- Subject has acceptable haematological and biochemical function, in the opinion of the investigator, as demonstrated by appropriate laboratory parameter levels including liver and renal function (estimated glomerular filtration rate as measured by the Cockcroft-Gault formula >0.5 lower limit of normal, aspartate aminotransferase/alanine aminotransferase <2.5 the upper limit of normal (ULN) and bilirubin <1.5 ULN), and in the opinion of the investigator, acceptable bone marrow reserve.