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Article History

Accepted: 19 January 2025

First Online: 6 February 2025

Declarations

:

: Open access funding provided by University of Southern Denmark. This post-authorization safety study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Janssen Research & Development, LLC, Spring House, PA, USA. MedEngine DK ApS (formerly the Institute of Applied Economics and Health Research ApS, ApHER), an independent research institute, was contracted by Merck Sharp & Dohme LLC to conduct the study.

: JL has consulted or served on an advisory board for AbbVie, Amgen, Arena Pharmaceuticals, Bridge Biotherapeutics, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Entasis Therapeutics, Galapagos, Gilead, Janssen Pharmaceuticals, Samsung Bioepis, Merck, Nestle Health Science, UCB, Pfizer, Protagonist Therapeutics, Sanofi, and Scipher Medicine; has received research funding from Nestle Health Science, Takeda, Janssen Pharmaceuticals, and AbbVie; has received educational grants from Takeda and Janssen; and has received in-kind support from Eli Lilly and Company. VA is member of the Merck advisory board and has consulted for Janssen. LM, SMH, and LK were employees at ApHER/MedEngine while the study was conducted. ZH, DDH, and CW are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may hold stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. SE and AK were employees at Janssen while the study was conducted. KB and AG were responsible for the study in Sweden as consultants for ApHER/MedEngine. AKE, LCT, TMK, MSK, SK, FRH, NQ, and EH have no conflicts of interest to declare.

: Register-based micro-level data sharing is not permitted. The researchers (AKE and AG) have access to data at secure servers at the Danish Health Data Authority and at secure local servers.

: Different ethical approvals are needed in Denmark and Sweden [, ]. In Denmark, register-based studies do not need ethical approval []. The study was approved by the Research and Innovation Organisation at University of Southern Denmark (reference number: 10.186). The Swedish Ethical Review Authority approved the initial study protocol (reference 2019-04411) and amendments (reference 2020-00038). In Denmark, a minimum of five observations is needed to present results because of privacy regulations. Consequently, numbers less than five are masked as “<5” for results. So that the masked number cannot be calculated, further results have been masked and indicated as not permissible.

: Not applicable.

: Not applicable.

: Not applicable.

: AKE: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing – original draft, writing – review and editing, visualization, and project administration. LCT: conceptualization, methodology, software, investigation, resources, data curation, writing – review and editing, and supervision. TMK: conceptualization, methodology, software, investigation, resources, data curation, and writing – review and editing. MSK: conceptualization, methodology, software, investigation, resources, data curation, and writing – review and editing. SK: methodology, software, resources, writing – review and editing, and visualization. FRH: methodology, software, resources, and writing – review and editing. NQ: conceptualization, investigation, writing – review and editing, visualization, and supervision. VA: conceptualization, investigation, writing – review and editing, visualization, and supervision. EH: conceptualization, investigation, writing – review and editing, visualization, and supervision. JL: conceptualization, investigation, writing – review and editing, and visualization. LM: software, formal analysis, investigation, resources, data curation, writing – review and editing, and project administration. SMH: conceptualization, investigation, writing – review and editing, and project administration. LK investigation, resources, writing – review and editing, visualization, and project administration. SE: conceptualization, investigation, and writing – review and editing. AK: conceptualization, investigation, and writing – review and editing. CW: conceptualization, methodology, investigation, writing – review and editing, and supervision. DDH: conceptualization, investigation, methodology, writing – review and editing, supervision, and project administration. ZH: conceptualization, methodology, validation, investigation, writing – review and editing, supervision, and project administration. KB: conceptualization, resources, data curation, and writing – review and editing. AG: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing – review and editing, visualization, supervision, and project administration. All authors read and approved the final manuscript.