Who will take informed consent? {26a}
Every participant must give written consent before participating in the clinical trial.An investigator will provide and obtain the informed consent form. Therein, the investigator will thoroughly inform the participant in oral and written form in an understandable manner for the patient about the character, importance, relevance, and consequences of the clinical trial. Before the participant may sign the informed consent form, there will be ample opportunity to consider participation and discuss questions with the investigators. The informed consent file must be signed and dated by the participant and the investigator and stored in the investigator site file. Nevertheless, if the participant decides not to participate any time before the intervention, he will not be included without negative impacts on the procedure.