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(rJ GILEAU CLINICAL STUDY PROTOCOLStudy Title:A Phase 3, Randomized, DoubleBlind Study to Evaluate the Safety an d Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose.

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Phase II studies determine the effectiveness of an experimental drug on a particular disease or condition in approximately 100 to 300 volunteers. This phase may last from several months to two years. A Phase II trial answers the question, "Does Drug X improve Disease Y?"

Phase 3: About 33% of drugs will make it past the second phase and go on to Phase 3.

Phase III trials The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment.

Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years. The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition.

Table 1 TreatmentOrganizationPhaseLecanemabEisai/Biogen3mRNA-1273 and bivalent vaccineSouth Africa Medical Research Council3Mirvetuximab soravtansineImmunogen3FexinidazoleDrugs for Neglected Diseases2/37 more rows • Dec 23, 2022

Phase 4 is sometimes written as phase IV. These trials are done after a drug has been shown to work and has been licenced. Phase 4 trials aim to find out: more about the side effects including the rarer side effects and safety of the drug. what the long term risks and benefits are.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232