The first step towards enrollment is to see if you pre-qualify for this study. If your medical condition and symptoms match the study criteria, you will be contacted by a study coordinator for further evaluation. If you do not qualify for this specific trial, you can submit your contact information and we will contact you if you match to new trials in the future.
After pre-qualification, the next step is to have an in-person appointment at a local study site to enroll in the research study. Study sites are medical facilities (like hospitals, clinics and universities) where study-related activities will occur. At your first visit, you will receive additional information about the trial. You may be required to complete further screening at the study site to confirm your eligibility.
Before fully enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. This consent document is not a contract, and participants can withdraw their consent from the study at any time.
Participation will last between 42 to 44 Weeks. During the study, you and your child will be asked to come to the study site approximately 6 times, including an initial screening visit to see if your child is eligible for the study. You will also have the option to administer the investigational medication to your child at home after appropriate training by the investigator. Your child will need to comply with blood draws and physical examinations during clinic visits. Parents/caregivers will complete e-diary entries throughout the study to note their child’s daily symptoms and any adverse reactions to medication will be reported in the paper home dosing diary.