- Patients with clinically significant abnormal baseline laboratory values (hematology, blood chemistry or urinalysis) which define a disease or condition, which in the opinion of the investigator may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate and complete the study. Should there be a laboratory value which, upon initial screening, is substantially outside the normal range, the test should be repeated.