 - Any clinically relevant abnormal laboratory value FSH 25 miuml, renal function, greater than two times normal value, hepatic function greater than two times normal value, blood biochemistry, hematology elevated white blood count greater than 1.5 times the normal value, hemoglobin 10mgdL, thrombocytopenia, abnormal cholesterol profile total cholesterol 300mgdL, abnormal LDL greater than 2 times normal value, based on a fasting sample during the screening phase 