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STATISTICAL ANALYSIS PLANProtocol Number: Pelle926202 Study Title: DoubleClick, Dose Escalating, Randomized, VehicleControlled Proof of Concept Clinical Trial of Patidegib Gel 2×, 4×, and Vehicle
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Understand the purpose of the phase II randomized trial.
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Gather all necessary information and documentation.
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Determine the sample size and allocation ratio.
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Randomly assign participants to the experimental and control groups.
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Implement the study protocol and collect data.
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A Phase II randomized trial is a type of study where participants are randomly assigned to different treatments or interventions in order to compare their effectiveness.
Researchers or organizations conducting clinical trials are required to file a Phase II randomized trial with the relevant regulatory authorities.
To fill out a Phase II randomized trial, researchers must follow the protocol outlined in the study design, including randomizing participants, administering treatments, and collecting data for analysis.
The purpose of a Phase II randomized trial is to determine the efficacy and safety of a new treatment or intervention in a controlled and unbiased manner.
Information that must be reported on a Phase II randomized trial includes study design, participant demographics, treatment protocols, adverse events, and results of statistical analysis.
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