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An OpenTable Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Berating NCT04366713 Version: Original 04Sep2019An OpenTable Phase 2 Study to
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Obtain informed consent from participants.
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Clearly define the criteria for inclusion and exclusion of participants.
03
Randomly assign participants to treatment groups.
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An open-label phase 2 is a stage in clinical trials where both the researchers and the participants are aware of the treatment being administered.
Researchers conducting clinical trials are required to file an open-label phase 2.
To fill out an open-label phase 2, researchers need to accurately report the treatment being administered, monitor participants, and record any relevant data.
The purpose of an open-label phase 2 is to gather data on the safety and efficacy of a treatment in a controlled setting.
Researchers must report the treatment being administered, any adverse reactions, participant responses, and overall outcomes.
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