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The frequency of treatment-related grade 3-4 adverse events was similar between treatment arms 48% vs 43% for the combination and paclitaxel arms, respectively. ORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone; however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-100 did not appear to augment the adverse event profile of paclitaxel and was well tolerated. ORR in the EP-100 combination arm was similar to that in the group treated w