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Advanced injectable protocol Goal: Maximum efficacy, willing to inject, committed to comprehensive protocol

(2019) performed a Cochrane systematic review of Cerebrolysin for vascular dementia, evaluating the available RCT evidence for efficacy and safety in this population (PMID: 31710397) Neurotrophic Modulation: Rejdak et al

2021;106(9):e370413

FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes

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At the same time, the absence of human RCTs means that promising animal data is the accurate characterization not established efficacy