Institutional Review Board Statement
This study was conducted in accordance with the principles of the Declaration of Helsinki. The trial protocol and any amendments were approved by the ethics committee of the Takara Clinic, Medical Corporation Seishinkai (approval number: 2204-00145-0004-0E-TC), and statistical analysis was performed by Ortho Medico. This trial has been registered in the UMIN Clinical Trials Registry (UMIN000044258).