Author contributions
CM
DC is the chief investigator for ASCOT. SC, GP, VC, CB and DC wrote the statistical analysis plan for this manuscript. SC, GP and VC conducted the statistical analysis for this manuscript. SC, GP and DC wrote the first draft of the manuscript. SC, GP, VC, PB, MZ, EC, SS, CB and DC interpreted the data and critically reviewed the manuscript. PB, VC, and CB are co-investigators for ASCOT. DC, VC, PB and CB designed the ASCOT study. ER was the ASCOT trial manager. CM and JK were involved in the trial design, trial and data management. All authors read and approved the final manuscript.