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BACKGROUND: In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data collection and analysis. Important aspects of this approach included regular reviews of aggregate data by a multidisciplinary team focusing on safety. PURPOSE: This article provides information to facilitate the planning and implementation of aggregate data reviews. METHODS: Our recommendations are based on experience of the authors and review of relevant literature. RESULTS: We present information regarding the planning of aggregate data reviews as well as examples of data displays that are useful for many different compounds. A subset of these data displays could form a set of 'core' analyses to be generated for aggregate data reviews.
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Xia et al. (2011) studied this question.
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