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In the case of concussion or severe TBI, the course of recovery generally follows the same pattern: an initial period of impaired brain function, a period of improvement, and a period where the mental functioning stabilizes without significant additional deterioration or improvement

Mass spectrometry can support identity confirmation, but a matching mass alone does not characterize sequence-related impurities, positional isomers, disulfide variants, aggregates, residual reagents, or all degradation products

The agency also cites the absence of human testing

Location, size, and accompanying symptoms matter

PMID 3656429