Females who are of childbearing potential must be using a reliable method of contraception at the time they agree to study participation and must agree to continue using a reliable method of contraception include hormonal products (e.g. approved oral contraceptives or long-term injectable or implantable contraceptives), double barrier methods (e.g. condom plus diaphragm; condom plus spermicidal foam; condom plus spermicidal sponge). an intra-uterine device or tubal ligation.