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In March 2015, FDA approved LIXELLE as a Class III Humanitarian Use Device (HUD) with an approved Humanitarian Device Exemption (HDE)

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The HMR Committee then makes its recommendations to WADAs ExCo, which approves the List during its September meeting

However, clinical translation has been challenging due to delivery issues and side effects

From the ASV table (Supplementary Table S1), sums of ASVs within each respective phylum or genus for each sample were calculated to establish the abundance of each phylum or genus per sample