 7. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal ULN and alkaline phosphatase ALP, alanine aminotransferase ALT, and aspartate aminotransferase AST less than or equal to 3 times the ULN in the case of liver metastasis less than or equal to 5 times ULN. In the case ALP greater than 3 times the ULN in the absence of liver metastasis or greater than 5 times the ULN in the presence of liver metastasis, and the participant was also known to have bone metastasis, the liver specific ALP were separated from the total and used to assess the liver function instead of the total ALP 