 - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are: women whose career, lifestyle or sexual orientation precludes intercourse with a male partner, at the judgment of the investigator; women who have been surgically sterilized or whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control i.e. one that results in a less than 1 per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices IUDs. Double barrier and periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods are not acceptable means of contraception; A woman who is postmenopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural sp ntaneous amenorrhea with an appropriate clinical profile e.g. age appropriate, history of vasomotor symptoms or six months of spontaneous amenorrhea with known or reported serum FSH levels 40 mIUmL or have had surgical bilateral oophorectomy with or without hysterectomy at least six weeks before. In the case of oophorectomy alone, women are considered post-menopausal only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 