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Article History

Received: 21 March 2024

Accepted: 20 August 2024

First Online: 5 September 2024

Declarations

:

: The study was approved by the ethical review committees of 34 study sites: Hokkaido University Hospital, Wakkanai City Hospital, Sapporo Hanazono Hospital, Sapporo City General Hospital, Akita University Graduate School of Medicine, Seimou Hospital, Chiba University Hospital, Kisarazu Hospital, Tokyo Women’s Medical University, National Center of Neurology and Psychiatry, Tokyo Metropolitan Police Hospital, Tokyo Welfare Pension Hospital, Showa University Karasuyama Hospital, Toho University Faculty of Medicine, Seijin Hospital, Showa University East Hospital, Kichijoji Hospital, St. Marianna University School of Medicine, Holy Cross Hospital, Fujita Health University, Okehazama Hospital Fujita Kokoro Care Center, Kyowa Hospital, Ehime University Hospital, National Hospital Organization Sakakibara Hospital, Osaka Medical University, Osaka Prefectural Psychiatric Center, Ainohanazono Hospital, Osaka University Hospital, Kokubu Hospital, Nara Medical University Hospital, Tottori University Faculty of Medicine, Yowa Hospital, Zikei Hospital, and Tokushima University Hospital. In addition, Shinagawa Clinic Ethics Review Committee, a central ethics review committee, approved the implementation of this study at 42 other study sites. The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice, and the Ethics Guidelines for Clinical Research (The Ministry of Health, Labour and Welfare, 2008). All patients provided written informed consent.

: All patients provided written informed consent.

: Not applicable.

: Conflicts of interestJun Ishigooka reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; payment or honoraria from Astellas Pharma Inc. (chair), Mochida Pharmaceutical Co., Ltd. (chair), Otsuka Pharmaceutical Co. Ltd. (adviser), Takeda Pharmaceutical Co., Ltd. (speaker, adviser), Novartis Pharma K.K. (adviser), and Alfresa Pharma Corporation (adviser) in the past 36 months; and support for transportation to attend meetings from Astellas Pharma Inc. and Mochida Pharmaceutical Co., Ltd. in the past 36 months. Kazuyuki Nakagome reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; grants paid to his institution from Shionogi & Co., Ltd., Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corp., Nippon Boehringer Ingelheim Co., Ltd., and Mochida Pharmaceutical Co., Ltd. in the past 36 months; payment or honoraria from Sumitomo Pharma Co., Ltd. (speaker, chair, adviser, interview), Otsuka Pharmaceutical Co., Ltd. (speaker, chair, adviser, supervisor), Meiji Seika Pharma Co., Ltd. (speaker), Janssen Pharmaceutical K.K. (speaker, chair, supervisor panelist), Mitsubishi Tanabe Pharma Corp. (chair), Takeda Pharmaceutical Co., Ltd. (adviser), Lundbeck Japan (adviser), Viatris Inc. (chair), Eisai Co., Ltd. (chair), Nippon Boehringer Ingelheim Co., Ltd. (chair, adviser, supervisor), and Mochida Pharmaceutical Co., Ltd. (speaker) in the past 36 months; and support for transportation to attend meetings from Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corp., Takeda Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., and Mochida Pharmaceutical Co., Ltd. in the past 36 months. Tetsuro Ohmori reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; and payment or honoraria as a chair or speaker from Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Eli Lilly Japan K.K., Takeda Pharmaceutical Co., Ltd., Eisai Co., Ltd., Yoshitomi Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corp., Meiji Seika Pharma Co., Ltd., Tsumura Co., Ltd., and MSD Co., Ltd. in the past 36 months. Nakao Iwata reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Viatris Inc., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd, Eli Lilly Japan K.K., and Eisai Co., Ltd. in the past 36 months. Ken Inada reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; grants from Mochida Pharmaceutical Co., Ltd. and Sumitomo Pharma Co., Ltd. in the past 36 months; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Daiichi Sankyo, Eisai Co., Ltd., Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., Lundbeck Japan, Meiji Seika Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corp., Mochida Pharmaceutical Co., Ltd., MSD Co., Ltd., Nipro Pharma Corp, Novartis, Otsuka Pharmaceutical Co., Ltd., Pfizer, Shionogi & Co., Ltd., Sumitomo Pharma Co., Ltd., Yoshitomiyakuhin Corp., and Viatris Inc. in the past 36 months. Jun-ichi Iga reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Eisai Co., Ltd., Janssen Pharmaceutical K.K., Merck, Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Kyowa Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Yoshitomiyakuhin Corp., Daiichi Sankyo, Viatris Inc., and Shionogi & Co., Ltd. in the past 36 months. Taro Kishi reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; grants from Eisai Co., Ltd. in the past 36 months; and honoraria for speaker from Sumitomo Pharma Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Viatris Inc., Mitsubishi Tanabe Pharma Corp., and MSD Co., Ltd. in the past 36 months. Kiyoshi Fujita reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd, and Meiji Seika Pharma Co., Ltd. in the past 36 months. Hideaki Tabuse reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; clinical trial expense for his institution from AbbVie GK, Janssen Pharmaceutical K.K., and Otsuka Pharmaceutical Co., Ltd.; payment or honoraria as conference chair from Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Viatris Inc. in the past 36 months; and transportation/accommodation fee from Janssen Pharmaceutical K.K., MSD Co., Ltd., and Takeda Pharmaceutical Co., Ltd. Hiroshi Terada reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and payment or honoraria for lecture/conference chair from Meiji Seika Pharma Co., Ltd., Lundbeck Japan K.K., Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Yoshitomiyakuhin Corp., Janssen Pharmaceutical K.K., and Eli Lilly Japan K.K. in the past 36 months. Haruko Terada reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and payment or honoraria for lecture/conference chair from Sumitomo Pharma Co., Ltd. Toshiaki Shichijo reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work; clinical trial fees paid to the institution from Sumitomo Pharma Co., Ltd. and Shionogi & Co., Ltd. in the past 36 months; and lecture honoraria from Otsuka Pharmaceutical Co., Ltd. and Sumitomo Pharma Co., Ltd. in the past 36 months. Yuichiro Tsutsumi reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and lecture honoraria from Janssen Pharmaceutical K.K., Sumitomo Pharma Co., Ltd., and Mitsubishi Tanabe Pharma Corp. in the past 36 months. Shotatsu Koretsune reports funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work, and honoraria for a conference chair from Takeda Pharmaceutical Co. Ltd. in the past 36 months. Yuka Kikuchi, Toshifumi Kishimoto, and Kazutaka Ohi report funding for writing support from the Waksman Foundation of Japan, Inc., since the initial planning of the work.