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Repair-focused therapies may require longer follow-up to detect changes in motor recovery, participation, and quality of life [41,42,43,44,45,46,47]

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In addition, the FDA also must ensure the integrity of the drug approval process and, thus, does not permit 503B compounders to market versions of compounded products that are essentially duplicate copies of approved drug products unless there is a documented patient-specific need for an alternate form of the compounded product

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