| Double-blind Period | Open-label Period | ||
---|---|---|---|---|
nVNS | Sham | P Value | nVNS | |
% (n/N) (95% CI) | % (n/N) (95% CI) | % (n/N) (95% CI) | ||
All Attacks | ||||
 Pain-free | ||||
  24 h | 79.0 (71/93) (67.9, 87.1) | 83.7 (54/66) (69.9, 91.9) | 0.532a | 80.8 (118/146) (73.5, 86.6) |
  48 h | 65.7 (59/93) (53.3, 76.3) | 71.2 (46/66) (56.5, 82.5) | 0.537a | 70.3 (102/146) (61.6, 77.7) |
 Pain relief | ||||
  24 h | 80.9 (109/138) (72.3, 87.3) | 80.3 (78/99) (69.4, 87.9) | 0.916a | 80.5 (185/230) (74.5, 85.3) |
  48 h | 74.1 (99/138) (64.0, 82.1) | 72.1 (70/99) (60.7, 81.3) | 0.775a | 71.9 (165/230) (65.2, 77.7) |
First Attack | ||||
 Pain-free | ||||
  24 h | 75.0 (27/36) (57.8, 87.9) | 84.6 (22/26) (65.1, 95.6) | 0.359b | 75.4 (46/61) (62.7, 85.5) |
  48 h | 58.3 (21/36) (40.8, 74.5) | 69.2 (18/26) (48.2, 85.7) | 0.381b | 65.6 (40/61) (52.3, 77.3) |
 Pain relief | ||||
  24 h | 77.3 (58/75) (66.2, 86.2) | 79.3 (46/58) (66.7, 88.8) | 0.784b | 78.8 (108/137) (71.0, 85.3) |
  48 h | 69.3 (52/75) (57.6, 79.5) | 71.0 (41/58) (57.3, 81.9) | 0.866b | 70.1 (96/137) (61.7, 77.6) |