The primary safety end point was the first serious asthma-related event, a composite end point that included death, endotracheal intubation, and hospitalization. Events were reviewed by members of the joint adjudication committee who were unaware of the study-group assignments. All hospitalization events underwent initial screening by a member of the joint adjudication committee, and if the patient’s condition was considered to be potentially asthma-related, a complete adjudication followed. All intubations and deaths were fully adjudicated. All nonserious adverse events leading to withdrawal from the trial and all serious adverse events were documented. The vital status and mortality of all patients who received at least one dose of a study drug were assessed after the 6-month trial period.