Statistical Analysis Plan

TABLE OF CONTENTS

List of Abbreviations

whether the manifestation is “present” or "absent" in the last 4 weeks. It is a weighted instrument, in which descriptors are multiplied by a particular organ’s “weight”. Fo

2K 6

42K 6

whether the manifestation is “present” or "absent" in the last 4 weeks. It is a weightedinstrument, in which descriptors are multiplied by a particular organ’s “weight”. Fo

2K 6

42K 6

The gene signature and the neutralization levels will be . Subgroup analysis of

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o– –

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serious AEs are captured during the first year of subject’s participation only.

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MedImmune’s Clinical Pharmacology & DMPK group.

6 20

7 and decrease from BL 1.5

0.18 0.64

0.21 and decrease from BL 15%

2, <1 20

20

0.5

0.5, 0.25 10.0

1.4, 5.0

1.5, 5.0

1.0, 2.0

20 600

50 and decrease from BL 25

4.5

3 x ULN, 5 x ULN

3 x ULN, 5 x ULN

3 x ULN

500, 2000

5 x ULN

2 x ULN

20 100

25 and decrease from BL 10 70 and increase from BL 10

18

140, 190

132 152

3 5.5

90 120

2.5 7.0, 11.1

7.25

0.395

0.8

5.2

3.6, 5.4

50 120

50 and decrease from BL 20 120 and increase from BL 20

90 160

90 and decrease from BL 20 160 and increase from BL 20

50 100

50 and decrease from BL 10 100 and increase from BL 10