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A blinded randomized placebo-controlled is a type of clinical trial design where participants are randomly assigned to receive either the experimental treatment or a placebo, and neither the participants nor the researchers know who receives which treatment, to eliminate bias.
Researchers and organizations conducting clinical trials that involve testing new drugs or treatments are required to file a blinded randomized placebo-controlled study.
To fill out a blinded randomized placebo-controlled, researchers must include information on study design, participant eligibility criteria, randomization methods, treatment assignments, and outcome measures.
The purpose of a blinded randomized placebo-controlled study is to assess the efficacy and safety of a new treatment while minimizing biases that could affect the results.
Information that must be reported includes study objectives, methodology, participant demographics, adverse events, efficacy results, and statistical analyses.
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