Ethics approval and consent to participate
The study was approved by institutional review boards and independent ethics committees at each center (leading ethics committee: ethics committee at the medical faculty of the University of Bonn) and conducted in accordance with all local legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Pts, Guidelines for Good Clinical Practice and the Declaration of Helsinki. All pts provided written informed consent at study inclusion.