FCBP must agree to ongoing pregnancy testing Agree to ongoing pregnancy testing during the course of the study as outlined in the PPRMP. Females of childbearing potential (FCBP) must agree to pregnancy testing and to practice contraception Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. Male subjects must agree to practice contraception Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within hours prior to the initiation of the study and they must agree to ongoing pregnancy testing and to practice contraception Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception Females of child-bearing potential must agree to ongoing pregnancy testing and to practice contraception as directed Females of childbearing potential must also agree to ongoing pregnancy testing agree to ongoing pregnancy testing Females of childbearing potential (FCBP) must agree to a pregnancy test at study enrollment and to practice contraception during the study Females of childbearing potential must have a negative pregnancy test and agree to ongoing pregnancy testing and to practice contraception; (birth control methods should be determined in consultation with the investigator) FCBP must also agree to ongoing pregnancy testing Females of childbearing potential (FCBP) must undergo pregnancy testing based on the frequency outlined in the Pregnancy Prevention Risk Management Plan (PPRMP) and pregnancy results must be negative. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception or abstain from heterosexual intercourse Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception FCBP must also agree to ongoing pregnancy testing (weekly for the first four weeks and then every days while on therapy and at discontinuation of treatment)