37. 9,000 patients from 300 centres in 16 countries Preliminary data from the trial's 6-week lead-in phase, during which 10,742 patients received treatment with sibutramine, provides reassurance regarding the cardiovascular safety of sibutramine: There was a low incidence of serious adverse events (conformers: 1.0%; nonconformers: 2.8%) NB: The FDA reported that the rate of cardiovascular events was 11.4% in the sibutramine arm versus 10% in the placebo arm.