Pain reduction was a secondary endpoint. You can only do statistical analysis on a secondary endpoint if your study meets its primary endpoint. The FDA won't approve a treatment on a secondary endpoint if the primary endpoint is not met - they will just tell you to go off and run another Phase III trial and come back later.
This is exactly what happened in the CHF trial - a great result stuffed by terrible trial design. Heads need to roll.
Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-174
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