Full integrated statistical analysis plan including cost effectiveness and integration of qualitative and process data

For primary and secondary endpoints, including integration of clinical and health economic findings. This will include dummy tables, figures and listings (TFLs) to be used after the completion of the statistical analyses, processes for handling missing data. The SAP will be written before database consolidation and locking; and no final unblinded statistical analysis will be undertaken until database locking is in accordance with good clinical practice, to avoid outcome reporting bias. Once the TFLs are available according to the statistical analyses performed, they will be assembled in a statistical report to be used for a specific evaluation for primary and secondary endpoints. The SAP will be agreed with the Trial Management Group (TMG), the Trial Steering Committee (TSC), and with all researchers directly involved in the design and conduct of the Main Trial, including statisticians in charge for the statistical analyses.