Table 1.

Baseline characteristics of the patients were evenly distributed between arms

Characteristic	Placebo (n = 184)	DFMO/sulindac (n = 191)
Age, y
Median	60	60
Mean ± SD	61 ± 8.2	60 ± 8.6
Range	42–78	41–79
Male sex, n (%)	138 (75.0)	147 (77.0)
Race or ethnic group, n (%)
White	158 (85.9)	155 (81.2)
Black	6 (3.3)	10 (5.2)
Hispanic	12 (6.5)	14 (7.3)
Asian or Pacific Islander	4 (2.2)	9 (4.7)
Other	4 (2.2)	3 (1.6)
Body mass index (mean ± SD)
Men	28.4 ± 4.5	29.2 ± 5.5
Women	29.4 ± 7.5	27.7 ± 5.8
No. reported adenomas*	2.51 ± 2.3	2.49 ± 2.2
Largest adenoma ≥ 1 cm, n (%)†	40 (21.7)	38 (19.9)
Use of low-dose aspirin, n (%)	69 (37.5)	77 (40.3)
History of cardiovascular disease, n (%)	67/155 (43.2)	73/158 (46.2)
History of high blood pressure or hypertension, n (%)‡	47/155 (30.3)	48/158 (30.4)
History of diabetes, n (%)‡	21/151 (13.9)	25/152 (16.4)
Current or prior cigarette smoker, n (%)‡,§	41/99 (41.4)	42/100 (42.0)

^*Placebo, n = 183; DFMO/sulindac, n = 189. Number of polyps reported as “multiple” for three patients.

^†Adenoma is defined as tubular, tubulovillous, villous, cancer in situ, adenoma, or tubular adenoma with high-grade dysplasia.

^‡The denominator is the number of subjects for whom information was recorded. Missing values are not included.

^§Self-reported information.