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Development of the trial was informed by earlier feasibility work.
For EcLiPSE, we felt that a qualitative study was necessary in addition to PPI to ensure that the trial was informed by systematic exploration and analysis of the perspectives of a diverse group of parents, whose experiences were pertinent to the trial.
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All patients who entered the trial were informed of the nature of the study, and provided written informed consent for participation.
Lynda Budreau-Smaganis, a Cree elder supporting Gladue's family, wasn't sure family members, who sat through the trial, were informed ahead of time about the inclusion of Gladue's pelvis.
Any volunteers who were found to have a medical condition that excluded them from participation in the trial were informed at a private appointment with a member of the clinical staff.
Patients - referred by their rheumatologist to the outpatient department for multi-disciplinary NPT - eligible for both the GOA health care program and the trial are informed about the trial.
If a young person indicated on their ACQ that they were willing to participate in the study, the researcher then discussed with a member of the school's pastoral care team the eligibility of that young person (young people who volunteered for the trial were informed that this consultation would take place).
All women in this trial were informed of this result.
This method of applying utilities from a clinical trial was informed by the NICE Clinical Guideline on alcohol use disorders and has the advantage of being able to capture the disutility of adverse events relating to nalmefene.
The statisticians and DSMB of the other trial are informed of these results.
25 The survey and trial were informed by a pilot randomised trial (ISRCTN45091963).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com