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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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Follow the study protocol and administer the assigned treatments accordingly.
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Collect data on the outcomes of the treatments and analyze the results.
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Report the findings and conclusions of the phase III randomized study.

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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.
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.
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.
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.
Information that must be reported includes study design, participant demographics, intervention details, outcome measures, adverse events, and statistical analyses.
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