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As evidenced by James et al ., histology from the hyper pigmented area showed irregular epidermal atrophy, absence of basal orientation of epidermal cells, patchy pigmentation of the lower epidermis, and numerous pigment-laden macrophages in the upper dermis and increase of melanin in the basal layer

A comprehensive safety and tolerability study evaluated approximately 900 participants across six trials with the following protocols: Subcutaneous/Intravenous Protocols: Single doses ranging from 25 to 400 mcg/kg body weight were tested

PMID 27886704