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The primary end points of the study were change in total testosterone and weight. Study measurements After an overnight fast, weight and blood pressure were measured and blood samples were taken at screening, randomization, and on completion of the 12-wk study period.
Compliance was monitored based on counting returned medication. Fasting venous blood was collected into serum gel and fluoride oxalate tubes.
Samples were separated by centrifugation at gfor 15 min at 4 C, and the aliquots stored at —20 C within 1 h of collection.
Low-density lipoprotein cholesterol was calculated using the Friedewald equation. The coefficient of variation for this assay was 1. Statistical analysis and sample size calculation The power of the study to demonstrate a significant reduction in total testosterone was based on a previous study showing a significant reduction in total testosterone concentration after treatment with metformin 9.
In absolute terms, mean weight loss was greatest in the 120 mg group 9. Orlistat was well tolerated.
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