+ All Categories
Home > Documents > 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙...

2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙...

Date post: 04-Oct-2020
Category:
Upload: others
View: 0 times
Download: 0 times
Share this document with a friend
38
285 2.7.6.19 OCT1 1/167 2.5 mg5 mg 5.3.5.1-2 YM905 155 JA 155 20 20 YM905 5 mg10 mg 20 mg 12 24 YM905 YM905 YM905 YM905 1 350 1,400 2049 456 1593 FAS 1533 PPS 1507 1582 QOL 1514 1 20 224 8 1 3 24 1 24 1 3 6 4 5 1 2 31 3000 mL 4100 mL 5 4 1 6 7 8 6 3
Transcript
Page 1: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 285 -

2.7.6.19 ������OCT1� 1/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

��)*�YM905 ��� ! #$%&'()* !

�+,-.��+ ,- . / 1550�/001�JA12345678459: ;<=> . / 155?@2�34�ABC

�56 78(�

20 D E FG20 D E F

9:�;<=>�

��� !

?@�HIJKLMNOPQ)RS YM905 5 mg�10 mg�T�UVW��� 20 mgXYUZ[\Q 12]^_`abc�24d^efghijk<lmhnopSqrs YM905htuvwYM905hT�UVW���S)xyz{v�YM905 hUZ[\S)xy|}v~�� YM905 h��vQ&�xy��Q���cf�

��AB��?@��#$%&�^'( !

C� 8 DEFGHIJF(�

/�d�1� 350��� �/ 1,400�����d���� 2049���������� 456������ � 1593�

FAS��)R� 1533��PPS��)R� 1507����v��)R� 1582��QOL��)R� 1514�

KLGHM�NOPQRST�

¡¢h£¤q¥Q�¦§fc�¨©ªMq¥h«¬­S®¯°c±«HIJKLhOPQ)R

�cf�

²£¤q¥³

1~�´µ¶dS·¸yD¹º 20»��hMNOP�v¼½¾�2~24 d^efghk<lmºij 8 l��hOP¿��¡hÀÁQ±s�® 1 ©��§fxOPw��� 3F^hOPFÃÄgÅÆ~�Çijc¦�24d^efg±s�® 1lhÈÉv<ÊËQtxy�Çijc¦�24d^efg±s�® 1lh<´ÈÉÌQtxy�

3~���ÍÎÏ 6ÐE��SÑfgHIJKLhÒÓQtxyOP�4~ÔÕ±cSÖ׿ث¦ÙÚÛS s��º¿Ü�Ö׿k<pQÝÞ¿ÜyOP�5~ßà¨áâã¿h�´Q¶á­fOP�

²ªMq¥³

1~HIJKLhä9�^�SÈÉv<ÊËh_!º±«OP� 2~åᨱæçv<ÊËOP� 3~1Fijk<pº 3000 mLQèéy�<hOPw���hOPFÃÄgÅÆ~� 4~���^êSë?cfì<pÝÞSÄg�100 mL��hì<pºÅÆí­fOP�XY�îï�S¾ð�±y¡ñ<òóôõOwÏö÷øùÒú~heyOP�

5~���ÍÎÏ 4]^��S¡ñ<òóôõOwÏö÷øùÒú~h��hfûS�üw�1ý

þ�ú~ºabí­fOP�

6~HIJKL��Ñ­yÒÓw�<�ÈÉv<ÊË�<´ÈÉÌ~h��º�Hvw�üv���vú~¿eyOP�

7~Ð�� Që?c¦«yOP�XY^��Ö��<Që?c¦«yOP� 8~<òÌ�ÒwÏö÷��KL�ú~�<ò��w<����<3���KL��ú~�^�vKL�Q��xyOP�XY��v<òÌ�Òw�´µ¶Ï 6ÐE��S 3l���Ò~h��ºeyOP�

Page 2: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 286 -

2.7.6.19 ������OCT1� 2/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

9~KL��Q��c¦«y�XY��ºeyOP�10~Ïö÷����Q ¸fOP�<ò!"S#$Q�%x&'(�)Q ¸fOP�XYÏö÷øùÒS)xy*+�)Q ¸fOP�

11~���ÍÎÏ 12]^��S�<ò!"S#$Q�%x,"vheyM>��)wTUR-P�Û-�)ú~Q ¸fOP�

12~���ÍÎÏ 4 ]^��S�./01)�2Ú3�4526�)�KLÙÛ7�8XY9:;<=>úhz�?�)Që?cfOP�

13~@���üabºËA¿eyOPwB�C�DEvÚÛFG�HXYI��Ù7�$Ò<JKÒ�IóôhOPú~�

14~îï�¾ð�±y$L±�õO�MõO�NõO�OPQ�õO�RõOúQtxyOP�XYSv��QtxyOPwTc����ÍÎÏ 5 D��Sv��h��º Ñ­¬��ºJ«�Uþí­fOPY)R�c¦®Ä«~�

15~îï�¾ð�±y$L±îï&VWhXYQtxyOP�16~@���ü�Z�ÙGS)xy�?HZÒQtxyOP�17~H[ 5D��S�?XY����ê\]QtxyOP�XY�h 1D��S�?XY����^_]ºeyOP�

18~�´µ¶Ï 12]^��S�.h�!�Q`_cfOP�19~�ÏS YM905h�!�Q`_cfOP�20~���_�!�abFÏ 4]^��ST�UVW���Q`_cfOP�21~cd�efêhgvXY�!�^êhchQijxygvwchh,"vºeyOPSY�&VSÄgchhtJQÅÆxy��~�

22~kh.��!lmnoXY�!×pnoº�!)R�c¦½qr�UþcfOP�C�UV&WGHXYABVZ[\���

1(C�U�sYM905 5 mg��1�êS YM905�c¦ 5 mgttxy�ßüYus�x«vwh�4�x�4�8Q?cf�ü¿ey�yf YM905 5 mgUZ[\��M��z¼½"±�ü¿ey�

{YM905 10 mg��1�êS YM905�c¦ 10 mgttxy�ßüYus�x«W��wh�4�x�4�8Q?cf�ü¿ey�yf YM905 10 mgUZ[\��M��z¼½"±�ü¿ey�

|YM905 5 mgUZ[\��YM905Qttc±« YM905 5 mg��M��z¼½"±f}¨á±y�ü¿ey�ßüYus�x«vwh�4�x�4�8Q?cf�ü¿ey�

~YM905 10 mgUZ[\��YM905Qttc±« YM905 10 mg��M��z¼½"±f}¨á±y�ü¿ey�ßüYus�x«W��wh�4�x�4�8Q?cf�ü¿ey�

�T�UVW��� 20 mg��1�êST�UVW��� 20 mgttxy�ßüY�w�i�Óh�4�x�4�8�¿ey�yfT�UVW���UZ[\��M��z¼½"±�ü

¿ey�

�T�UVW���UZ[\��T�UVW���Qttc±«T�UVW��� 20 mg��M��z¼½"±f}¨á±y�ü¿ey�ßüY�w�i�Óh�4�x�4�8�¿ey�

Page 3: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 287 -

2.7.6.19 ������OCT1� 3/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

2(XYAB�1F 1l���S¡¢h 3�Q`_cf�

ab� ��� ���

UZ[\ �����

YM905 5 mg �����

YM905 10 mg �����

T�UVW���

�����

�����

w�~YM905 5 mg�w�~YM905 5 mg��M��z¼½"±UZ[\�w�~YM905 10 mg�w�~YM905 10 mg��M��z¼½"±UZ[\�w�~T�UVW��� 20 mg�w�~T�UVW��� 20 mg��M��z¼½"±UZ[\�

3(Z[\�� ����_�!��NH9059P�NK9059P ���_�!��79501/OCT1

�/0DE]^_`aRb�UXY56����w2]^~����w12]^~cdUef&U_`�

²�_�³

ÇC 1S¢�cf�_Ë��Y����_�!�abd¨á�����dy¿�_QË��cf�f�c�_�ü�����wÌ���HI�ú~Y�_,"�cf�yf�T�UVW���S

©«¦Y����_�!�abF 4]^Ϩá�����dy¿kh�_QË�cf�ÇC 1S¢�cf¡ñ<òóôõOwÏö÷øùÒú~h��hfûh�üw�1ýþ�ú~º��

��ÍÎÏ 4]^��Sabí­fOPY�ß�!S���­y��Y¿Ü±«���cf�ÇÌ�úS)xy@�G���üey«Y@�G�����ü�@���üQt� ov¡��

w�ü~�����¢Ú�úh£�^h�_Y,"�º����_�!�abd¨á�����d

y¿h^S�/ 15 F^��h�_YË��cf�yf�OPFâ��^Ykh�_QË��cf�

Ǥ¥¦þúh o�&VhÏa ��S§_xy¨©Ìª_«¬Çýþ�h�d�±�_Y,

"�cf�f�c�OPF�^Ykh�_Q��cf�

²z�?�)³

Ç./01)�2Ú3�4526�)�KLÙÛ7�8XY9:;<=>úhz�?�)Y�

���ÍÎh 4]^Ϩá�����dy¿khë?QË��cf�

Page 4: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 288 -

2.7.6.19 ������OCT1� 4/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

� 1 f&ghUijgekidU

@���­_ü®@¯°ü �2�5Û��� ±=01ülmnop&q�rsUt

D�

@�©�w²³´��µ³´~

@�G���ü

�ÚU ¶ @½·¸�

¨©Ìª_«¬Çýþ�

¹º������

@���üQt� ov¡��

u�v�Uw

Ïö÷øùÒ���

»b�w¼k<C½S)xy~

MAO¾½���¿À�Á�´Âª�Þü

CYP3A4Ã�ü���­J�

���ÄGZž½�

�UÆ<�

xyST�

�z{|}=~

���^ ���^

d� � 1N:F

� 2N:F

� 3N:F

� 4N:F

� 5N:F

wê�d~

âã�´ Ç qÈvÅÆ Ç Ç

Ò��� Ç

���_�!�ab Ç ���_�!�ab Ç Ç Ç

OPFÃ�É Ç Ç Ç Ç

OPFÃlÊ Ç Ç Ç Ç

`�ÓËÅÆ Ç Ç Ç Ç

Ì!PÍÎÏV Ç º�8¤¥ÏVÐ Ç Ç

ì<pÅÆ Çw���^êÑ~

îï&V Ç Ç Ç Ç

�?ÒÓêÔÕÝÞ Ç

12Ã��.Ö Çw���^êÑ~ Ç

×ØÒçǸÙm Ç Ç Ç Ç

ch&V �

Ï���Ç�_�ÏV Ç Ç Ç Ç Ç

t½ÚR Ç Ç Ç Ç Ç

Ç�ë?

��)R�±ygvOPSh�ë?

w���^êÑ~����^êw���_�!�abF¨á���_�!�abFy¿~

Page 5: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 289 -

2.7.6.19 ������OCT1� 5/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

����

(1)M�xy�?�ÛÜÝÞß�Y����¨áà�ÝÞN:dh 24d^efghijk<lmhnopwà�ÝÞdk<lmnop~�cf�

à�ÝÞd�Y� 5N:Fh¢��xyº�� 5N:Fh¢�º�Ýhá�Y�k­�Ïh¢�¿� 5N:FSà®â«¢�Qà�ÝÞdh¢��cf�

(2)��xy�?�¨ãÝÞß�Y 24 d^efghijk<lmw<ÊËh�Qtûfk<lm~hnop�24d^efghij<ÊËlmhnop�24d^efghijÈÉv<ÊËlmhnop�24d^efghij<´ÈÉÌlmhnop�1 lefghijk<phnop���ijä^k<lmhnop�cf�

(3)QOLzm��QOLÝÞY� 2N:F�� 5N:FwXYê�d~hº�8¤¥ÏVÐS¢�í­¦«y Quality

of LifeG��h5åÚ�G��hnopQÝÞß��cf�

����

(1)����ræ�!��hç6vhtJY¾Ñ¬��!�abÍΨá�!�ab��dh&VÇ��º

��xyy¿Sè�yéycs±«ey«Y´Öc±«êëwîï&VWúh&VhXYQt

�ì�ÒÓXY9/S©«¦t½ÚR�c¦µg�íf�f�c�t½ÚRh��Fº���h®

hw���t½ÚR~����h®hw���t½ÚR~Qî¼c¦·�±ïf�±·���Ò

ey«Y���t½ÚRº����_�!�abÍÎ�SðYh_HQèéåá¨SSocfá

�Y����t½ÚRhSoey«Y��ÒhSo�c¦���t½ÚRSµg�íy���c

f�f�c�ß�!¿YñõOhSoYt½ÚR�Yc±¨ïf�

±·�t½ÚRhòÕhUÞSYón�ôúh¨­_h$LÕ×õq¥öwi÷ 4D 6E 29F��� 80ø~h8Û5Qùú�c��hq¥SûÞí­¦«±«ß�S©«¦Y�¡¢h²t½ÚRhòÕh��³Qùú�c¦UÞcf�

���������?��

ü Õ�FY�IJºýíá­±«®h

êúÕ�FY�IJºýíá­y®h

$ Õ�FY�IJº½"�±y®h

yf�t½ÚRY�¡¢h²�!��h�þç�UÞq¥³S�«�!��hç6vQUÞcf�

Page 6: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 290 -

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

)�*+�,-./01234

���� !"#$

�%&'

()�*+,-./01234&56��789'&:;<�=>

:?�@AB�<CD�CE��CEFGH�I1J�KL>,M

NOP>;<Q

�%&:,R:N&:

()�*+,-./0KSOT&23456��789'�@AB�

<CD�CE��CEFGH�I1J�KL>,UVWX>7�(

)�KL>YZ[R\"WX&:;<Q

]^�%=_

()�*+,-./0KSOT&23456��789'�T`�

@AB�<CD�CE��CEFGH�()�ab1J�7�cd

ebfP>;<Q

SOTK�%=_

()�*+,-./0KSOT&23456��789'�gNh�

ij1:kPTKlmn>;<&o

SOTK()�1�pqEK#rs;<

t*+KL_�uv1wxyz{>;< H

|}�%&:,R:N&:~�}]^�%=_~�}SOTK�%=_~1:kPTKlm'�R1y�}()�

,1�%[7\"WX&:��-.~,"�'��qE,'��_���Q

(2)567"1) 89:;01 <=>(�

()���^����?�� 1 ���K��fP��������������������

����1���y#$,'�� 2 ���K��fP������TO�ij1 ¡¢£���

��¤¥¦§!"1#$¨K©:¤¥¦§1�ªy!"'�Q¤¥¦§�1;<�«¬'� �

�-.1­®1¯°¨y±MK²1­®y!³'�Q

)<=>567"?89:;01�234

´� 1 ���1V"�7µ¥�W=_�� 2 ���1V"�7¤¥�,&��;<W�� 2 ��

�1¤¥�7� 1 ���1V"�K¶· 20%a¸¹�'�;<Q

´� 1 ���1V"��� 2 ���1V"�7,RK¤¥�W=>7�� 2 ���1¤¥�7� 1���1�K¶· 20%a¸¹�'�;<Q

2) 89:; @>(�()���^����?�� 2 ����(º£E()�*+»«�K��fP�������

�����������������1���y#$,'�(º£E()�*+¼K��fP�

�����TO�ij1 (º£�����¤¥¦§!"1#$¨K©:�¤¥¦§1�ªyD

g½¾¿KjÀ'�Q¤¥¦§�1;<�«¬'� ��-.1­®1¯°¨y±MK²1­®

y!³'�Q

)@>567"?89:;01�234

´(º£Á»«1V"�7µ¥�W=_�(º£1V"�7¤¥�,&��;<W�(º£1

¤¥�7(º£Á»«1V"�K¶· 20%a¸¹�'�;<Q

´(º£Á»«1V"��(º£1V"�7,RK¤¥�W=>7�(º£1¤¥�7(º£

Á»«1�K¶· 20%a¸¹�'�;<Q

2.7.6.19 ������OCT1� 6/167

Page 7: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 291 -

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

3) �*+�.AB�

()���^����?�¤¥¦§�(º£�K`:��Ã)Ä1ÅÆ�<CD�CE��C

EFG�()�*+,1234��HyÇÈ'��«¬'� ()�,1����!"#$¨K

©:()�,1�%[y 4 ÉÊW!"'�Q

()�,1�%[W�����1\"Ë�&:��%&:,R:N&:�]^�%=_ÌÍS

OTK�%=_���-.ÌÍ�����¤¥¦§y�qE,'��_���Q

)�CDE+�*+�.AB014

�%[ �%&' ()�,1�%[7\"�&:��-.��qE�

�%[1^Î �%&'�%&:,R

:N&:]^�%=_ SOTK�%=_

(3)FGHIJGK� 1 ����� 2 ����� 3 ���ÌÍ� 5 ����=>:?ÏÐ��KÑÒÓÔÕÒ�,

'��Ö×�ØÌÍÙÚÛyV"'�Q()���^����?�� 1 ���K��fP���

�y#$,'� 2 ���K��fP����TO�¡¢£1¤¥¦§!"y�Ü��� 2 ���

K��fP����y#$,'� 3 ���ÌÍ� 5 ����=>:?ÏÐ��K��fP���

�TO�(º£1¤¥¦§!"yÝ��Q¤¥¦§!"?�()���^����7Þß1BÄ

1ÅÆHyÇÈ'�Ýàá,,'�Q

¤¥¦§1()�,1�%[K`:�?������1¤¥¦§,uv,'�Q

(4)12LMNOP1) NOP89:;�

¡¢£3Ï�¡¢£E()�Fâ�TO(º£E()�Fâ�ÜW�ÌÍ� 5 ����=>:

?ÏÐ2�Kã 1 ä�12 åæçèéyV"'�Q

V"'�çèé?�çèé!"êë7ìí'�îz'�Q

çèé!"êë?�ãß1çèéK`:�µ¥¤¥1!ïyÝ:�¡¢£1çèéð�K¶ñ

'� 5 ����=>:?ÏÐ2�1çèéð�K��¸òó,&>¦§7=>T\Ty!³'�

çèé!"EôKjÀ'�Q��¸òó,&>¦§7z{OP>,!³'�;<�çèé!"ê

ë?²1�õ�ÌÍö÷®y!"'�Q

n·�1!"ð�?�()���øù�úûüÑý�fP�²1àþ��¸òó,&>¦§7

z{OP�;<K?�()���^����?�²1�õ�/0��ö÷®�FG���,,R

K�«¬'� ()�,1����!"#$¨K©:()�,1�%[y 4 ÉÊW!"'�Q

&��çèéwxW?­®1!³?Ý�&:á,,'�Q

2) NOPQRSTH QTc(��()K��>çèé�ûÓû1�VÌͲ1� ��?�()��ÄTOê�y���

ÌÍ 7��'�QÜ��çè

é�����ÌÍçèé�ý�����?�uvK 7��'�Q&��

çèé!"êë?�����1U�K�'���üÑÒ�yÝà,�K��VÌÍ ûÓK`:

�1îzÌÍ!"yÝ��Q

UVWX�

��!��üÑÒ"û,#$1R,�ij1â%W&'yÝ��QÜ��Á(«ÜWK!�&

2.7.6.19 ������OCT1� 7/167

Page 8: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 292 -

2.7.6.19 ������OCT1� 8/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

�h=>Q¢cf8/��/�ãQ­÷cf��¦h8/����Ü?Y�8/��/�ãS�ï

¦­÷í­f�8/��/�ã¨áh@�YA#��ãS¢�cf�±·�¡¢hb;S©«¦

ÛܱBêhnCQ �á�SY��!ë?/�ãQDExy���cf�

(1)IJ­�®¯�`°ñF�c¦¡¢hb;�xyº�Ò�hµg�«YnQGHI��nQ8/�52Ú-h

´�ÇÕJQùú�c�Í<ÏSÒ�&�Q «KÞcf�

1) ���IJ­�s Full Analysis SetwFAS~���_�!�Q 1 l��`�c�tuvSçxyÝÞß�wÛÜÝÞß��¨ãÝÞß�Q¾Ñ¬~º����ÍÎÏ�����S 1ß�¿®ÝÞí­¦«yÒ�Q FAS�cf�{ Per Protocol SetwPPS~�!ë?/�ãSÞûf$ܱ£¤q¥ÇªMq¥Q§fxÒ��c��¡S¢�cfÀÁS

e¦Yyyá�Y�PPS¨áªMxy���cf�Ç���_�����_�!�abh`�Lº 70%A§XY 115%Q}éyá��f�c�`�L ëNS`_cf�ümO�^êS`_x�Ü�ümP100 �c�`�LSçxyQ�YÒ���ãS¢�í­fQ�QqScf�

�¡S¢�cfÀÁSe¦Yyyá�Y�khærxyRÚ�ÙQ PPS¨áªMcf�Ç�_Ë��ºabí­fá���_Ë��)ºë?í­fá��

ÇN:SSTùí­yOPFÃ�¿�¢�í­y�Ü6Ucf 3F^×hÒÓh¢�h�� 2F^×��h¢�º±í­±¨ïfá��

2) ���IJ­����_�!�Q 1 l��`�c����S��vSçxyQ�º¶á­¦«yÒ�Q��v��)R��cf�yf�QTc ÝÞY��v��)R�h���.ÖUÞ!"S·«¦Ì!�abÏ�h�.ÖÀVÙº�SW_�í­fÒ�S©«¦ ïf�

3) QOLIJ­�FASh���15åÚ���h5åÚ�G��ºX�¿Ü¦����_�!�hab�^º 14F��hÒ�Q QOL��)R��cf�4) Uw�±IJ­�� 5N:FwXYê�d~S 12Ã��.Ö�ÒÓêÔÕ¢�QtxyÒ�Q��?J���

)R�cf�

(2)² ³´GHST��IJFAS�PPS����v��)RS©«¦��Q ïf�ab�^¿'(,"vQÝÞxyfûS�¢�hv�SYZfqȱ&Þb)w�2 &Þ�H

&Þ�×[×�~Q_«�ab�^h½j\Q&�cf�t´]¥Y^_ 15%Q���cf�±·�ab�^S½j\ºÆûá­fß�¿uþS#$Q�%x�úéá­y�`S©«¦YÛÜ

ÝÞß�h��S·«¦ñ×ab¼h����Ï·��Q «�kh#$Qú�xy���cf�

(3)����IJÛÜÝÞß���¨ãÝÞß�Sçc¦Y FASQÛfy��)Rab�c�̈ ã�S PPSS©«¦®��Q ïf�

1) M�xy�?

Page 9: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 293 -

2.7.6.19 ������OCT1� 9/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

s��

à�ÝÞdS·¸yijk<lmnopS©«¦�Ü?8/pQX�cf�

YM905 hT�UVW���S)xyz{v�YM905 hUZ[\S)xy|}vQ&cxyfû�à�ÝÞdk<lmnopS©«¦�¡hd�¿��Q ïf�±·��¡hijWheh

^_ 95%f.î^hX��� t&Þ¿Y 4�h��×[Q_«f�g) YM905 10 mg�hUZ[\�S)xy|}vQ&cxyfûS�UZ[\�� YM905 10 mg�h'(Q t&ÞQ_«¦ ïf�t´]¥Yh_ 2.5%�cf�

i) g)¿ YM905 10 mg�hUZ[\�S)xy|}vºÆûá­fá�h��YM905 10 mg�hT�UVW����S)xyz{vQ&cxyfûS�YM905 10 mg ��T�UVW����hijWheh^_ 95%f.î^QX�cf�f.î^h�jº 0.6 Q¡lïfá��YM905 10 mg�hT�UVW����S)xyz{vºÆûá­f�Uþxy���cf�

k) g)¿ YM905 10 mg�hUZ[\�S)xy|}vºÆûá­fá�h��YM905 5 mg�hUZ[\�S)xy|}vQ&cxyfûS�UZ[\�� YM905 5 mg�h'(Q t&ÞQ_«¦ ïf�t´]¥Yh_ 2.5%�cf�

l) i)¿ YM905 10 mg�hT�UVW����S)xyz{vºÆûá­�¨©�k)¿ YM905 5 mg�hUZ[\�S)xy|}vºÆûá­fá�h��YM905 5 mg�hT�UVW����S)xyz{vQ&cxyfûS�YM905 5 mg��T�UVW����hijWheh^_ 95%f.î^QX�cf�f.î^h�jº 0.6Q¡lïfá��YM905 5 mg�hT�UVW����S)xyz{vºÆûá­f�Uþxy���cf�

±·�ab�^h8/Q�&Þm�Sehf.î^hX�® ïf�

�­áh��Y�� 2N:d��� 5N:dhÝÞº�®S Ñ­fÒ�S©«¦®��S ïf� ab��¿� 2 N:dS)xyà�ÝÞd�hijk<lmh'(Q)Yhey t &ÞQ_

«¦ ïf�yf�noSijk<lm�poSÝÞd�Q�g�ab�¼S�Ò�u�h��

��ab�u�hijWqr¥seQt­(8Z�¿ucf�

{¨ã��

g) à�ÝÞdijk<lmhnopS©«¦�� 2N:dhijk<lm¿Ï·cf��Q ïf�ab�^h'(Y�Û������cf�

i) ÝÞd�w� 3 N:d�� 4 N:d�� 5 N:d~¼Sijk<lmnophÜ?8/p��^_ 95%f.î^QX�c�­ÖQ ïf�

k) ab��¿�� 2N:dS)xy� 3N:d�� 4N:d��� 5N:dhijk<lmQ)Yhey t&ÞQ_«¦'(cf�f�c�&Þh�$vYúvc±«���cf�

l) ÝÞd�w� 2N:d�� 3N:d�� 4N:d�� 5N:d~¼Sijk<lmhÜ?8/pQX�c�­ÖQ ïf�

w) à�ÝÞdS�ijk<lmº 8lA§S±ïf(�Yocf)Ò�x�QX�cf�ÝÞdy¼S��h��Q ïf�

2) ��xy�?¨ãÝÞß�Y�¡hß��cf�

sijk<lmw<ÊËh�Qtûy~

{ij<´ÈÉÌlm

|ij<ÊËlm

~ijÈÉv<ÊËlm

�ijk<p

Page 10: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 294 -

2.7.6.19 ������OCT1� 10/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

�ijä^k<lm

sG�h¨ãÝÞß�S©«¦�¡h��Q ïf���¿�ÝÞW�Y��¢hsG�hi

jlmwXYp~h��Qzx�

g) à�ÝÞdh nopS©«¦�Ü?8/pQX�xy��®S�ab�^h'(Q t&ÞQ_«¦ ïf�eÑ{¦ab�^hijWheh^_ 95%f.î^Q/Xcf� ab��¿� 2N:dS)xyà�ÝÞd�h ÝÞß�hÝÞWQ)Yhey t&ÞQ_«¦'(cf�yf� ¨ãÝÞß�S©«¦�|ÜSYZ�� 2 N:Fh¢�QabÏW�c¦Ï·cf��Q ïf�

�­áh��Y�� 2 N:d��� 5 N:dhÝÞº�®S Ñ­fÒ�S©«¦®��S ïf�

i) ÝÞd�w� 3 N:F�� 4 N:F�� 5 N:F~¼S ÝÞß�hnophÜ?8/p��^_ 95%f.î^QX�c�­ÖQ ïf�

k) ab��¿�� 2N:FS)xy� 3N:F�� 4N:F��� 5N:Fh ÝÞß�hÝÞWQ)Yhey t&ÞQ_«¦'(cf�

l) ÝÞd�w� 2N:F�� 3N:F�� 4N:F�� 5N:F~¼S ÝÞß�hÝÞWhÜ?8/pQX�c�­ÖQ ïf�

w) à�ÝÞdyhij<ÊËlm��ij<´ÈÉÌlmS©«¦ 0 lS±ïf}�YocfìÒ�x�QX�cf�f�c����SkhÚRhÝÞWº~�c�¨©� ÝÞd�S·

«¦ÝÞWº~�xyÒ�Q)R�cf�ÝÞdy¼S��h��Q ïf�

3) QOLzm��IJQOLG��Sçc¦Y QOL��)R�QÛfy��)Rab�c�¨ã�S FASS©«¦®

��Q ïf�

s�^S·¸y5åÚ�G��noph'(

ÝÞdySh5åÚ�G��nophÜ?8/p�^_ 95%f.î^QX�cf�à�ÝÞdhnopQab�^¿'(cf�UZ[\��YM905 5 mg��YM905 10 mg�S©«¦Y���v&ÞSÄg_p-~vQ&�cf�t´]¥Yh_ 2.5%�cf�UZ[\��YM905 5 mg��YM905 10 mg���T�UVW����h)'(Y�t&ÞSÄg ïf�t´]¥Y^_ 5%�cf�yf�noSnop�poS5åÚ�(�ø�)Q�g�ab�u�SijWqr¥seQucf�

±·��$vhÏ·Y Ñ±¨ïf�

{��S·¸yabÏ�¿h5åÚ�G��h'(

ÝÞdySh5åÚ�G��hÝÞWhÜ?8/p�^_ 95%f.î^QX�cf�noSÝÞW�poSÝÞd�Q�g�Ò�u�h����ab�u�hijWqr¥seQt­(

8Z�¿ucf�

ab��¿� 2 N:dS)xyà�ÝÞdhÝÞWh'(Q)Yhey t &ÞQ_«¦ ïf�

µ¶·����IJ

��v��)R�S©«¦��Q ïf�t½ÚRh��SY�MedDRA7.0 h SOC}System Organ Classì� PT}Preferred Termìh×õQ_«f�t½ÚR���ÕQa/c���L��kh^_ 95%f.î^QX�xy��®S���Lh

ab�^h'(Q ïf�UZ[\��YM905 5 mg��YM905 10 mg�h��LS©«¦Y�

Page 11: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 295 -

2.7.6.19 ������OCT1� 11/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

Cochran-Armitage&ÞSÄg_p-~vQ&�cf�t´]¥Yh_ 2.5%�cf�UZ[\��YM905 5 mg��YM905 10 mg���T�UVW����h)'(Y�Fisherh Exact&ÞSÄg ïf�t´]¥Y^_ 5%�cf�¨­_S©«¦®��S��Q ïf�îï&VWXYnJ��.ÖhXYnJS©«¦®���S��LQX�c�_p-~vh&

�m�S�^'(Q ïf�

2Ú���Ú�hXYnJS©«¦Y��LhX�h� ïf�

QTcS©«¦Y�.Ö¹Zå�Qa/c�abÏ�hnop��kh^_ 95%f.î^QX�cf�yf�t½ÚR���S_p-~vh&���^'(Q ïf�íáS�ÒÓêÔÕ¢

��hç�Q&�cf�

±·��$vhÏ·Qc±¨ïf�

¸¹�º»�

���­Ò�h��QÖ 1Sucf�ß�!S���­á­fÒ�mY 2049�¿eïf��h��������h 456��Ì!�Qxg)¸á­fS®¨¨Ñá¬A`�¿eïf 8��m�SÌ!�h`�º½å¿eg�Ì!�ab�htuv����vhÝÞß�º�¦AÝÞ¿eï

f1�Qªs1584�QÌ!�ab��cf�Ì!�ab�h��YUZ[\�405��YM905 5 mg� 398��YM905 10 mg� 381���T�UVW���� 400�¿eïf�

ê���Y�mhß�SærxyÒ�eg

�����S��cft½ÚRhfûSê�cfÒ�Qt�

§ 1 OPQR¸¹�º»

������

456 �

Ì!�A`��

Ì!�h`�º½å

9 �

���­Ò�m

2049 �

UZ[\�

405 �YM905 5mg�

398 �YM905 10mg�

381 �����������

400 �

�!��

371 ��!ê�

34 ��!��

364 ��!ê�

34 ��!��

349 ��!ê�

32 ��!��

364 ��!ê�

36 �

��

t½ÚR 12�*�!/�ã@� 3��´h�l 23�kh. 3�

��

t½ÚR 22�*�!/�ã@� 3��´h�l 15�kh. 3�

��

t½ÚR 26��!/�ã@� 2��´h�l 21�kh. 1�

��

t½ÚR 26��!/�ã@� 2��´h�l 22�kh. 2�

Ì!�ab�

1584 �

Page 12: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 296 -

2.7.6.19 ������OCT1� 12/167

��� ���������

����� ��� 2.5 mg�5 mg

��������������� �

�������

������

5.3.5.1-2

!"#$%&'(

(1)���IJ­�¹1) FAS��)R�

��v��)R�h���Ì!�Q 1l��`�c�tuvSçxyÝÞß�wÛÜÝÞß��¨ãÝÞß�Q¾Ñ¬~º����ÍÎÏ�����S 1ß�¿®ÝÞí­¦«yÒ�Q)R�cf�FAS��)R�mY 1533�wUZ[\� 395��YM905 5 mg� 383��YM905 10 mg� 371��T�UVW���� 384�~¿eïf�

2) PPS��)R�FAS ��)R�h���!ë?/�ãQ��cfÒ�Q)R�cf�PPS ��)R�mY

1507�wUZ[\� 390��YM905 5 mg� 379��YM905 10 mg� 359��T�UVW���� 379�~¿eïf�

(2)���IJ­�¹Ì!�Q 1l��`�c�a��h��vSçxyQ�º¶á­¦«yÒ�Q)R�cf�

��v��)R�mY 1582�wUZ[\� 405��YM905 5 mg� 396��YM905 10 mg� 381��T�UVW���� 400�~¿eïf�

(3)QOLIJ­�¹FAS ��)R�h���1 5åÚ���h5åÚ�G��ºX�¿Ü�Ì!�hab�

^º 14F��hÒ�Q)R�cf�QOL��)R�mY 1514�wUZ[\� 394��YM905 5 mg� 375��YM905 10 mg� 367��T�UVW���� 378�~¿eïf�

¼½]�¾��20 D E F

��¿ÀÁ

����À��

ÛÜÝÞß���¨ãÝÞß�S©«¦Y FAS��)R�S·¸y�þQucf�QOLG��S©«¦Y�QOL��)R�S·¸y�þQucf�(1)M�xy�? ÂÃÄiÅ8( ab�hà�ÝÞdS·¸yijk<lmhnopQX�c�YM905hUZ[\S)xy|

}vm�S YM905hT�UVW���S)xyz{vQ&�cf�±·�ÛÜÝÞß�¿eyk<lmhX�SY<ÊËh�há�QX�c±«���cf�

à�ÝÞdhijk<lmnopYUZ[\��YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�k­�­-0.94l�-1.93l�-2.19l�-1.87l¿eïfwC 2ì�

� 2 ÆÇxyF�ÂÃÄiÅ8�ÈW FAS(^_ 95%f.î^

ab� Ò�m ijW r¥se¡j �j

UZ[\ 395 -0.94 2.286 -1.164 -0.712YM905 5 mg 383 -1.93 1.974 -2.133 -1.736

YM905 10 mg 371 -2.19 2.090 -2.406 -1.979T�UVW��� 384 -1.87 2.702 -2.140 -1.598

UZ[\�� YM905 10 mg�h'(Q t&ÞQ_«¦ ïfwt´]¥h_ 2.5%ì�kh�þ�UZ[\�S)xy YM905 10 mg�h|}vº&cí­f�Uþcfwp<0.0001ì�

Page 13: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 297 -

2.7.6.19 ������OCT1� 13/167UZ[\�S)xy YM905 10 mg�h|}vº&cí­f��¨á�YM905 10 mg��T�U

VW����hà�ÝÞdk<lmnophewYM905 10 mg� T�UVW����~��^

_ 95%f.î^QX�cf�kh�þ�^_ 95%f.î^Y-0.6492~0.0025 ¿eg�f.î^h�jºÚÏS�!ë?/�ã¿ûÞcfz{vhj�W¿ey 0.6 Q¡lïf��¨á�T�UVW����S)xy YM905 10 mg�hz{vº&cí­f�Uþcf�

UZ[\�S)xyYM905 10 mg�h|}vº&cí­f��¨á�UZ[\��YM905 5 mg�h'(Q t &ÞQ_«¦ ïfwt´]¥h_ 2.5%ì�kh�þ�UZ[\�S)xy YM905 5 mg�h|}vº&cí­f�Uþcfwp<0.0001ì�T�UVW����S)xy YM905 10 mg�hz{���UZ[\�S)xy YM905 5 mg�

h|}vº&cí­f��¨á�YM905 5 mg��T�UVW����hà�ÝÞdk<lmnophewYM905 5 mg � T�UVW����~��^_ 95%f.î^QX�cf�kh�þ�^_ 95%f.î^Y-0.3882~0.2583 ¿eg�f.î^h�jºÚÏS�!ë?/�ã¿ûÞcfz{vhj�W¿ey 0.6Q¡lïf��¨á�T�UVW����S)xy YM905 5 mg�hz{vº&cí­f�Uþcf�

ab�^S·¸yà�ÝÞdhijk<lmnoph'(Q t&ÞQ_«¦ ïfwC 3ì�

� 3 ÂÃÄiÅ8�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -1.255 -1.5783G-0.9311 -7.6058 <0.0001 UVW��� vs. YM905 10 mg -0.323 -0.6492G0.0025 -1.9467 0.0259 UZ[\ vs. YM905 5 mg -0.996 -1.3173G-0.6753 -6.0887 <0.0001 UVW��� vs. YM905 5 mg -0.065 -0.3882G0.2583 -0.3941 0.3468 UZ[\ vs. UVW��� -0.931 -1.2521G-0.6106 -5.6956 <0.0001 Ñ�t´]¥h_ 2.5%

à�ÝÞdhijk<lmº 8 lA§S±ïfÒ�hx�w�YoL~YUZ[\�21.0%}83/395�ì�YM905 5 mg� 28.5%}109/383�ì�YM905 10 mg� 36.9%}137/371�ì��T�UVW���� 26.3%}101/384�ì¿eg�YM905 5 mg��YM905 10 mg�YT�UVW����Q�ly�YoLQucf�

(2)��xy�?1) ÂÃÄiÅ8 ijg�PqÌÍs(��ÈW<ÊËh�ºÆûá­yá�®k<lmSX�cfNhà�ÝÞdS·¸ynopS©«¦&

�cf�þ�<ÊËh�ºÆûá­yá�Qk<lmSX�c±«á����h�þ¿eïfwC

4�C 5ì�

� 4 ÆÇxyF�ÂÃÄiÅ8 ijg�PqÌÍs(�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 395 -0.97 2.314 -1.196G-0.738

YM905 5 mg 383 -2.03 1.972 -2.228G-1.832 YM905 10 mg 371 -2.24 2.107 -2.455G-2.025

T�UVW��� 384 -1.95 2.611 -2.216G-1.692

Page 14: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 298 -

2.7.6.19 ������OCT1� 14/167

� 5 ÂÃÄiÅ8 ijg�PqÌÍs(�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -1.274 -1.5950G-0.9524 -7.7755 <0.0001 UVW��� vs. YM905 10 mg -0.287 -0.6103G0.0367 -1.7387 0.0411 UZ[\ vs. YM905 5 mg -1.063 -1.3821G-0.7447 -6.5447 <0.0001 UVW��� vs. YM905 5 mg -0.076 -0.3974G0.2445 -0.4674 0.3201 UZ[\ vs. UVW��� -0.987 -1.3054G-0.6684 -6.0781 <0.0001 Ñ�t´]¥h_ 2.5%

2) ÂÃiÎÏÐÑÅ8��ÈWà�ÝÞdS·¸yij<´ÈÉÌlmhnopY�UZ[\��YM905 5 mg��YM905 10 mg

���T�UVW����S·«¦�k­�­-1.28l�-2.41l�-2.78l��-2.30l¿eïfwC6ì�ab�^S·¸yij<´ÈÉÌlmnoph'(Q t &ÞQ_«¦ ïfwt´]¥h_

2.5%ì�kh�þ�UZ[\��'(c YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�8/�St´±�ºÆûá­f�yf�YM905 10 mg�YT�UVW�����'(c�8/�St´±�ºÆûá­fwC 7ì�

� 6 ÆÇxyF�ÂÃiÎÏÐÑÅ8�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 395 -1.28 2.899 -1.563G-0.989

YM905 5 mg 383 -2.41 2.877 -2.697G-2.119 YM905 10 mg 371 -2.78 2.819 -3.072G-2.497

T�UVW��� 384 -2.30 3.080 -2.613G-1.995

� 7 ÂÃiÎÏÐÑÅ8�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -1.508 -1.9226G-1.0942 -7.1427 <0.0001 UVW��� vs. YM905 10 mg -0.480 -0.8972G-0.0630 -2.2579 0.0120 UZ[\ vs. YM905 5 mg -1.132 -1.5427G-0.7209 -5.4032 <0.0001 UVW��� vs. YM905 5 mg -0.103 -0.5173G0.3103 -0.4906 0.3119 UZ[\ vs. UVW��� -1.028 -1.4389G-0.6177 -4.9124 <0.0001 Ñ�t´]¥h_ 2.5%

à�ÝÞdhij<´ÈÉÌlmº 0 lS±ïfÒ�hx�w�YoL~YUZ[\�20.8%}82/395�ì�YM905 5 mg� 32.9%}126/383�ì�YM905 10 mg� 37.2%}138/371�ì��T�UVW���� 33.3%}128/384�ì¿eg�YM905 10 mg�ºà®�¨ïf�

3) ÂÃijgÅ8��ÈWà�ÝÞdS·¸yij<ÊËlmhnopY�UZ[\��YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�k­�­-0.72 l�-1.59 l�-1.60 l��-1.25 l¿eïfwC8ì�ab�^S·¸yij<ÊËlmnoph'(Q�t&ÞQ_«¦ ïfwt´]¥h_ 2.5%ì�kh�þ�UZ[\��'(c YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�8/�St´±�ºÆûá­fwC 9ì�

Page 15: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 299 -

2.7.6.19 ������OCT1� 15/167

� 8 ÆÇxyF�ÂÃijgÅ8�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 283 -0.72 1.951 -0.950G-0.493

YM905 5 mg 274 -1.59 2.117 -1.843G-1.339 YM905 10 mg 270 -1.60 1.810 -1.817G-1.383

T�UVW��� 295 -1.25 2.793 -1.566G-0.926

� 9 ÂÃijgÅ8�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -0.879 -1.2478G-0.5093 -4.6687 <0.0001 UVW��� vs. YM905 10 mg -0.354 -0.7192G0.0119 -1.8984 0.0290 UZ[\ vs. YM905 5 mg -0.870 -1.2376G-0.5020 -4.6395 <0.0001 UVW��� vs. YM905 5 mg -0.345 -0.7091G0.0192 -1.8585 0.0317 UZ[\ vs. UVW��� -0.525 -0.8860G-0.1638 -2.8518 0.0022 Ñ�t´]¥h_ 2.5%

���^êS<Ê˺Æûá­fÒ�S·«¦�à�ÝÞdhij<ÊËlmº 0 lS±ïfÒ�hx�w�YoL~YUZ[\� 37.1%}105/283�ì�YM905 5 mg� 56.2%}154/274�ì�YM905 10 mg� 59.6%}161/270�ì��T�UVW���� 55.9%}165/295�ì¿eg�YM905 10 mg�ºà®�¨ïf�

4) ÂÃÏÐ�ijgÅ8��ÈWà�ÝÞdS·¸yijÈÉv<ÊËlmhnopY�UZ[\��YM905 5 mg ��YM905

10 mg���T�UVW����S·«¦�k­�­-0.69l�-1.45l�-1.52l��-1.19l¿eïfwC 10ì�ab�^S·¸yijÈÉv<ÊËlmnoph'(Q�t&ÞQ_«¦ ïfwt´]¥h_

2.5%ì�kh�þ�UZ[\��'(c YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�8/�St´±�ºÆûá­fwC 11ì�

� 10 ÆÇxyF�ÂÃÏÐ�ijgÅ8�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 260 -0.69 2.002 -0.932G-0.443

YM905 5 mg 235 -1.45 1.886 -1.688G-1.204 YM905 10 mg 255 -1.52 1.771 -1.735G-1.298

T�UVW��� 262 -1.19 2.195 -1.452G-0.918

� 11 ÂÃÏÐ�ijgÅ8�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -0.829 -1.1698G-0.4872 -4.7638 <0.0001 UVW��� vs. YM905 10 mg -0.331 -0.6719G0.0094 -1.9081 0.0283 UZ[\ vs. YM905 5 mg -0.758 -1.1068G-0.4097 -4.2692 <0.0001 UVW��� vs. YM905 5 mg -0.261 -0.6089G0.0869 -1.4721 0.0707 UZ[\ vs. UVW��� -0.497 -0.8363G-0.1583 -2.8788 0.0020 Ñ�t´]¥h_ 2.5%

Page 16: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 300 -

2.7.6.19 ������OCT1� 16/167

5) 1ÅÒbÓ�ÂÃÄiW��ÈWà�ÝÞdS·¸y 1lefghijk<phnopY�UZ[\��YM905 5 mg��YM905

10 mg ���T�UVW����S·«¦�k­�­+11.67 mL�+35.78 mL�+43.59 mL ��+36.62 mL¿eïfwC 12ì�ab�^S·¸y 1lefghijk<pnoph'(Q�t&ÞQ_«¦ ïfwt´]¥h_ 2.5%ì�kh�þ�UZ[\��'(c YM905 5 mg��YM905 10 mg���T�UVW����S·«¦�8/�St´±��ºÆûá­f�yf�YM905 10 mg�YT�UVW�����'(c�8/�St´±��ºÆûá­fwC 13ì�

� 12 ÆÇxyF�ÂÃÄiW�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 393 11.67 33.740 8.328G15.020

YM905 5 mg 381 35.78 43.385 31.406G40.147 YM905 10 mg 369 43.59 44.519 39.037G48.151

T�UVW��� 383 36.62 37.989 32.807G40.441

� 13 ÂÃÄiW�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -31.920 -37.6157G-26.2245 -10.9931 <0.0001 UVW��� vs. YM905 10 mg -6.970 -12.7014G-1.2384 -2.3853 0.0086 UZ[\ vs. YM905 5 mg -24.102 -29.7515G-18.4532 -8.3689 <0.0001 UVW��� vs. YM905 5 mg 0.848 -4.8375G6.5332 0.2925 0.6150 UZ[\ vs. UVW��� -24.950 -30.5919G-19.3086 -8.6748 <0.0001 Ñ�t´]¥h_ 2.5%

6) ÂÃÔ6ÄiÅ8��ÈWà�ÝÞdS·¸yijä^k<lmhnopY�UZ[\��YM905 5 mg��YM905 10 mg

���T�UVW����S·«¦�k­�­-0.30l�-0.41l�-0.46l��-0.43l¿eïfwC14ì�ab�^S·¸yijä^k<lmh'(Q t&ÞQ_«¦ ïfwt´]¥h_ 2.5%ì�kh�þ�UZ[\��'(c YM905 10 mg�S·«¦8/�St´±�ºÆûá­fwC 15ì�

� 14 ÆÇxyF�ÂÃÔ6ÄiÅ8�ÈW FAS(ab� Ò�m ijW r¥se ^_ 95%f.î^UZ[\ 361 -0.30 0.909 -0.396G-0.208

YM905 5 mg 344 -0.41 0.962 -0.515G-0.311 YM905 10 mg 334 -0.46 0.898 -0.553G-0.360

T�UVW��� 348 -0.43 1.208 -0.561G-0.307

� 15 ÂÃÔ6ÄiÅ8�ÈW�É6ÊË FAS(ab� ijWhe ^_ 95%f.î^ tW h_ pWÑ

UZ[\ vs. YM905 10 mg -0.155 -0.3039G-0.0054 -2.0321 0.0212 UVW��� vs. YM905 10 mg -0.023 -0.1733G0.1279 -0.2954 0.3839 UZ[\ vs. YM905 5 mg -0.111 -0.2590G0.0373 -1.4677 0.0712 UVW��� vs. YM905 5 mg 0.021 -0.1284G0.1706 0.2771 0.6091 UZ[\ vs. UVW��� -0.132 -0.2797G0.0158 -1.7525 0.0400 Ñ�t´]¥h_ 2.5%

Page 17: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 301 -

2.7.6.19 ������OCT1� 17/167(3)QOLzm� ab�S·¸yà�ÝÞdh QOL 5åÚ�G��nophÜ?8/pm�SUZ[\��

YM905 5 mg��� YM905 10 mg�h_p-~vS©«¦�Jonckheere-Terpstra&ÞSÄgt´]¥h_ 2.5%S¦&�cf�þQC 16 Sucf���5�±¤¥Ó�öQªs QOL 5åÚ�S·«¦�UZ[\��YM905 5 mg��� YM905 10 mg�S_p-~vºÆûá­f�ab�^S·¸y QOL 5åÚ�G��noph'(Q t &ÞQ_«¦ ïfwt´]¥^_

5%ì�kh�þ��5I&h#$����ÚÇIÚh¬j����=�IJh¬j�����IJh¬j����h¾ð�����ÇIK���$ÒÕöS·«¦�YM905 5 mg��YM905 10 mg���T�UVW����YUZ[\��'(c¦8/�St´±5åÚ�G��h�ÂwQOLG��hD ~ºÆûá­���5�±¤¥Ó�öS·«¦ YM905 5 mg���T�UVW����YUZ[\��'(c¦8/�St´±5åÚ�G��h�º���à�±à^ç�öS·«¦ YM905 10 mg ���T�UVW����Y�UZ[\��'(c¦8/�St´±5åÚ�G��h�ºÆûá­fwC 17ì�yf��$ÒÕöS·«¦�YM905 10 mg�YT�UVW�����'(c�8/�St´±5åÚ�G��h�ÂwQOLG��hD ~ºÆûá­f�

Page 18: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 302 -

2.7.6.19 ������OCT1� 18/167

� 16 ÆÇxyF� QOLÕª ozm��ÈW QOLIJ­�(5åÚ� ab� Ò�m ijW r¥se ^_ 95%f.î^ h_ pWÑ

UZ[\ 394 -0.7 20.28 -2.71G1.31YM905 5 mg 375 -4.0 20.70 -6.10G-1.90YM905 10 mg 367 -3.1 20.89 -5.21G-0.92

0.0606�5�±¤¥Ó�

w5åÚ� 1~UVW��� 378 -4.2 20.30 -6.22G-2.11 UZ[\ 394 -8.0 29.39 -10.86G-5.04YM905 5 mg 375 -20.5 32.09 -23.79G-17.27 YM905 10 mg 367 -19.4 32.28 -22.75G-16.12

<0.00015I&h#$

w5åÚ� 2~UVW��� 378 -16.9 31.02 -20.07G-13.79 UZ[\ 394 -7.3 26.57 -9.95G-4.69YM905 5 mg 375 -15.3 26.29 -17.96G-12.62 YM905 10 mg 367 -17.3 26.46 -20.06G-14.63

<0.0001�ÚÇIÚh¬j

w5åÚ� 3~UVW��� 378 -14.4 25.42 -16.94G-11.80 UZ[\ 394 -6.9 25.93 -9.42G-4.28YM905 5 mg 375 -15.2 26.03 -17.84G-12.56 YM905 10 mg 367 -16.8 26.42 -19.56G-14.14

<0.0001�=�IJh¬j

w5åÚ� 4~UVW��� 378 -13.4 27.88 -16.27G-10.63 UZ[\ 394 -5.2 19.61 -7.19G-3.30YM905 5 mg 375 -8.7 22.01 -10.92G-6.45YM905 10 mg 367 -10.1 20.63 -12.24G-8.01

0.0001��IJh¬j

w5åÚ� 5~UVW��� 378 -8.7 21.85 -10.88G-6.46UZ[\ 292 -1.2 17.02 -3.16G0.76YM905 5 mg 272 -3.7 20.27 -6.10G-1.26YM905 10 mg 255 -6.4 18.54 -8.69G-4.12

0.0015�à�±à^ç�

w5åÚ� 6~UVW��� 279 -4.8 20.07 -7.14G-2.41UZ[\ 394 -8.6 23.29 -10.94G-6.32YM905 5 mg 375 -16.3 25.82 -18.92G-13.67 YM905 10 mg 367 -19.9 26.66 -22.63G-17.15

<0.0001�h¾ð

w5åÚ� 7~UVW��� 378 -18.4 26.08 -21.07G-15.79 UZ[\ 394 -7.3 20.40 -9.30G-5.26YM905 5 mg 375 -12.6 22.12 -14.87G-10.38 YM905 10 mg 367 -14.4 22.38 -16.65G-12.05

<0.0001��ÇIK

wÄ¡�¢~

w5åÚ� 8~UVW��� 378 -12.1 23.83 -14.54G-9.71UZ[\ 394 -5.9 17.14 -7.62G-4.22YM905 5 mg 375 -13.7 18.33 -15.55G-11.83 YM905 10 mg 367 -15.8 19.21 -17.74G-13.80

<0.0001$ÒÕ

w5åÚ� 9~UVW��� 378 -12.8 17.88 -14.65G-11.03

Ñ�UZ[\��YM905 5 mg��YM905 10 mg�h Jonckheere-Terpstra1&Þwt´]¥h_ 2.5%~

Page 19: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 303 -

2.7.6.19 ������OCT1� 19/167

� 17 QOLÕª ozm��ÈW�É6ÊË QOLIJ­�(5åÚ� ab� ijWhe ^_ pWÑ

UZ[\ vs. YM905 10 mg -2.37 0.1123 UVW��� vs. YM905 10 mg 1.10 0.4645 UZ[\ vs. YM905 5 mg -3.30 0.0260 UVW��� vs. YM905 5 mg 0.17 0.9114

�5�±¤¥Ó�

w5åÚ� 1~

UZ[\ vs. UVW��� -3.47 0.0191 UZ[\ vs. YM905 10 mg -11.48 <0.0001 UVW��� vs. YM905 10 mg -2.51 0.2731 UZ[\ vs. YM905 5 mg -12.58 <0.0001 UVW��� vs. YM905 5 mg -3.60 0.1133

5I&h#$

w5åÚ� 2~

UZ[\ vs. UVW��� -8.98 0.0001 UZ[\ vs. YM905 10 mg -10.03 <0.0001 UVW��� vs. YM905 10 mg -2.97 0.1215 UZ[\ vs. YM905 5 mg -7.97 <0.0001 UVW��� vs. YM905 5 mg -0.91 0.6318

�ÚÇIÚh¬j

w5åÚ� 3~

UZ[\ vs. UVW��� -7.06 0.0002 UZ[\ vs. YM905 10 mg -10.00 <0.0001 UVW��� vs. YM905 10 mg -3.40 0.0810 UZ[\ vs. YM905 5 mg -8.35 <0.0001 UVW��� vs. YM905 5 mg -1.75 0.3658

�=�IJh¬j

w5åÚ� 4~

UZ[\ vs. UVW��� -6.60 0.0006 UZ[\ vs. YM905 10 mg -4.88 0.0014 UVW��� vs. YM905 10 mg -1.46 0.3450 UZ[\ vs. YM905 5 mg -3.44 0.0237 UVW��� vs. YM905 5 mg -0.01 0.9947

��IJh¬j

w5åÚ� 5~

UZ[\ vs. UVW��� -3.43 0.0238 UZ[\ vs. YM905 10 mg -5.21 0.0014 UVW��� vs. YM905 10 mg -1.63 0.3234 UZ[\ vs. YM905 5 mg -2.48 0.1220 UVW��� vs. YM905 5 mg 1.10 0.4960

�à�±à^ç�

w5åÚ� 6~

UZ[\ vs. UVW��� -3.58 0.0246 UZ[\ vs. YM905 10 mg -11.26 <0.0001 UVW��� vs. YM905 10 mg -1.46 0.4339 UZ[\ vs. YM905 5 mg -7.67 <0.0001 UVW��� vs. YM905 5 mg 2.13 0.2504

�h¾ð

w5åÚ� 7~

UZ[\ vs. UVW��� -9.80 <0.0001 UZ[\ vs. YM905 10 mg -7.07 <0.0001 UVW��� vs. YM905 10 mg -2.23 0.1715 UZ[\ vs. YM905 5 mg -5.35 0.0009 UVW��� vs. YM905 5 mg -0.50 0.7587

��ÇIK

wÄ¡�¢~

w5åÚ� 8~UZ[\ vs. UVW��� -4.85 0.0025 UZ[\ vs. YM905 10 mg -9.85 <0.0001 UVW��� vs. YM905 10 mg -2.93 0.0278 UZ[\ vs. YM905 5 mg -7.77 <0.0001 UVW��� vs. YM905 5 mg -0.85 0.5206

$ÒÕ

w5åÚ� 9~

UZ[\ vs. UVW��� -6.92 <0.0001 Ñ�t´]¥^_ 5%

����À��

ß�!S·¸yt½ÚRhÜ?QC 18Sucf�t½ÚRh��¿Y�MedDRA7.0h SOCwSystem Organ Class~� PTwPreferred Term~h×õQ§_cf�±·�=£¼ù×õ¼h&�SY SOC�ÒÓ¼h&�SY PTQ§_cf�

Page 20: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 304 -

2.7.6.19 ������OCT1� 20/167

� 18 �������UZ[\ YM905 5 mg YM905 10 mg ���������

��v��)R�m 405 396 381 400

¤¥�m 0 1/396}0.3%ì 0 0

$L±t½ÚR��L5/405}1.2%ì

11/396 }2.8%ì

5/381}1.3%ì

6/400}1.5%ì

abê�Q¦Üè�cft½ÚR��L11/405 }2.7%ì

20/396 }5.1%ì

26/381 }6.8%ì

26/400 }6.5%ì

abê�Q¦Üè�cf¨­_��L3/405}0.7%ì

14/396 }3.5%ì

21/381 }5.5%ì

19/400 }4.8%ì

t½ÚR��L189/405 }46.7%ì

224/396 }56.6%ì

275/381 }72.2%ì

253/400 }63.3%ì

¨­_��L68/405 }16.8%ì

133/396 }33.6%ì

201/381 }52.8%ì

168/400 }42.0%ì

$Õ±t½ÚR��L3/405}0.7%ì

7/396}1.8%ì

4/381}1.0%ì

4/400}1.0%ì

$Õ±¨­_��L 0 3/396}0.8%ì

2/381}0.5%ì 0

îï&VWXYnJ��L224/405 }55.3%ì

205/394 }52.0%ì

217/381 }57.0%ì

215/399 }53.9%ì

Ì!��hç6vº�޿ܱ«îï&VWXYnJ��L57/405 }14.1%ì

44/394 }11.2%ì

48/381 }12.6%ì

52/399 }13.0%ì

���m®��)R�m

w��L~

(1)������Öt½ÚR�ÚR��LYUZ[\� 46.7%�YM905 5 mg� 56.6%�YM905 10 mg� 72.2%��

T�UVW���� 63.3%¿eïf�UZ[\�Qªsab�h����Lºà®§¨ïfhY�YM905 5 mg�¿eïf�xGÐ�� ±=¨@�S'(�Äs�á­yt½ÚR¿ey`�©ªYUZ[\� 5.7%�

YM905 5 mg� 16.9%�YM905 10 mg� 34.1%��T�UVW���� 25.8%SÆûá­f�«¬YUZ[\� 4.0%�YM905 5 mg� 10.6%�YM905 10 mg� 18.9%��T�UVW���� 11.3%SÆûá­f�­®YUZ[\� 2.0%�YM905 5 mg� 1.8%�YM905 10 mg� 4.2%��T�UVW���� 3.8%SÆûá­f�k<¯°YUZ[\� 1.0%�YM905 5 mg� 1.8%�YM905 10 mg� 3.9%��T�UVW���� 3.3%SÆûá­f�$Õ±t½ÚRYUZ[\� 0.7%�YM905 5 mg� 1.8%�YM905 10 mg� 1.0%�T�UVW���� 1.0%SÆûá­f�

YM905 5 mg��YM905 10 mg���T�UVW����h«¬­¨S·«¦�1%��h��LºÆûá­ft½ÚRh=£¼ù×õ¼ÇÒÓ¼��LQC 19Sucf�yf�=£¼ù×õ¼ht½ÚR��LQC 20Sucf�UZ[\��YM905 5 mg��YM905

10 mg�h_p-~vS©«¦�Cochran-Armitage&ÞQ_«¦&�cf�þwt´]¥h_ 2.5%ì�t½ÚR�ÚR��LS_p-~vºÆûá­�=£¼ù×õ¼¿Y±C½�HIC½�N��

<òC½S·«¦_p-~vºÆûá­f�

Page 21: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 305 -

2.7.6.19 ������OCT1� 21/167

� 19 ×ØÙÚ�ÛÙe¸ÜÙ�����:ÝÞ :ÝÞ 1%ßà(UZ[\ YM905 5 mg YM905 10 mg UVW���

��v��)R�m 405 396 381 400 �ÚR 189 (46.7%) 224 (56.6%) 275 (72.2%) 253 (63.3%)

�²C½ �³v�MÊ´ 5 (1.2%) 3 (0.8%) 4 (1.0%) 3 (0.8%)

±C½ ��C 1 (0.2%) 4 (1.0%) 1 (0.3%) 0 ­® 8 (2.0%) 7 (1.8%) 16 (4.2%) 15 (3.8%)

HIC½ �æñµ 1 (0.2%) 5 (1.3%) 2 (0.5%) 6 (1.5%)

«¬ 16 (4.0%) 42 (10.6%) 72 (18.9%) 45 (11.3%) ¡¶ 13 (3.2%) 2 (0.5%) 6 (1.6%) 14 (3.5%)

`�©ª 23 (5.7%) 67 (16.9%) 130 (34.1%) 103 (25.8%)  o½· 1 (0.2%) 3 (0.8%) 5 (1.3%) 4 (1.0%)

H� 2 (0.5%) 4 (1.0%) 3 (0.8%) 5 (1.3%) ¸¹� 1 (0.2%) 2 (0.5%) 1 (0.3%) 4 (1.0%) S� 2 (0.5%) 5 (1.3%) 2 (0.5%) 3 (0.8%)

H½ºÌ 3 (0.7%) 7 (1.8%) 3 (0.8%) 7 (1.8%) `�� 2 (0.5%) 1 (0.3%) 4 (1.0%) 4 (1.0%) »¼ 3 (0.7%) 2 (0.5%) 1 (0.3%) 8 (2.0%)

��C½��ab½ �� ¾µ 0 4 (1.0%) 1 (0.3%) 2 (0.5%)

OP´C½ ¿Àv�Û�¢ 2 (0.5%) 2 (0.5%) 5 (1.3%) 3 (0.8%)

Ì�Ò��Á5ÂÒ KL� 11 (2.7%) 18 (4.5%) 24 (6.3%) 15 (3.8%)

ÃÄÅ� 41 (10.1%) 51 (12.9%) 37 (9.7%) 51 (12.8%) �/3Ì� 13 (3.2%) 6 (1.5%) 6 (1.6%) 3 (0.8%) <òÌ� 2 (0.5%) 0 5 (1.3%) 2 (0.5%)

ÆÇ��ÈÉC½ �Ê½Ë 0 0 0 4 (1.0%)

<9È´�����ÌC½ Íñµ 8 (2.0%) 5 (1.3%) 2 (0.5%) 7 (1.8%)

ª_´C½ ÍJvûy« 3 (0.7%) 3 (0.8%) 6 (1.6%) 2 (0.5%)

ŵ 7 (1.7%) 10 (2.5%) 12 (3.1%) 17 (4.3%) N��<òC½

k<¯° 4 (1.0%) 7 (1.8%) 15 (3.9%) 13 (3.3%) �Î���¡�ÌC½

Ï°v�Î� 0 1 (0.3%) 4 (1.0%) 3 (0.8%) ÐÑ 5 (1.2%) 6 (1.5%) 3 (0.8%) 1 (0.3%)

ÒDÑ 1 (0.2%) 2 (0.5%) 5 (1.3%) 2 (0.5%) ���mw��L~

Page 22: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 306 -

2.7.6.19 ������OCT1� 22/167

� 20 ×ØÙÚ�ÛÙ�����:ÝÞUZ[\ YM905 5 mg YM905 10 mg UVW��� h_ pWÑ

��v��)R�m 405 396 381 400

�ÚR189(46.7%)

41.72G51.66 224(56.6%)

51.52G61.51 275(72.2%)

67.39G76.62 253(63.3%)

58.32G67.99 <0.0001

Ò�����¹´C½1(0.2%)

0.01G1.37 0 0 1(0.3%) 0.01G1.38

�²C½11(2.7%)

1.36G4.81 9(2.3%)

1.04G4.27 9(2.4%)

1.09G4.44 9(2.3%)

1.03G4.23 0.6693

Ó��ÔòC½ 0 4(1.0%) 0.28G2.57

4(1.0%) 0.29G2.67

4(1.0%) 0.27G2.54 0.0553

�×;C½ 0 0 1(0.3%) 0.01G1.45 0 0.3223

±C½15(3.7%)

2.09G6.04 20(5.1%)

3.11G7.69 31(8.1%)

5.60G11.35 24(6.0%)

3.88G8.80 0.0044

HIC½68(16.8%)

13.28G20.79 126(31.8%)

27.26G36.66 181(47.5%)

42.40G52.65 167(41.8%)

36.87G46.75 <0.0001

��C½��ab½ ��10(2.5%)

1.19G4.49 8(2.0%)

0.88G3.94 8(2.1%)

0.91G4.10 8(2.0%)

0.87G3.90 0.6832

MÕ3´C½2(0.5%)

0.06G1.77 1(0.3%)

0.01G1.40 1(0.3%)

0.01G1.45 1(0.3%)

0.01G1.38 0.8018

OP´C½3(0.7%)

0.15G2.15 4(1.0%)

0.28G2.57 7(1.8%)

0.74G3.75 3(0.8%)

0.15G2.18 0.1067

Ì�Ò��Á5ÂÒ74(18.3%)

14.63G22.39 81(20.5%)

16.59G24.77 79(20.7%)

16.77G25.16 82(20.5%)

16.65G24.79 0.2038

Ö½�ê\��a ��Ò6(1.5%)

0.55G3.20 7(1.8%)

0.71G3.61 13(3.4%)

1.83G5.76 8(2.0%)

0.87G3.90 0.0436

îï&V2(0.5%)

0.06G1.77 5(1.3%)

0.41G2.92 3(0.8%)

0.16G2.28 1(0.3%)

0.01G1.38 0.3927

ÆÇ��ÈÉC½ 0 0 1(0.3%) 0.01G1.45

5(1.3%) 0.41G2.89 0.3223

<9È´�����ÌC½17(4.2%)

2.46G6.64 13(3.3%)

1.76G5.55 9(2.4%)

1.09G4.44 17(4.3%)

2.49G6.72 0.9384

·v�Sv��=>½åh×5

?wØÙ��R�UQt�~

2(0.5%) 0.06G1.77

2(0.5%) 0.06G1.81

2(0.5%) 0.06G1.88

1(0.3%) 0.01G1.38 0.5727

ª_´C½17(4.2%)

2.46G6.64 19(4.8%)

2.91G7.39 23(6.0%)

3.86G8.92 23(5.8%)

3.68G8.50 0.1365

ch�ÚÛ��ÜÚ�hÓ� 0 1(0.3%) 0.01G1.40 0 0 0.6574

ªC½4(1.0%)

0.27G2.51 2(0.5%)

0.06G1.81 1(0.3%)

0.01G1.45 4(1.0%)

0.27G2.54 0.9418

N��<òC½6(1.5%)

0.55G3.20 10(2.5%)

1.22G4.59 16(4.2%)

2.42G6.73 17(4.3%)

2.49G6.72 0.0126

5Ý´��fÞC½6(1.5%)

0.55G3.20 0 5(1.3%) 0.43G3.04 0 0.6800

ßà=�¾á��nâC½12(3.0%)

1.54G5.12 5(1.3%)

0.41G2.92 10(2.6%)

1.27G4.77 10(2.5%)

1.21G4.55 0.6784

�Î���¡�ÌC½15(3.7%)

2.09G6.04 21(5.3%)

3.31G7.99 24(6.3%)

4.08G9.23 10(2.5%)

1.21G4.55 0.0572

Ò�C½3(0.7%)

0.15G2.15 4(1.0%)

0.28G2.57 2(0.5%)

0.06G1.88 3(0.8%)

0.15G2.18 0.7027

��UZ[\��YM905 5 mg��YM905 10 mg�h Cochran-Armitage&Þwt´]¥h_ 2.5%~ ���m}��Lì

^_ 95%f.î^

(2)C�U�����áâ`^ãNä���� �p&(��Ö¨­_��LYUZ[\� 16.8%�YM905 5 mg� 33.6%�YM905 10 mg� 52.8%��T�UV

W���� 42.0%¿eïf�yf�$Õ�UÞí­f¨­_º�YM905 5 mg�¿ 3�S 4Áwl'vãä 1Á�S� 1Á�

¤¥ 1Á�åÚ 1Áì�YM905 10 mg�¿ 2�S 2Áwæ�Ò 1Á�çvM� 1Áì�Æûá­f�¤¥�QªÜ�«¬­hÚR® ÊºÅÆí­¦«y�

Page 23: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 307 -

2.7.6.19 ������OCT1� 23/167YM905 5 mg��YM905 10 mg���T�UVW����h«¬­¨S·«¦�1%��h��

LºÆûá­f¨­_h=£¼ù×õ¼ÇÒÓ¼��LQC 21Sucf�yf�=£¼ù×õ¼h¨­_��LQC 22Sucf�UZ[\��YM905 5 mg��YM905

10 mg�h_p-~vS©«¦�Cochran-Armitage&ÞQ_«¦&�cf�þwt´]¥h_ 2.5%ì�¨­_�ÚR��LS_p-~vºÆûá­�=£¼ù×õ¼¿Y±C½�HIC½�Ì�Ò�

�Á5ÂÒ�N��<òC½S·«¦_p-~vºÆûá­f�

� 21 ×ØÙÚ�ÛÙe¸ÜÙ��p&:ÝÞ :ÝÞ 1%ßà(UZ[\ YM905 5 mg YM905 10 mg UVW���

��v��)R�m 405 396 381 400 �ÚR 68 (16.8%) 133 (33.6%) 201 (52.8%) 168 (42.0%)

±C½ ­® 4 (1.0%) 7 (1.8%) 15 (3.9%) 15 (3.8%)

HIC½ «¬ 15 (3.7%) 41 (10.4%) 71 (18.6%) 44 (11.0%)

`�©ª 22 (5.4%) 66 (16.7%) 130 (34.1%) 102 (25.5%)  o½· 1 (0.2%) 1 (0.3%) 3 (0.8%) 4 (1.0%)

S� 1 (0.2%) 4 (1.0%) 2 (0.5%) 2 (0.5%) H½ºÌ 2 (0.5%) 3 (0.8%) 2 (0.5%) 6 (1.5%) »¼ 1 (0.2%) 0 0 4 (1.0%)

Ì�Ò��Á5ÂÒ KL� 1 (0.2%) 5 (1.3%) 7 (1.8%) 2 (0.5%)

ª_´C½ ŵ 2 (0.5%) 5 (1.3%) 4 (1.0%) 5 (1.3%)

N��<òC½ k<¯° 2 (0.5%) 6 (1.5%) 15 (3.9%) 11 (2.8%)

���mw��L~

Page 24: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 308 -

2.7.6.19 ������OCT1� 24/167

� 22 ×ØÙÚ�ÛÙ��p&:ÝÞUZ[\ YM905 5 mg YM905 10 mg UVW��� h_ pWÑ

��v��)R�m 405 396 381 400

�ÚR68(16.8%)

13.28G20.79 133(33.6%)

28.95G38.47 201(52.8%)

47.61G57.86 168(42.0%)

37.11G47.01 <0.0001

Ò�����¹´C½ 0 0 0 1(0.3%) 0.01G1.38

�²C½3(0.7%)

0.15G2.15 3(0.8%)

0.16G2.20 5(1.3%)

0.43G3.04 3(0.8%)

0.15G2.18 0.2626

Ó��ÔòC½ 0 1(0.3%) 0.01G1.40

1(0.3%) 0.01G1.45

2(0.5%) 0.06G1.79 0.3199

±C½4(1.0%)

0.27G2.51 12(3.0%)

1.58G5.23 23(6.0%)

3.86G8.92 18(4.5%)

2.69G7.02 <0.0001

HIC½46(11.4%)

8.44G14.86 106(26.8%)

22.47G31.42 167(43.8%)

38.78G48.98 144(36.0%)

31.29G40.92 <0.0001

��C½��ab½ ��3(0.7%)

0.15G2.15 2(0.5%)

0.06G1.81 4(1.0%)

0.29G2.67 1(0.3%)

0.01G1.38 0.3904

MÕ3´C½1(0.2%)

0.01G1.37 0 1(0.3%) 0.01G1.45

1(0.3%) 0.01G1.38 0.6530

Ì�Ò��Á5ÂÒ1(0.2%)

0.01G1.37 9(2.3%)

1.04G4.27 12(3.1%)

1.64G5.44 4(1.0%)

0.27G2.54 0.0017

îï&V 0 1(0.3%) 0.01G1.40

2(0.5%) 0.06G1.88 0 0.1377

ÆÇ��ÈÉC½ 0 0 0 3(0.8%) 0.15G2.18

<9È´�����ÌC½1(0.2%)

0.01G1.37 2(0.5%)

0.06G1.81 0 0 0.8420

ª_´C½5(1.2%)

0.40G2.86 7(1.8%)

0.71G3.61 10(2.6%)

1.27G4.77 8(2.0%)

0.87G3.90 0.0962

ch�ÚÛ��ÜÚ�hÓ� 0 1(0.3%) 0.01G1.40 0 0 0.6574

ªC½ 0 0 0 3(0.8%) 0.15G2.18

N��<òC½3(0.7%)

0.15G2.15 8(2.0%)

0.88G3.94 16(4.2%)

2.42G6.73 14(3.5%)

1.93G5.80 0.0008

5Ý´��fÞC½1(0.2%)

0.01G1.37 0 1(0.3%) 0.01G1.45 0 0.6530

ßà=�¾á��nâC½3(0.7%)

0.15G2.15 3(0.8%)

0.16G2.20 5(1.3%)

0.43G3.04 1(0.3%)

0.01G1.38 0.2626

�Î���¡�ÌC½5(1.2%)

0.40G2.86 7(1.8%)

0.71G3.61 4(1.0%)

0.29G2.67 2(0.5%)

0.06G1.79 0.6401

Ò�C½ 0 2(0.5%) 0.06G1.81 0 0 0.6530

��UZ[\��YM905 5 mg��YM905 10 mg�h Cochran-Armitage&Þwt´]¥h_ 2.5%~ ���m}��Lì

^_ 95%f.î^

Page 25: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 309 -

(3)�����å¸�Ù:ÝÞGH���Ù:ÝÞ��Ö

t½ÚRh$ÒÕ¼��L��t½ÚRhç6v¼��LQC

23¨áC

30Sucf�

�23�����å¸�Ù:ÝÞæç©èéê u�ë(

t½ÚR

x�¦ht½ÚR

���m

183����Ám

318Á

ç6vº�޿ܱ«t½ÚR

���m

66����Ám

83Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

��v��)R�m

405�

40

5�

�ÚR

165(

40.7

%)[

293]

15(3

.7%

)[22

]3(

0.7%

)[3]

183(

45.2

%)[

318]

63(1

5.6%

)[80

]3(

0.7%

)[3]

0 66

(16.

3%)[

83]

ìíGHno¨îï�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

èÒ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

¥ðï�

2(0.

5%)[

2]

1(0.

2%)[

1]

0 3(

0.7%

)[3]

1(

0.2%

)[1]

0 0

1(0.

2%)[

1]é¸

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�<êô

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ñï�

15(3

.7%

)[17

] 0

0 15

(3.7

%)[

17]

4(1.

0%)[

4]0

0 4(

1.0%

)[4]

±hXYÌ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

±Âìí

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

��C

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�î�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�Û�¢v�î�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

±h�Û�¢

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

ïî�Ò

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

­®

8(2.

0%)[

8]

0 0

8(2.

0%)[

8]

4(1.

0%)[

4]0

0 4(

1.0%

)[4]

vðñò

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

±k�óÒ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

òóï�

65(1

6.0%

)[82

] 3(

0.7%

)[3]

0

68(1

6.8%

)[85

] 44

(10.

9%)[

51]

2(0.

5%)[

2]0

46(1

1.4%

)[53

] æñ½ºÌ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

æñô§

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]0

0 2(

0.5%

)[2]

æµ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

�æñµ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ùI�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 25/167

Page 26: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 310 -

�23�����å¸�Ù:ÝÞæç©èéê u�ô(

t½ÚR

x�¦ht½ÚR

���m

183����Ám

318Á

ç6vº�޿ܱ«t½ÚR

���m

66����Ám

83Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

«¬

15(3

.7%

)[16

] 1(

0.2%

)[1]

0

16(4

.0%

)[17

] 14

(3.5

%)[

15]

1(0.

2%)[

1]0

15(3

.7%

)[16

] ¡¶

12(3

.0%

)[14

] 1(

0.2%

)[1]

0

13(3

.2%

)[15

] 4(

1.0%

)[4]

0 0

4(1.

0%)[

4]`�©ª

23(5

.7%

)[23

] 0

0 23

(5.7

%)[

23]

22(5

.4%

)[22

]0

0 22

(5.4

%)[

22]

 o½·

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

H�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

¸¹µ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

¸¹�÷

1(0.

2%)[

2]

0 0

1(0.

2%)[

2]

0 0

0 0

¸¹�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

S�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

�3�

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 1(

0.2%

)[1]

0 1(

0.2%

)[1]

øvù�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�Iú

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

H½ºÌ

3(0.

7%)[

4]

0 0

3(0.

7%)[

4]

2(0.

5%)[

2]0

0 2(

0.5%

)[2]

`��

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

¸h��

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

¸µ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

»¼

3(0.

7%)[

3]

0 0

3(0.

7%)[

3]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

�õï�GHXY$ö÷±

10(2

.5%

)[12

] 0

0 10

(2.5

%)[

12]

3(0.

7%)[

4]0

0 3(

0.7%

)[4]

JKÒ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

¾ñ½ºÌ

2(0.

5%)[

3]

0 0

2(0.

5%)[

3]

2(0.

5%)[

3]0

0 2(

0.5%

)[3]

XYÌ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

ûüÌ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

ýþvÍ�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

�+

4(1.

0%)[

5]

0 0

4(1.

0%)[

5]

0 0

0 0

øùúîï�

2(0.

5%)[

3]

0 0

2(0.

5%)[

3]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ÕØ�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

Õ�Ò

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

M!"XY

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ûüîï�

3(0.

7%)[

3]

0 0

3(0.

7%)[

3]

0 0

0 0

¿Àv�Û�¢

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

À�J?0Ö�Û�¢

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 26/167

Page 27: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 311 -

�23�����å¸�Ù:ÝÞæç©èéê u�ý(

t½ÚR

x�¦ht½ÚR

���m

183����Ám

318Á

ç6vº�޿ܱ«t½ÚR

���m

66����Ám

83Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

Ñþ¸GH���¸

70(1

7.3%

)[96

] 4(

1.0%

)[4]

0

74(1

8.3%

)[10

0]1(

0.2%

)[1]

0 0

1(0.

2%)[

1]çv¨Ã��

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

çv���

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

çv/���

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

KL�

9(2.

2%)[

12]

2(0.

5%)[

2]

0 11

(2.7

%)[

14]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

HI�

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

0 0

0 0

��M�

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

���G

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

*Ó�Ñ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�Ñ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

���

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

ÃÄÅ�

41(1

0.1%

)[47

] 0

0 41

(10.

1%)[

47]

0 0

0 0

êÓ�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

ÄÅ�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

�ñ��

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�/3�

13(3

.2%

)[14

] 0

0 13

(3.2

%)[

14]

0 0

0 0

<òÌ�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

�Ð�Á�Ò

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

M�ñ�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

FÚ�Gv¡¶

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

¸¹Ì�

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

/3�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

��V��GH�f¸

5(1.

2%)[

5]

1(0.

2%)[

3]

0 6(

1.5%

)[8]

0

0 0

0 '�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�9t

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

çÀ��

1(0.

2%)[

1]

1(0.

2%)[

1]

0 2(

0.5%

)[2]

0

0 0

0 a �µ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

�Ö

1(0.

2%)[

1]

1(0.

2%)[

2]

0 2(

0.5%

)[3]

0

0 0

0 ���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 27/167

Page 28: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 312 -

�23�����å¸�Ù:ÝÞæç©èéê u��(

t½ÚR

x�¦ht½ÚR

���m

183����Ám

318Á

ç6vº�޿ܱ«t½ÚR

���m

66����Ám

83Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

���"

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

��8����ÙZ�G��ZÅ��

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

� �îGHÀO�ï�

13(3

.2%

)[13

] 3(

0.7%

)[3]

1(

0.2%

)[1]

17(4

.2%

)[17

] 1(

0.2%

)[1]

0 0

1(0.

2%)[

1]çÀµ

1(0.

2%)[

1]

1(0.

2%)[

1]

0 2(

0.5%

)[2]

0

0 0

0 Íñµ

7(1.

7%)[

7]

1(0.

2%)[

1]

0 8(

2.0%

)[8]

1(

0.2%

)[1]

0 0

1(0.

2%)[

1]µ�µ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

çÀÜ��

3(0.

7%)[

3]

0 0

3(0.

7%)[

3]

0 0

0 0

��Ò

0 1(

0.2%

)[1]

1(

0.2%

)[1]

2(0.

5%)[

2]

0 0

0 0

���ú

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

��V��GH�������w

µ��GH�n=çqÌ�·

1(0.

2%)[

1]

1(0.

2%)[

1]

0 2(

0.5%

)[2]

0

0 0

0

f�

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

( v���

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

��îï�

15(3

.7%

)[17

] 1(

0.2%

)[1]

1(

0.2%

)[1]

17(4

.2%

)[19

] 5(

1.2%

)[6]

0 0

5(1.

2%)[

6]ÍJvûy«

2(0.

5%)[

2]

1(0.

2%)[

1]

0 3(

0.7%

)[3]

0

0 0

0 =Øvûy«

1(0.

2%)[

2]

0 0

1(0.

2%)[

2]

1(0.

2%)[

2]0

0 1(

0.2%

)[2]

!"XY

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ŵ

7(1.

7%)[

7]

0 0

7(1.

7%)[

7]

2(0.

5%)[

2]0

0 2(

0.5%

)[2]

Ì"�#

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

0 0

0 0

��

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

^Æv¯°

0 0

1(0.

2%)[

1]1(

0.2%

)[1]

0

0 0

0 ��ï�

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

0 0

0 0

�©9

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

½�Ò

3(0.

7%)[

3]

0 0

3(0.

7%)[

3]

0 0

0 0

�GHi�ï�

6(1.

5%)[

6]

0 0

6(1.

5%)[

6]

3(0.

7%)[

3]0

0 3(

0.7%

)[3]

k<¯°

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

2(0.

5%)[

2]0

0 2(

0.5%

)[2]

<3µ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

KL��ÒÓ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 28/167

Page 29: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 313 -

�23�����å¸�Ù:ÝÞæç©èéê u� (

t½ÚR

x�¦ht½ÚR

���m

183����Ám

318Á

ç6vº�޿ܱ«t½ÚR

���m

66����Ám

83Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

�!îGH"#ï�

5(1.

2%)[

5]

0 1(

0.2%

)[1]

6(1.

5%)[

6]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

gv�ñk�óÒ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

��E_

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

Ïö÷�

0 0

1(0.

2%)[

1]1(

0.2%

)[1]

0

0 0

0 `$R�U

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

%´v��

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

&�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

$%×V&'GH()ï�

8(2.

0%)[

8]

4(1.

0%)[

4]

0 12

(3.0

%)[

12]

2(0.

5%)[

2]1(

0.2%

)[1]

0 3(

0.7%

)[3]

'(

0 2(

0.5%

)[2]

0

2(0.

5%)[

2]

0 0

0 0

ß௰

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

)*

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

H+/

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 0

0 0

ÄŽºÌ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

�Û�¢vÃ�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

Ã,

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

'-

0 1(

0.2%

)[1]

0

1(0.

2%)[

1]

0 1(

0.2%

)[1]

0 1(

0.2%

)[1]

�/3h�Ò

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

*+GH*,O�ï�

15(3

.7%

)[16

] 0

0 15

(3.7

%)[

16]

5(1.

2%)[

5]0

0 5(

1.2%

)[5]

./

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

ÐÑ

5(1.

2%)[

5]

0 0

5(1.

2%)[

5]

2(0.

5%)[

2]0

0 2(

0.5%

)[2]

k�óÒ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

©�

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

1(0.

2%)[

1]0

0 1(

0.2%

)[1]

�Ñ

4(1.

0%)[

5]

0 0

4(1.

0%)[

5]

0 0

0 0

ÒDÑ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

øvÒDÑ

1(0.

2%)[

1]

0 0

1(0.

2%)[

1]

0 0

0 0

ì-ï�

2(0.

5%)[

2]

1(0.

2%)[

1]

0 3(

0.7%

)[3]

0

0 0

0 �Òç

2(0.

5%)[

2]

1(0.

2%)[

1]

0 3(

0.7%

)[3]

0

0 0

0 ���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 29/167

Page 30: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 314 -

�24�����å¸�Ù:ÝÞæ.n;</0o

5 m

gê u�ë(

t½ÚR

x�¦ht½ÚR

���m

220����Ám

395Á

ç6vº�޿ܱ«t½ÚR

���m

131����Ám

194Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

��v��)R�m

396�

39

6�

�ÚR

197(

49.7

%)[

369]

16(4

.0%

)[17

]7(

1.8%

)[9]

220(

55.6

%)[

395]

12

1(30

.6%

)[18

2]7(

1.8%

)[8]

3(0.

8%)[

4]13

1(33

.1%

)[19

4]¥ðï�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

½·¸

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

1GH2�ï�

1(0.

3%)[

1]

1(0.

3%)[

1]2(

0.5%

)[2]

4(1.

0%)[

4]

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

Ó-

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

l'vãä

0 0

2(0.

5%)[

2]2(

0.5%

)[2]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

ÅØvãä

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 ñï�

20(5

.1%

)[21

] 0

0 20

(5.1

%)[

21]

12(3

.0%

)[13

] 0

0 12

(3.0

%)[

13]

ÏÀC½

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

±Âìí

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

��C

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

0 0

0 0

±µ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

±h0Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1î�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

©v1�î�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

2®Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

­®

7(1.

8%)[

7]

0 0

7(1.

8%)[

7]

7(1.

8%)[

7]

0 0

7(1.

8%)[

7]

®K§¡

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

òóï�

119(

30.1

%)[

156]

4(1.

0%)[

4]3(

0.8%

)[3]

126(

31.8

%)[

163]

10

1(25

.5%

)[13

0]4(

1.0%

)[4]

1(0.

3%)[

1]10

6(26

.8%

)[13

5]æñ½ºÌ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

æñô§

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

æµ

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

¡æñµ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�æñµ

5(1.

3%)[

5]

0 0

5(1.

3%)[

5]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

«¬

42(1

0.6%

)[43

] 0

0 42

(10.

6%)[

43]

41(1

0.4%

)[42

] 0

0 41

(10.

4%)[

42]

¡¶

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

`�©ª

64(1

6.2%

)[64

] 3(

0.8%

)[3]

0 67

(16.

9%)[

67]

63(1

5.9%

)[63

] 3(

0.8%

)[3]

0 66

(16.

7%)[

66]

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 30/167

Page 31: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 315 -

�24�����å¸�Ù:ÝÞæ.n;</0o

5 m

gê u�ô(

t½ÚR

x�¦ht½ÚR

���m

220����Ám

395Á

ç6vº�޿ܱ«t½ÚR

���m

131����Ám

194Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

 o½·

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

34«

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

5I

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

H¡�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

H�

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

HIC½

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

¸¹�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

6�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

Ò«k7

1(0.

3%)[

1]

0 1(

0.3%

)[1]

2(0.

5%)[

2]

0 0

0 0

`8©ª

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

S�

3(0.

8%)[

3]

1(0.

3%)[

1]1(

0.3%

)[1]

5(1.

3%)[

5]

2(0.

5%)[

2]

1(0.

3%)[

1]1(

0.3%

)[1]

4(1.

0%)[

4]

¸Ü�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

H½ºÌ

7(1.

8%)[

7]

0 0

7(1.

8%)[

7]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

`��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

6C½

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

¸h��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

»¼

1(0.

3%)[

1]

0 1(

0.3%

)[1]

2(0.

5%)[

2]

0 0

0 0

9H�Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

 o�:JC½

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�õï�GHXY$ö÷±

7(1.

8%)[

7]

0 1(

0.3%

)[1]

8(2.

0%)[

8]

1(0.

3%)[

1]

0 1(

0.3%

)[1]

2(0.

5%)[

2]

¾µ

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

¤¥

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

XYÌ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ýþvÍ�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

S;

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

øùúîï�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

<=M

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 31/167

Page 32: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 316 -

�24�����å¸�Ù:ÝÞæ.n;</0o

5 m

gê u�ý(

t½ÚR

x�¦ht½ÚR

���m

220����Ám

395Á

ç6vº�޿ܱ«t½ÚR

���m

131����Ám

194Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

ûüîï�

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

0 0

0 0

¿Àv�Û�¢

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

À�J?0Ö�Û�¢

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

Ñþ¸GH���¸

77(1

9.4%

)[97

] 4(

1.0%

)[4]

0 81

(20.

5%)[

101]

9(

2.3%

)[11

] 0

0 9(

2.3%

)[11

] /���

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

Ð�Á�Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

KL�

18(4

.5%

)[20

] 0

0 18

(4.5

%)[

20]

5(1.

3%)[

6]

0 0

5(1.

3%)[

6]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���G

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

*Ó�Ñ

1(0.

3%)[

1]

2(0.

5%)[

2]0

3(0.

8%)[

3]

0 0

0 0

����-

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 ��Gv1î�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

ÃÄÅ�

50(1

2.6%

)[59

] 1(

0.3%

)[1]

0 51

(12.

9%)[

60]

1(0.

3%)[

2]

0 0

1(0.

3%)[

2]

�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�ñ��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�/3�

6(1.

5%)[

7]

0 0

6(1.

5%)[

7]

0 0

0 0

M�ñ�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

M�ñ��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Ä?Å�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

��V��GH�f¸

4(1.

0%)[

4]

3(0.

8%)[

3]0

7(1.

8%)[

7]

0 0

0 0

À�J?0Ö

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

@/

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 '�

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 çÀ�A

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 BHÖ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�Ö

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 32/167

Page 33: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 317 -

�24�����å¸�Ù:ÝÞæ.n;</0o

5 m

gê u��(

t½ÚR

x�¦ht½ÚR

���m

220����Ám

395Á

ç6vº�޿ܱ«t½ÚR

���m

131����Ám

194Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

���"

5(1.

3%)[

5]

0 0

5(1.

3%)[

5]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

Òê�Û�À�CGCº�Å��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Ò秡

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Òç�D

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

=$��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

� �îGHÀO�ï�

11(2

.8%

)[11

] 2(

0.5%

)[2]

0 13

(3.3

%)[

13]

0 2(

0.5%

)[2]

0 2(

0.5%

)[2]

çÀµ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Íñµ

4(1.

0%)[

4]

1(0.

3%)[

1]0

5(1.

3%)[

5]

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

_æñµ

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]0

1(0.

3%)[

1]

j½v9çÀ�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Eñµ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�;<î�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

<9ÈF�

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

0 0

0 0

��V��GH�������w

µ��GH�n=çqÌ�·

0 0

2(0.

5%)[

2]2(

0.5%

)[2]

0

0 0

0

H�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 RhSv×5?

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 ��îï�

18(4

.5%

)[20

] 1(

0.3%

)[1]

0 19

(4.8

%)[

21]

7(1.

8%)[

8]

0 0

7(1.

8%)[

8]

dG�Òë�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ÍJvûy«

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

0 0

0 0

!"XY

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

HIDE

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

0 0

0 ŵ

10(2

.5%

)[11

] 0

0 10

(2.5

%)[

11]

5(1.

3%)[

6]

0 0

5(1.

3%)[

6]

Ì"�#

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

hŵ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

JKvŵ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

34V56GH755�ܱ

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

åÚ

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 33/167

Page 34: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 318 -

�24�����å¸�Ù:ÝÞæ.n;</0o

5 m

gê u� (

t½ÚR

x�¦ht½ÚR

���m

220����Ám

395Á

ç6vº�޿ܱ«t½ÚR

���m

131����Ám

194Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

��ï�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

½�Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ª_Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�GHi�ï�

10(2

.5%

)[10

] 0

0 10

(2.5

%)[

10]

8(2.

0%)[

8]

0 0

8(2.

0%)[

8]

k<¯°

7(1.

8%)[

7]

0 0

7(1.

8%)[

7]

6(1.

5%)[

6]

0 0

6(1.

5%)[

6]

k<XY

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

<3µ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

$%×V&'GH()ï�

4(1.

0%)[

4]

1(0.

3%)[

1]0

5(1.

3%)[

5]

2(0.

5%)[

2]

1(0.

3%)[

1]0

3(0.

8%)[

3]

éª

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

ÄŽºÌ

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]0

1(0.

3%)[

1]

Ã,

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

*+GH*,O�ï�

20(5

.1%

)[20

] 1(

0.3%

)[1]

0 21

(5.3

%)[

21]

6(1.

5%)[

6]

1(0.

3%)[

1]0

7(1.

8%)[

7]

./

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

IL

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ϰv��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�üv�Î�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�Ωª

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

ÐÑ

6(1.

5%)[

6]

0 0

6(1.

5%)[

6]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

óÑ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

k�óÒ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�Ñ

0 1(

0.3%

)[1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]0

1(0.

3%)[

1]

ÒDÑ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

©�Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ì-ï�

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

MN

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�Òç

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

ýþOÌ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 34/167

Page 35: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 319 -

�25�����å¸�Ù:ÝÞæ.n;</0o

10 m

gê u�ë(

t½ÚR

x�¦ht½ÚR

���m

272����Ám

528Á

ç6vº�޿ܱ«t½ÚR

���m

199����Ám

315Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

��v��)R�m

381�

38

1�

�ÚR

240(

63.0

%)[

484]

28(7

.3%

)[38

]4(

1.0%

)[6]

272(

71.4

%)[

528]

179(

47.0

%)[

290]

18(4

.7%

)[23

]2(

0.5%

)[2]

199(

52.2

%)[

315]

¥ðï�

1(0.

3%)[

1]

0 1(

0.3%

)[1]

2(0.

5%)[

2]

1(0.

3%)[

1]

0 1(

0.3%

)[1]

2(0.

5%)[

2]

æ�Ò

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1GH2�ï�

2(0.

5%)[

2]

2(0.

5%)[

2]

0 4(

1.0%

)[4]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

Ó-

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

l'vãä

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

PK§¡

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 0

0 0

Q�°P

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

º�8ï�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

RÓ÷�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ñï�

27(7

.1%

)[29

] 4(

1.0%

)[4]

0

31(8

.1%

)[33

] 19

(5.0

%)[

20]

4(1.

0%)[

4]

0 23

(6.0

%)[

24]

ÏÀC½

2(0.

5%)[

2]

1(0.

3%)[

1]

0 3(

0.8%

)[3]

2(

0.5%

)[2]

1(

0.3%

)[1]

0

3(0.

8%)[

3]

��C

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�Û�¢v�î�

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

±<

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

©v1�î�

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

§±çB�C

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

±0Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

­®

14(3

.7%

)[14

] 2(

0.5%

)[2]

0

16(4

.2%

)[16

] 13

(3.4

%)[

13]

2(0.

5%)[

2]

0 15

(3.9

%)[

15]

®K§¡

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

T`=ÍU?

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 35/167

Page 36: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 320 -

�25�����å¸�Ù:ÝÞæ.n;</0o

10 m

gê u�ô(

t½ÚR

x�¦ht½ÚR

���m

272����Ám

528Á

ç6vº�޿ܱ«t½ÚR

���m

199����Ám

315Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

òóï�

168(

44.1

%)[

241]

13(3

.4%

)[14

]0

181(

47.5

%)[

255]

155(

40.7

%)[

214]

12(3

.1%

)[13

]0

167(

43.8

%)[

227]

æñô§

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

æµ

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

¡æñµ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

�æñµ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

V9

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

«¬

69(1

8.1%

)[71

] 3(

0.8%

)[3]

0

72(1

8.9%

)[74

] 68

(17.

8%)[

70]

3(0.

8%)[

3]

0 71

(18.

6%)[

73]

¡¶

5(1.

3%)[

6]

1(0.

3%)[

1]

0 6(

1.6%

)[7]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

`�©ª

124(

32.5

%)[

124]

6(1.

6%)[

6]

0 13

0(34

.1%

)[13

0]12

4(32

.5%

)[12

4]6(

1.6%

)[6]

0

130(

34.1

%)[

130]

 o½·

5(1.

3%)[

5]

0 0

5(1.

3%)[

5]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

W¡C½

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

I�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

34«

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

H�

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

¸¹�÷

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

¸¹�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

6�

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

XY

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

S�

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

1(

0.3%

)[1]

1(

0.3%

)[1]

0

2(0.

5%)[

2]

¸Ü9

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Zåv�3�

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

H½ºÌ

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

`��

4(1.

0%)[

4]

0 0

4(1.

0%)[

4]

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

¸µ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

»¼

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�3R�U

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

X�Ò

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ZåvH�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 36/167

Page 37: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 321 -

�25�����å¸�Ù:ÝÞæ.n;</0o

10 m

gê u�ý(

t½ÚR

x�¦ht½ÚR

���m

272����Ám

528Á

ç6vº�޿ܱ«t½ÚR

���m

199����Ám

315Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

�õï�GHXY$ö÷±

7(1.

8%)[

7]

1(0.

3%)[

1]

0 8(

2.1%

)[8]

4(

1.0%

)[4]

0

0 4(

1.0%

)[4]

¾µ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ìí

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

ûüÌ

2(0.

5%)[

2]

1(0.

3%)[

1]

0 3(

0.8%

)[3]

2(

0.5%

)[2]

0

0 2(

0.5%

)[2]

ýþvÍ�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

�+

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

øùúîï�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

çvM�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 1(

0.3%

)[1]

1(0.

3%)[

1]

ûüîï�

7(1.

8%)[

7]

0 0

7(1.

8%)[

7]

0 0

0 0

¿Àv�Û�¢

5(1.

3%)[

5]

0 0

5(1.

3%)[

5]

0 0

0 0

À�J?0Ö�Û�¢

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

Ñþ¸GH���¸

76(1

9.9%

)[93

] 2(

0.5%

)[2]

1(

0.3%

)[1]

79(2

0.7%

)[96

] 12

(3.1

%)[

14]

0 0

12(3

.1%

)[14

] çv/���

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

[\�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 KL�

24(6

.3%

)[28

] 0

0 24

(6.3

%)[

28]

7(1.

8%)[

9]

0 0

7(1.

8%)[

9]

ùI]vKL�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���G

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

*Ó�Ñ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

����-

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

ÃÄÅ�

35(9

.2%

)[36

] 2(

0.5%

)[2]

0

37(9

.7%

)[38

] 3(

0.8%

)[3]

0

0 3(

0.8%

)[3]

ÄÅ�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

�ñ��

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

�/3�

6(1.

6%)[

8]

0 0

6(1.

6%)[

8]

0 0

0 0

<òÌ�

5(1.

3%)[

5]

0 0

5(1.

3%)[

5]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

Ä?Å�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

>]v�î�

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

/3�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 37/167

Page 38: 2.7.6.19 OCT1 1/167...- 287 - X é.\6Î é ù ã ü 2.7.6.19 OCT1 3/167 2.5 mg 5 mg ˘ˇˆ ˙ ˘ˇ ˆ˙˝˛˚˜ 5.3.5.1-2 !"#$%&’(2(XYAB1 F1 l—–ƒS¡¢h3 Q‘_cf‹

- 322 -

�25�����å¸�Ù:ÝÞæ.n;</0o

10 m

gê u��(

t½ÚR

x�¦ht½ÚR

���m

272����Ám

528Á

ç6vº�޿ܱ«t½ÚR

���m

199����Ám

315Á

$ÒÕ

üÕ

êúÕ

/üÕ

êúÕ

/

��V��GH�f¸

8(2.

1%)[

9]

3(0.

8%)[

3]

2(0.

5%)[

3]13

(3.4

%)[

15]

0 0

0 0

�çÀñ9t

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 0

0 0

'�

0[1]

1(

0.3%

)[1]

0

1(0.

3%)[

2]

0 0

0 0

�9t

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 +ìí

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

1î^Ö

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

çÀ��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

¡�hç�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 _99t

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

0

0 0

0 MÖvÒ�

0 0

1(0.

3%)[

1]1(

0.3%

)[1]

0

0 0

0 a �µ

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

HI^Ö

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�Ö

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

���"

2(0.

5%)[

2]

1(0.

3%)[

1]

0 3(

0.8%

)[3]

1(

0.3%

)[1]

1(

0.3%

)[1]

0

2(0.

5%)[

2]

Òê�ÛGV���

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Òê�Û�À�CGCº�Å��

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

<`Òav

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

9:GH;<ï�

0 1(

0.3%

)[2]

0

1(0.

3%)[

2]

0 0

0 0

�Ò}

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 0

0 0

§Ò}Ò

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 0

0 0

� �îGHÀO�ï�

9(2.

4%)[

9]

0 0

9(2.

4%)[

9]

0 0

0 0

Íñµ

2(0.

5%)[

2]

0 0

2(0.

5%)[

2]

0 0

0 0

b�8�3�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

Eñµ

3(0.

8%)[

3]

0 0

3(0.

8%)[

3]

0 0

0 0

çÀÜ��

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

EcdÒë�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

�^eQ�

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

��V��GH�������w

µ��GH�n=çqÌ�·

1(0.

3%)[

1]

1(0.

3%)[

1]

0 2(

0.5%

)[2]

0

0 0

0

Hh·v×5?

1(0.

3%)[

1]

0 0

1(0.

3%)[

1]

0 0

0 0

fÞ×5?

0 1(

0.3%

)[1]

0

1(0.

3%)[

1]

0 0

0 0

���mw��L~õ��Ámö

�.ÖSç6xyt½ÚRS©«¦Y$ÒÕwòÕ~QUÞc¦«±«fû��hÄ�±t½ÚRh�Q��cfÒ�Y���mSty­±«�

2.7.6.19 ������OCT1� 38/167


Recommended