 11. The use of oral or topical nitrates nitroglycerin, glyceryl trinitrate GTN, isosorbide dinitrate, and isosorbide mononitrate within 1 month 30 days prior to BaselineDay 1 or throughout the AIR001-CS06 study until EOS or Termination visit. Note: Intravenous GTN in an emergency setting may be administered by starting with a low dose and titrating upward, while the subject is being monitored closely for changes in blood pressure and heart rate. 