Table 3.

Adverse Events

Preferred term	Placebo (n = 52) n (%)	LX1031 250 mg QID (n = 54) n (%)	LX1031 1000 mg QID (n = 49) n (%)
Nausea	4 (7.7)	5 (9.3)	4 (8.2)
Diarrhea	2 (3.8)	1 (1.9)	5 (10.2)
Dyspepsia	2 (3.8)	3 (5.6)	0
Vomiting	0	2 (3.7)	2 (4.1)
Headache	2 (3.8)	3 (5.6)	3 (6.1)
Somnolence	1 (1.9)	2 (3.7)	1 (2.0)
Dizziness	0	2 (3.7)	0
Dysgeusia	0	2 (3.7)	0
Urinary tract infection	1 (1.9)	0	2 (4.1)
Blood amylase level increased	0	2 (3.7)	0
White blood cell increased	0	2 (3.7)	0
Back pain	2 (3.8)	0	2 (4.1)

NOTE. AEs occurring in more than 1 patient at a rate greater than placebo by preferred term.

QID, 4 times/day