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Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12)

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[2] Frequent recurrences may indicate inadequately controlled diabetes, immunosuppression, antibiotic overuse, concurrent SGLT2 inhibitor therapy, or other underlying health conditions requiring specific management

A clinical review published in the International Journal of Molecular Sciences documenting the pharmacological basis and clinical applications of therapeutic peptides, confirming their classification as off-label compounded preparations outside FDA-approved indications provides the regulatory context