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In the context of plaque biology, fibrous-plaque expansion is a favorable structural change: dense, collagen-rich fibrous tissue forms a thicker cap that insulates the thrombogenic lipid core from circulating coagulation factors
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"If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data." These actions may include requiring labeling changes or development of a Risk Evaluation and Mitigation Strategy, a program that helps ensure a medication's benefits outweigh its risks
[13] Pouliot M-C, Desprs J-P, Nadeau A, et al
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