aPatients could meet more than 1 ineligibility criterion.
bChild-Pugh score >11.
cOther was used when the reason for a patient’s exclusion was not among those predefined in the protocol; the most commonly specified free-text explanations included rapid improvement or deterioration in clinical status.
dRandomization was stratified by site.
eThis patient was randomized twice in error and was randomized to the same group.