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The independent trial Steering Committee terminated the main trial in July 2007 for ethical reasons, as the independent Data Monitoring Committee noted a significant reduction in all cause mortality in participants on active treatment at the second interim analysis. All final visits related to the main trial were completed by 12 October 2007. The final visit was counted as the entry visit to the extension.To be eligible for entry into the extension, participants simply needed to be on double blind treatment at the time of their final visit.

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