Table 2.

Skin Cancer Results

	Treatment	Group
	DFMO (n = 143)	Placebo (n = 147)	Overall (n = 290)
Subject with new cancer (p=0.475)	86 (60%)	95 (65%)	181
Total new cancer (p=0.069)	260	363	623
Time under observation (years)	599.8	603.5	1202.3
New cancer/year (SE)	0.43 (0.05)	0.60 (0.07)	0.52
Subject with basal cancer	69	77	146
Total basal cancer	163	245	408
Subject with squamous cancer	40	50	90
Total squamous cancer	95	116	211

P-values were calculated with chi-square tests for dichotomous data, and Wilcoxon rank-sum test for ordinal data. The exception to this is total new cancers – as specified in the protocol for the efficacy analysis, the DFMO and placebo arms were compared by a two-sample t-statistic testing the difference in rates of new cancers/years on study using the exact probability value from the permutation test obtained from the statistic’s randomization distribution.”