Although the study did not reach statistical significance in the intention-to-treat analysis, in the pre-specified per-protocol analysis, the mean OS was 53 months (95% confidence interval [CI] 40 months to not reached) in the capecitabine group and 36 months (95% CI 30–44) in the observation group (adjusted hazard ratio [HR] 0.75, 95% CI 0.58–0.97; P = 0.028).
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