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FULFILL Pharmaceuticals U.S.A., Inc. Protocol FAVICOVUS201Version 6.0 15July2020Open Label, Randomized, Controlled Phase 2 ProofofConcept Study of the Use of Favipiravir Compared to Standard of Care
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An open label randomized controlled trial (RCT) is a type of clinical trial where participants are randomly assigned to different treatments, but both the researchers and participants are aware of the treatment assignments.
Researchers or organizations conducting clinical trials involving human participants are required to file open label randomized controlled trials for regulatory approval and compliance.
To fill out an open label randomized controlled trial, researchers must provide detailed information about the study design, population, randomization process, treatment protocols, and outcome measures in the appropriate regulatory forms.
The purpose of open label randomized controlled trials is to evaluate the effectiveness and safety of a treatment while allowing both participants and researchers to know the treatment being administered.
Information that must be reported includes trial objectives, study design, participant eligibility criteria, randomization methods, treatment details, outcome measures, and statistical analysis plans.
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