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doi:10.1242/jcs.098806

Evidence Tier Framework Tier 1 FDA-approved therapy large randomized trials Tier 2 human trials demonstrating biological effect Tier 3 small human studies or limited clinical data Tier 4 animal models or anecdotal reports Stacking should generally involve: at least one Tier 1 therapy no more than one Tier 3 compound Stacks composed entirely of Tier 34 compounds should not be considered clinical protocols

The mechanism (HGF/c-Met activation, synaptic plasticity support) is theoretically matched recovery from brain injury

US Food and Drug Administration, Center for Drug Evaluation and Research

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