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Type I error rate was controlled for the primary end point analyzed at 12 weeks.
The multiple comparison type I error rate was controlled using a false discovery rate criterion procedure41.
In each simulation, the target type I error rate is contained in the 95% confidence interval for the corresponding empirical type I error rate.
A two-tailed level of 0.05 was chosen for a type I error rate.
All tests were two-tailed with a 0.05 type I error rate.
We found that such procedures do not control the type I error rate well.
Confounding by PS could lead to an inflated type I error rate for the association test.
For each scenario, 1000 simulated datasets were generated to estimate power or type I error rate.
Alpha was set to 0.025 to maintain the family-wise type I error rate.
1) Increased type I error rate.
The type I error rate was fixed at 0.05.
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