 - Patients with the following comorbidities who may not be healthy enough to successfully complete all protocol requirements or in whom results may be particularly difficult to assess: Concurrent severe congestive heart failure NYHA Classes III and IV; Life-threatening ventricular arrhythmias, unstable angina characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration, andor myocardial infarction within 4 weeks before enrollment; Coronary artery bypass grafting or percutaneous coronary intervention within 3 months before enrollment; A renal andor carotid revascularization procedure within 1 month of enrollment; Transient ischemic attack within 3 months before enrollment; Deep vein thrombosis within 3 months before enrollment; Severe chronic obstructive pulmonary disease room air arterial PO2 60 mmHg or PCO2 50 mmHg, or abnormal pulmonary function tests FEV1 1.2 Lsec; Thrombocytopenia defined as platelet count 100,000mm3; Undergoing hemodialysis; Patients with immunocompromised conditions, organ transplant recipients andor need for immunosuppressive therapy; Neurological dementia i.e., Alzheimers Disease; Hemorrhagic stroke 