Ethics approval and consent to participate
The study protocol conformed to the Declaration of Helsinki and was approved by the institutional review boards of Kobe University Hospital, Teikyo University Hospital, Iwate Medical University Hospital, Kagawa University Hospital, Hyogo Medical University Hospital, Kobe City Medical Center General Hospital, and Institute of Biomedical Research and Innovation Hospital. A clinical trial notification was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and the study was initiated after obtaining the PMDA’s permission. Furthermore, ethical approval was obtained from all seven participating hospitals. All patients provided written informed consent to participate in this trial. This trial has been registered at UMIN-CTR under UMIN000022814. There are no restrictions on study-related materials.