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All adverse events that occured between the trial reference start and end date were included.
The Regional Ethical Review Board in Gothenburg approved the trial (reference number 277 07).
This study was funded by the Medical Research Council (UK) as part of the txt2stop trial (reference 80492).
The Medical Ethics Committee Erasmus MC acts as central ethics committee for this trial (reference number MEC-2009-178 MEC-2009-178 MEC-2009-178
The MREC Erasmus MC (Rotterdam, The Netherlands) acts as central ethics committee for this trial (reference number MEC-2012-296 MEC-2012-296 MEC-2012-296
A1C was measured using ion-exchange high-pressure liquid chromatography with Diabetes Control and Complications Trial reference values.
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Seinfeld brilliantly worked in more O.J. Simpson jokes and trial references than you probably remember and I'm not just talking about Jackie Chiles.
Individual study designs and clinical trial references are listed in Supplementary Materials and Methods online (Supplementary Table S1 online).
For RV5 the trial references are: 1: Finland and US, 2: Finland, 3: Finland and US, 4: Kenya, 5: Vietnam, Ghana, 6: Bangladesh.
Missing published studies: The two other clinical trial references provided (3, 4) do meet the inclusion criteria for the systematic review and should have been included in the review.
The trial was registered with Current Controlled Trials, reference ISRCTN30080637.
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