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Article History

Accepted: 5 August 2021

First Online: 8 September 2021

Declarations

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: Mia Aakjær's Ph.D. project was partly funded, and Morten Andersen's professorship was funded by a grant from the Novo Nordisk Foundation (NNF15SA0018404) to the University of Copenhagen.

: At the time of the study, Marie Louise De Bruin was an employee of the Copenhagen Centre for Regulatory Science (CORS). CORS is a cross-faculty university-anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private (Novo Nordisk A/S, Lundbeck A/S, Ferring pharmaceuticals A/S, LEO pharma A/S) stakeholders as well as patient organisations (Rare Diseases Denmark). The center is purely devoted to the scientific aspects of the regulatory field and has a patient-oriented focus, and the research is not a company-specific product or directly company related. Currently, Marie Louise De Bruin is employed by Utrecht University to conduct research under the umbrella of the Utrecht Centre for Pharmaceutical Policy and Regulation. This centre receives no direct funding or donations from private parties, including the pharma industry. Research funding from public–private partnerships, e.g. IMI, The Escher Project (), is accepted under the condition that no company-specific study is conducted. The centre has received unrestricted research funding from public sources, e.g., World Health Organization, Netherlands Organisation for Health Research and Development, the Dutch National Health Care Institute, EC Horizon 2020, the Dutch Medicines Evaluation Board, and the Dutch Ministry of Health. During the past 10 years, Morten Andersen has 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; he has also personally received fees from Atrium, the Danish Pharmaceutical Industry Association, for teaching pharmacoepidemiology courses. Mia Aakjær and Murat Kulahci have no conflicts of interest that are directly relevant to the content of this article.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: Not applicable.

: All authors contributed to the study conception and design. MAa and MAn performed data management and analysis. MAa wrote the first draft of the manuscript, and all authors revised subsequent versions of the manuscript. All authors read and approved the final manuscript.