What Will Happen In The SALTO study?
Before a child begins the SALTO study, the parent(s)/guardian(s) must agree to their child's participation and sign a document called an Informed Consent Form (ICF). During this process, the parent(s)/guardian(s) and child can ask the study doctor questions and learn more about the study. Your child (if able to read and write) must also agree to participate and sign a similar form called an “Assent Form”.
Next, your child will undergo some tests to see if he or she is eligible or qualifies for this study. If your child qualifies, he or she will be randomly assigned (like flipping a coin) to receive either the investigational medicine or placebo. All children will have an equal chance of receiving either the investigational medicine or placebo. The study is blinded meaning that neither you nor the study doctor will know which study medicine your child will receive.
During the study, you and your child will visit the study hospital
for medical exams, reviews of your child’s general health and
current pulmonary arterial hypertension (PAH) status, and tests
and assessments. The study doctor/study staff will discuss this
with you and your child in more detail.