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Consent Form Study Title: A Phase I/II Study of Decidable in Combination with Sequential Kanamycin or Riboviria in High Risk AML Patients Clinical trials.gov # NCT02109744 Principal Investigator:

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How to fill out a phase i-ii study

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Define the objectives and endpoints of the study.

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Recruit eligible participants following inclusion and exclusion criteria.

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Administer the investigational drug or treatment according to the study protocol.

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Monitor and collect data on safety and efficacy throughout the study.

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What is a phase i-ii study?

A Phase I-II study is a clinical trial that combines Phase I and Phase II of drug development. Phase I focuses on safety and dosing, while Phase II assesses effectiveness and side effects.

Who is required to file a phase i-ii study?

Drug developers and researchers conducting clinical trials are required to file a Phase I-II study.

How to fill out a phase i-ii study?

To fill out a Phase I-II study, researchers must collect data on safety, dosing, effectiveness, and side effects of the drug being tested.

What is the purpose of a phase i-ii study?

The purpose of a Phase I-II study is to determine the safety, dosing, effectiveness, and side effects of a new drug in human subjects.

What information must be reported on a phase i-ii study?

A Phase I-II study must report data on safety, dosing, effectiveness, and side effects of the drug being tested, along with any adverse events that occur during the trial.

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