Reinold, Jonas http://orcid.org/0000-0001-8266-2574
Kollhorst, Bianca http://orcid.org/0000-0001-5964-954X
Temme, Hellen L. http://orcid.org/0000-0001-9558-3939
Wentzell, Nadine http://orcid.org/0000-0002-2983-0222
Haug, Ulrike http://orcid.org/0000-0002-1886-2923
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
Article History
Accepted: 2 October 2023
First Online: 31 October 2023
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. The study was funded by the German Federal Institute for Drugs and Medical Devices, Bonn (BfArM, V-18281/ 68605 / 2019-2020) (ExternalRef removed). The study proposal was submitted by UH. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
: Jonas Reinold, Nadine Wentzell, Bianca Kollhorst, 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 (PASS) 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. All authors have declared that no competing interests exist.
: 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 institutional review board review.
: JR and UH: study concept and design, analysis and interpretation of data, drafting of the manuscript, critical revision of manuscript. BK: data management and statistical analysis, critical revision of manuscript. HLT: critical revision of manuscript. NW: interpretation of data, critical revision of manuscript. The final version of the manuscript was approved by all authors.
: As we are not the owners of the data we are not legally entitled to grant access to the data of the German Pharmacoepidemiological Research Database. 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.
: Not applicable.
: Not applicable.