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The protocol omitted data on grade 12 AEs and routine labs, optimizing trial logistics without regulatory compromise (C3TI, 2024) (Reckamp et al, 2024) VICTORION-2-PREVENT (Cardiovascular) This large, multinational trial evaluating Inclisiran implemented (Selective Safety Data Collection) SSDC by limiting safety assessments to SAEs, AEs of special interest, and discontinuations
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