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NCT# 01596699IRB NUMBER: 1208641 IRB APPROVAL DATE: 04/10/2014 IRB EXPIRATION DATE: 05/02/2015UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (UCSF) ASSENT TO BE IN A RESEARCH STUDYStudy Title: CC#110819:
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01
Determine the objective of the phase 2 randomized trial.
02
Select a study population that meets the inclusion and exclusion criteria.
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Randomly assign participants to different treatment arms.
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Administer the assigned treatment to each participant according to the protocol.
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Monitor and collect data on the outcomes of interest for each participant.
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Analyze and interpret the collected data to evaluate the efficacy and safety of the treatments.
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Draw conclusions and make recommendations based on the results of the trial.

Who needs a phase 2 randomized?

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Phase 2 randomized trials are needed by researchers and pharmaceutical companies developing new drugs or treatments.
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Regulatory authorities may also require phase 2 randomized trials to assess the effectiveness and safety of a potential treatment before it can progress to phase 3 trials.
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Patients who are willing to participate in clinical trials can also benefit from phase 2 randomized trials to access potentially innovative treatments.
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A phase 2 randomized trial is a type of study in which participants are randomly assigned to different treatment groups.
Investigators conducting clinical trials are required to file a phase 2 randomized.
To fill out a phase 2 randomized, investigators need to provide detailed information about the study design, treatment groups, and outcome measures.
The purpose of a phase 2 randomized trial is to assess the safety and efficacy of a new treatment approach.
Information such as study protocol, patient demographics, treatment regimens, and study results must be reported on a phase 2 randomized.
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