Alibone, M.
Ludwig, M.
Obermüller, D.
Pawlowska-Phelan, D.
Norris, R.
Jacob, J.
Article History
Received: 6 January 2026
Accepted: 10 June 2026
First Online: 18 June 2026
Declarations
:
: The present study was conducted using the anonymized InGef research database, which ensures that individual patients, health insurance companies, and healthcare providers cannot be identified and comply with German data protection regulations and federal law. More precisely, Recital 26 of the EU general data protection regulation (referring to the EU General Data Protection Regulation Article 2 and 4) states that the data protection law does not apply to anonymized data and the data can thus be processed for statistical or scientific purposes. Consequently, the current guidelines for epidemiological studies based on routine data (Gute Praxis Sekundärdatenanalyse, Gesundheitswesen 2005, DOI: ; Gute epidemiologische Praxis, Gesundheitswesen 2000, DOI: ) do not require submission to an institutional review board or medical ethics committee; therefore, formal ethics approval and informed consent were not required. The study used fully anonymized data and therefore did not involve human subjects as defined by the Declaration of Helsinki. All procedures complied with the ethical principles for research using health-related data.
: Not applicable.
: The authors declare no competing interests.