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Article History

Received: 17 May 2024

Accepted: 3 June 2024

First Online: 24 June 2024

Declarations

:

: Ichizo Tsujino received lecture fees from Nippon Shinyaku Co. Ltd. and Janssen Pharmaceutical K.K., as well as funding for the endowed division from Mochida Pharmaceuticals K.K., Nippon Shinyaku Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Medical System Network Co. Ltd., Kaneka Corp. and Takeyama Co. Ltd. Kazuki Kitahara, Junichi Omura and Toshiyuki Iwahori are employees of Janssen Pharmaceutical K.K. Toshiyuki Iwahori is a visiting Associate Professor at Shiga University of Medical Science and an advisor of Mizuta Seisakusho, Inc. Toshiyuki Iwahori received lecture fees from Shiga University of Medical Science and Yahad Club for Doctors Physicians in Israel as a visiting associate professor of Shiga University of Medical Science. Satoshi Konno received funding for the endowed division from Mochida Pharmaceuticals K.K., Nippon Shinyaku Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Medical System Network Co. Ltd., Kaneka Corp. and Takeyama Co. Ltd.

: Written informed consent will be obtained from all participants, including the consent for publication of the study. The decision of patients to participate will not impact their standard of care, and the treatment decision will have been made prior to and independently of the patient’s inclusion. All aspects of treatment and clinical management will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating (or treating) physician. The Hokkaido University Hospital Clinical Research Supervision Center Biomedical Research Ethics Review Board approved the study protocol (No. 023-0067) on 14 June 2023, and the study is registered in the Japan Registry of Clinical Trials (jRCT1010230018). The Asahikawa Medical University Research Ethics Committee approved the study protocol (No. C2315) on 31 July 2023 and the Sapporo Medical University Hospital Institutional Review Board approved the study protocol (No. 352-95) on 24 August 2023. The study will be performed in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Life Science and Medical Research Involving Human Patients (Notification No. 1 of the Ministry of Education, Culture, Sports, Science and Technology/Ministry of Health, Labour and Welfare/Ministry of Economy, Trade and Industry in 2021).