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This lack of transparency is a legitimate concern, as 503B facilities generally provide more consistent quality due to stricter FDA inspection requirements

Long-term graft function of adult rat and human islets encapsulated in novel alginate-based microcapsules after transplantation in immunocompetent diabetic mice

The gap reflects both the early stage of adoption and the scale of the opportunity ahead

Lancet Diabetes Endocrinol 13(6):482493

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Our analysis also includes a survivorship component: users who remain active long enough to reach the 12-week milestone may differ systematically from those who discontinue earlier