Table 2.

Summary of Change From Baseline to Week 24 in Serum ALP—Primary Endpoint

Serum ALP	Baseline Absolute Value (U/L)	Week 24 Absolute Value (U/L)	Week 24 Change From Baseline (U/L)	Week 24 Change From Baseline (%)
n	24	20	20	20
Mean (SD)	420.7 (262.9)	382.7 (230.8)	−32.7 (175.1)	−4.5 (34.8)
Median	369.0	295.5	−49.5	−18.0
Min, Max	173, 1,377	109, 917	−460, 416	−46, 89
LS mean				−3.111
95% CI of LS mean				(−15.5; 9.2)

Baseline is defined as the last available predose value. A linear mixed‐effect repeated‐measures model was used with percent change from baseline as the dependent variable, visit (screening, weeks 4, 8, 12, 16, and 24) as fixed factors, baseline score and baseline score by visit interaction as covariates, and subject included as a random effect to model correlations among the within‐subject repeated measures. ALP (%) on‐treatment change = (value at each visit – baseline value) / baseline value × 100. Denominator degrees of freedom were estimated using the Kenward–Roger method.

Abbreviations: LS, least squares; Max, maximum; Min, minimum.