Document is current

Article History

Received: 4 October 2023

Accepted: 2 January 2024

First Online: 23 January 2024

Declarations

:

: Oliver Scholle, Jost Viebrock, 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. 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. Lotte Rasmussen participates in a regulator-mandated phase IV-study funded by Novo Nordisk with funds paid to the institution where she is employed (no personal fees) and with no relation to this study. Mette Reilev declares no conflicts of interest.

: According to Danish legislation, approval from an ethics Committee is not required for registry-based studies. The study was approved by the Danish Data Protection Agency (11.106). 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 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.