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Statistical analysis The objectives of the extension phase of the study were to assess long-term safety of tesamorelin, including adverse events and effects on glucose and insulin, in individuals receiving tesamorelin for 52 weeks and 26-week safety in patients randomized to placebo for 26 weeks in the main phase of the study followed by tesamorelin for 26 weeks in the extension phase, to assess duration of effect on VAT and secondary endpoints among individuals initially randomized to tesamorelin for 26 weeks followed by placebo for 26 weeks in the extension phase, and to collect data on VAT and secondary endpoints in those individuals receiving tesamorelin for 52 weeks