Comparison of Placebo vs MNTX Efficacy (%)

Time to values Placebo (n=42) MNTX(n=37) (0.15 mg/kg) p-Value MNTX(n=45) (0.30 mg/kg) p-Value

Rescue free laxation within 4 hours (301) 16.7 59.5 0.0001** 55.6 0.0003**
Laxation within 4 hours (302) 14.6a 51.4 0.0007*
At least 2 laxations within 4 hours over the first 4 doses (302) 7.3a 59.5 <0.0001*
Rescue free laxation within 24 hours (301) 28.6 67.6 0.0007* 62.2 0.0025*

* Fishers exact test,

** Cochran-Mantel-Haenszel,

*** log rank; MNTX = methylnaltrexone;

a n=41