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Safety, Product Integrity, and the Problem of Unregulated Supply The primary clinical concern is not simply uncertainty regarding biologic effects, but uncertainty regarding product composition, sterility, and manufacturing quality

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No Standardized Human Dosage: No FDA approval means no regulator-vetted human dosing standard exists, leaving human safety and efficacy data thin for orthopedic use

All statistical tests will be performed with intention to treat and per protocol

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Methylene Blue Injection may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs