For 6-MWT, the median change from baseline to Month 12 was -8.15 meters for the patisiran group and -21.345 meters for the placebo group; the Hodges-Lehmann estimate of the median difference was 14.7 meters (p-value 0.0162) favoring patisiran.
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For 6-MWT, the median change from baseline to Month 12 was -8.15 meters for the patisiran group and -21.345 meters for the placebo group; the Hodges-Lehmann estimate of the median difference was 14.7 meters (p-value 0.0162) favoring patisiran.
没任何影响，因为这个是一个小临床，也只有1年的时间。本身就不是设计用来测试心血管并发症，住院死亡率这些终点的。这个临床的终点是和FDA商量出来怎么样才能最快速度上市的。 后面2代产品才是大临床+跟踪3年。这才是测试这些硬终点的。