There were 71 asthma-related deaths and intubations among the 685 composite outcomes (Table 1) or 10.3 such events in every 100 composite outcomes. If all patients experiencing these outcomes were receiving mandatory ICS therapy, 1 excess death or intubation would be seen in 38,591 patients (4,000 × 685/71). However, again, the great majority of events (43 of 44 in LABA-exposed patients) occurred in subjects not using mandatory randomized ICSs, although 19 and 23, respectively, are said to have received baseline ICS therapy or received concomitant ICS therapy throughout the trial. Even if we generously assume that 50% of those experiencing death or intubation in the FDA database were prescribed and were actually receiving an ICS, 1 excess death or intubation would be seen among 77,182 subjects receiving ICS therapy. For a clinically relevant trial outcome, for example, 5 excess deaths or intubations, 385,910 subjects would be required, assuming the true RD is exactly 0.25 per 1,000. However, the 95% CI of this estimate was −0.69 to 2.18 per 1,000 patients. If the true RD is only slightly less, for example, 0.15 per 1,000 patients, then > 640,000 subjects would be needed to identify 5 excess deaths and intubations. Given the CI, the true RD could be closer to or even below 0.0, in which case the number required for a study escalates enormously, including to infinity of the RD is in fact 0.0, which is statistically quite possible. So, a study examining deaths and intubations as the primary outcome also appears not to be feasible.