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Mitochondria and inflammatory bowel diseases: toward a stratified therapeutic intervention

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In one specific embodiment of the auris-acceptable controlled-release formulations described herein, the active agent is provided in a gel matrix, also referred to herein as auris-acceptable gel formulations, auris interna-acceptable gel formulations, auris media-acceptable gel formulations, auris externa-acceptable gel formulations, auris gel formulations, or variations thereof

Risk of Fetal Malformations During Dosage Initiation or Escalation in Pregnancy XENPOZYME dosage initiation or escalation, at any time during pregnancy, is not recommended as it may lead to elevated sphingomyelin metabolite levels that may increase the risk of fetal malformations