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Authors
Wentzell, Nadine https://orcid.org/0000-0002-2983-0222
Kollhorst, Bianca https://orcid.org/0000-0001-5964-954X
Reinold, Jonas https://orcid.org/0000-0001-8266-2574
Haug, Ulrike https://orcid.org/0000-0002-1886-2923
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Funding
Funding for this research was provided by:
Bundesinstitut für Arzneimittel und Medizinprodukte (V-18281/ 68605 / 2019-2020)
Leibniz-Institut für Präventionsforschung und Epidemiologie – BIPS GmbH
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Article History
Accepted: 14 November 2022
First Online: 21 December 2022
Declarations
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: The study was funded by the German Federal Institute for Drugs and Medical Devices, Bonn (BfArM, V-18281/68605/2019-2020). Open Access funding enabled and organized by Projekt DEAL.
: Nadine Wentzell, Bianca Kollhorst, Jonas Reinold, and Ulrike Haug are working at an independent, non-profit research institute, the Leibniz Institute for Prevention Research and Epidemiology - BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorization safety studies requested by health authorities. The design and conduct of these studies as well as the interpretation and publication are not influenced by the pharmaceutical industry. The study presented was not funded by the pharmaceutical industry and was performed in line with the ENCePP Code of Conduct.
: In Germany, the utilization of health insurance data for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the German Federal Office for Social Security and the Senator for Health, Women and Consumer Protection in Bremen as their responsible authorities approved the use of GePaRD data for this study. Informed consent for studies based on claims data is required by law unless obtaining consent appears unacceptable and would bias results, which was the case in this study. According to the Ethics Committee of the University of Bremen, studies based on GePaRD are exempt from an institutional review board review.
: Not applicable.
: Not applicable.
: As we are not the owners of the data, we are not legally entitled to grant access to the data of the GePaRD. In accordance with German data protection regulations, access to the data is granted only to BIPS employees on the BIPS premises and in the context of approved research projects. Third parties may only access the data in cooperation with BIPS and after signing an agreement for guest researchers at BIPS.
: Not applicable.
