Table 4.

CFA, CNA, stool characteristics, body weight, and body mass index at baseline and end of the OLE, unadjusted mean ± s.d. (OLE full analysis sample)

	Baseline (n = 58)	End (n = 48)	P-value*
CFA, %	53.6 ± 20.6	78.4 ± 20.7	<0.001
CNA, %	52.8 ± 24.4	74.6 ± 14.0	<0.001
Stool fat, g/day	46.7 ± 26.0	19.1 ± 13.6	<0.001
Stool nitrogen, g/day	6.7 ± 3.5	3.2 ± 1.8	<0.001
Fat intake, g/day†	101.2 ± 32.3	94.4 ± 30.9	n.d.
Nitrogen intake, g/day†	14.8 ± 5.7	13.6 ± 5.8	n.d.
Stool weight, g/day	467 ± 231	235 ± 121	<0.001
Number of stools per day	2.4 ± 1.6	1.5 ± 0.8‡	<0.001
Body weight, kg	68.2 ± 15.8	70.5 ± 16.3§	<0.05
Body mass index, kg/m2	23.6 ± 5.2	24.5 ± 5.4§	<0.05

CFA, coefficient of fat absorption; CNA, coefficient of nitrogen absorption; n.d., not determined; OLE, open-label extension; s.d., standard deviation.

^*P-value is for study end vs. baseline.

^†n = 50 at end of OLE.

^‡n = 52 at end of OLE.

^§n = 51 at end of OLE.