aJapan ALS severity classification grades, which were used for the pivotal clinical trial (J19), range from 1 to 5 as follows9:
1. Able to work or perform housework. 2. Independent living but unable to work. 3. Requiring assistance for eating, excretion, or ambulation. 4. Presence of respiratory insufficiency, difficulty in coughing out sputum, or dysphagia. 5. Using a tracheostomy tube, tube feeding, or tracheostomy positive-pressure ventilation. Return to content
ADL=activities of daily living; BL=baseline; FVC=forced vital capacity; LS=least squares; QD=once daily; SE=standard error.
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