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Given that establishing biological efficacy is the primary objective of the trial, according to the pre-specified estimand, all participants who achieve at least 80% study medication compliance and provide a 180-day blood sample will be included in the primary efficacy analysis

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The Akt-regulated forkhead transcription factor FOXO3a controls endothelial cell viability through modulation of the caspase-8 inhibitor FLIP

However, despite the reported positive effects, several critical factors and the absence of evaluation of more robust markers may limit our conclusions, as can be seen below