 - Serious concurrent illness medical or psychiatric, uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow or congestive heart failure condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body not under medical control, or any uncontrolled medical condition for example: uncontrolled diabetes, including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study 