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All clinical complaints during the 6-mo lead-in weight-loss period and adverse events during the 1-y treatment period were recorded.
To ensure consistency of gastrointestinal event reporting between study centers, a dictionary of standard terms was used to describe changes in defecation patterns.
Statistical analysis Efficacy analyses were performed on the intent-to-treat population, which consisted of subjects who received at least one dose of study medication during the 1-y treatment phase and for whom at least one body weight measurement was taken before and after random assignment.
The safety analysis population included all subjects who had received at least one dose of medication in a double-blind fashion and had at least one follow-up safety evaluation.