Observational Study Template

May 28, 2014 · Total bilirubin> 2.0 times the upper limit of normal. Hemoglobin < 9 gm/dL. White blood cell count< 3,000/ mm3. Platelet count< 100,000/mm3. Pregnant or lactating females. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. ................
................