A randomised clinical trial of STAtin therapy for Reducing Events in the Elderly (STAREE): Statistical analysis plan
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The STAREE randomised controlled trial of 9971 community-dwelling older adults without cardiovascular disease, diabetes or dementia is designed to compare daily 40mg atorvastatin to placebo. We present a statistical analysis plan to pre-specify the analytical approaches that will be taken when reporting the main findings from the trial. The plan describes the analysis approach for the co-primary endpoints: (a) death, dementia, and persistent physical disability; (b) major cardiovascular events; and all secondary endpoints. A pre-specified economic evaluation is also included as part of this plan.
