11. Continued from Inclusion # 10. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. b) Child-bearing potential and agrees to use one of the contraception methods listed in Inclusion # 12 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 4 weeks after the last dose of study medication, and must have a negative serum or urine pregnancy test within 14 days prior to the start of dosing.