Table 5.

Adverse Events

	XR-NTX	Placebo	Total Sample
Adverse Event
Transaminase level 5x Upper Limit of Normal
Aspartate aminotransferase (AST)
Baseline; N=98	0% (0)	0% (0)	0% (0)
Month 6; N=65	4% (2)	0% (0)	3% (2)
Alanine transaminase (ALT)
Baseline; N=98	0% (0)	0% (0)	0% (0)
Month 6; N=66	0% (0)	0% (0)	0% (0)
Gamma-glutamyl transferase (GGT)
Day of Release; N=69	0% (0)	0% (0)	0% (0)
Month 6; N=50	5% (2)	0% (0)	4% (2)
Any reported adverse events	67	33	100
Skin and Soft Tissue Infection	0% (0)	3% (1)	1% (1)
Signs of Edema	1% (1)	3% (1)	2% (2)
Immediate Injection Reaction	16% (11)	9% (3)	14% (14)
Any reported adverse events	51	20	71
Injection Site Reaction	1% (1)	0% (0)	1% (1)
Nausea	19% (13)	9% (3)	16% (16)
Vomiting	6% (4)	3% (1)	5% (5)
Diarrhea	9% (6)	3% (1)	3% (3)
Decreased Appetite	3% (2)	3% (1)	3% (3)
Increased Appetite	0% (0)	3% (1)	1% (1)
Headache	13% (9)	9% (3)	12% (12)
Dizziness	7% (5)	0% (0)	5% (5)
Fatigue	10% (7)	3% (1)	8% (8)

There were no statistically significant differences between groups for all above adverse events.

^**No subjects discontinued due to significant adverse events.