Trial design and participants
The PRIZE study was a multicentre, prospective, randomized, open‐label, blinded‐endpoint clinical experiment. The specifics of the study rationale and design have been previously reported.The trial was performed in full compliance with the Declaration of Helsinki and following the Ethical Guidelines for Medical and Health Research Involving Human Subjects established by the Ministry of Health, Labour and Welfare and the Ministry of Education, Culture, Sports, Science, and Technology in Japan. Before enrollment, all participants received a sufficient explanation of the research plan and gave written informed consent.The current subanalysis was secondarily planned and conducted after the publication of the main investigation in the PRIZE study,