"But the question I am asking is “how plausible is it for the ulcer of placebo subjects to heal 50% after four weeks of placebo, given that they have already had at least a total of 6 weeks compression bandaging and exclude subjects whose ulcers healed more than 30% in the pre-trial screening?”
This question, of course, is the null hypothesis question...how likely it is that placebo group will respond equally to the potion group, and that both groups will equally contribute to the impressive-sounding 50% healing after just four weeks of treatment.
If prior findings from other studies don’t show 50% ulcer healing after four weeks in a margolis1-type placebo or control group which has already had a 2 week exposure to “perfect” standard care and another 4 weeks of general standard care, then it is unlikely that FTT's placebo subjects will show such an impressive response.
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Charles Armstrong, MD & CEO
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