 - Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunologic, or cardiovascular diseases eg, myocardial infarction within previous month, ventricular arrhythmia recent severe heart insufficiency, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, and untreated endocrine disorders; 