Patient education and written informed consent
EVENT
All consecutive patients were screened for potential inclusion by the investigator at the respective participating centres. Eligible patients are asked for informed consent. Before randomization, each patient will be informed by authorized investigators about the nature, objectives, expected benefits, and potential risks of the trial. Each patient must declare his or her willingness to participate in the study verbally and in writing after being informed in a manner that he or she can understand. Each patient must be informed that he or she is allowed to withdraw their informed consent verbally or in written form at any time without receiving any reprisals or disadvantages. In the event of revocation of the declaration of consent, the data stored up to this point in time will continue to be used without naming a name if this is necessary to evaluate the effects of the investigational product and to ensure that the interests of the person concerned worthy of protection are not impaired.