Total bilirubin < . x upper limit of normal (ULN) if no liver metastases or =< times ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinaemia) or liver metastases within weeks before randomization Alanine aminotransferase (ALT) > . times the upper limit of normal (ULN) if no demonstrable liver metastases, or > times ULN in presence of liver metastases Aspartate aminotransferase (AST) > . times ULN if no demonstrable liver metastases, or > times ULN in presence of liver metastases Total bilirubin < . times the upper limit of normal (ULN) if no liver metastases or < times the ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinemia) or liver metastases Total bilirubin < . times the upper limit of normal (ULN) if no liver metastases or < times the ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinemia) or liver metastases Alanine aminotransferase > . times the upper limit of normal (ULN) if no demonstrable liver metastases or > times the ULN in the presence of liver metastases. Aspartate aminotransferase > . times the ULN if no demonstrable liver metastases or > times the ULN in the presence of liver metastases. Total bilirubin > . times the ULN if no liver metastases or > times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases. ALT and/or AST >. times the upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of liver metastases Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < . times upper limit of normal (ULN) if no demonstrable liver metastases or < times ULN in the presence of liver metastases obtained =< days prior to study initiation Total bilirubin < . times ULN if no liver metastases or < times ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinaemia) or liver metastases obtained =< days prior to study initiation Bilirubin =< X ULN or < X ULN in the presence of liver metastases Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >. times the upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of liver metastases Total bilirubin >. times ULN if no liver metastases or times ULN in the presence of liver metastases or documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) Total bilirubin > . times the upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of documented Gilberts syndrome or liver metastases Alanine aminotransferase (ALT) >. times the upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of liver metastases Aspartate aminotransferase (AST) >. times ULN if no demonstrable liver metastases or > times ULN in the presence of liver metastases Alanine aminotransferase > . times the upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of liver metastases Aspartate aminotransferase > . times ULN if no demonstrable liver metastases or > times ULN in the presence of liver metastases Total bilirubin > . times ULN if no liver metastases or > times ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinemia) or liver metastases Alanine aminotransferase > . times upper limit of normal (ULN) if no demonstrable liver metastases or > times ULN in the presence of liver metastases; aspartate aminotransferase > . times ULN if no demonstrable liver metastases or > times ULN in the presence of liver metastases Total bilirubin > . times ULN if no liver metastases or > times ULN in the presence of documented Gilberts syndrome (unconjugated hyperbilirubinemia) or liver metastases Total bilirubin >. x ULN if no liver metastases or > x ULN in the presence of liver metastases (except in the case of Gilbert's disease) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?. times ULN for participants without liver metastases, or ? times ULN in the presence of liver metastases Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? . times ULN for subjects without liver metastases, or ? times ULN in the presence of liver metastases