TABLE 2.

Mean total circumference measurements

	MEAN COMBINED CIRCUMFERENCE, cm	SIGNIFICANCE*
Baseline	423.34	--
Midpoint (Week 3)	415.01	p<0.01
Endpoint (Week 6)	409.72	p<0.01
2-week follow-up	407.54	p<0.01

^*Change from baseline measurement, ITT population, N=54