Subject disposition.

The diagram shows subject disposition for the various stages of Study 19 and reasons for discontinuation. Note that for the overall study, subjects who returned for follow-up through cycle 11 were considered to have “completed” the study; however, a total of 5 subjects did not have data available for cycle 12 (2 subjects in the edaravone-edaravone group and 3 in the placebo-edaravone group, as indicated in the figure) and those subjects were excluded from the statistical analyses presented in this study. Adapted with permission [19]. ALS, amyotrophic lateral sclerosis; FVC, forced vital capacity (% of predicted); PaCO₂, partial pressure of carbon dioxide in arterial blood.