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Article History

Received: 26 December 2024

Accepted: 10 March 2025

First Online: 28 March 2025

Declarations

:

: Nobuhisa Ishiguro received speakers’ bureau honoraria from Asahi Kasei Pharma Corporation and Shionogi & Co., Ltd., and received study grants from Shionogi & Co., Ltd. Ichiro Morioka received speakers’ bureau honoraria from Shionogi & Co., Ltd., MSD Co., Ltd., Sanofi K.K., AstraZeneca K.K., Pfizer Japan Inc., and Mitsubishi Tanabe Pharma Corporation and received study grants from Shino-Test Corporation. Takashi Nakano received speakers’ bureau honoraria from Daiichi Sankyo Co., Ltd., Sanofi K.K., Mitsubishi Tanabe Pharma Corporation, Meiji Seika Pharma Co., Ltd., Moderna Japan, and KM Biologics Co., Ltd. Atsushi Manabe provided his services as a non-compensated advisor for this study and does not have any competing interests to declare. Keiko Kawaguchi, Shintaro Tanaka, and Masahiro Kinoshita are employees of Shionogi & Co., Ltd., Japan.

: The study protocol was reviewed and approved by the Hokkaido University Certified Review Board (CRB Approval No. 020-005, October 2020). The study was conducted according to the clinical trials act (Act No. 16, April 14, 2017), declaration of Helsinki, and ethical guidelines for medical and health research involving human subjects in Japan. It was registered at the Japan Registry of Clinical Trials (Registration No. jRCTs011200011). Written informed assents from each patient and written informed consent from a parent/legal guardian for each enrolled patient were obtained according to their level of comprehension and capabilities. A patient and a parent/legal guardian were free to withdraw participation from the trial at any time upon request. More information on informed consent is available in the previously published protocol paper [].