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For each linear and logistic regression model, we performed sensitivity analyses by calculating E-values 70,71 , which provide estimates of the magnitude of unmeasured confounding that could explain the observed effects and have been recommended as a type of sensitivity analysis 70,72

NAMs (new approach methodologies) are nonclinical tools

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A later ANDA filing also positions the company to launch into a genericized market once the 180-day period expires, which may still be commercially attractive for a drug with high volume even at low margins