Ishikawa, Hiroshi
Yoshino, Osamu
Taniguchi, Fuminori
Harada, Tasuku
Momoeda, Mikio
Osuga, Yutaka
Hikake, Tamiki
Hattori, Youko
Hanawa, Michiko
Inaba, Yosuke
Hanaoka, Hideki
Koga, Kaori
Funding for this research was provided by:
the Ministry of Economy, Trade and Industry in Japan (the 2022 Growth-Oriented Small and Medium-Sized Enterprises Research and Development Support Project)
Article History
Received: 4 January 2024
Accepted: 15 January 2024
First Online: 26 January 2024
Declarations
:
: The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and registered by the Japan Registry of Clinical Trials (jRCTs032230278, ExternalRef removed). An overview of this research is publicly available through the Japan Registry of Clinical Trials. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act enacted in 2017 (ExternalRef removed) and relevant notifications. Principal investigators and study co-investigators in this study will obtain informed written consent from the study participants. They will create case report forms using EDC in accordance with the requirements of clinical research methods and relevant guidelines. Participant identification will be conducted solely using a unique participant identification number. Documents containing personal information of the participants will be treated as confidential documents by the principal investigator. Only the principal investigator and co-investigators will have access to the final dataset.
: Not applicable.
: All authors have no competing interests in relation to this study.