About The Study
This study involves comparing an investigational drug against a placebo. We learn about the effectiveness and safety of the study drug by comparing the experiences of the participants who receive the study drug to those who receive the placebo. In addition to the study drug or placebo, all participants will receive treatment for [Indication] that your doctor recommends. This study will enroll 500 participants from 10 countries.
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What To Expect
All study participants will receive treatment for [Indication] that your doctor recommends. All study participants will be closely monitored during the study.
Your participation in the study will last about 6 months. Here's how the study will work:
A computer will randomly assign you to receive either the study drug or placebo. Neither you nor the study doctor will know if you are receiving the study drug or placebo. Half of the study participants will receive the study drug, and the other half will receive the placebo.
You will take the first dose on the same day you enter the study. You will then take the following 9 doses at home twice daily over 5 days, for a total of 10 doses.
You will have a total of 10 study visits during your participation with the study team or by telemedicine (over the telephone or computer). You will also be asked to track any changes in your health in an electronic diary (e-diary).
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Why Participate?
As an eligible participant, you will receive study drugs and related tests at no cost to you. You may be eligible for compensation for your time and travel in this study.
Taking part in this study may or may not make your symptoms better.
Knowledge gained from this study may help future patients to better manage their symptoms and maintain a better quality of life.
Your study doctor will discuss potential risks and other available treatments for your condition prior to the start of the study.