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A randomized, controlled, blinded human trial of GHK-Cu monotherapy, with a vehicle-only control (and a needling-plus-vehicle arm if a procedure is used), objective endpoints such as blinded global photography and target-area hair counts over at least several months, adequate statistical power, pre-registration, and independent replication

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To rule out inferiority, the FDA required CVOTs to show an upper boundary risk ratio of 1.3 (post approval), utilizing a two-sided 95% confidence interval (CI), for major adverse cardiovascular events (MACE) [55]

Biochem Biophys Acta 1822:625630 Schachter AS, Davis KL (2000) Alzheimer's disease