Table 2.

Reasons for study discontinuation

Reason for discontinuation	Intent-to-treat population, n = 303, n (%)
Lost to follow-up	33 (45.8)
Withdrawal of consent	13 (18.1)
Protocol violation	10 (13.9)
Early band removal due to a complication	9 (12.5)
SAE leading to removal of gastric band	3 (4.2)
Lack of effectiveness leading to explant or additional obesity surgical procedure	1 (1.4)
Death	1 (1.4)
Other	2 (2.8)
Total	72

SAE = serious adverse event.