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Article History

Accepted: 20 March 2025

First Online: 30 April 2025

Declarations

:

: This study was funded by Johnson & Johnson.

: Stefan Söderberg has received speaker and consultancy fees, and financial support for participation in scientific events from Johnson & Johnson and MSD. Pilar Escribano-Subias has received grants / research support from Ferrer and GlaxoSmithKline, consulting fees from Johnson & Johnson, Acceleron, Ferrer and MSD, payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing or educational events from Johnson & Johnson, MSD, Ferrer and AOT, has received support from Johnson & Johnson and MSD for attending meetings and/or travel, and has participated on a Data Safety Monitoring Board or Advisory Board for Johnson & Johnson, MSD, Ferrer, Gossamer, AOT, Acceleron and GlaxoSmithKline. Ciara Archey is an employee of Johnson & Johnson and has Johnson & Johnson shares. Audrey Muller is an employee of Johnson & Johnson and has Johnson & Johnson shares. Martina Fontana is an employee of Johnson & Johnson and has Johnson & Johnson shares. Tobias J. Lange has received speaker fees and/or consultancy fees and/or financial and non-financial support for participation in scientific events and/or participated on a Data Safety Monitoring Board or Advisory Board for Acceleron Pharma Inc, AOP orphan pharmaceuticals, Bayer, BMS, Böhringer Ingelheim, CGI medicare, Ferrer, Gossamer Bio, Johnson & Johnson, MSD, and Pfizer. Sean Gaine has had relations, such as funding, with the following subjects that have commercial interests in the pharmaceutical and medical field: Aerovate Therapeutics, Acceleron Pharma Inc, Altavant, Gossamer Bio, Johnson & Johnson, MSD and United Therapeutics.

: These data are not currently publicly available for sharing, requests for sharing can be sent to the corresponding author and will be evaluated on an individual basis.

: The study was conducted in compliance with the Declaration of Helsinki and the protocol was approved at each study site (and at the national level in Sweden) by an Institutional Review Board or Independent Ethics Committee (Table , see ESM). The study was conducted in accordance with the International Society for Pharmacoepidemiology Guidelines for Good Pharmacoepidemiology Practices and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Guide on Methodological Standards in Pharmacoepidemiology.

: Written informed consent was obtained for each patient for accessing and processing anonymized patient data and their use in scientific research.

: Not applicable.

: Stefan Söderberg, Pilar Escribano-Subias, Ciara Archey, Tobias J. Lange and Sean Gaine contributed to the conceptualization, writing – original draft and writing – reviewing and editing. Audrey Muller contributed to the conceptualization, data curation, formal analysis, methodology, writing – original draft and writing – reviewing and editing of the manuscript. Martina Fontana contributed to the data curation, formal analysis, validation, writing – original draft and writing – reviewing and editing. All authors read and approved the final manuscript.