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Article History

Received: 4 November 2022

Accepted: 22 March 2023

First Online: 1 April 2023

Declarations

:

: In the Netherlands, the Medical Research Involving Human Subjects Act (Wet Medisch wetenschappelijk onderzoek met mensen, WMO [CitationRef removed]) came into force since 1998. All medical scientific research in which human participants are subjected to (medical) procedures or are required to follow rules of behaviour, falls under the scope of this Act. All other research with humans (e.g. research with medical data or interviews) is not subject to the WMO, and does not require approval by an accredited independent committee of experts [CitationRef removed]. According to this legislation, neither obtaining informed consent nor approval by a medical ethics committee is obligatory for this kind of observational studies [CitationRef removed–CitationRef removed]. Because this study does not subject participants to (medical) procedures or rules of behaviour, this study was never assessed by a medical ethical committee. Patients were never directly assessed by the researchers; patients’ characteristics were obtained by surveying GPs. General practices that participate in Nivel Primary Care Database signed a contract by which they provided written informed consent for participating in research. In addition, they are contractually obliged to inform their patients about their participation in Nivel Primary Care Database, and about the option to opt-out if patients do not wish to include their data in the database [CitationRef removed]. The study design and procedures were discussed and approved in the Sentinel Practices and Surveillance Advisory Board Meeting of 11 October 2016, NZR064-111016 (meeting report). This study was conducted in accordance with relevant guidelines and the WMA Declaration of Helsinki.

: Not applicable.

: The authors declare they have no competing interests.