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doi:10.1016/j.jand.2016.09.025
TB-4 The July 23, 2026 PCAC recommendation covered TB-500, not the full-length TB-4 used in GLOW
Medical supervision requirement: All AOD-9604 therapy requires comprehensive physician oversight including baseline health assessment and laboratory work, informed consent regarding research-purposes-only status, regular monitoring of body composition and metabolic markers, dose adjustments based on individual response, and integration with comprehensive health optimization strategies
The program established a favorable safety profile but the Phase IIb endpoint did not differentiate sufficiently from placebo to support continued development for obesity
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