 - Clinically relevant abnormal findings in the clinical history, physical examination, electrocardiogram ECG, or laboratory tests at the screening assessment that would interfere with the objectives of the study or that would, in the investigators opinion, preclude safe completion of the study. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection such as hepatitis B or C, acute systemic infections defined as patients undergoing treatment with antibiotics, gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury. 