Trial Design
bleeding
BLEEDING, EVENT, MAY, SECONDARY, EVENTS
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted at 100 centers in China from February 1, 2016, to May 1, 2018. Details of the trial rationale, design, and methods were provided in the trial protocol (The steering committee was responsible for the design and supervision of the trial, the development of and amendments to the protocol, and the interpretation of the data. The steering committee was also responsible for ensuring the integrity of the data, analysis, presentation of results, and the fidelity of the trial to the protocol. An independent clinical event adjudication committee, whose members were unaware of the trial group assignments, adjudicated the primary and secondary efficacy outcomes and bleeding events. An independent data and safety monitoring committee monitored the progress of the trial, with regular assessment of safety outcomes, overall trial integrity, and trial conduct.