Analysis plan
REGRESSION
Study data will be examined and summarized by descriptive statistics including median, mean, and standard deviation for quantitative variables and by frequencies and proportions for categorical ones. All variables of interest will be summarized for the whole sample, by clinic sites, and by study arms. We will control for baseline covariates and use either logistic or linear regression models, depending on the type of outcome variable. Graphic displays, such as boxplots and histograms, will be used to inspect skewness and normality for quantitative variables and to identify possible outliers. All randomized subjects will be included and the intention to treat principle will be applied.Missing data will be handled using multiple imputation techniques that assume data are missing at random [