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The test graphs are generated using the protocol defined in [26].
All patients were scanned according to the protocol defined in [6].
Some patients completed their 3, 6 or 12 month visit earlier or later than scheduled (see results) based on the protocol defined visit schedule and visit windows.
Power calculations were conducted using tools provided by Emphron Informatics (www.emphron.com) according to the protocol defined by Hunt et al [18].
Protein features chosen for mass spectrometric analysis were excised from the gels and manually in-gel digested with trypsin following the protocol defined by Shevchenko [15].
The protocol defined independent dose reduction criteria.
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Rapid test results were used to make treatment decisions, but the blood film results (read in duplicate) were used to define the protocol-defined study endpoint, presence or absence of malaria.
Note: One patient in AZD9773 cohort 1 was recorded as having no organ failure as study drug was administered outside the protocol-defined time limit.
One patient in AZD9773 cohort 3 was recorded as having no organ failure as they received study drug outside the protocol-defined time limit; inclusion of this patient was a protocol deviation Twenty-six patients (55.3%) across AZD9773 cohorts had a culture-positive infection prior to study entry, compared to eight patients (34.8%) in the placebo group.
The between-treatment difference for office DBP averaged to +1.095%5% CI −0.4, +0.8) mmHg (P = 0.150), the upper limit of the 95% confidence interval being inferior to the protocol-defined non-inferiority limit (3 mmHg).
The between-treatment difference for office DBP (primary end point) averaged to +1.09595% CI −0.4, +0.8) mmHg (P = 0.150), with the upper limit of the 95% confidence interval being inferior to the protocol-defined non-inferiority limit of 3 mmHg.
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