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1

2

3 =7y/> *-z r f -t V)t /ttv 2mg t-z rf,t Y)t/ttv 5mg t-7 rf -t Y)t7ttv l}mg

4 NTBC2mg NTBC5mg NTBClOmg

5 Cmax (uelml) rt,z

6

7

8 Boehringer Ingelheim

9

10 5ng n=6 ttzz s rhl

11 CLn ezl ImLlnin]

12 ,l5ue(n=70)

13

14

15 Page 1

16 Page2

17 Page 3 AUCsasp (oo. hrlml-) tttz ftr) Xn-4 lvz (hr)

18 Page 4 x:u:6il

19 Page 5

20

21

22

23

24 Trz (h)

25 p<0 000f' -2 3Yol ?q o. rz4okl'

26

27

28

29

30

31 (mean*sd. n=12)

32

33

34

35

36 34.5 mg

37

38 CL (ml,/midkg) trn (min)

39

40

41 l6 1ms ll I nrq )--< 2 ::- l. - 1y o 17 ilrq

42 itif fllf f

43

44

45

46

47

48

49

50

51

52 tb NovARr I s

53 trfl4^/l^7

54 Cmax (uglml)

55 300m9 I 50mg I 5omg 75nC tlogisticelb (60t181fl\ 3E/62$l 15mg 300mg 75mg 300ng I 5Omg 15mg

56 3inaruho vltrfifft=ta?t

57 tlr NovnRr I s

58 trb+^/l^7,

59 Cmar (ug/ml)

60 l5omg 75mE 300m9 300mg I 5omg l5omg 75mg 75mg t289/3t2lf'l\

61 tlttl: E-*9:(xFl7:3() (frbeuetriern<) w\,\rw. novartis.co.jp inaruho vlt,fi#frrte?t

62

63

64

65

66

67 PtviFTzffiz+omg

68 Grade 4

69

70

71 c.- Lti2 I pg/nl) (h)

72 - <^,'r=^ rrtu,1tta -flrffi I 16@ll frll\t>r M 2S l fl I I ^Laa'=1* M 3n 26 ua t62 lll & $ 14 6 I A4Fffi H (OS) O Kaplan-Meierffi fr (2010+I2E30E h v lt7)

73

14 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 11 12 20 0 0 0 0 0 0 0 0 0 0 0 0 21 0 0 0 0 0 0 0 0 0 0 0 0 22 0 0 0 0 0 0 0 0 0 0 0 0 23 0 0 0 0 0 0 0 0 0 0 0 0 24 0 0 0 0 0 0 0 0 0 0 0 0 25 0 0 0 0 0 0 0 0 0

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