 6. Evidence of post-menopausal status or negative urineserum pregnancy test for nonmenopausal female patients Women will be considered postmenopausal if they are amenorrheic for 1 year or more without an alternative medical cause. The following age-specific requirements apply: i Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 1 year or more following cessation of exogenous hormonal treatments and with Luteinizing hormone LH and Follicle stimulating hormone FSH levels in the post-menopausal range. 