Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SENSITIVITY
Medical adherence will be defined by patient diary (see main protocol section 5.10). Adherent patients will be analysed within the adherent set. For the primary analysis, missing values will be considered treatment failures in the composite primary endpoint. Additionally, meaningful missing values will be imputed by statistical models for the data according to the underlying mechanism of missing data. Sensitivity analyses will be performed for imputed data.