Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
We plan to apply multiple imputation to impute missing outcome data, using comprehensive imputation models that include both non-missing measurements from the variables included in the data analysis as well as additional auxiliary variables that are considered to be predictive either of the risk of missingness or the values of the variables whose missing values are being imputed. The multiple imputation approach has been established as superior to alternatives, including complete case analysis or simplified ad hoc single imputation approaches [