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In May, NIH awarded a contract to the Mayo Clinic in Rochester, Minnesota, to maintain the study's biobank of blood, urine, and other samples.
Both hylan G-F 20 and placebo were packaged identically in order to maintain the study blind.
Dummy infusions were used to maintain the study blinding and blinding of study medication was performed in the pharmacy.
We continued enrolling patients after the required sample size was achieved to maintain the study infrastructure required for the subsequent implementation study.
If the responsible investigator is no longer able to maintain the study records, a second person will be nominated to take over this responsibility.
Lacosamide 300 mg/day, an established effective dose for adjunctive therapy, was included to maintain the study blind and to ensure a study design consistent with the historical-control studies.
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To maintain the original study design of a blinded randomised controlled trial, the treatment code was kept secret for one of the authors who analysed the data (MH).
All personnel with access to data containing personal identifiers will sign a pledge to maintain the confidentiality of study subjects.
In practice, to maintain the integrity at the study level, it is possible (though not ideal) to remove the outliers with appropriate testing.
The number was too small to maintain the homogeneity of the study population; therefore, these 15 patients were excluded.
To maintain the blinding of the study design, placebo capsules were given on all remaining days of the week.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com