Wednesday, August 13, 2008 1:22:36 PM
1) Subjects were anxious, causing variability in the baseline measurements, so they brought them in for a 'dry run' in order to reduce their anxiety, and also excluded some subjects who were overly anxious.
2) Retightening the mask during each of the four measurements.
Of course the $64,000 question is whether these corrections were also made in RD-1, or was it too late to make changes there. I doubt the anxiety/'dry run' aspect was addressed in RD-1, though perhaps the more experienced University group running RD-1 didn't have the loose mask problem -
>>> "Thanks for your note Bob. I believe Roger was going to comment on this, but as you correctly stated, the clock ran out on him. It turns out the re-breathing procedure is a little more complicated than one might think, and a particularly sensitive measure. Some volunteers were anxious during the exercise, resulting in variable baseline data. This was reduced by bringing in the volunteers in the 2100mg group for a dry run first, so that during the first study their anxiety was reduced. It also gave us a chance to exclude those volunteers who were overly anxious with this exercise. There were also procedures put in place to refit the mask (i.e. re-tighten it) during each of the four measurements, and a couple of other details that appeared to improve the reliability of the measurements.
Regards, Mark" <<<
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