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Authors
Given, Joanne https://orcid.org/0000-0003-4921-1944
Paoletti, Olga https://orcid.org/0009-0009-0434-8745
Bromley, Rebecca https://orcid.org/0000-0003-4008-0917
Ballardini, Elisa
Beau, Anna-Belle
Bartolini, Claudia https://orcid.org/0000-0001-8630-4598
Caillet, Anthony
Coldea, Alex
Damase-Michel, Christine https://orcid.org/0000-0001-5018-0108
Evans, Hywel T. https://orcid.org/0000-0001-6745-4187
Jordan, Sue https://orcid.org/0000-0002-5691-2987
Leinonen, Maarit K. https://orcid.org/0000-0002-7631-4749
Manfrini, Marco https://orcid.org/0000-0003-3154-9269
Martikainen, Visa
Morris, Joan K. https://orcid.org/0000-0002-7164-612X
Neville, Amanda J.
Nordeng, Hedvig https://orcid.org/0000-0001-6361-2918
Puccini, Aurora
Coste, Florence https://orcid.org/0000-0001-7109-388X
Loane, Maria https://orcid.org/0000-0002-1206-3637
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Funding
Funding for this research was provided by:
Innovative Medicines Initiative (821520)
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Article History
Accepted: 17 July 2025
First Online: 22 August 2025
Declarations
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: None.
: Ethical approval for this study was given by the Ulster University Institute of Nursing and Health Research Ethics Filter Committee (FCNUR), approval number FCNUR-21-110. Finland Ethical approval is not required for register-based studies. Institutional Review Board at the Finnish Institute for Health and Welfare approved the study and waived the requirement for obtaining informed consent for the secondary use of health administrative data from study participants (THL/543/6.02.00/2021). Data were handled and stored in accordance with the General Data Protection Regulation. France The EFEMERIS cohort was approved by the French Data Protection Authority on 7 April 2005 (authorization number 05-1140). This study was performed on anonymized patient data. The women included in the EFEMERIS database were informed of their inclusion and of the potential use of their anonymized data for research purposes. They could oppose the use of their data at any time. The women included in the EFEMERIS database know that their collected and anonymized data can be used for medical research purposes and can thus be published. The study was approved by the EFEMERIS steering group. Data were handled and stored in accordance with the General Data Protection Regulation. Italy The study was approved by the local ethical committee (approval number 593/2023/Oss/UniFe). Data were handled and stored in accordance with the General Data Protection Regulation and in agreement with the Authority for Healthcare and Welfare, Emilia Romagna Regional Health Service, Bologna, Italy. We thank Elisa Ballardini and Aurora Puccini for their contributions to this work. Norway The study was approved by the Regional Committee for Research Ethics in South-East Norway (approval number 85224) and by the Data Protection Officer at the University of Oslo (approval number 519858). Data were handled and stored in accordance with the General Data Protection Regulation. Wales This study uses anonymised data held in the Secure Anonymised Information Linkage (SAIL) Databank.1,2 The SAIL Databank independent Information Governance Review Panel (IGRP) approved the study as part of project 0823, on 16th October 2020.
