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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 3–4 compounds should not be considered clinical protocols