The REGINA Studies are being conducted to test an investigational study drug in adults aged 18 to 75. These research studies will evaluate whether the investigational study drug may safely and effectively reduce symptoms.

Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.

A placebo looks like the investigational study drug but does not contain any active medicine. Some research studies have a placebo and some do not. All of the REGINA studies will have a placebo. The study doctor will give you more information depending on which research study is the best fit for you.

The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.

Yes, your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final visit and return any unused study drugs.

No, you will receive the study drugs at no cost. You will also get all study-related medical tests at no cost.

No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.

A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational study drug is safe and effective. These research studies may help doctors find new ways to help prevent, detect, or treat health problems.

Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.

Before a research study can begin, a review board or ethics committee must review the research study. In the US, this group is called an IRB or Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.

Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine whether you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.

An investigational study drug is a drug that hasn’t yet been approved for use in the general public. In order to be approved, the investigational study drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.

If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.

For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/