- All sexually active women of childbearing potential must agree to use two forms of highly effective method of contraception from the Screening Visit throughout the study period and for 99 days following the last dose of study drug. If using hormonal agents the same method must have been used for at least 1 month before study dosing and subjects must use a barrier method as the other form of contraception. Lactating women must agree to discontinue breast feeding before study investigational medicinal product administration