Table 3.

Adverse events.

		Treatment group
		Placebo N = 33	500 mg BID N = 33	1000 mg BID N = 34
Subjects with TEAEs related to study drug reported in two or more subjects in any treatment group	Diarrhea	0	4 (12%)	9 (26%)
	GERD	0	2 (6%)	0
	Nausea	0	1 (3%)	5 (15%)
	Headache	1 (3%)	2 (6%)	1 (3%)
Subjects with TEAEs requiring discontinuation of study drug	Diarrhea	0	0	2 (6%)
	GERD	0	1 (3%)	1 (3%)
	Abdominal distension	0	0	1 (3%)
	Melena	0	0	1 (3%)
	Acute myocardial infarction	0	0	1 (3%)
	Bladder cancer	1 (3%)	0	0
	Headache and facial rash	0	0	2 (6%)