Study design
Ethik-Kommission Albert-Ludwigs-Universität
This is an open-label, multicenter, randomized phase III trial with two parallel arms. The study design was approved by the leading ethics committee (Ethik-Kommission Albert-Ludwigs-Universität Freiburg, Germany) and the local ethics committees of the participating centers. The protocol was also subject to authorization by the competent authorities as mandatory by federal law. All participants have to provide written informed consent. The trial was assigned the EudraCT number 2020-001181-10 and is registered at German clinical trials registry (DRKS00024085, registration date March 29th, 2023).