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statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr...

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Page 1: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

18Oct2018

CD-IA-MEDI-551-1155

CD-IA-MEDI-551-1155

PPD

PPD PPD

PPD

PPD

PPD

PPD PPD

PPD PPD

PPD

Page 2: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

Statistical Analysis Plan

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-

551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Protocol Number: CD-IA-MEDI-551-1155

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List of Abbreviations

Page 4: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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TABLE OF CONTENTS

Page 6: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 7: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 8: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 9: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 14: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 19: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 21: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

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Page 22: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 25: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 27: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 30: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

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Page 31: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

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Page 32: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 34: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
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Page 36: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 37: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 38: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq
Page 39: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

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Page 40: statistical analysis plan cd-ia-medi-551-1155 amendment 4 … · 2019. 10. 24. · ,77 ,qwhqw wr 7uhdw ,9 ,qwudyhqrxv ,9,* ,qwudyhqrxv lppxqrjorexolq .0 .dsodq 0hlhu /3 /ljkw shufhswlrq

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1155 NW 13th St Gainesville Fl. 32601

1155 Howard Robinson

HP 1155 All-In-One Desktop PC

1155 page 2014 05 27

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1155 Lecture 02

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