Ethics
This international study will be conducted in Belgium, Germany, Hungary and Spain. Study sponsor is the University of Leipzig, Germany. The study protocol has been already approved by both the leading Ethics Committees (EC) and Health Authorities in Germany, Hungary and Spain as well as the responsible Health Authority in Belgium. The investigator is responsible for ensuring that no patient is subject to any study-related examination or activity before that patient has given written informed consent, after the receipt of detailed information. The investigator will inform the patient of the aims, methods, anticipated benefits and potential hazards of the study including any discomfort it may entail. This information will be summarized in integrated patient information and consent sheets. The study has been registered on the EudraCT database (EudraCT number 2010-023992-24) and at ClinicalTrials.gov (NCT01541605). The trial will be conducted in accordance with the latest version of the Declaration of Helsinki and the International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines for clinical trials.