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Only 190 patients were eligible to randomization into one of the study groups according to strict inclusions criteria, and the study protocol was in concordance with the protocol guidelines of the LUNA Trial Collaboration [3] (Fig. 1).
All participating clinicians will attend a training session in the use of HNA to enhance standardisation and concordance with the protocol.
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The standard trauma care in the hospital is in concordance with the ATLS protocol and French recommendations of the «Haute Autorité de Santé» [16].
It is possible that, if the ventilation strategies had been in greater concordance with the ARDSNet protocol earlier on, our results may have been different; however, it is unlikely that it would change our acceptance of the null hypothesis, namely that the institution of positive pressure ventilation is not associated with an increase in biomarkers of lung injury.
All aspects of the research study were explained to all participants and informed consent was obtained, in concordance with the IRB protocols at each of these research centers.
The ventilation strategy of the patients was determined by their critical care physicians but was generally in concordance with the ARDS Network (ARDSNet) protocol [ 5], in which the tidal volume/ideal body weight is reduced toward a target of 6 ml/kg as tolerated, maintaining the plateau pressure at less than 30 cm H2O.
In the case of the latter, non-concordance with the T2T protocol could have been underestimated.
The study protocol is in concordance with the Helsinki declaration and its amendments, and it was approved by the local ethics committee.
Genotyping was performed using the Sequenom MassARRAY platform with 10 ng of genomic DNA in concordance with the manufacturer's specifications for the iPLEX protocol.
Manual auditing has long been considered as the gold standard for measuring concordance with hand hygiene protocol.
The study was conducted in concordance with the Declaration of Helsinki and approved by the MD Anderson Cancer Center Institutional Review Board as protocol 2004 0475.
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