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Article History

Received: 17 October 2023

Accepted: 14 December 2023

First Online: 16 January 2024

Declarations

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: Taku Hatano reports receiving grants from the Setsuro Fujii Memorial, the Osaka Foundation for Promotion of Fundamental Medical Research, JSPS KAKENHI (under grant number 21K07424), Japan Agency for Medical Research and Development (grant number 20dm0107156, 21wm0425015, and 21dk0207055); speaker’s honoraria from Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K., Sanofi K.K., Eisai Co. Ltd. and Otsuka Pharmaceutical Co., Ltd. during the conduct of the study. Taku Hatano also reports receiving grants and speaker’s honoraria from Kyowa Kirin Co., Ltd. during the conduct of the study. Renpei Sengoku reports no relevant disclosures. Renpei Sengoku, Hiroshi Nagayama, Naotake Yanagisawa, Keisuke Suzuki, and Hiroo Terashi report grants and consultation fees from Kyowa Kirin Co., Ltd. during the conduct of the study. Asako Yoritaka received speaker’s honoraria from Kyowa Kirin Co., Ltd. during the conduct of the study. Noriko Nishikawa, Kyoichi Nomura, Norihito Yoshida, Morinobu Seki, Miho Kawabe Matsukawa, Shigeki Hirano, Hidetomo Murakami, Hideto Joki, Tsuyoshi Uchiyama, Kotaro Ogaki, Jiro Fukae, Kazushi Takahashi, and Toshimasa Yamamoto report grants from Kyowa Kirin Co., Ltd. during the conduct of the study. Hiroshi Nagayama reports no relevant disclosures. Naotake Yanagisawa reports no relevant disclosures. Asako Yoritaka received lecture fees from Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Eisai Co., Ltd. and Kyowa Kirin Co., Ltd. Keisuke Suzuki reports receiving speaker honoraria from Kyowa Kirin Co. Ltd, Otsuka Pharmaceutical, Co. Ltd, Sumitomo Pharma Co. Ltd, Takeda Pharmaceuticals Co. Ltd, Eisai Co. Ltd, and Novartis Pharma K.K. Noriko Nishikawa reports no relevant disclosures. Yohei Mukai reports no relevant disclosures. Yohei Mukai reports receiving honoraria fee for lectures from Kyowa Kirin Co., Ltd. during the conduct of the study. Kyoichi Nomura reports no relevant disclosures. Norihito Yoshida reports no relevant disclosures. Morinobu Seki received a Takeda Japan Medical Affairs Funded Research Grant 2018, and grants from Kanae Foundation for the Promotion of Medical Science, outside the submitted work. Miho Kawabe Matsukawa reports no relevant disclosures. Hiroo Terashi reports no relevant disclosures. Katsuo Kimura reports personal fees from Medtronic Japan Co., Ltd., Boston Scientific Corporation, Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., AbbVie GK, Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Sumitomo Pharma Co., Ltd., and grants from Novartis AG, outside the submitted work. Katsuo Kimura reports grants and lecture fees from Kyowa Kirin Co., Ltd. during the conduct of the study. Jun Tashiro reports grants and non-financial support from Kyowa Kirin Co., Ltd. during the conduct of the study. Hideki Shimura reports grants and lecture fees from Kyowa Kirin Co., Ltd. during the conduct of the study. Yoshio Tsuboi, Kenichi Kaida, Ryoko Ihara, Kazutomi Kanemaru, and Osamu Kano report no relevant disclosures during the conduct of the study. Jun Tashiro reports grants and non-financial support from CSL Behring K.K. and personal fees and non-financial support from Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., FP Pharmaceutical Corporation, Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., and AbbVie GK outside the submitted work. Shigeki Hirano reports grants from Eli Lilly Japan K.K., and grants and lecture fees from Nihon Medi-Physics Co., Ltd. outside the submitted work. Hidetomo Murakami reports no relevant disclosures. Hideto Joki reports no relevant disclosures. Tsuyoshi Uchiyama reports no relevant disclosures. Hideki Shimura reports no relevant disclosures. Kotaro Ogaki reports receiving grants from JSPS KAKENHI (under grant number 19K17047), speakers honoraria from Sumitomo Pharma Co., Ltd, Takeda Pharmaceutical Co. Ltd., Kyowa Kirin Co. Ltd., Otsuka Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., FP Pharmaceutical Co. Ltd., Mochida Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd, and Eli Lilly Japan K.K. Jiro Fukae reports no relevant disclosures. Yoshio Tsuboi received personal fees from Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K., Sumitomo Pharma Co., Ltd., AbbVie GK, and Otsuka Pharmaceutical Co., Ltd., and Kyowa Kirin Co., Ltd., outside the submitted work; and were supported by a grant from Nipro Corporation. Kazushi Takahashi reports no relevant disclosures. Toshimasa Yamamoto reports no relevant disclosures. Kenichi Kaida reports no relevant disclosures. Ryoko Ihara reports no relevant disclosures. Kazutomi Kanemaru reports no relevant disclosures. Osamu Kano reports honoraria from AbbVie GK, Alexion Pharmaceuticals, Inc., Biogen Japan Ltd., Biogen Inc., Chugai Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Eisai Co., Ltd, Kyowa Kirin Co., Ltd., Mitsubishi Tanabe Pharma Co., Mochida Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and scholarship grants from Eisai Co., Ltd., and Otsuka Pharmaceutical Co., Ltd., and writing fees from Mitsubishi Tanabe Pharma Co., outside the submitted work, and grants for commissioned work from Alexion Pharmaceuticals, Inc., and Mitsubishi Tanabe Pharma Co.

: We carried out the present study in compliance with the Japan Clinical Trials Act and all related national and international guidelines for human trials, and with the Declaration of Helsinki. The Juntendo University Certified Review Board (J18-006) reviewed and approved the study protocol (Version 6.0, 1 November 2021) and all other study documentation (approval number CRB3180012). This trial was registered with the Japan Registry of Clinical Trials (jRCTs031180248). All patients provided written informed consent before enrollment. We anonymized all patient data so that no personal information was associated with the wearable devices. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.