Further also in the 2nd Cohort the first 6 patients of the 2nd cohort will be enrolled in a step-wise manner. The first step is the enrolment of 1 patient followed by an observation period of 1 week, thereafter enrolment of 2 patients followed by an observation period of 1 week thereafter enrolment of 3 patients followed by an observation period of 1 week. The sponsor will evaluate the adverse events following every enrolment step and initiate the enrolment of the next enrolment step. After 6 patients enrolled in that way the subsequent enrolment can be performed without further restrictions.