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Systematic evaluation of AIS is crucial to better understand the underlying pathophysiological mechanism. This can be achieved using standardized blood sampling to measure specific AIS biomarkers. The results of these analyses can be used to decide whether mitigation measures are needed, such as potential IMP re\u2010exposure and the use of pre\u2010medication. Additionally, systematic evaluation of AIS biomarkers throughout early phase clinical trials contributes to a better understanding of the IMP\u2010specific mechanism of action. This supports more informed decision making as the development progresses. 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