 9. Severe comorbidities diabetes mellitus requiring insulin; CHF of any severity or myocardial infarction or cerebrovascular accident or transient ischemic attack within 3 months of screening visit; unstable angina pectoris, uncontrolled hypertension sitting systolic BP 80 mm Hg or 160 or diastolic BP 100 mm Hg, oxygen-dependent severe pulmonary disease, history of cancer within 5 years other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer 