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Collectively, these signals indicate that additional regulatory guidance or policy refinement may be forthcoming as the Agency continues to assess safety, quality, and appropriate use within this category (FDA, 2024)
From this model, the estimated mean difference in log-transformed AUC 024h,sema,Day10 (described as AUC 024h Day 10 from here on) between pairs of treatment groups was estimated and back-transformed to the original scale and presented as a ratio of geometric means together with the corresponding two-sided 95% CI and p value
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