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periodic safety update
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Periodic Safety Update Report List more TABLE OF CONTENTS TABLE OF CONTENTS. 1. Abbreviations and definitions. 2. psuR Data 2.1 Background Information... 2.2 Worldwide Commercalization Status.. 2.3 Overview of exposure and safety data 2.4 Lack ffi 2.5 Clinical Data review. 3. Risk Evaluation. 3.1 Evaluation of risks and new information. 3.2 Characterization of risks 4. BenefitRisk bala 4.1 Recommendations on benefit risk balance. 5. Assessment conclusions and actions.