Paal, Michael
Habler, Katharina
Ewert, Alice
Vogeser, Michael
Grosse, Leonie
Lieftüchter, Victoria
Tauber, Simone C.
Schiefer, Johannes
Allartz, Petra
Tappe, Dennis
Pörtner, Kirsten https://orcid.org/0000-0001-8191-8056
Funding for this research was provided by:
Robert Koch-Institut
Article History
Received: 26 March 2025
Revised: 21 July 2025
Accepted: 26 August 2025
First Online: 4 October 2025
Declarations
:
: Our investigation was performed in the context of an individual treatment attempt according to the Declaration of Helsinki, Article 37. Ethics approval is unnecessary within individual treatment attempts (§40 Arzneimittelgesetz, AMG), since German Pharmaceuticals Act (AMG) does not apply. Ethical clearance for the additional retrospective analysis of the patients´ clinical files was obtained from the Medical Board of Hamburg (no. PV5616). Both legal guardians had agreed by written informed consent concerning the individual treatment attempt and, later on, the retrospective therapeutic drug monitoring of stored samples. Written informed consent was also obtained for the anonymous publication of the results.
: The authors declare no competing interests.