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Article History

Received: 4 July 2025

Accepted: 23 September 2025

First Online: 8 October 2025

Declarations

:

: Keiko Hosohata is an Editorial Board member of Clinical Drug Investigation. Keiko Hosohata was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The remaining authors declare no conflicts of interest.

: The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

: Ethics approval was not sought for this study, given the database-related, observational design without direct involvement of any research subjects. All results were obtained from data openly available online from the PMDA website []. All data from the JADER were fully anonymized by the relevant regulatory authority before being accessed. All methods were therefore performed in accordance with the relevant guidelines and regulations.

: Not applicable.

: Not applicable.

: Not applicable.

: Yuko Kanbayashi and Keiko Hosohata contributed equally to this work. Yuko Kanbayashi: writing original draft and writing—review and editing. Risa Morioka: data curation—review and editing. Keiko Hosohata: data curation; conceptualization; supervision; and writing—review and editing. All authors read and approved the final version and agree to be accountable for the work.