Table 21SPARK Study — Mean Change in Dietary Phe Tolerance (mg/kg/day) From Baseline to End of Treatment (Intention-To-Treat Population)

SPARK
SAP + Diet
(n = 27)		Diet Alone
(n = 29)
Baseline
n
Mean (SD)		27
37.1 (17.3)		29
35.8 (20.9)
Week 26 LOCF
n
Mean (SD)		27
74.0(38.6)		27
49.8 (24.2)
Week 26 LOCF — Baseline
n
Mean (SD)
(95% CI); P value		27
36.9 (27.3)
(26.1 to 47.7); < 0.001		27
13.1 (19.6)
(5.4 to 20.9); 0.002

CI = confidence interval; LOCF = last observation carried forward; Phe = phenylalanine; SAP = sapropterin; SD = standard deviation.

Note: P value was derived by paired t test.

Source: Clinical Study Report SPARK study.11

From: Appendix 4, Detailed Outcome Data

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