Wild.
So you are certain the FDA has signed off on this trial design? They stated they have the endpoints signed off in the release, but they didn't elaborate on anything further.
If you can confidently say the FDA oversees every aspect of every clinical trial that happens in America, including control groups, then I stand corrected. I was unaware.
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-85
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