Author contributions
JCP
Trial design: AFG, GAOT, and JCP. Writing of the trial protocol: AFG. Screening, randomization, and follow-up of the patients: MPN, JCY, JGB, and RMN. Statistical analyses: AFG and AIS. Critical evaluation of the results: AFG, DCC, AIS, JHM, GAOT, CAO, and JCP. Writing of the first draft of the manuscript: AFG and RMN. All authors made relevant intellectual contributions to the manuscript, and all authors approved the final version for journal submission. All authors read and approved the final manuscript.