 5. If female, is not of childbearing potential defined as premenarchal or if of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Study Day 1, if the Screening visit and Day 1 are not on the same day, and must use medically acceptable methods of birth control as listed below and agrees to continue its use throughout the study:1 hormonal methods e.g., oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full menstrual cycle before study drug administration, 2 Total abstinence from sexual intercourse since the last menses before study drug administration, 3 intrauterine device, 4 double-barrier method e.g., condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. 