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PP Median (IQR)
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ITT Median (IQR)
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Difference ITT – PP Median (IQR)
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Wilcoxon signed-rank test p-value
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PP analysis is more conservative N (%)
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|---|
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Point estimate
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−0.2 (−2.6, 2.2)
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0.04 (− 2.6, 2.6)
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− 0.01 (− 1.6, 1.9)
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0.7025
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81 (49.4%)
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CI width
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12.4 (9.7, 16.6)
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13.3 (11.2, 17.5)
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0.9 (−0.4, 2.0)
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< 0.0001
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58 (35.4%)
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Lower CI limit
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−6.9 (− 10.0, −4.0)
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−7.5 (− 10.3, −4.7)
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−0.5 (− 1.8, 1.2)
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0.0402
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72 (43.9%)
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- A positive value for the difference in CI width indicates less precise estimation of the ARR with ITT analysis. A negative difference for the lower CI limit signifies that the PP lower CI limit lies above the ITT CI limit, so ITT analysis has a more conservative result
- ARR Absolute risk reduction, CI Confidence interval, IQR Interquartile range, ITT Intention-to-treat, PP Per-protocol