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Even if orphan designation is granted it may be withdrawn by the FDA for non-compliance with regulations
Ongoing monitoring: Expect periodic A1C testing, immediate reporting of dose changes/side effects and re-grounding after each dose adjustment as required
AE-S: conceptualization, experimental design and procedures, and manuscript editing
1 The origin of bone tissue is rooted in early embryonic development, which follows two distinct pathways that include intramembranous ossification and endochondral ossification
10 , e001115 (2023)
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