In reply:

We thank Dr. Frei for his interest in our study. Unfortunately, we are not in the position to completely defend the original power analysis for 2 reasons: Dr. Homel, who was the statistician for our study, died suddenly soon after completing this work. In retrospect, his wording concerning significant clinical difference of 1.3 units among 3 groups is somewhat unclear, so we cannot now exactly explain or justify his method. We reiterate here that we characterize this study as an equivalence trial.

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