Data source
SECONDARY
Allocation to randomised interventions remains concealed until the time it is revealed to site investigators. The assessment of primary and secondary outcomes by site investigators will not be blinded to knowledge of allocated intervention. All trial and site investigators will remain blinded to aggregated trial outcomes. Only the SNAP analytic team and data safety and monitoring committee members will have access to unblinded aggregated trial outcomes. Scheduled updates will be performed using all available data from eligible SNAP trial participants. Unblinded data will be extracted from the SNAP trial database immediately prior to each update and provided to the SNAP trial analytic team. The SNAP analytic team and data safety and monitoring committee, unblinded to treatment allocation, are independent of all other trial committees to ensure independence.