BANDICOOT Statistical Appendix

This appendix summarises the statistical framework of the BANDICOOT trial as specified in the BANDICOOT core protocol, which defines the overarching objectives, primary outcome, decision rules and governance structure. The trial also has domain-specific appendices, which are appendices to the core protocol describing the protocol relating to a given domain. This statistical appendix provides details of the randomisation strategies and statistical model/s that will be used to analyse the trial data from BANDICOOT along with the decision rules that will guide the trial adaptations. This appendix proceeds by describing, in general, the trial structure, statistical models, randomisation strategy, and the trial decision rules. Specific aspects of the design, including the analysis schedule, maximum sample size, decision rule thresholds, and trial operating characteristics will be summarised in a separate BANDICOOT Simulation Report which is a living document and will be updated as new interventions and domains are added to the trial.