Ethics declarations
Written informed consent was obtained from all patients and/or their legal guardians before inclusion into the EuroNet-PHL-C2 trial. The trial was performed in accordance with good clinical practice and the Declaration of Helsinki. The Ethics Committee of the Medical Faculty of the University of Leipzig which is registered as Institutional Review Board (IBF) at the Office of Human Research Protections (OHRP) approved the evaluation presented here (498/17-ek).