Table 6

Intent-to-treat analysis of histological response rates at 6 and 12 months, assuming that the outcome in dropouts does not favor 4-HPRa (n = 39)

End pointTreatment group
Placebo4-HPR
6-mo responders85
6-mo nonresponders917
Response rate47%23%
6-mo proportionate difference (95% confidence interval)0.24
(−0.06–0.53)
P = 0.12
12-mo responders92
12-mo nonresponders814
Response rate53%13%
12-mo proportionate difference (95% confidence interval)0.40
(0.09–0.68)
P = 0.01
  • a Two of the three unknown patients were randomized to 4-HPR.