Table 2—

Summary of reasons for premature withdrawal from study

Reason for withdrawalPlaceboOrlistat
Adverse event22 (8)35 (13)
Non-safety126 (46)102 (37)
Insufficient therapeutic response11
Protocol violation73
Refused treatment*7955
Failure to return3536
Total148 (54)137 (50)
  • Data are n (%). Percentages are based on total randomized population, including seven patients in the placebo group and eight patients in the orlistat group who were excluded from the intent-to-treat population because there were no efficacy assessments.

  • *

    * Including “did not cooperate” and “withdrew consent.”