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Official Title:A Phase I/II, Randomized, Double blind, Placebo controlled, Single center Study of the Effects of Cannabidiol (CBD) on Opioid Plasma
Levels in Participants With Chronic Radiculopathies
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Gather all necessary information and documentation required for the study.
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Randomly assign participants to different treatment groups.
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Report the findings and conclusions of the phase III randomized study.
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Pharmaceutical companies developing new drugs.
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What is a phase iii randomized?
A Phase III randomized trial is a clinical study that randomly allocates participants to different treatment groups to compare the effectiveness and safety of a new intervention versus standard treatment or a placebo.
Who is required to file a phase iii randomized?
Sponsors of clinical trials, such as pharmaceutical companies or research organizations, are required to file a Phase III randomized trial with regulatory authorities before conducting the study.
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The submission typically involves completing forms that detail the study design, objectives, methodology, and statistical analysis plan, along with supporting documents like protocols and informed consent forms.
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The purpose of a Phase III randomized trial is to confirm the efficacy and safety of a treatment in a larger population, gather more information about its potential benefits and risks, and provide a basis for regulatory approval.
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Information that must be reported includes study design, participant demographics, intervention details, outcome measures, adverse events, and statistical analyses.
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