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The monitors will verify that all adverse events were documented in the correct format, and are consistent with protocol definition.
Through previous collaborations with various clinical research groups, the Center for Biostatistics and Advanced Informatics (CBAI) staff has over 40 years collective experience in the design, development, validation and implementation of survey forms that are consistent with protocol, reporting and various sponsor requirements.
Through previous collaborations with various clinical research groups, our Center for Biostatistics and Advanced Informatics CBAII) staff has over 40 years collective experience in the design, development, validation and implementation of data collection forms that are consistent with protocol, reporting and various sponsor requirements.
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Overall, 85 AEs occurring in 67 participants (9.6%) resulted in protocol-driven discontinuation of study medication or permanent dose reduction, consistent with protocol-driven safety algorithms; 65% of these medication alterations (55 of 85 occurring in 42 participants) were due to elevated liver transaminases.
After physical examination and a 30-minute period of rest, a needle was inserted in an anticubital vein and all included subjects had to undergo a 12-lead-ECG-controlled graded bicycle exercise test according to the ergometry protocol of the Austrian Society of Cardiology which is consistent with the protocol of the The German Society of Cardiology and the Bruce Protocol [ 21].
According to the ADO for each locus, the number of repetitions needed for reliable homozygous genotypes reached five which was consistent with our protocol.
In both cases, the details in the publication were consistent with the protocol.
The trial details documented here are consistent with SMART Trial protocol V.7 (date: 21 August 2013).
A contracting party may take an import decision under its domestic regulatory framework, provided this is consistent with the Protocol.
Consistent with hospital protocol, patients whose mean arterial pressure (MAP) was less than 60 mmHg and unresponsive to a volume challenge received intravenous dopamine and noradrenalin infusion.
First, early intervention is consistent with the protocol in the Kiss trial[ 3] in which screening and subsequent treatment of candidiasis occurred between 15 weeks and 19 weeks gestation.
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