A total of 707 patients underwent randomization during the period from June 1, 2004, through July 1, 2009. Figure 1 shows the enrollment, random
assignment, and follow-up of the patients. After randomization, 12 patients were found to be ineligible, in most cases because there was not a definitive diagnosis of metastatic disease; in addition,
1 patient withdrew consent. Therefore, 694 patients were included in the intention-totreat analysis. Table 1 shows the characteristics of the patients, which were well balanced between the two groups.