Table 1.

Patient characteristics by study arm (for those evaluable on relative percent change in total lesion area at six months)

CharacteristicOverallDrugPlaceboDifference between arms
Number of participants894346% dropouts NS
 Age
 Mean60.758.762.6NS
 Median61.859.763.0
 Range29–8229:8235:82
Sex (%male)64% (57/89)65% (28/43)63% (29/46)NS
Race/Ethnicity (%White)78% (69/89)33/4336/46NS
Alcohol Use (self report)
 Yes35/8916/4319/46NS
 No20/8911/439/46
 Unknown34/8916/4318/46
Tobacco use (self report)
 Yes20/8912/438/46NS
 No29/8911/4318/46
 Unknown40/8920/4320/46
Total lesion area at randomization
 Mean502.6492.4512.1NS
 Median310300317.5
 Range48–350048–350055–2550