- Laboratory values (haematology, biochemistry, urine tests) outside the normal ranges, unless considered not to be clinically relevance by the Investigator. Hemoglobin must be greater than 12g/dl at visits 1, 3 and 4. If the hemoglobin is <12g/dl the visit can be rescheduled within 2 weeks at the discretion of the investigator/physician and the hemoglobin measurement repeated at the subsequent visit;