Study design, setting, and location
A randomized, double-blind, crossover study was conducted by CPCC Co., Ltd. (Tokyo, Japan) of a contract research organization (CRO) under contract to Nippi Inc. (Tokyo, Japan) at the Chiyoda Paramedical Care Clinic (Tokyo, Japan) under the principal investigator physician. The study protocol was approved by the Ethics Review Committee of Chiyoda Paramedical Care Clinic (approval number: 20022102) and registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR ID: UMIN000041441). This clinical trial was carried out from 21 August to 16 December 2020 (Schedule of the clinical trial.