Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SENSITIVITY
Where data are missing for the primary outcome (MANSA at 6 months), individual level single imputations in which missing values are replaced by a fixed value following a predetermined rule will be used. The conditions in which imputation will occur will be specified in the statistical analysis plan, including circumstances where data would not be imputed (for example, the patient is deceased). Sensitivity analyses will be conducted to assess the impact of missing data under reasonable assumptions about the behaviour of those lost to follow-up. In each case, analysis will be carried out on the subset of participants for whom the outcome in question has been recorded and model estimates compared against analogous estimates from the imputation analysis to ascertain the impact of loss to follow-up in this study.