Table 2 Phase II protocol: physiologic parameters

23 ± 0.6

31 ± 1.3*

37 ± 1.9*^†

38 ± 2.0*^†

37 ± 2.0*^†

37 ± 2.0*^†

37 ± 2.0*^†

36 ± 1.9*^†

9 ± 0.4

11 ± 0.1*

12 ± 0.3*

12 ± 1.0*

12 ± 1.0*

12 ± 1.0*

12 ± 1.0*

11 ± 0.3*

30 ± 4

18 ± 3*

17 ± 2*

15 ± 3*

18 ± 2*

18 ± 2*

19 ± 2*

19 ± 2*

8.5 ± 1

6.6 ± 1.2

4.9 ± 0.6*

3.7 ± 0.8*^†

3.3 ± 0.4*^†

3.4 ± 0.5*^†

3.4 ± 0.5*^†

2.7 ± 0.3*^†

100 ± 1

80 ± 2.3*

84 ± 1.0*

90 ± 4.2*

91 ± 1.2

92 ± 1.5*

92 ± 0.6*

90 ± 1.0*

295 ± 22

54 ± 5*

53 ± 3*

64 ± 8*

65 ± 5*

70 ± 5*

71 ± 6*

71 ± 4*

38 ± 0.6

51 ± 2.7*

41 ± 2.0^†

36 ± 3.2^†

36 ± 1.9^†

35 ± 4.1^†

33 ± 2.5^†

32 ± 0.6^†

7.52 ± 0.1

7.42 ± 0.1

7.49 ± 0.1

7.51 ± 0.1

7.53 ± 0.1

7.53 ± 0.1

7.54 ± 0.1

7.54 ± 0.1

28 ± 13

596 ± 5*

566 ± 40*

578 ± 27*

572 ± 17*

543 ± 25*

520 ± 34*

523 ± 34*

23 ± 1.0

33 ± 0.9*

49 ± 0.9*^†

40 ± 1.8*^†

42 ± 2.0*^†

42 ± 2.5*^†

42 ± 3.1*^†

43 ± 3.8*^†

10 ± 0.9

12 ± 0.6*

25 ± 0.3^‡*^†

24 ± 0.3*^†‡

25 ± 0.3*^†‡

25 ± 0.7*^†‡

25 ± 0.7*^†‡

26 ± 0.9*^†‡

33 ± 4

19 ± 2*

12 ± 1*^†

12 ± 1*^†

12 ± 1*^†

13 ± 2*^†

15 ± 2*^†

15 ± 2*^†

7.4 ± 1.8

8.9 ± 0.8

8.1 ± 0.8^‡

6.6 ± 0.8

5.8 ± 1.3

5.0 ± 1.4*

5.9 ± 1.9

5.0 ± 2.0*

99 ± 0.3

64 ± 3.2^‡ *

98 ± 0.3^†‡

96 ± 1.0^†

95 ± 0.3^†‡

88 ± 6.5^†

98 ± 0.8^†‡

98 ± 1.0^†‡

361 ± 115

59 ± 14*

216 ± 62^‡

178 ± 37^‡

139 ± 14^‡

127 ± 10^‡

138 ± 15^‡

142 ± 15*^‡

49 ± 1.9^‡

62 ± 0.7^‡

108 ± 8.9*^†‡

122 ± 15*^†‡

119 ± 15*^†‡

114 ± 13*^†‡

112 ± 17*^†‡

103 ± 14*^†‡

7.41 ± 0.1^‡

7.30 ± 0.1*^‡

7.12 ± 0.1*^†‡

7.07 ± 0.1*^†‡

7.07 ± 0.1*^†‡

7.06 ± 0.1*^†‡

7.05 ± 0.1*^†‡

7.09 ± 0.1*^†‡

53 ± 15

576 ± 14*

362 ± 64*^†

382 ± 46*^†‡

425 ± 30*^†‡

444 ± 27*^†

463 ± 36*^†

473 ± 31*^†