METHODS
This multicenter, randomized, open-label, parallel-group comparative trial was conducted from August 2017 to August 2019 with the approval of the Institutional Review Board of each facility in compliance with relevant laws and regulations, including the Declaration of Helsinki and the Japanese Ministerial Ordinance on Good Clinical Practice for Medical Devices. The study was registered in the University Hospital Medical Information Network clinical trial registration system (UMIN000042009). Before conducting the study, the principal investigator or subinvestigators explained the details of the study to the patients and obtained their written informed consent.