Slingerland, P.
van Hunsel, Florence P. A. M. http://orcid.org/0000-0001-8965-3224
Lieber, T.
van Balveren, L. http://orcid.org/0000-0002-3815-9434
Duijster, J. W. http://orcid.org/0000-0002-9197-9079
Article History
Accepted: 20 September 2023
First Online: 26 October 2023
Declarations
:
: No funding was received for this study.
: The authors declare no relevant conflicts of interest.
: All data relevant to the study are included in the article or uploaded as Supplementary Information. The datasets for this manuscript are not publicly available because of the data protection policy of the Pharmacovigilance Centre Lareb. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.
: The SQL statements for the data used in this article are not publicly available because of the data protection policy of Lareb. Requests to access the datasets should be directed to the corresponding author and will be granted on reasonable request.
: L.v.B. designed the original cohort event monitoring (CEM) studies and performed data collection and cleaning. P.S., J.D., and F.v.H. designed the study part covering analysis of the total cohort data. J.D. and T.L. performed data aggregation, and L.v.B. and P.S. performed data preparation and preanalysis data coding. P.S. performed statistical data analysis and original draft preparation. All authors contributed to the article and approved the submitted version.
: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
: If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the central committee on research involving human subjects (CCMO). This study was deemed not to fall under the WMO act. The observational study was conducted in compliance with the Methodological Standards for ENCePP Study Protocols and Dutch national laws and regulations. The Netherlands Pharmacovigilance Centre Lareb is registered at the Dutch Data Protection Authority (College Bescherming Persoonsgegevens) under registration numbers 1315581 and 1315591. On the study website, background information about the study and a statement regarding the protection of the privacy of the participants involved is mentioned. Participants are informed that their data will be used for the purpose of the research and publication of study results. Informed consent is given upon participant’s registration on the study website.
: Not applicable.