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What Sponsors Should Actually Do The fixes that recur across current industry and peer-reviewed sources are architectural, not incremental: Build Quality by Design into study design from day one, so decentralized elements are explicitly defined and operationalizable within an investigator's existing governance not added after the protocol is finalized

Indeed, in a clinical study without any patients who developed GID, the postmortem analysis revealed a 2:1 ratio of dopaminergic to serotonergic neurons in the graft regions

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Disclosures: Lijie Gu: Nothing to Disclose, Yanhong Du: Nothing to Disclose, Jianglei Chen: Nothing to Disclose, Mohammad Nazmul Hasan: Nothing to Disclose, Tiangang Li: Nothing to Disclose 2070 RESMETIROM EFFECTS ON NASH WITH LIVER FIBROSIS IN PATIENTS WITH NASH GENETIC RISK ALLELES Naga Chalasani 1 Dominic Labriola 2 Rebecca Taub 2 Quentin Anstee 3 , 1 Indiana University Medical Center, 2 Madrigal Pharmaceuticals, 3 Newcastle University, UK Background MAESTRO-NASH (NCT03900429) is an ongoing 54-month, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy of resmetirom in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and fibrosis