Voss, Annemarie http://orcid.org/0000-0001-8109-1108
Smits, Elisabeth http://orcid.org/0000-0003-1882-4748
Swart, Karin M. A. http://orcid.org/0000-0003-2521-5780
Balabanova, Yanina http://orcid.org/0000-0002-5065-4788
Brobert, Gunnar http://orcid.org/0000-0002-7446-9851
Suzart-Woischnik, Kiliana http://orcid.org/0000-0002-3189-6378
Herings, Ron M. C. http://orcid.org/0000-0002-2561-8734
Schink, Tania http://orcid.org/0000-0002-0224-1866
Haug, Ulrike http://orcid.org/0000-0002-1886-2923
Funding for this research was provided by:
Pharmaceuticals Bayer
Article History
Accepted: 13 December 2022
First Online: 1 February 2023
Declarations
:
: These studies were funded by Bayer AG, Berlin, Germany.
: AV, TS and UH work for the Leibniz Institute for Prevention Research and Epidemiology—BIPS, an independent, non-profit research institute, which performs amongst others financially supported studies for government and related healthcare authorities and pharmaceutical companies; RH, LS and KS-P work for the PHARMO Institute for Drug Outcomes Research, an independent research institute which performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies; YB and KS-W are employees of Bayer AG; GB was an employee of Bayer AB at the time the study programme was conducted. This post-authorization safety study (PASS) was requested by the EMA, financed by Bayer AG and performed in line with the ENCePP Code of Conduct.
: Approval of individual study protocols has been granted by the appropriate research ethics committees and regulatory authorities. All studies are registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) electronic register and/or the ClinicalTrials.gov website. All of the studies were conducted in collaboration with ENCePP centres and in accordance with Good Pharmacoepidemiology Practices [CitationRef removed].
: 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 German Pharmacoepidemiological Research Database. In accordance with German data protection regulations, access to the data is granted only to employees of the Leibniz Institute for Prevention Research and Epidemiology—BIPS 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.
: All authors contributed to the study conception and design or the data acquisition. The first draft of the manuscript was written by AV and UH. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.