 14. Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause or have been sterilized surgically ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy.If a patient of childbearing potential is neither surgically sterile nor postmenopausal, contraceptive measures must start either prior to or at Screening and continue throughout the entire study period and for 5 months after the last dose of Test Article is administered. Pregnant andor lactating females are excluded 