Oura, Keita
Tanaka, Mizuki
Matsumoto, Kiyoka
Satake, Riko
Inoue, Misaki
Yoshida, Yu
Wakabayashi, Wataru
Hasegawa, Shiori
Iwata, Mari
Suzuki, Takaaki
Maezawa, Mika
Nakao, Satoshi
Liao, Jun
Iguchi, Kazuhiro
Nakamura, Mitsuhiro
Funding for this research was provided by:
Japan Society for the Promotion of Science (21K06646)
Article History
Received: 3 August 2023
Accepted: 6 March 2024
First Online: 14 March 2024
Declarations
:
: Not applicable. 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), ExternalRef removed,” “Ethical guidelines for human genome and gene analysis research, ExternalRef removed,” and “Ethical Guidelines for Medical and Health Research Involving Human Subjects, ExternalRef removed.” 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.No administrative permissions or licenses were required to access the raw data from the Japanese Adverse Drug Event Report database because all results were obtained from data openly available online from the PMDA website. All data from the JADER database were fully anonymized by the regulatory authority before we accessed them.
: Not applicable.
: The authors declare no competing interests.