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Study evaluation included general methodological quality features, including allocation concealment, sequence generation, a description of who was blinded, use of intention-to-treat analysis and proportion of study population lost-to-follow-up.
After completion of the blinded use, subjects were instructed to use the device on a daily basis and to verify the accuracy of glucose measurements with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).
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Proteome analysis was performed blinded using high-resolution capillary electrophoresis coupled with mass spectrometry (CE-MS).
Analyses were performed blinded using the Computer Assisted Stereology Toolbox version 2.0 (Olympus).
Images were then analyzed double blinded using IMAGE J software (http://rsbweb.nih.gov/ij/).
Scoring of PAD staining was also performed blinded using the same 1 to 3 scale.
Quantitative image analysis was performed blinded using ImageJ software (rsb.info.nih.gov/ij/).
After additional washing with FACS buffer samples were analyzed blinded using a BD LSRFortessa™ cell analyser (BD Biosciences, Allschwil, Switzerland).
The identity of the active medicines and placebos will be blinded using placebos that match the appearance of the active drugs.
Subjects are randomised using blinded envelopes, using a pre-stratification for the headache diagnosis.
Analyses were carried out blinded, making use of custom-developed counting software.
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CEO of Professional Science Editing for Scientists @ prosciediting.com