 - Women of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices. This applies since signing of the informed consent form until 30 5 days after the last study drug administration. 