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。
In this decade, an attempt has been made to harmonize the requirements in the form of an ich GCP document which has been adapted as regulation by many countries.
在这的十几年，ICH GCP文件作为一个尝试，用来协调这种要求，已经被许多国家作为法规采用。
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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