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Authors
Matsumoto, Kiyoka
Goto, Fumiya
Maezawa, Mika
Nakao, Satoshi
Miyasaka, Koumi
Hirofuji, Sakiko
Shiota, Kohei
Ichihara, Nanaka
Yamashita, Moe
Nokura, Yuka
Yamazaki, Tomofumi
Sugishita, Kana
Tanaka, Hideyuki
Tamaki, Hirofumi
Ishiguro, Motoyuki
Iguchi, Kazuhiro
Nakamura, Mitsuhiro
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Funding
Funding for this research was provided by:
Japan Society for the Promotion of Science (21K11100, 21K11100)
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Article History
Received: 2 July 2024
Accepted: 28 November 2024
First Online: 3 December 2024
Declarations
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: The authors declare no competing interests.
: Ethical approval was not sought for this study because the study was a database-related observational study which did not directly involve any research subjects. All results were obtained from data openly available online from the PMDA website (). All data from the JADER database were fully anonymized by the relevant regulatory authority before we accessed them.
: Our research does not fall within the purview of any of the following laws and guidelines: “Clinical Trials Act (Act No. 16 of April 14, 2017),” “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law number: Act No. 145 of 1960, Last Version: Amendment of Act No. 50 of 2015),” “Guideline for good clinical practice E6 (R1), ,” “Ethical guidelines for human genome and gene analysis research, ,” and “Ethical Guidelines for Medical and Health Research Involving Human Subjects, .” Therefore, it is not subject to ethical examination. The study was an observational study without any research subjects. No consent to participate was required due to the retrospective nature of this study.
