 1. Independent monitoring of source data. Informed consent forms, case report forms, and data will be reviewed by the principal investigator following enrollment of every 5 subjects and an independent data and safety monitor following enrollment of every 50 subjects to the protocol to ensure safety of the study subjects. The safety data that will be reviewed includes: patient-, nurse-, research-assistant, or investigator-reported adverse events such as reason for early termination of the protocol, or adverse reaction to NO. Other data to be reviewed includes appropriate handling and processing of blood samples and maintenance of patient confidentiality throughout the study. 