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Imatinib mesylate is obtained having less than 5000 ppm of n-Butanol, normally around 3000 ppm and in any case always above 1000 ppm and below 5000 ppm, and therefore as a matter of fact always in compliance with the current ICH limits for such solvent.

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An independent data and safety monitoring board made recommendations regarding the continuation of the trial.

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Although the majority of patients with CML respond well to imatinib, a minority of patients have relapsed.

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