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According to the FDAs brief , the concern was whether the stability of the peptide would hold during manufacturing and how much the quality of the compounded product could change as a result

Differentially expressed genes (DEGs) between OA and normal cartilage tissues in the GSE98918 dataset were identified using the limma package 21 , with the significance threshold set at |logFC| 0.5 and adjusted p -value 0.8 indicates good diagnostic performance 24

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Table 2: Variation of regional brain metabolite levels with diagnosis group, age, and sex as fixed effects in robust linear mixed-effects (LME) models