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After several washes purified inclusion bodies were obtained and solubilized in a urea containing buffer

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That's why absence of FDA approval here is about business case, not about lack of evidence

Using an untargeted metabolomics approach combined with multivariate, univariate, and network-based analyses, we identified a set of metabolites and pathways that differed between children with ASD and neurotypical controls and showed partial normalization following dietary intervention

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