Bell, Max https://orcid.org/0000-0001-7464-0324
Ekbom, Anders https://orcid.org/0000-0001-6674-5003
Linder, Marie https://orcid.org/0000-0003-2619-2189
Funding for this research was provided by:
Karolinska Institute
Article History
Received: 10 August 2022
Accepted: 12 January 2023
First Online: 28 January 2023
Declarations
:
: ML is an employee of the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies. MB has received research grants from Baxter Medical and has had speaker assignments from Fresenius Medical, Astute Medical and Baxter Medical, all outside the current work. AE has received grants from Bayer outside the current work.
: The study was granted ethical permission by the Swedish Ethical Review Authority (registration number 2020–03,631 [amendment] to 2013/1850–31/1 [original]).
: Data cannot be shared due to Swedish legislation concerning secrecy.
: The lead author Max Bell affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
: To be provided if accepted.
: Informed consent is not required for register-based research in Sweden. The ethical approval and the data holders’ secrecy assessments cover this aspect, see Ludvigsson JF, Håberg SE, Knudsen GP, Lafolie P, Zoega H, Sarkkola C, von Kraemer S, Weiderpass E, Nørgaard M. Ethical aspects of registry-based research in the Nordic countries. Clin Epidemiol. 2015 Nov 23;7:491–508. . PMID: 26,648,756; PMCID: PMC4664438.