The primary endpoint of the study is safety which will be evaluated according to the following parameters:  Adverse event monitoring - AEs and SAEs  Physical examination  Vital sign monitoring (blood pressure, pulse rate, temperature, respiratory rate)  Oxygen saturation  Safety lab including coagulation

The primary endpoint of the study is safety which will be evaluated according to the following parameters:  Adverse event monitoring - AEs and SAEs  Physical examination  Vital sign monitoring (blood pressure, pulse rate, temperature, respiratory rate)  Oxygen saturation  Safety lab including coagulation