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The FDA warns that both CJC-1295 and ipamorelin carry risks of immunogenicity (triggering immune responses) and cardiovascular effects, including "increased heart rate and systemic vasodilatory reaction." One clinical trial of CJC-1295 was discontinued following a participant’s death, though the attending physician believed the event was "unrelated to treatment." Neither CJC-1295 nor ipamorelin is FDA-approved

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This confirms the cascade’s central role in mediating therapeutic effects and validates the mechanistic understanding developed through years of investigation