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Toxicity grades were determined in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events grading system. The primary endpoint for this trial is defined as reduction of grade 3 or greater toxicity, as defined by the NCI Common Terminology Criteria for Adverse Events, version 3, in the CoFactor/5-FU arm, compared with the leucovorin/5-FU control arm. Furthermore, patients enrolled in this trial have exhibited no grade 3 or 4 gastrointestinal or hematological toxicities as determined in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events grading system. |
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