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However, the 91.6% response rate and 6-month durability in a knee pain population that presumably included treatment-resistant cases is a signal

Any important protocol modification such as changes to eligibility criteria, outcome analyses will be thoroughly communicated with DSMB members and will obtain amendment clearance from the institutional review board (IRB)

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compounding pharmacies and have not been reviewed by the FDA for safety, effectiveness, or quality

Since there are obvious differences between rodent and human physiology, it cannot be ignored that this may have a significant impact on the efficacy and safety of (any) novel agents