Diazoxide Choline Extended-Release Tablet in People With Prader-Willi Syndrome: A Double-Blind, Placebo-Controlled Trial.

Exploratory End Points Lean body mass/fat mass ratio was increased significantly in the DCCR group compared to the placebo group (see Table 2 ; P = .001), with a significant reduction in body fat mass in the DCCR group compared to the placebo group (see Table 2 ; P = .003) and a nonsignificant trend toward an increase in lean body mass (see Table 2 ; P = .058).

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Similarly, there were highly significant relationships between circulating drug levels (Cmin) and leptin change from baseline, with leptin baseline as a significant covariate ( Fig. 4 ; leptin change from baseline = 1.46-0.364 × Cmin + 0.070 × (baseline leptin-32) – 0.012 × Cmin × (baseline leptin-32; P < .001)).

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