Ethics approval and consent to participate
This investigator-initiated prospective comparative study was approved by the local Certified Review Board (Shinanozaka Clinic/Hattori Clinic CRBs, Tokyo, Japan) and registered with the Japan Registry for Clinical Research (identifier: jRCTs032210305). This study was conducted in accordance with the tenets of the Declaration of Helsinki and Clinical Trials Act of Japan (Act No. 16, 2017).