Sounds like a bit of back pedal to me there Doc. Took your time on Sunday too. NA as a control. Why ? It is not standard of care. If we going to have multiple control groups perhaps just the usual cortisone injection . But if I was a trial participant I would be very peed off , bad enough having only a 50% chance of receiving the good cells.
Perhaps we could terminate the control group early say at 3 months, note how flat the results for the control are at 3 months onwards . That would mean that every one would get treatment.
Depending on how consent the results of individuals that have been treated in the last trial we may be able to also split that group in the confirmatory trial at 3 and or 6 months for a second treatment .
This would answer the question
Would a second treatment be useful ?
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-181
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