 - Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure NYHA Class 3 or 4; unstable angina; cardiac arrhythmia; recent within the preceding 6 months myocardial infarction or stroke; hypertension requiring 2 medications for adequate control; diabetes mellitus with 2 episodes of ketoacidosis in the preceding 12 months 