Protocol amendments
During the study, the protocol was amended to allow extended treatment
delay or interruption between treatment periods to permit recovery from
toxicity or other reason, lowered Hb eligibility threshold from 100g/L
to 90g/L, and added inclusion criteria of gamma glutamyl transferase
<10 × ULN to demonstrate adequate liver function based on
emerging safety data from other ongoing studies of oPac+E. Other changes
were non-substantive.