Statistical Analysis
The sample size calculation assumed that the experimental group would have an improvement in the proportion achieving 6-month survival from 60% to 80%, with a final sample size of 128 patients needed (64 in each group; α = .10, power = 80%, and 2-sided test). We expected 10% attrition, thus the planned randomization was therefore 142, with 71 patients in each treatment group. The choices underlining these decisions are described in the protocol,All analyses were performed on the intention-to-treat population, unless otherwise specified. Comparison of proportions were performed with χ