Data sharing among data monitoring committees and responsibilities to patients and science.

Although the US trial results did not have sufficient follow-up to report on the primary outcome (long term survival without major disability), they showed a marginally statistically significant ( P < 0.04) higher level of mortality when lower levels of oxygen were targeted.

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By contrast, prompted by a worrying trend in one of two trials of combination antiretroviral therapy in HIV/AIDS, the two DMCs agreed to share key outcome data on the basis of strict confidentiality, and the resulting analysis provided the reassurance needed to allow continued recruitment [ 13 ].

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Using conservative statistical assumptions, the combined analysis suggested strongly that targeting arterial oxygen to remain within the higher range was associated with a convincing, and statistically highly significant, increased survival.

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