2.1. Study design
This prospective, multicenter, single-blind, randomized controlled study was conducted at Hiroshima University Hospital and JA Hiroshima General Hospital (a regional hospital). The study was approved by the Ethics Committee of Hiroshima University on November 25, 2020 (C-306) and the Ethics Committee of JA Hiroshima General Hospital on February 22 2022 (21–73) and registered in the UMIN Clinical Trials Registry database (UMIN000042568, first registration date 26/11/2020). Written informed consent was obtained from all patients, and all study-related procedures were performed in accordance with the Declaration of Helsinki.