Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products by the FDA (source code)

= Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products by the FDA
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{title2=2023}

https://www.fda.gov/media/148910/download

FDA guidance, May 2023. Sections I–II, printed pp. 1–2: prognostic pre-randomization covariates and precision. Institutional source; reuse live FDA entry if present. Numerical residual-variance example is an independent derivation under the stated conditional noise assumptions.