Table 1.

Study medication administered during the open-label phase

Treatment summarya	Descriptive statistic (N =370)
	Mean (SD)	Median	Range
Treatment duration (days)	47.6 (9.13)	49.0	2–90
Average daily dose (mg)b	47.5 (13.93)	46.4	18–82
Average daily dose (mg)c	46.5 (14.18)	46.3	15–82
Last dose (mg)	52.6 (19.29)	54.0	18–90
Maximum dose (mg)	57.6 (18.11)	54.0	18–108
Minimum dose (mg)d	29.4 (8.88)	36.0	18–54

Distribution of last dose and maximum dose, n (%)
Daily dose	Last dose	Maximum dose
18 mg	29 (7.9)	5 (1.4)
36 mg	108 (29.3)	96 (26.0)
54 mg	127 (34.4)	133 (36.0)
72 mg	73 (19.8)	93 (25.2)
90 mg	32 (8.7)	40 (10.8)
108 mg	–	2 (0.5)e

Notes:

^aMedication data not available for one patient;

^bExcludes zero dose days;

^cIncludes zero dose days;

^dExcludes zero dose days; minimum dose was generally the starting dose;

^eTwo patients assigned to a 54 mg daily dose took a double dose for one day and two days, respectively.