 - In the opinion of the Investigator, has a history of pulmonary, cardiovascular including uncontrolled hypertension, neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patients well being by participation in this study or is mentally or emotionally unsuitable to participate, or unableunwilling to comply with the study assessments. 