743 patients with BMI 28-47 were recruited.
There was an initial placebo run-in period of 4 weeks during which a mildly hypocaloric diet was commenced.
Only patients (668) who completed this run-in and who had taken more than 75% of their tablets were enrolled into the 1 year single-blind trial of orlistat in combination with a hypocaloric diet.
In the second year patient were re-randomised to orlistat or placebo in combination with a eucaloric diet (one designed to maintain a stable weight).
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