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The pivotal trial supporting its 2010 FDA approval enrolled 816 HIV-infected adults with clinically defined lipodystrophy, and Phase 3 data documented visceral fat reductions of roughly 15-18% over 26 weeks of treatment a result robust enough to clear FDA review for a defined medical indication
Thomas Peter Geschftsfhrer Rock Story Bar, St
The "right model" is access with guardrails, qualified clinicians, licensed pharmacies, validated quality testing and "meaningful" patient follow-up, according to the expert
Counsel patients on the importance of returning for follow-up blood tests every 3 to 6 months to confirm adequacy of therapy [see Dosage and Administration (2.3)]
Common symptoms include tiredness, lethargy, feeling faint, becoming breathless
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