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2007 in the New England Journal of Medicine (NCT00123253, n = 412 HIV-infected adults, 2:1 tesamorelin to placebo, 26-week primary phase) met its pre-specified visceral-adipose-tissue primary endpoint by CT versus placebo, with concurrent IGF-1 elevation from baseline [6]
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Document any changes in the relevant research endpoints (recovery time, inflammation markers, dermal response) and adjust within the protocols design parameters