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A more realistic path forward is to adopt quality-by-design frameworks, define efficacy and risk boundaries through critical quality attributes, and establish auditable links from process parameters to structure and release behavior

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Concussion participants sustained a blunt head trauma and presented with an observed loss of consciousness, a Glasgow Coma Scale (GCS) score of 13 or 14, and/or at least one acute sign or symptom of concussion (i.e., post-traumatic amnesia, focal neurological deficits, skull fracture, posttraumatic seizure, vomiting, headache, dizziness, or other mental status abnormalities)