Screening Visit (Visit 1)
At the screening visit information and samples (blood, urine) will be collected from the patient to assess whether they meet the inclusion and exclusion criteria to participate in the study. The patient will also undergo a physical examination, have vital signs collected, and will undergo a 12-lead ECG if one has not been performed within the 6 months prior to enrollment in the study.
The infant will also undergo a physical exam and a blood sample will be collected via heel stick.
Study Visit 2
If the patient is deemed eligible to participate based on the Screening Visit, they will have a second study visit approximately 3 months after the first visit.
At this time, the patient will undergo a second shorter physical exam and information will be collected as to whether there have been any changes in medications/procedures or any adverse events for the patient or the infant.
Blood, urine, and breast milk samples will be collected from the patient and a second heel-stick blood sample will be collected from the infant.
Finally, a safety follow-up call will take place approximately 30-40 days after the second study visit.
There will be no changes to the patients’ medications or clinical care.
Eligible patients will receive compensation for providing information and samples to the study.