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The analyze protocol (obtainable at NEJM.org) was designed and designed by the sponsor, Santaris Pharma, combined with the principal investigator at each research web site and Associates of Duke Medical Research Institute. All authors participated in the gathering of the info, had entire usage of information, participated in the data Investigation, and were associated with the preparation and information evaluation of the final manuscript.
Every single EIP website was requested to recruit a complete of around twenty five typical and kids's acute care hospitals, with the following distribution As outlined by size, if possible: thirteen small hospitals (
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Patients were being also necessary to be seronegative for hepatitis B surface area antigen and antibodies to human immunodeficiency virus and to have an complete neutrophil count of 1500 or maybe more for each cubic millimeter, a platelet depend of one hundred,000 or more for every cubic millimeter, usual values for serum creatinine and for overall and direct bilirubin, and alanine aminotransferase levels fewer than 3 times the higher Restrict of the conventional range.
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