- Participants who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions include significant gastrointestinal, cardiovascular, vascular disease, pulmonary/respiratory, hepatic impairment, renal, metabolic diseases, endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.