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Authors
Gkolfi, Dimitra
van Rijt-Weetink, Yrea R. J. https://orcid.org/0000-0002-5997-3718
Taavola-Gustafsson, Henric https://orcid.org/0000-0002-2604-2810
Sandberg, Lovisa https://orcid.org/0000-0001-6982-5244
Raemaekers, Boukje C. https://orcid.org/0009-0008-3946-3340
van Hunsel, Florence P. A. M. https://orcid.org/0000-0001-8965-3224
Passier, Anneke L. M. https://orcid.org/0000-0001-5594-6360
Bromley, Rebecca L. https://orcid.org/0000-0003-4008-0917
Yates, Laura M. https://orcid.org/0000-0002-7963-625X
van Puijenbroek, Eugène P. https://orcid.org/0000-0002-2236-1398
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Funding
Funding for this research was provided by:
Innovative Medicines Initiative (821520)
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Article History
Accepted: 26 June 2025
First Online: 7 July 2025
Declarations
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: The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 821520. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
: Florence van Hunsel and Eugène van Puijenbroek are Editorial Board members of Drug Safety. These authors were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Rebecca L. Bromley’s institution received an honorarium from UCB Pharma for her participation in an international women’s health board. Dimitra Gkolfi, Yrea R.J. van Rijt-Weetink, Henric Taavola-Gustafsson, Lovisa Sandberg, Boukje C. Raemaekers, Anneke L.M. Passier and Laura M. Yates have no conflicts of interest that are directly relevant to the content of this article.
: Ethics approval was not needed for this study.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the World Health Organization Programme for International Drug Monitoring. Subject to these conditions, data are available from the authors on reasonable request.
: The code used in the extraction and analysis of data is available upon reasonable request.
: Study conception and design: DG, YvR, EvP; data extraction and statistical analysis; VigiBase data: HTG; interpretation of results and preparation draft manuscript: DG, YvR, EvP; all authors reviewed the results and approved the definitive version of this manuscript.
