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The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) without initiating prohibited weight management treatments

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The 12mg weekly arm produced a 24.2% mean body weight reduction over 48 weeks, with 26% of participants achieving at least 30% total body weight loss a threshold previously unattained by any pharmacological intervention in a clinical trial setting

Study 2 This study re-randomized 177 HIV-infected patients with lipodystrophy who completed tesamorelin treatment in the Main Phase to receive either tesamorelin (N=92) or placebo (N=85) for an additional 26-week duration (1:1 randomization ratio)

doi: 10.1186/1471-2105-9-559