Composition of the coordinating center and trial steering committee {5d}
The coordinating center consists of the principal coordinating investigator (PCI) (CR, sponsor representative, Friedrich-Schiller-University Jena, Germany), the co-principal coordinating investigator (AZ), the trial manager (SP), the statistician (PF), the data and safety management team (center for clinical studies Jena (ZKS Jena), Jena University Hospital, Germany), and the monitoring team (Coordinating Center for Clinical Studies Halle (KKS Halle), Martin Luther University Halle, Germany). The principal coordinating investigator and co-principal coordinating investigator together with the independent data and safety monitoring board (DSMB) assume the role of the trial steering committee.