Table 2—

Summary of reasons for premature withdrawal from study

Reason for withdrawalPlaceboOrlistat
n 276 274 
Adverse event 22 (8) 35 (13) 
Non-safety 126 (46) 102 (37) 
Insufficient therapeutic response 
Protocol violation 
Refused treatment* 79 55 
Failure to return 35 36 
Other 
Total 148 (54) 137 (50) 
Reason for withdrawalPlaceboOrlistat
n 276 274 
Adverse event 22 (8) 35 (13) 
Non-safety 126 (46) 102 (37) 
Insufficient therapeutic response 
Protocol violation 
Refused treatment* 79 55 
Failure to return 35 36 
Other 
Total 148 (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.”

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