Randomized 337 76 83 85 93

Table 5 provides the distribution of patients at baseline according to ulcer size. Ten percent (10%) of patients had ulcers of size 0.30 cm; 12.5% had ulcers of size greater than 0.30 but at most 0.40 cm; 17.8% had ulcers of size greater than 0.40 cm but at most 0.50 cm; 27.2% had ulcers of size between 0.50 cm and 1.00 cm; 17.8% had ulcers 1.00 cm in size; and 14.7% had

Table 6 provides the distribution of patients in the Placebo group by baseline ulcer size whose ulcers had healed by 4 weeks. Seventy-one percent (71%) of Placebo patients with ulcers of size 0.30 cm healed; 78% of Placebo patients with ulcers of size greater than 0.30 but at most 0.40 cm healed; 45% of Placebo patients with ulcers of size greater than 0.40 cm but at most 0.50 cm healed; 41% of Placebo patients with ulcers between 0.50 cm and 1.00 cm in size healed; 30% of Placebo patients with ulcers 1.00 cm in size healed; and 25% of Placebo patients with ulcers of size greater than 1.00 cm but at most 3.00 cm healed. Table 6

Week 1 304 67 80 73 84 Week 2 235 46 63 60 66 Week 4 174 41 47 47 39 ≥ 1 week 315 71 82 75 87

Total 0 mg 400 mg 800 mg 1600 mg

those of the interim analysis in terms of estimates of treatment effects.

Table 3. Number of Patients by Treatment Group (Mid Study Analysis)

**3.1.2 Distribution of patients according to ulcer size** 

ulcers of size greater than 1.00 cm but at most 3.00 cm.

**3. Results and discussion** 

consisting of many centers.

patients with the largest ulcers.
