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Protocol EB001SR201
IND 130880Version 2.0
02 May 2018CLINICAL STUDY PROTOCOL Phase 2 Study to Evaluate Safety and Efficacy of EB001 Injections in Facial
Scar Reduction After Undergoing Moss SurgeryStudy
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How to fill out a randomized double-blind placebo-controlled
How to fill out a randomized double-blind placebo-controlled
01
Collect a sample group of participants who will be involved in the study.
02
Randomly assign participants to different groups. Some will receive the actual treatment, some will receive a placebo, and some will receive no treatment at all.
03
Keep the assignment of participants secret, so neither the researchers nor the participants know who is receiving which treatment.
04
Administer the treatment or placebo to the respective groups.
05
Monitor and record any changes or effects experienced by the participants in each group.
06
Analyze the data collected to determine the efficacy and safety of the treatment compared to the placebo.
07
Repeat the study with a larger sample size to validate the results obtained.
08
Publish the findings in a scientific journal for peer review and further evaluation.
Who needs a randomized double-blind placebo-controlled?
01
Randomized double-blind placebo-controlled studies are typically needed in the field of medical research and pharmaceutical development.
02
They are conducted to evaluate the effectiveness and safety of new drugs, treatments, or interventions.
03
These studies are important for identifying potential benefits and risks associated with the interventions and ensuring the validity of research findings.
04
Healthcare professionals, regulators, and policymakers rely on the results of such studies to make informed decisions about medical treatments and interventions.
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What is a randomized double-blind placebo-controlled?
It is a type of clinical trial design where participants are randomly assigned to either the treatment group or the placebo group, and neither the participants nor the researchers know which group they belong to, to prevent bias.
Who is required to file a randomized double-blind placebo-controlled?
Researchers and institutions conducting clinical trials that involve human subjects and aim to demonstrate the efficacy and safety of a treatment or intervention.
How to fill out a randomized double-blind placebo-controlled?
Filling out involves providing details of the study design, participant selection, data collection methods, and ensuring compliance with ethical guidelines and regulatory requirements.
What is the purpose of a randomized double-blind placebo-controlled?
The purpose is to eliminate bias and ensure that the effects observed in the treatment group are solely due to the treatment itself and not influenced by participants' or researchers' expectations.
What information must be reported on a randomized double-blind placebo-controlled?
Key information includes the study design, participant demographics, intervention details, outcome measures, data analysis methods, and results.
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