Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least months after the last dose of study drug. Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Women of childbearing potential must have a negative serum pregnancy test performed within days prior to the start of study drug; post-menopausal women (defined as no menses for at least year) and surgically sterilized women are not required to undergo a pregnancy test; subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate but is generally defined as a hormonal or barrier method of birth control, or abstinence Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months for both females and males after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least days after the last dose of study drug; contraception can be either abstinence of penetrative intercourse, condom use, or prior vasectomy Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least weeks after the last dose of study drug Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least months after the last dose of study drug Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Patients (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate. Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the consent form until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n** NOTE: men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the consent form until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate. Subjects of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least months after the last dose of study drug; highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) by both sexes Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by both sexes Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at registration until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator Willingness to use adequate methods of contraception beginning at the signing of the ICF until at least days after the last dose of study drug Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate