Höller, Martina
Steindl, Hubert
Abramov-Sommariva, Dimitri
Kleemann, Julia
Loleit, Alexey
Abels, Christoph
Stute, Petra http://orcid.org/0000-0002-5591-1552
Funding for this research was provided by:
Bionorica SE, Germany
University of Bern
Article History
Received: 23 September 2023
Accepted: 24 December 2023
First Online: 23 February 2024
Declarations
: The study was conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value and rigor and follow generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice (GEP) guidelines issued by the International Epidemiological Association (IEA), Good Practices for Outcomes Research issued by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), International Ethical Guidelines for Epidemiological Research issued by the Council for International Organizations of Medical Sciences (CIOMS).
: Martina Höller, Hubert Steindl, Dimitri Abramov-Sommariva, Julia Kleemann and Christoph Abels are employees of Bionorica SE; Alexey Loleit is an employee of Traverse Health Europe B.V. and was an employee of Data Matrix GmbH during the conduct of the study. Petra Stute has received honoraria as a speaker at conferences.
: The study was approved by the Independent Ethics Committee PharmNadzor LLC, Saint Petersburg, Russia on May 26th 2022 (document number: Extract#7 from the minutes of the meeting #324).
: Verbal informed consent was obtained prior to the QoL interview. No informed consent was required for other data collected due to the retrospective nature of the study with fully anonymized data.