Table 1

Randomized clinical trial participants and distribution by treatment arm and histological end point

Treatment groupPatients randomized [crossover at 6 mo]Patients not seen after baseline]Total patients with 6-mo histological end point [total considering crossover]Total patients with 12-mo histological end point [total considering crossover]
Total39 [2]336 [36]30 [30]
4-HPR220 [22]14 [16]
Placebo116 [14]16 [14]