Study withdrawals were handled by the last observation carried forward method, which assumes that individual data at the time of drop out are representative of data at the end of the study if the participant had completed it. Therefore, the results of the study may be affected if participants with lower success drop out more often, or if the characteristics or timing of drop out differs between the 2 groups. However, we have verified that this was not the case: the timing of drop out was similar in the 2 groups (P = .90; Mann-Whitney test), and similar primary efficacy results were obtained for completers (BMI difference between the orlistat and placebo groups at 12 months: 0.70, 95% confidence interval, 0.19-1.21; P = .007). In addition, baseline characteristics among participants who dropped out were similar to those of completers within each study group (Table 1), and the timing of withdrawals was similar between the 2 groups. Taken together, these analyses show that last observation carried forward analysis did not affect the interpretation of our results.
Study withdrawals were handled by the last observation carried forward method, which assumes that individual data at the time of drop out are representative of data at the end of the study if the participant had completed it. Therefore, the results of the study may be affected if participants with lower success drop out more often, or if the characteristics or timing of drop out differs between the 2 groups. However, we have verified that this was not the case: the timing of drop out was similar in the 2 groups (P = .90; Mann-Whitney test), and similar primary efficacy results were obtained for completers (BMI difference between the orlistat and placebo groups at 12 months: 0.70, 95% confidence interval, 0.19-1.21; P = .007). In addition, baseline characteristics among participants who dropped out were similar to those of completers within each study group (Table 1), and the timing of withdrawals was similar between the 2 groups. Taken together, these analyses show that last observation carried forward analysis did not affect the interpretation of our results.
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