For one, the groups noted the analysis is a retrospective study, not a prospective, randomized controlled clinical trial, which many regard as a gold standard for ferreting out safety concerns.

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They asked Roche for full clinical study reports, with study protocols, the reporting analysis plan, the statistical analysis plan and individual patient data so that all they could more fully determine what could be concluded from the studies.

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The FDA analysis of posted clinical trial data from May 2012 appears to contradict the BMJ study.

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"The record, in short, is one of careful analysis at every stage, a continued commitment to research and prompt and decisive action in response to clinical-study results, " the scientists say.

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