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Introduction. The 2×2 Cross-Over Trial. Higher-Order Designs for Two Treatments. Designing Cross-Over Trials. Analysis of Continuous Data. Analysis of Discrete Data. Bioequivalence Trials. Case Study: Phase I Dose?Response Noninferiority Trial. Case Study: Choosing a Dose?Response Model. Case Study: Conditional Power. Case Study: Proof of Concept Trial with Sample Size Re-Estimation. Case Study: Blinded Sample Size Re-Estimation in a Bioequivalence Study. Case Study: Unblinded Sample Size Re-Estimation in a Bioequivalence Study That Has a Group Sequential Design. Case Study: Various Methods for an Unblinded Sample Size Re-Estimation in a Bioequivalence Study. Appendix A: Least Squares Estimation. Bibliography. |