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Article History

Accepted: 20 July 2022

First Online: 6 August 2022

Declarations

:

: This research was partially supported by the Japan Society for the Promotion of Science KAKENHI (grant numbers 20K10408, 21K06646). No additional external funding was received for this study.

: SH is an employee of Kaneichi Pharmaceutical. Co. Ltd. The other authors have no conflicts of interest to declare.

: Ethics approval was not sought because this was an observational study without any research subjects. All results were obtained from data openly available online from the website of the PMDA (). All data from the JADER database were fully anonymized by the 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, ”. The study is not subject to ethical examination as the study was an observational study without any research subjects. No consent to participate was required owing 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.

: All data generated or analyzed during this study are included in this published article and its supplementary information files.

: Not applicable.

: SH, HI, and MN contributed to the overall concept and design of the study. SH, HI, and MN wrote the main manuscript text. SH, RS, MU, and YY carried out the data extraction and statistical analysis. MT, KM, WW, and KO contributed to the data validation process. NM, TH, and KI revised the article critically for important intellectual content. All authors have reviewed the manuscript.