The experimental design was a Phase 2b, two-centre, double-blind (observer- and participant-blind), randomised (1∶1 ratio) controlled trial.
Transthoracic echocardiography was performed in control and diabetic animals at 30 days, by double-blind observers with the use of a SEQUOIA 512 (ACUSON Corporation, Mountain View, CA), which offers a 10 13 MHz multifrequency linear transducer.
This prospective double blinded (for observer and patient) randomized study was approved by the Independent Review Board Nijmegen (protocol number NL39628.072.12, date of approval 28-02-2012) and was registered at http://www.trialregister.nl (NTR3330, keyword TTFR) before onset of participant enrolment.
Review of subjective comments beyond the bowel preparation scores by the blinded observer after the double blind had been broken were remarkable only for the observation that two patients in the psyllium group were noted to have an unusual fecal coating or "paste-like" appearance in the right colon.
Experiments were performed in triplicate, repeated at least once and judged in a double blind fashion by two observers.
Photos were visually inspected for damage by five experienced observers and double blind ranked from low (value 1) to high (value 7) damage (10 replicates: two trays per line, five observers).
Safranin O/Fast green stained sections were merged together from several individual photos in order to get a full view of panorama and then assessed by three independent observers under double blind condition for regenerative changes using Wayne scoring system (available as a supplemental file) [ 39].
All tongue flicking was recorded double blind to the condition; therefore, the observer was unaware of which mouse carcass was injected with the control or venom sample, as well as which condition was being tested.
The number of blood vessels as the index of angiogenesis was analyzed by counting the branches of blood vessels in three representative areas (each 1.0 mm) by two observers in a double blind manner.
In the immunohistochemistry experiments, all PCNA positive nuclei were counted in five independent fields by two independent observers in a randomized double blind fashion.
Double blind scoring was performed by two calibrated observers for smear layer and erosion.
