Ethics approval and consent to participate
ThIlo
The ThIlo trial has been conducted in accordance with Good Clinical Practice guidelines and the guiding principles of the Declaration of Helsinki. The trial was approved by the Institutional Review Board of the Research Ethics Committee of the University of Tübingen (899/2018AMG1) and the corresponding ethical review boards of all the participating centers. The trial was approved by the Federal Institute for Drugs and Medical Devices (BfArM, EudraCT No. 2016-003168-37) and registered at clinicaltrials.gov (NCT03111212). Each patient or legal representative, respectively, was informed of the modalities of the clinical study in accordance with the provided patient information. It was made clear that consent could be withdrawn at any time without giving reasons and without any negative consequences for the patient. Informed consent was obtained from the patient using a form approved by the Ethics Committee (EC) of the University of Tübingen or the local EC if the patient was treated in a collaborating institution. The patient or their legal representative and physician/investigator personally signed an informed consent form with an integrated declaration on data privacy protection.