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The 5-year overall survival rate from randomisation for all randomised patients was 93% (Fig 4).
This study is registered with ClinicalTrials.gov, number NCT00041197.All randomised patients were included in the analysis.
Safety analyses were performed on the "safety" population (randomised patients who received study medication).
Efficacy analyses were performed on the ITT population of 606 randomised patients.
It was expected that approximately 667 patients would have to be screened in order to obtain 600 randomised patients, assuming an approximate rate of 10%% screening failures.
Included randomised patients were treated with an empirical anti-infective therapy combining imipenem and colistin, depending on our local bacterial ecology.
All 358 randomised patients were analysed in the intention to treat (ITT) analysis.
ITT: all randomised patients.
Safety analyses will be performed on all randomised patients.
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Corticosteroid-free remission was also assessed in all adalimumab-randomised patients using corticosteroids at baseline.
Fistula healing was assessed in adalimumab-randomised patients with fistula at baseline.
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