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FOOD AND DRUG ADMINISTRATION - page 198 / 263

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certain scheduling sampling routine and what we did in our analyses is to go well beyond what they have proposed.  Instead of just looking at three samples prior to dosing, we characterized the entirety of day minus 1 and then rather looking out to day 2, we took our sampling all the way out to day 4.  Rather than looking at just T4, we looked at T3 and TSH because we have been told that TSH is very critical in assessing the action of thyroid hormones.

Now I'll tell you a little bit about the correction procedures that we used in our study.  First, these three curves here are for those three very different doses and just looking at the curves, you can see they're very, very close to each other, very little difference between the three curves.

Now, to go to the various correction procedures that one might envision using, first, there's the horizontal correction.  The premise behind horizontal correction is that that large exogenous dose of T4 has absolutely no effect on endogenous T4.  In other words, there's no perturbation of the biology by that large a dose.

The next correction procedure takes just the

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