 - A male who is sexually active must use a condom as part of a method of highly effective contraception eg, condom spermicide, and an additional contraceptive method used by the partner during sexual intercourse with a women of childbearing potential for the duration of the study period up to the end-of-study visit and should not father a child in this period. Male patients also have to agree not to donate sperm for the duration of the study until the end-of-study visit. 