 3. Pregnancy, intention to become pregnant or failure to agree to use adequate contraceptive measures during the trial for females of current reproductive potential.Medically acceptable contraceptives include: 1 surgical sterilization such as tubal ligation or hysterectomy, 2 approved hormonal contraceptives pills, patches, implants, or injections, 3 barrier methods condom, diaphragm used with spermicide, or 4 intrauterine device IUD. Contraceptive measures such as Plan BTM, for emergency use after unprotected sex, are not acceptable methods for routine use. A lifestyle of abstinence from sexual activity is an acceptable means of contraception. If currently abstinent, the subject must agree to use a double-barrier method as described above if they become sexually active during the study period. 