Ethics approval and consent to participate
ICH
ADVERSE EVENTS
This study is conducted in agreement with either the Declaration of Helsinki (in its current version) or the laws and regulations in its current version. The protocol was written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice. The protocol is approved by the independent ethics committee of the faculty for medicine from the Technische Universität Munich. Before a patient can participate in the trial, he must provide written informed consent. All patients will be informed about the aims of the trial, the possible adverse events and benefits, the procedures and possible risks, the treatment, alternative treatments and the insurance protection.