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Article History

Received: 23 April 2025

Accepted: 20 October 2025

First Online: 8 November 2025

Declarations

:

: This study was performed under the umbrella of the Copenhagen Centre for Regulatory Science (CORS), a cross-faculty university anchored institution involving various public and private stakeholders, as well as patient organizations. The center is purely devoted to the scientific aspects of the regulatory field and has a patient-oriented focus. The research is not a company-specific product, nor directly company related. C.E.H. is employed by CORS, and L.W., D.D.G. and H.L. are PhD candidates at CORS. In the last three years, CORS and CEH have received funding from Novo Nordisk for projects not related to this study. L.W.'s PhD fellowship is funded by a grant to CORS from Novo Nordisk A/S, however the company was not involved in any aspect of this work. MA is an employee at the Department of Drug Design and Pharmacology, University of Copenhagen. His Professorship and the Pharmacovigilance Research Centre were funded by a grant from the Novo Nordisk Foundation to the University during 2016–2022. He has previously participated in research projects funded by AstraZeneca, H. Lundbeck & Mertz, Janssen, Novartis, Merck Sharp & Dohme, and Pfizer, with grants paid to the institutions where he was employed, and personally has received fees from Atrium, the Danish Pharmaceutical Industry Association, for leading and teaching pharmacoepidemiology courses. The authors declare no other known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The funders were not involved in the conception of ideas, study design, data collection methodology, statistical analysis, interpretation of results, manuscript preparation, or the decision to publish. The researchers maintained complete independence throughout all phases of this work, from initial conceptualization through final dissemination of findings.

: Under Danish law, register-based studies do not require informed consent or ethical approval.

: Not applicable.

: Not applicable.

: In accordance with data protection regulations, individual patient information cannot be made publicly available.

: Custom code is available from the authors upon reasonable request.

: L.W. and M.A. had full access to the data in this study and take responsibility for the integrity and accuracy of the analysis. Concept and design: L.W., D.D.G., H.L., and M.A.; Acquisition, analysis, or interpretation of data: L.W., D.D.G., H.L., C.E.H., and M.A.; Drafting of the manuscript: L.W. and D.D.G.; Critical review of the manuscript for important intellectual content: H.L., C.E.H., and M.A.; Statistical analysis: L.W., D.D.G., and M.A.; Administrative, technical, or material support: C.E.H. and M.A.; Supervision: C.E.H. and M.A.; All authors read and approved the final version of the manuscript.