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Official Title:A Prospective TripleBlinded Single-ended Study of LaserAssisted 5Fluorouracil Versus LaserAssisted Corticosteroid Treatment for Keloids NCT Number:NCT04786210Study Number:2001172Document

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What is a phase iii randomized?

A Phase III randomized trial is a large-scale study that tests the effectiveness and safety of a treatment or intervention in a diverse population, comparing it against a control group to draw statistically significant conclusions.

Who is required to file a phase iii randomized?

Sponsors of clinical trials, which may include pharmaceutical companies, academic institutions, or other organizations conducting research, are required to file information regarding Phase III randomized trials.

How to fill out a phase iii randomized?

To fill out a Phase III randomized trial submission, one must provide detailed information on the study's design, methodology, participant criteria, treatment regimens, data collection methods, and statistical analysis plans, typically using standardized forms provided by regulatory authorities.

What is the purpose of a phase iii randomized?

The purpose of a Phase III randomized trial is to confirm the effectiveness of a treatment or intervention, to monitor side effects, and to compare it with commonly used treatments, ultimately contributing to the evaluation for approval by regulatory bodies.

What information must be reported on a phase iii randomized?

Information that must be reported includes study objectives, design, participant demographics, treatment protocols, outcomes measures, statistical methods, and safety monitoring plans.

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