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Amato, A

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In practice, because the FDA governs drug approvals in the United States and most Western countries follow similar regulatory frameworks, the 27 threshold remains the functional standard for clinical practice

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However, these coding algorithms have been validated and commonly used in research [77, 78], and any misclassification is likely to be non-differential, which would bias results toward the null rather than create spurious associations

Strong eligibility across all pathways