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Authors
Toriumi, Shinya
Morikawa, Azumi
Kurihara, Yousuke
Shimokawa, Komei
Tanaka, Arihito
Araki, Norito
Kawai, Osamu
Uesawa, Yoshihiro
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Article History
Received: 24 June 2026
Accepted: 24 September 2026
First Online: 5 October 2026
Declarations
Ethics approval and consent to participate: This study consisted of two components: an analysis of the JADER database and a single-center retrospective cohort study. The study protocol was approved by the Ethics Committee of the National Hospital Organization Kanagawa Hospital (Approval No. 7–8). The JADER analysis used fully anonymized data obtained from a publicly available database provided by the PMDA; therefore, additional ethical approval and individual informed consent were not required for this component. The single-center retrospective cohort study was conducted following the Ethical Guidelines for Medical and Biological Research Involving Human Subjects. As this was a retrospective study, the requirement for informed consent was waived, and an opt-out procedure approved by the Ethics Committee was adopted.
Consent for publication: Not applicable.
Competing interests: The authors declare no competing interests.
