Table 5

Intent-to-treat analysis of histological response rates at 6 and 12 months, assuming that the outcome in dropouts favors 4-HPRa (n = 39)

End pointTreatment group
Placebo4-HPR
6-mo responders77
6-mo nonresponders1015
Response rate41%32%
6-mo proportionate difference (95% confidence interval)0.09
(−0.21–0.39)
P = 0.56
12-mo responders84
12-mo nonresponders912
Response rate47%25%
12-mo proportionate difference (95% confidence interval)0.22
(−0.11–0.53)
P = 0.18
  • a Two of the three unknown patients were randomized to 4-HPR.