Patients and methods
MAY
This multicenter, open-label, single-arm, prospective phase II clinical trial was conducted from June 2018 to May 2020 at 11 institutions in Japan. The study protocol was approved by the Clinical Research Network Fukuoka Certified Review Board. The study was conducted according to the tenets of the Declaration of Helsinki and the Clinical Trials Act. Written informed consent was obtained from all eligible patients prior to registration. The study protocol was registered in the Japan Registry of Clinical Trials (