Ethics approval and consent to participate
This study was approved by Ethics Committee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Okayama, Japan (approval number: Rin1967), which was a main research institution in this multicenter prospective phase II study, and then it was also approved by the institutional review board of each participating institution. Written informed consent was taken from each patient. This study moved toward a “specified clinical trial” based on Clinical Trials Act in Japan and was approved by Okayama University Certified Review Board (approval number: CRB18-011), followed by the confirmation of each participating institution.