Dubrall, Diana http://orcid.org/0000-0002-8763-051X
Leitzen, Sarah http://orcid.org/0000-0002-1207-4168
Toni, Irmgard http://orcid.org/0000-0002-0089-1494
Stingl, Julia http://orcid.org/0000-0002-1566-8156
Schulz, M.
Schmid, Matthias http://orcid.org/0000-0002-0788-0317
Neubert, Antje http://orcid.org/0000-0001-6575-1452
Sachs, Bernhardt http://orcid.org/0000-0001-8260-0891
Funding for this research was provided by:
Joint Federal Committee - Innovation Fund (01NVF16021)
Federal Institute for Drugs and Medical Devices and University Hospital of Bonn (IV-16703/68502/2016-2020)
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Article History
Received: 27 October 2020
Accepted: 6 September 2021
First Online: 7 October 2021
Declarations
:
: The study had been approved by the local ethics committee of the Medical Faculty of Bonn (009/17). Consent to participate was not applicable. The Federal Institute for Drugs and Medical Devices (BfArM) as a national competent authority is granted with the highest level of access to EudraVigilance since one of the core duties of the BfArM is to analyse EudraVigilance data in order to fulfill its pharmacovigilance obligations.
: Not applicable.
: The authors declare that they have no competing interests.