Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Missing data frequency and patterns will be studied for the main variables and, if appropriate, multiple imputation techniques will be considered. Unused and spurious data will be excluded from data analysis as soon as it is recognizedAny deviations from the statistical methods explained in the protocol will be described and justified in the final report.The SAP will be reviewed by the DSMB and updated where necessary as a result of interim analyses of the data. A formal record will be kept detailing when the SAP was finalized. It will suffice to update the statistical analysis plan with the considerations suggested from the reviews as well as any protocol amendment.A detailed review of the SAP will also be carried out prior to the study close-out to ensure any protocol amendments have been incorporated. Statistical changes such as rationale for newer or improved analytic methods for the data will be documented