Females who are pregnant or lactating, fertile males, or females of child-bearing potential who are not willing to comply with an effective double method of birth control are NOT eligible for participation Females of child-bearing potential and sexually-active males must consent to follow acceptable birth control methods to avoid contraception while on treatment Sexually active females of childbearing potential and males with partners of child bearing potential must agree to use birth control Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (