Kitade, Mari
Kumakiri, Jun
Kobori, Hiroyuki
Murakami, Keisuke
Funding for this research was provided by:
ASKA Pharmaceutical Co., Ltd.
Article History
Received: 21 November 2023
Accepted: 10 May 2024
First Online: 24 May 2024
Declarations
:
: The Chairman of the Clinical Research Review Committee of Juntendo University certified on 2 August 2022, 6 January 2023, 8 May 2023, and 1 August 2023, the appropriateness of the research and change in the implementation plan submitted on 15 July 2022 for jRCT s031210564 registered on 19 January 2022 in the Japan Registry of Clinical Trials (). This protocol, Explanatory Document and Consent Form for Clinical Research, and all other documents about this study shall be reviewed and approved by the Certified Review Board during the planning and implementation of the study. In addition, the chief investigator shall submit safety and progress reports to directors of the implementing medical institutions each year (starting from the date of submitting the implementation plan to the MHLW) and make periodic reports to the Certified Review Board, as specified in the implementation plan.All persons involved in this research will conduct the study following the Declaration of Helsinki of the World Medical Association, the Clinical Research Act, its implementing regulations, and other relevant notices with which all medical research involving human subjects must comply. Furthermore, investigators of all participating medical institutions will obtain written informed consent from participants in the study.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the study results. Informed consent materials are available from the corresponding author, Professor Mari Kitade, email: kitade@juntendo.ac.jp.
: MK, JK, and HK received honoraria as a speaker and consultant fee from ASKA Pharmaceutical Co., Ltd. KM received honoraria as a speaker from ASKA Pharmaceutical Co., Ltd.