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Investigators were masked to treatment assignment but treating physicians and patients were not; however, investigators, physicians, and patients were masked to study serum cardiac troponin-T concentrations and echocardiographic measurements.
There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group.
Laboratory assistants, masked to study group, examined thick blood films for parasitaemia.
Patients and investigators were not masked to study treatment.
The investigators were not masked to study data during data acquisition.
Participants, study partners, and study staff were masked to study group assignment during the trial.
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In this study, we use the predefined brain mask to study functional connectivity in AE patients instead of defining the ROI as the seed.
Study medication arms were masked to investigators, study personnel, and participants.
After randomization, A1C and FPG values and all glucose levels from the FS-MMTT were masked to the study centers, unless FPG/A1C values met specific study criteria for discontinuation; similarly, urine glucose results were not reported for urine dipsticks.
While subjects were given the overall results of the study after year 1, participants and staff remained masked to individual study assignment and data until all subjects had completed at least 2 years of follow-up and data lock had occurred.
The strengths of this study were that it is the first randomized trial in adults to examine a simple strategy for calorie reduction and weight control, with participants masked to the study purpose, including >50% racial and ethnic minorities, strong retention rates, 24-h dietary recalls, provision of beverages, an AC group, and objective weight and physiologic outcome measures.
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CEO of Professional Science Editing for Scientists @ prosciediting.com