A final analysis will be conducted when all patients have completed 144-week treatment and 48 weeks of follow-up. Primary and secondary efficacy parameters will be evaluated by an intention-to-treat analysis. Exact (1-sided) 95%-confidence interval from the binomial distribution will be provided for response rates in individual patient groups. All categorical and continuous variables will be analyzed by chi-square test and Student t test, respectively. For continuous variables with outliers, nonparametric test will be used instead. The analysis of histologic response will include only those who receive the pre- and post-treatment biopsy.