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Any compound that potentiates this pathway carries a theoretical risk of promoting neoplastic processes (PMID: 34179015) No Chronic Toxicity Data: Long-term effects of sustained HGF/c-Met potentiation are unstudied even in animal models Uncharacterized Dose-Response: The relationship between Dihexa dose and adverse effects in any living system is poorly defined beyond acute preclinical studies No Regulatory Review: Dihexa has never undergone the systematic safety evaluation required for regulatory submission Safety Comparison Summary: Cerebrolysin has a known, well-characterized safety profile from decades of clinical use

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PMID 25493285