Thursday, December 14, 2017 1:26:47 PM
Not a little difference.
Primary Outcome Measures:
Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ]
OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis. A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.
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