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Serious Adverse Events
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The prevention of adverse events should be rigorous and based on as much scientific information as in available. In order to protect subjects in research protocols, it is essential to adhere to safety precautions. It is also important that results are monitored throughout the course of the research and trends analyzed during the research related to potential negative effects. If the investigation risks become higher than the benefits, the study should be discontinued immediately and the subjects informed of the reasons for discontinuation.