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Clinical Study of the Effect of Combined Treatment of Aspirin and Zileuton on Biomarkers of Tobacco-Related Carcinogenesis in Current Smokers

Enrollment Statistics

Actual Registration: 123

  • 63 people randomized(63 of 123 registered)
    • 31 in Arm I: ASA+Zileuton (31 of 63 randomized)
      • 21 participants completed study
      • 21 participants completed study
        • 1 due to adverse event
        • 6 lost to follow-up
        • 2 withdrew from study
        • 1 for other reasons
    • 32 in Arm II: Placebo (32 of 63 randomized)
      • 22 participants completed study
      • 10 participants did not complete study
        • 1 due to adverse event
        • 5 lost to follow-up
        • 4 withdrew from study
  • 60 people not eligible and not randomized (60 of 123 registered)

Total Study Population Demographics (54 Randomized and Eligible People):
Overall (N = 64) ASA+Zileuton (N = 31) Placebo (N = 32) p
Ages(Years) 51.57 ± 9.85 49.55 ± 8.64 53.53 ± 10.67 0.11
BMI 28.23 ± 7.02 28.69 ± 6.60 27.78 ± 0.61 0.61
Pack-Years 35.67 ± 12.42 32.74 ± 12.52 36.53 ± 12.22 0.23
Male 36(57.14%) 18(58.06%) 18(56.25%) 1.00
Female 27(42.86%) 13(41.94%) 14(43.75%) 1.00
White 52(82.54%) 28(90.32%) 24(75.00%) 0.15
Hispanic 7(11.11%) 3(9.68%) 4(12.50%) 1.00

Final Analysis Population: 63