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Parents provided informed consent to blood sample drawing for research purposes, in accordance with the Declaration of Helsinki of 1975.
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All eligible patients had a blood sample drawn for assay analysis.
Consecutive series of all eligible patients had a single venous blood sample drawn for lactate assay analysis (index test) and a concurrent Kampala Trauma Score (KTS) II value determination (reference test).
In order to participate, the subjects would have to answer a questionnaire for assessment of their risk profile and to have a non-fasting blood sample drawn for lipid analyses.
Of the 2611 subjects with a molecular genetic diagnosis of FH or FDB who had been invited to participate, 956 (36.6%) actually answered the questionnaire and had a blood sample drawn for lipid measurements.
The sample drawn for the study represented all the geographic zones in the country.
All patients had a baseline blood sample drawn for rheumatoid factor (RF) and ACPA analysis.
One case reportedly had a sample drawn for viral testing 4 days before their first reported presentation for medical care.
In virtually all patients a blood sample drawn for other measurements could be used for this study, which limited the number of extra blood sampling.
At visit 1 (prescreening), all patients had a fasting blood sample drawn for blood chemistry, HDL-C, TG, and LDL-C levels.
Participants had MBG calculated from data uploaded from the patient's home glucose meter and a sample drawn for A1C at each clinic visit.
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