The document re-produces extracts from section 5 of ICH Q11 verbatim in black text, and provides subsequent commentary on EU expectations in the form of explanatory notes within grey-shaded boxes.
文件中摘要的ICH Q 11第5部分内容以黑体字表示,相应的欧盟态度的解说以注释形式放在灰色阴影方框中。
Intracerebral hemorrhage(ICH)is the most devastating form of disease with a high morbidity and mortality.
脑出血是致残、致死率极高的疾病,其危害与急性期的再出血密切相关。
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