In the initial phase of the study 6 patients of the 1st Cohort will be treated step-wise and observed for 21 days according to a pre-specified enrolment plan. The first step is the enrolment of 1 patient followed by an observation period of 21 days, thereafter enrolment of 2 patients followed by an observation period of 21 days thereafter 3 patients followed by an observation period of 21 days. The sponsor will evaluate the adverse events and laboratory data 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.