects will be evaluated in terms of Cohen’s 