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Authors
Yamamoto, Kazuko https://orcid.org/0000-0002-1357-1676
Inoue, Tsuyoshi
Ikeda, Takaya
Sawai, Toyomitsu
Nagayoshi, Yosuke
Hashiguchi, Koji
Futsuki, Yoji
Matsubara, Yuichi
Harada, Yosuke
Ashizawa, Nobuyuki
Fukahori, Susumu
Iwanaga, Naoki
Takazono, Takahiro
Kido, Takashi
Ishimoto, Hiroshi
Hosogaya, Naoki
Sakamoto, Noriho
Tashiro, Masato
Tanaka, Takeshi
Fukushima, Chizu
Jounai, Kenta
Tsuji, Ryohei
Fujiwara, Daisuke
Ota, Kenji
Kosai, Kosuke
Furumoto, Akitsugu
Yanagihara, Katsunori
Izumikawa, Koichi
Mukae, Hiroshi
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Funding
Funding for this research was provided by:
Kirin Holdings Co., Ltd. (H21003539)
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Article History
Received: 17 August 2025
Accepted: 2 October 2025
First Online: 25 October 2025
Declarations
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: Kazuko Yamamoto received research funds from Kirin Holdings Co., Ltd. for this study and another research grant from Fisher & Paykel Healthcare Ltd. Tsuyoshi Inoue received research funds from Kirin Holdings Co., Ltd. for this study. It belonged to a donated course from Kyowa Kirin Co., Ltd. Kenta Jounai, Ryohei Tsuji, and Daisuke Fujiwara are employees of Kirin Holdings Co. Ltd. Koichi Izumikawa received a research grant for this study from Kirin Holdings Co., Ltd. Hiroshi Mukae received a research grant from Taisho Pharmaceutical Co. Ltd. All funding agencies, except Kirin Holdings Co., Ltd., played no role in the study design, data collection and analysis, decision to publish, or manuscript preparation. Takaya Ikeda, Toyomitsu Sawai, Yosuke Nagayoshi, Koji Hashiguchi, Yoji Futsuki, Yuichi Matsubara, Yosuke Harada, Nobuyuki Ashizawa, Susumu Fukahori, Naoki Iwanaga, Takahiro Takazono, Takashi Kido, Hiroshi Ishimoto, Naoki Hosogaya, Noriho Sakamoto, Masato Tashiro, Takeshi Tanaka, Chizu Fukushima, Kenji Ota, Kosuke Kosai, Akitsugu Furumoto, and Katsunori Yanagihara declare no conflicts of interest.
: The study protocols were inspected and approved (approval no. CRB21-009) in November 2021 by the Clinical Research Review Board of Nagasaki University. This study was registered with the Japan Registry of Clinical Trials (jRCT) (registration number: jRCTs071210097) in December 2021. The trial protocol has been described previously [ ]. Patient enrollment was conducted from December 2021 to April 2022. The study was conducted in accordance with the Declaration of Helsinki, Clinical Trials Act, and other current legal regulations in Japan. Written informed consent was obtained from all enrolled patients who met the eligibility criteria before the intervention. To avoid bias and ensure quality, a third-party entity (Soiken, Inc., Osaka, Japan) performed data collection, management, monitoring, audits, and statistical analyses.
