 - Irregular menstrual periods and on hormone replacement therapy HRT, with a documented serum follicle stimulating hormone FSH level 35 mIUmL Women who are using oral contraceptives, other hormonal contraceptives vaginal products, skin patches, or implanted or injectable products, or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy, or are practicing abstinence or where their partner is sterile eg, vasectomy should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test minimum sensitivity 25 IUL or equivalent units of human chorionic gonadotrophin HCG within 72 hours prior to the start of investigational product IP. Sexually active fertile men with partners of childbearing potential must use an approved barrier method of contraception while on study and until at least 3 months after the last dose of IP. 