International Circulation: What is your guidance for interpreting ITT and PP analysis results of clinical trials? What is the significance of the ITT and PP results from the RE-LY study?
　　《国际循环》：对解释临床试验的ITT和PP分析结果，您有何高见？来自RE-LY研究的ITT和PP结果有何意义？
　　Dr. Ezekowitz: The standard of the interpretation of clinical trials for efficacy is intention-to -treat. There is no question about that. In trials where the primary endpoint is non-inferiority then you can make a case for doing an on-treatment analysis. The reason you can make that case is if you are in a clinical trial and all patients stop all medications based on an intention-to-treat analysis， it would mean that both arms would be non-inferior and therefore you meet your objective. I think an on-treatment analysis of a non-inferiority trial has logic but if you are looking for superiority， the standard analysis is intention-to-treat.
　　In the RE-LY study， the primary analysis plan called for an intention-to-treat for superiority and the results were based on an intention-to-treat analysis. We also performed an on-treatment analysis and the results were better but comparable and there was no difference in the outcome.
　　Dr. Ezekowitz：解释临床试验疗效的标准是意向性治疗（ITT）。在主要终点为非劣效性的试验中，可以进行实际处理分析，如果所有患者基于ITT分析停用所有药物，那意味着两组达到非劣效性。我认为，非劣效性试验的实际处理分析要有逻辑性，但如果想要达到优效性，那么标准分析是ITT。
　　在RE-LY研究中，主要分析是对优效性进行ITT分析，其结果也是一项基于ITT的分析。我们还开展了实际处理分析，其结果更好但类似，在研究结局上无差异。

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