Something of note with the FDA and the clinical trial. The only comments left by the Quality Control Review panel reads:
"Quality Control Review Comment provided by the National Library of Medicine:
The description of the scale or categories does not include sufficient information to understand the results reported."
The only point of clarification still needed by the FDA was the way UHP represented the rate of bleeding at the target areas. Frankly doing a web search the "Lewis Bleeding Scale" brings back 0 results other than PR released by UHP which is odd. However, it was the third party that conducted trials that used this scale. Should be an easy fix via conversion to a more universally accepted measure of internal bleeding such as the Bleeding Assessment Tool (BAT).
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