In Reply In response to the comments by Dr Mai and colleagues about the change in the primary outcome of the CHOICE trial,1 we would like to provide several clarifications. First, the definition of the primary outcome in the original protocol was submitted for publication on July 15, 2019.2 Second, the registered protocol () was first posted on March 15, 2019, but the primary outcome definition was changed and posted on March 19, 2021. Third, the summary of the history of these protocol changes was included in Supplement 2 of the article. As required by Spanish law, these changes were also communicated to the Spanish Agency of Medicines and Medical Devices before their implementation.