 2. Alkaline phosphatase ALP, alanine aminotransferase ALT, and aspartate aminotransferase AST 3 x ULN 5 x ULN if participant has liver metastases. If ALP is 3 x ULN in the absence of liver metastases or 5 x ULN in the presence of liver metastases AND participants are also known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. 