A comprehensive description of the randomization process is reported. This should include details about the timing of randomization relative to screening/consent, the random sequence generation process, any concealment of the random generation process, and whether randomization resulted in balanced groups. Minimum, maximum, unadjusted (and adjusted, if applicable) mean, standard deviation and standard error (for adjusted mean), and sample size for each outcome variable (raw scores) are reported per randomized group at each baseline and follow-up time point. For any count outcome variables, the percent of zero observations for the variable is reported per randomized group at each baseline and follow-up time point. For any count outcome variables, the distributional properties of the variable are examined based on descriptive statistics (#2 and #3) and visual inspection of outcome distributions. Histograms, density plots, or other similar graphical tools can be used for visual inspection and reporting of outcome distributions. The mechanisms and assumptions of missing data and handling of missing data are reported. This should include details about the prevalence of missing data, assumptions about the mechanisms behind the missing data, and methods for addressing the missing data in the analysis models (e.g., maximum likelihood estimation and multiple imputations). Report the number of imputed datasets, a list of auxiliary variables used in imputation, and state whether imputations were conducted separately for groups/conditions in the trial. The software programs or packages and their versions used to conduct the analyses are reported.
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