ballast

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Ballast




Description

Refits one pre-specified mixed model for repeated measures (MMRM) under families of data and analytic perturbations (covariance structure, degrees-of-freedom method and variance estimator, covariate set, analysis population, alternative analysis data sets, leave-one-out deletions, crossed specification grids, re-randomisation tests, delta-adjusted and reference-based multiple imputation, and alternative estimators) and judges every refit against the pre-specified estimate, confidence interval and p-value. Classifies the result as robust, sensitive or fragile, with a separate flag for marginal significance, and estimates by simulation the probability that a planned design gives a significant and robust result. Fitting uses 'mmrm' (Sabanes Bove et al., 2024, <https://openpharma.github.io/mmrm/>) with 'SAS' 'PROC MIXED' conventions for the least-squares-mean contrast, Kenward-Roger adjustment and the corrected Akaike criterion. Reference-based multiple imputation follows Carpenter, Roger and Kenward (2013) <doi:10.1080/10543406.2013.834911> and was checked against 'rbmi' (Gower-Page, Noci and Wolbers, 2022) <doi:10.21105/joss.04251>.






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