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Sponsor: Marines Pharmaceuticals, Inc.
Study 1042CDD3001Statistical Analysis Plan
22 August 2019Statistical Analysis Plan
Protocol No.: 1042CDD3001
A double-blind, randomized, placebo controlled trial
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How to fill out a double-blind randomized placebo-controlled
How to fill out a double-blind randomized placebo-controlled
01
Gather a pool of eligible participants for the study.
02
Randomly assign participants to either the treatment group or the control group.
03
Ensure that neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo.
04
Administer the treatment or placebo to the participants according to the assigned groups.
05
Monitor and record the outcomes of the study in a blinded manner to prevent bias.
06
Analyze the results to determine the effectiveness of the treatment.
Who needs a double-blind randomized placebo-controlled?
01
Researchers conducting clinical trials to test the efficacy of a new medication or treatment.
02
Regulatory bodies and health organizations looking for reliable evidence on the effectiveness of a treatment before approving it for public use.
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What is a double-blind randomized placebo-controlled?
A double-blind randomized placebo-controlled study is a type of research design where neither the participants nor the researchers know who is receiving the treatment and who is receiving the placebo.
Who is required to file a double-blind randomized placebo-controlled?
Researchers conducting clinical trials are typically required to conduct, file, and report double-blind randomized placebo-controlled studies.
How to fill out a double-blind randomized placebo-controlled?
To fill out a double-blind randomized placebo-controlled study, researchers must carefully design the study, obtain ethical approval, recruit participants, administer treatments, collect data, and analyze results.
What is the purpose of a double-blind randomized placebo-controlled?
The purpose of a double-blind randomized placebo-controlled study is to evaluate the efficacy and safety of a new treatment compared to a placebo or standard treatment.
What information must be reported on a double-blind randomized placebo-controlled?
Information such as study design, participant demographics, treatment allocation, efficacy outcomes, safety data, and statistical analysis must be reported on a double-blind randomized placebo-controlled study.
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