Study design
This study was designed as a single-center, prospective, single-blinded, randomized controlled trial. The study was approved by the Institutional Research Ethics Board at Osaka University Hospital (No. 14372) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients prior to their inclusion in the study. Moreover, this study was registered in the clinical registry (UMIN-CTR, number: UMIN000018801) (