Patients received gemcitabine in a dose of 1000 mg/m2 as a 30-min intravenous infusion once weekly for 3 weeks of each 28-day cycle Dose interruption or reduction of gemcitabine was performed according to predefined criteria (Supplementary Text 2). Patients received Z-360 tablets in a fixed dose of 60, 120, or 240 mg or matching placebo tablets orally twice daily until disease progression, unacceptable toxic effects, or the withdrawal of consent.
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