 3. Females of child bearing potential must not be pregnant or lactating at Screening and Randomization as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlUmL or equivalent units of human chorionic gonadotropin. Women of childbearing potential must agree to the use of a reliable method of contraception e.g., total abstinence, IUD, a double-barrier method such as condom plus diaphragm with spermicide, oral, transdermal, injected or implanted non- or hormonal contraceptive, throughout the study. A sterile sexual partner is not considered an adequate form of birth control. 