% FVC and the 6 minute walk distance, as seen in Figure 7. Subjects who demonstrated improvement in one of the endpoints cannot be predicted to have demonstrated improvement in the other. This can be interpreted as indicating the observed changes in % FVC in the study are not large enough to have notable impact upon the distance walked in 6 minutes for these subjects, thus raising uncertainty as to the clinical meaning %FVC changes of the size observed in the study.
Figure 7. Baseline to week 26 changes in the % FVC plotted against the changes in the 6 minute walk distance in individual subjects
Legend: Points shown as filled circles represent placebo-treated subjects and points represented as empty circles represent laronidase-treated subjects.
Apnea / Hypopnea Index (AHI) of the sleep study
The endpoint used for the analysis of efficacy was the mean AHI change from baseline to week 26 comparison between the treatment groups by ANOVA. The AHI is defined