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Clin Epidemiol. 2015;7:491\u2013508.","journal-title":"Clin Epidemiol"}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01519-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-025-01519-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01519-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T17:37:29Z","timestamp":1744220249000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-025-01519-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,6]]},"references-count":43,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["1519"],"URL":"https:\/\/doi.org\/10.1007\/s40264-025-01519-8","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,6]]},"assertion":[{"value":"19 January 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 February 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"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.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"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 \u201c<5\u201d for results. So that the masked number cannot be calculated, further results have been masked and indicated as not permissible.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"AKE: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing \u2013 original draft, writing \u2013 review and editing, visualization, and project administration. LCT: conceptualization, methodology, software, investigation, resources, data curation, writing \u2013 review and editing, and supervision. TMK: conceptualization, methodology, software, investigation, resources, data curation, and writing \u2013 review and editing. MSK: conceptualization, methodology, software, investigation, resources, data curation, and writing \u2013 review and editing. SK: methodology, software, resources, writing \u2013 review and editing, and visualization. FRH: methodology, software, resources, and writing \u2013 review and editing. NQ: conceptualization, investigation, writing \u2013 review and editing, visualization, and supervision. VA: conceptualization, investigation, writing \u2013 review and editing, visualization, and supervision. EH: conceptualization, investigation, writing \u2013 review and editing, visualization, and supervision. JL: conceptualization, investigation, writing \u2013 review and editing, and visualization. LM: software, formal analysis, investigation, resources, data curation, writing \u2013 review and editing, and project administration. SMH: conceptualization, investigation, writing \u2013 review and editing, and project administration. LK investigation, resources, writing \u2013 review and editing, visualization, and project administration. SE: conceptualization, investigation, and writing \u2013 review and editing. AK: conceptualization, investigation, and writing \u2013 review and editing. CW: conceptualization, methodology, investigation, writing \u2013 review and editing, and supervision. DDH: conceptualization, investigation, methodology, writing \u2013 review and editing, supervision, and project administration. ZH: conceptualization, methodology, validation, investigation, writing \u2013 review and editing, supervision, and project administration. KB: conceptualization, resources, data curation, and writing \u2013 review and editing. AG: conceptualization, methodology, software, validation, formal analysis, investigation, resources, data curation, writing \u2013 review and editing, visualization, supervision, and project administration. All authors read and approved the final manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}