Methods
The study was conducted at Nagasaki University Hospital with the approval of Nagasaki University’s Clinical Research Review Board (`7180001) and written informed consent was obtained from all subjects participating in this study. This clinical trial was registered prior to patient enrollment in the Japan Registry of Clinical Trials (jRCTs072190021; Principal investigator: Takao Ayuse; Date of registration: August 26, 2019). The authors have previously reported the aims and protocol of the current study [