Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

DiscussionConsistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.Trial registrationClinicalTrials.gov, ID:NCT02040103. Registered on 3 November 2013;Current controlled trials, ID:ISRCTN44653506. Registered on 30 October 2013.
Source: Trials - Category: Research Source Type: clinical trials