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Moreover, as predicted (24), CFTR is easily inactivated by oxidants (30), which would have the same impact as pancreas-selective mutations in CFTR (85), compromising the delivery via ductal cells of bicarbonate into pancreatic juice and, thereby, contributing to lithogenicity (34, 81)

Wu, J.D

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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

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