How do the authors minimize the risks to the subjects?

1.       In which ways are the subjects in this study vulnerable? Which protections should be put in place to protect these subjects from harm?

2.       Identify the potential risks inherent in this study for the subjects. What should specifically be included in the informed consent for this study?

3.       What evidence is provided by the authors that the study was reviewed by the IRB and that appropriate informed consent was obtained?

4.       How do the authors minimize the risks to the subjects?

5.       In your opinion, do the potential benefits of this treatment outweigh the potential risks to the infant? Why or why not?