Table 1. Study Events Schedule.
| Procedure | Time point | ||||||
|---|---|---|---|---|---|---|---|
| Screening/enrollment | Pre-drug | During 24 Hours of drug | Post Study Drug Completion (±3 h) | Sooner of day 5 or Discharge | 28-Day Phone Follow-up | 3 Months | |
| Informed Consent | X | ||||||
| Inclusion/Exclusion Review | X | ||||||
| Physical Exam | Physician to complete after ICS is obtained (pre physical exam) AND within 12 hours after study dug is complete (post physical exam). | ||||||
| Doppler Echo | X (optional) | X | |||||
| Blood draw | X | X | |||||
| Blood Pressure | X | X | |||||
| Borg Score | X | X | X | ||||
| SaO2% | X | Continuously | |||||
| MtHb% | X | Continuously | |||||
| Adverse Events Assessment | X | X | X | X | |||
| Outcome Assessment | X | ||||||
| Dyspnea & Quality of Life Questionnaire | X | ||||||