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Novel Statistical Approaches to Assessing the Risk of QT Prolongation and Sample Size Calculations in 'thorough QT/QTc studies'

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Figure

Figure 1.1: Schematic representation of normal ECG trace, with waves, segments, andintervals labeled
Figure 1.2: Plot of power vs. σw for the crossover design with n = 50, 75, and θ = 5 (Powerbased on 1000 simulations with MCSE = 0.01)
Table 1.1: Data schematics for change from 24 hour baseline ECG assessment for a repeat-dose parallel study.
Table 1.2: Data schematics for change from 24 hour baseline ECG assessment for a repeat-dose crossover study.
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