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PADE requirements were not correctly embedded into written procedures Procedures contained decision logic that was not consistent with FDA requirements, particularly in relation to causality, relatedness, and case validity

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DATA AVAILABILITY STATEMENT Data underlying the findings described in this manuscript may be obtained in accordance with AstraZenecas data sharing policy described at: Data for studies directly listed on Vivli can be requested through Vivli at www.vivli.org

The decision to discontinue should be individualized and ideally made with a healthcare provider who understands your complete metabolic picture