 6. Subjects with clinically important disease, as judged by the investigator, within 3 months of the study eg, significant laboratory test abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases scleroderma, systemic lupus erythematous, systemic infection, uncontrolled diabetes, etc., including those with medical conditions that might require the use of immunosuppressive medications during the trial eg, severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc. 