Yamaguchi, Shigeki
Terahara, Takaaki
Okawa, Koji
Inakura, Hiroshi http://orcid.org/0000-0001-9771-797X
Funding for this research was provided by:
Hisamitsu Pharmaceutical Co., Inc.
Article History
Received: 30 June 2023
Accepted: 29 September 2023
First Online: 20 October 2023
Declarations
:
: Shigeki Yamaguchi received medical consultant fees from Hisamitsu Pharmaceutical Co., Inc. Shigeki Yamaguchi received honoraria from The Nakatomi Foundation. Takaaki Terahara, Koji Okawa, and Hiroshi Inakura are employees of Hisamitsu Pharmaceutical Co., Inc., Tokyo, Japan.
: The phase III study was conducted in compliance with the Declaration of Helsinki of 1964 and its later amendments and Good Clinical Practice guidelines. The 75 participating institutions acquired approval of the protocol from one of the following institutional review boards: Shinagawa East One Medical Clinic Institutional Review Board, Sugiura Clinic Institutional Review Board, and Jimbo Orthopedics Institutional Review Board. Prior to enrollment, all participants provided written informed consent to participate in the study. Throughout the study period, no ethical problems or medical malpractice occurred, and the participants’ identities were kept confidential. The phase III study was registered with the Japan Primary Registries Network (JPRN) as JPRN-JapicCTI-205134 and the Japan Registry for Clinical Trials (jRCT) as jRCT2080225040.