Sample size
SECONDARY, EVENT, RECRUITMENT
The BPROAD study has a single primary outcome (composite major CVDs) and several key secondary outcomes. The sample size calculation is based on the primary outcome and use of the following assumptions:Event rate of composite major CVDs of 2.0% per year among patients in the standard treatment group20% effect size for the intervention (HR of 0.80)Two‐year uniform recruitment period and total study length of 5 years (defined by the time between randomization of the first participant and study closeout)2% per year loss to follow‐up rateTwo‐sided significance test at the 5% level, and a statistical power of 90%Based on these assumptions, the BPROAD study will need to enroll a total of 12 702 patients with equal numbers in both treatment groups.