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In the double-blind, randomized, placebo-controlled, dose-escalation phase 1 study of ASHMI (600 mg, 1200 mg, 1800 mg), no grade 3 adverse events occurred, laboratory parameters before and after treatment remained within normal ranges, and no unexpected immunological changes were detected, supporting its safety and tolerability allowing for advancement to phase 2 study [99]

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Spontaneous development of L forms of streptococci requiring secretions of other bacteria or sulphydryl compounds for normal growth

Immune Reactivity: The FDA has previously flagged concerns that compounded peptides like BPC 157 carry risks of triggering unexpected immune or allergic reactions