Evaluation of Astigmatic Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

-RKQVRQ	-RKQVRQ9LVLRQ&DUH
&HQWXULRQ3DUNZD\
-DFNVRQYLOOH)/
3URWRFRO1XPEHU&5
9HUVLRQ
'DWH0DUFK
&OLQLFDO6WXG\3URWRFRO
(YDOXDWLRQRI$VWLJPDWLF&RQWDFW/HQVHV

'LVWULEXWLRQ 
&'DYLV
-7RNDUVNL
 
 
 
 
 
 
&21),'(17,$/
7KLVGRFXPHQWFRQWDLQVFRQILGHQWLDOLQIRUPDWLRQZKLFKVKRXOGQRWEHFRSLHGUHIHUUHGWRUHOHDVHGRUSXEOLVKHG
ZLWKRXWZULWWHQDSSURYDOIURP-RKQVRQDQG-RKQVRQ9LVLRQ&DUH7KHLQIRUPDWLRQPD\QRWEHGLVFORVHGWR
RWKHUVH[FHSWWRWKHH[WHQWQHFHVVDU\WRREWDLQ,QVWLWXWLRQDO5HYLHZ%RDUG,QGHSHQGHQW(WKLFV&RPPLWWHH
DSSURYDODQGLQIRUPHGFRQVHQWRUDVUHTXLUHGE\,QWHUQDWLRQDO)HGHUDODQG6WDWH/DZVDVDSSOLFDEOH3HUVRQV
WRZKRPWKLVLQIRUPDWLRQLVGLVFORVHGPXVWEHLQIRUPHGWKDWWKLVLQIRUPDWLRQLVSULYLOHJHGDQGFRQILGHQWLDODQG
WKDWLWVKRXOGQRWEHIXUWKHUGLVFORVHGZLWKRXWWKHZULWWHQSHUPLVVLRQRI-RKQVRQDQG-RKQVRQ9LVLRQ&DUH$Q\
VXSSOHPHQWDOLQIRUPDWLRQWKDWPD\EHDGGHGWRWKLVGRFXPHQWLVDOVRFRQILGHQWLDODQGSURSULHWDU\WR-RKQVRQ
DQG-RKQVRQ9LVLRQ&DUHDQGPXVWEHNHSWLQFRQILGHQFHLQWKHVDPHPDQQHUDVWKHFRQWHQWVRIWKLVGRFXPHQW
.H\:RUGV
0RQWKO\5HSODFHPHQW
6XEMHFWLYH5HVSRQVHV
3K\VLRORJLFDO
5HVSRQVH'LVSHQVLQJ
$VWLJPDWLVP
 
 
 
 
 
CR-5871 Protocol v4.0
 (4) 
Page 1 of 141
CONFIDENTIAL

7$%/(2)&217(176
 
35272&2/7,7/(180%(5'$7( 
 
1$0($1'$''5(662)6321625 
 
$87+25,=('6,*1$785(6 
 
0(',&$/021,725 
 
,19(67,*$72566,*1$785(3$*( 
 
(67,0$7('5(3257'$7( 
 
&+$1*(+,6725< 
 
35272&2/6<1236,6 
 
1$0($1''(6&5,37,212),19(67,*$7,21$/352'8&76 
 
6800$5<2)),1',1*6)520121&/,1,&$/678',(6 
 
6800$5<2).12:15,6.6$1'%(1(),7672+80$168%-(&76 
 
'(6&5,37,212)75,$/75($70(176 
 
67$7(0(172)&203/,$1&(7235272&2/*&3$1'$33/,&$%/(5(*8/$725<
*8,'(/,1(6 
 
'(6&5,37,212)3238/$7,2172%(678',('(152//0(177$5*(76$1'678'<
'85$7,21 
 
5(/(9$17/,7(5$785(5()(5(1&(6$1'35,25'$7$ 
 
'(6&5,37,212)2%-(&7,9(6$1'385326( 
 
35,0$5<$1'6(&21'$5<(1'32,176 
 
,1&/86,21&5,7(5,$ 
 
678'<'(6,*17,0($1'(9(176&+('8/()/2:&+$57 
 
7,0($1'(9(176&+('8/( 
 
5$1'20,=$7,21$1'0$6.,1* 
 
:($5$1'5(3/$&(0(176&+('8/(6,1&/8',1*)2503$&.$*,1*$1'/$%(/,1* 
 
'(7$,/('678'<352&('85(6 
 
6(48(1&(2)(9(176 
 
',6&217,18$7,21&5,7(5,$ 
 
$&&2817$%,/,7<352&('85(6)25,19(67,*$7,21$/352'8&7$1'&21752/ 
 
352&('85(6)250$,17$,1,1*$1'%5($.,1*5$1'20,=$7,21&2'(6 
 
5(3257,1*352'8&748$/,7<&203/$,176 
 
:,7+'5$:$/&5,7(5,$ 
 
35(678'<$1'&21&20,7$177+(5$3< 
 
021,725,1*75($70(17&203/,$1&( 
 
816&+('8/('9,6,76 
 
()),&$&<3$5$0(7(56 
CR-5871 Protocol v4.0
 (4) 
Page 2 of 141
CONFIDENTIAL

 
0(7+2'6)25$66(66,1*5(&25',1*$1'$1$/<=,1*()),&$&< 
 
6$)(7<3$5$0(7(56 
 
$'9(56((9(176 
 
$'9(56((9(17'(),1,7,216 
 
0(7+2'6)25$66(66,1*5(&25',1*$1'$1$/<=,1*6$)(7< 
 
$'9(56((9(176)2//2:83 
 
67$7,67,&$/0(7+2'672%((03/2<(' 
 
180%(52)68%-(&76%<6,7($1'-867,),&$7,21)256$03/(6,=( 
 
/(9(/2)67$7,67,&$/6,*1,),&$1&( 
 
&5,7(5,$)25678'<7(50,1$7,21 
 
352&('85()25$&&2817,1*)250,66,1*8186('$1'6385,286'$7$ 
 
352&('85()255(3257,1*'(9,$7,216)52067$7,67,&$/3/$1 
 
(9$/8$%/(68%-(&76 
 
(/(&7521,&&$6(5(3257)250'$7$&2//(&7,21 
 
6285&('2&80(17$7,21 
 
$&&(66726285&('$7$'2&80(17 
 
&21),'(17,$/,7<2),1)250$7,21 
 
'$7$48$/,7<$6685$1&( 
 
678'<63(&,),&'(6,*1&216,'(5$7,216 
 
,19(67,*$7255(63216,%,/,7< 
 
,1'(3(1'(17(7+,&6&200,77((25,167,787,21$/5(9,(:%2$5',(&,5% 
 
,1)250('&216(17 
 
35,9$&<2)3(5621$/'$7$ 
 
'$7$+$1'/,1*$1'5(&25'.((3,1* 
 
),1$1&,$/&216,'(5$7,216 
 
38%/,&$7,21 
 
3$7,(175(3257('287&20(6678'<48(67,211$,5(6 
 
&/,1,&$/7(&+1,&$/352&('85(6&736 
 
3$7,(17,16758&7,21*8,'($33529('352'8&7 
 
3$&.$*(,16(57 
 
/,672)$%%5(9,$7,216 
$33(1',;$
/LPEDO	&RQMXQFWLYDO%XOEDU5HGQHVV 
$33(1',;%
([SDQGHG6RGLXP)OXRUHVFHLQ&RUQHDO6WDLQLQJ 
$33(1',;&
/HQV)LWWLQJ&KDUDFWHULVWLFV 
$33(1',;'
6XEMHFW5HSRUWHG2FXODU6\PSWRPV3UREOHPV 
CR-5871 Protocol v4.0
 (4) 
Page 3 of 141
CONFIDENTIAL

$33(1',;(
7UDSSHG%DFN6XUIDFH'HEULVDQG0XFLQ3OXJ*UDGLQJ3URFHGXUH 
$33(1',;)
)URQWDQG%DFN6XUIDFH/HQV'HSRVLW*UDGLQJ3URFHGXUH 
$33(1',;*
'HWHUPLQDWLRQRI'LVWDQFH6SKHURF\OLQGULFDO5HIUDFWLRQV 
$33(1',;+
%LRPLFURVFRS\6FDOH 
$33(1',;,
&RQMXQWLYDO6WDLQLQJ 
$33(1',;-
'LVWDQFHDQG1HDU9LVXDO$FXLW\(YDOXDWLRQ 
$33(1',;.
7RULF)LW(YDOXDWLRQ 
$33(1',;/
'LVWDQFH/RJ0$59LVXDO$FXLW\0HDVXUHPHQW3URFHGXUH 
$33(1',;0
:KLWH/LJKW/HQV6XUIDFH:HWWDELOLW\ 
$33(1',;1
9LVXDO$FXLW\&KDUW/XPLQDQFHDQG5RRP,OOXPLQDWLRQ7HVWLQJ 






CR-5871 Protocol v4.0
 (4) 
Page 4 of 141
CONFIDENTIAL


35272&2/7,7/(180%(5'$7(
7,7/((YDOXDWLRQRI$VWLJPDWLF&RQWDFW/HQVHV
35272&2/180%(5&5
9(56,21
'$7(0DUFK

1$0($1'$''5(662)6321625
-RKQVRQ	-RKQVRQ9LVLRQ&DUH
&HQWXULRQ3DUNZD\-DFNVRQYLOOH)/

$87+25,=('6,*1$785(6




$XWKRU
6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH.ULVW\&DQDYDQ2')$$2
7LWOH3ULQFLSDO5HVHDUFK2SWRPHWULVW


'$7(


%LRVWDWLVWLFLDQ
6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH%RUP.LP/LWWOH06
7LWOH%LRVWDWLVWLFLDQ,,


'$7(

&OLQLFDO'DWD
0DQDJHU

6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH5DQGDOO3DXON
7LWOH&OLQLFDO3URMHFW0JU'DWD	6\VWHPV

'$7(


5HYLHZHG
6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH1RHO%UHQQDQ
7LWOH5HVHDUFK)HOORZ3ODWIRUP/HDG0\RSLD

'$7(

&OLQLFDO
2SHUDWLRQV

6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH0DUJDUHW%DOVDPR&&5$
7LWOH&OLQLFDO2SHUDWLRQV0DQDJHU

'$7(


$SSURYHU
6HH(OHFWURQLF6LJQDWXUH5HSRUW



1DPH*LRYDQQD2OLYDUHV2')$$2
7LWOH*OREDO3ODWIRUP'LUHFWRU5	'
$VWLJPDWLVP

'$7(


7KHVLJQDWXUHEHORZFRQVWLWXWHVWKHDSSURYDORIWKLVSURWRFRODQGWKHDWWDFKPHQWVDQGSURYLGHVWKHQHFHVVDU\
DVVXUDQFHVWKDWWKLVWULDOZLOOEHFRQGXFWHGDFFRUGLQJWRDOOVWLSXODWLRQVRIWKHSURWRFROLQFOXGLQJDOOVWDWHPHQWV
UHJDUGLQJFRQILGHQWLDOLW\DQGDFFRUGLQJWRORFDOOHJDODQGUHJXODWRU\UHTXLUHPHQWVDQGDSSOLFDEOH86IHGHUDO
UHJXODWLRQV,&+JXLGHOLQHVDQGWKH'HFODUDWLRQRI+HOVLQNL
CR-5871 Protocol v4.0
 (4) 
Page 5 of 141
CONFIDENTIAL


,19(67,*$72566,*1$785(3$*(














3ULQFLSDO,QYHVWLJDWRU




6LJQDWXUH


BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB
1DPH3ULQWHG


'DWH


,QVWLWXWLRQ1DPHBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB
7KH3ULQFLSDO,QYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWDOOVWXG\VLWHSHUVRQQHOLQFOXGLQJVXELQYHVWLJDWRUVDQG
RWKHUVWDIIPHPEHUVDGKHUHWRDOO,&+UHJXODWLRQVDQG*&3JXLGHOLQHVUHJDUGLQJFOLQLFDOWULDOVGXULQJDQGDIWHU
VWXG\FRPSOHWLRQ
,KDYHUHDGDQGXQGHUVWDQGWKHSURWRFROVSHFLILHGDERYHDQGDJUHHRQLWVFRQWHQW,DJUHHWRFRQGXFWWKLVVWXG\
DFFRUGLQJWRWKLVSURWRFRODQG*&3DQG,&+JXLGHOLQHVWKH'HFODUDWLRQRI+HOVLQNLDQGWKHSHUWLQHQWLQGLYLGXDO
FRXQWU\ODZVUHJXODWLRQVDQGWRFRPSO\ZLWKLWVREOLJDWLRQVVXEMHFWWRHWKLFDODQGVDIHW\FRQVLGHUDWLRQV,VKDOOQRW
GLVFORVHWKHLQIRUPDWLRQFRQWDLQHGLQWKLVSURWRFRORUDQ\UHVXOWVREWDLQHGIURPWKLVVWXG\ZLWKRXWZULWWHQ
DXWKRUL]DWLRQ
CR-5871 Protocol v4.0
 (4) 
Page 7 of 141
CONFIDENTIAL

(OLJLELOLW\&ULWHULD
6XEMHFWVPXVWPHHWDOOVWXG\,QFOXVLRQ&ULWHULDDVRXWOLQHGEHORZ
 +HDOWK\DGXOWPDOHVRUIHPDOHVDJH\HDUVRIDJHZLWKVLJQHGLQIRUPHGFRQVHQW
 7KHVXEMHFWPXVWDSSHDUDEOHDQGZLOOLQJWRDGKHUHWRWKHLQVWUXFWLRQVVHWIRUWKLQWKLVFOLQLFDOSURWRFRO
 6XEMHFWPXVWEHDKDELWXDOVRIWWRULFFRQWDFWOHQVZHDUHU+DELWXDOZHDUHULVGHILQHGDVVRPHRQHZKR
ZHDUVFRQWDFWOHQVHVIRUDWOHDVWKRXUVDGD\GD\VDZHHNIRUWKHSDVWGD\V
 6XEMHFW¶VYHUWH[FRUUHFWHGVSKHULFDOFRPSRQHQWRIWKHLUGLVWDQFHUHIUDFWLRQPXVWEHEHWZHHQWR
'LQFOXVLYHLQHDFKH\H
 6XEMHFW¶VYHUWH[FRUUHFWHGUHIUDFWLYHF\OLQGHUPXVWEHEHWZHHQDQG'&LQFOXVLYHLQHDFKH\H
 6XEMHFW¶VUHIUDFWLYHF\OLQGHUD[LVPXVWEHDQGLQHDFKH\H
 7KHVXEMHFWPXVWKDYHYLVXDODFXLW\EHVWFRUUHFWDEOHWRRUEHWWHUIRUHDFKH\H
 7KHVXEMHFWPXVWUHDGDQGVLJQWKH,QIRUPHG&RQVHQWIRUP

6XEMHFWVPHHWLQJDQ\RIWKHIROORZLQJ([FOXVLRQ&ULWHULDZLOOQRWEHHOLJLEOHWRSDUWLFLSDWHLQWKHVWXG\
 :RPHQZKRDUHSUHJQDQWRUEUHDVWIHHGLQJ
 $Q\RFXODURUV\VWHPLFDOOHUJLHVRUGLVHDVHVWKDWPD\FRQWUDLQGLFDWHFRQWDFWOHQVZHDU
 $Q\RFXODUPHGLFDWLRQVXVHZLWKLQWKHODVWRQHPRQWK
 $Q\V\VWHPLFGLVHDVHDXWRLPPXQHGLVHDVHRUXVHRIPHGLFDWLRQZKLFKPD\LQWHUIHUHZLWKFRQWDFWOHQV
ZHDU
 $Q\LQIHFWLRXVGLVHDVHHJKHSDWLWLVWXEHUFXORVLVRUDFRQWDJLRXVLPPXQRVXSSUHVVLYHGLVHDVHHJ
+,9E\VHOIUHSRUW
 +DELWXDOZHDUHURIH[WHQGHGZHDUFRQWDFWOHQVHV
 .QRZQVHQVLWLYLW\WR5HYLWDOHQV2FX7HF
 $Q\SUHYLRXVKLVWRU\RIRFXODUDQGRUUHIUDFWLYHVXUJHU\HJUDGLDONHUDWRWRP\35./$6,.HWF
 $FOLQLFDOILQGLQJRUKLVWRU\RIHQWURSLRQHFWURSLRQH[WUXVLRQVFKDOD]LDUHFXUUHQWVW\HVJODXFRPD
KLVWRU\RIUHFXUUHQWFRUQHDOHURVLRQVDSKDNLDRUPRGHUDWHRUDERYHFRUQHDOGLVWRUWLRQE\VHOIUHSRUW
 +LVWRU\RIELQRFXODUYLVLRQDEQRUPDOLW\RUVWUDELVPXVE\VHOIUHSRUW
 +DELWXDOZHDUHURIULJLGJDVSHUPHDEOH5*3OHQVHVRUWKRNHUDWRORJ\OHQVHVRUK\EULGOHQVHVHJ
6\QHUJ(\HV6RIW3HUPZLWKLQWKHSDVWPRQWKV
 (PSOR\HHRILQYHVWLJDWLRQDOFOLQLFHJ,QYHVWLJDWRU&RRUGLQDWRU7HFKQLFLDQ
 3DUWLFLSDWLRQLQDQ\FRQWDFWOHQVRUOHQVFDUHSURGXFWFOLQLFDOWULDOZLWKLQGD\VSULRU
WRVWXG\HQUROOPHQW
 &OLQLFDOO\VLJQLILFDQWJUDGHRUKLJKHUFRUQHDOHGHPDFRUQHDOYDVFXODUL]DWLRQFRUQHDOVWDLQLQJWDUVDO
DEQRUPDOLWLHVEXOEDULQMHFWLRQRUDQ\RWKHUDEQRUPDOLWLHVZKLFKZRXOGFRQWUDLQGLFDWHFRQWDFWOHQVZHDU
 $Q\KLVWRU\RIDFRQWDFWOHQVUHODWHGFRUQHDOLQIODPPDWRU\HYHQWZLWKLQWKHSDVW\HDUWKDWPD\
FRQWUDLQGLFDWHFRQWDFWOHQVZHDU
 $Q\DFWLYHRFXODULQIHFWLRQ
 $Q\FRUQHDOGLVWRUWLRQUHVXOWLQJIURPSUHYLRXVKDUGRUULJLGJDVSHUPHDEOHFRQWDFWOHQVZHDU
 $Q\IOXFWXDWLRQVLQYLVLRQGXHWRFOLQLFDOO\VLJQLILFDQWGU\H\HRURWKHURFXODUFRQGLWLRQV


'LVDOORZHG0HGLFDWLRQV8VHRIDQ\SUHVFULSWLRQRURYHUWKHFRXQWHU27&PHGLFDWLRQVWKDWPD\DIIHFWFRQWDFW
OHQVZHDUIURPKRXUVSULRUWRUHFHLYLQJWKHVWXG\SURGXFWWKURXJKRXWVWXG\SDUWLFLSDWLRQ




CR-5871 Protocol v4.0
 (4) 
Page 9 of 141
CONFIDENTIAL


6800$5<2).12:15,6.6$1'%(1(),7672+80$168%-(&76
6HH


'(6&5,37,212)75,$/75($70(176
7KHWHVWOHQVLVVHQRILOFRQ&IRUPXODWHGXVLQJWKHVDPHPRQRPHULFFRPSRQHQWVIRUFXUUHQWO\PDUNHWHGVHQRILOFRQ
$LQGLIIHUHQWUDWLRV7KHFRQWUROOHQVLV$OFRQ$LU2SWL[IRU$VWLJPDWLVPZKLFKLVFXUUHQWO\PDUNHWHGDVD
PRQWKO\UHSODFHPHQW7KHVWXG\OHQVHVZLOOEHZRUQLQDELODWHUDODQGUDQGRPIDVKLRQXVLQJDSDUDOOHOJURXSGHVLJQ
8VLQJDFRPSXWHUJHQHUDWHGUDQGRPL]DWLRQVFKHPHHDFKVXEMHFWZLOOUDQGRPO\EHDVVLJQHGWRRQHRIWZROHQVHVLQD
UDWLR7KHWHVWDQGFRQWUROOHQVHVZLOOEHZRUQDVGDLO\ZHDUIRUDSSUR[LPDWHO\WKLUW\GD\V

67$7(0(172)&203/,$1&(7235272&2/*&3$1'$33/,&$%/(5(*8/$725<
*8,'(/,1(6
7KLVWULDOZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKHSURWRFROWKH,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ*RRG
&OLQLFDO3UDFWLFH(,&+*&3WKH'HFODUDWLRQRI+HOVLQNLDQGDOODSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV

'(6&5,37,212)3238/$7,2172%(678',('(152//0(177$5*(76$1'678'<
'85$7,21
$SSUR[LPDWHO\HOLJLEOHVXEMHFWVZLOOEHHQUROOHGDQGDPLQLPXPRIDUHWDUJHWHGWRFRPSOHWHWKHVWXG\
VXEMHFWVSHUDUP6XEMHFWVZLOOEHDQG\HDUVRIDJH(QUROOHGVXEMHFWVPXVWEHKDELWXDOZHDUHUVRIVRIWWRULF
FRQWDFWOHQVHVLQERWKH\HV
$SSUR[LPDWHO\RIVWXG\VXEMHFWVZLOOEHKDELWXDOPRQWKO\UHSODFHPHQWPRGDOLW\WRULFZHDUHUVLQFOXGLQJ$LU
2SWL[IRU$VWLJPDWLVPDQG%LRILQLW\7RULF+DELWXDOLVGHILQHGDVDWOHDVWRQHPRQWKRIOHQVZHDUZKHUHWKHOHQVHV
DUHZRUQDPLQLPXPRIVL[KRXUVSHUGD\DQGDPLQLPXPRIILYHGD\VSHUZHHN6XEMHFWSDUWLFLSDWLRQLVH[SHFWHGWR
EHDSSUR[LPDWHO\GD\V

5(/(9$17/,7(5$785(5()(5(1&(6$1'35,25'$7$
6HH


'(6&5,37,212)2%-(&7,9(6$1'385326(
7KHREMHFWLYHVRIWKLVVWXG\DUHWRHYDOXDWHFRUQHDOVWDLQLQJOHQVILWWLQJFKDUDFWHULVWLFVYLVXDODFXLW\URWDWLRQDO
SHUIRUPDQFHDQGWKHVXEMHFWLYHFRPIRUWRIVHQRILOFRQ&WRULFFRQWDFWOHQVFRPSDUHGWR$LU2SWL[IRU$VWLJPDWLVP
ZKHQZRUQIRUDSSUR[LPDWHO\GD\V
7KHIROORZLQJZLOOEHPRQLWRUHGDQGHYDOXDWHG
$GYHUVHHYHQWV
/HQVILWFKDUDFWHULVWLFV
9LVLRQFKDUDFWHULVWLFV
3K\VLRORJLFDOFKDUDFWHULVWLFV
2FXODUV\PSWRPV
/HQVGHSRVLWV
$YHUDJHZHDUWLPH
5HDVRQVIRUGLVFRQWLQXDWLRQ
/HQVGDPDJH

CR-5871 Protocol v4.0
 (4) 
Page 11 of 141
CONFIDENTIAL


35,0$5<$1'6(&21'$5<(1'32,176
7KHSULPDU\HQGSRLQWVIRUWKLVVWXG\DUH
x
0RQRFXODUGLVWDQFHYLVXDODFXLW\RUEHWWHU
x
&RQWDFWOHQVUHODWHGFRUQHDOVWDLQLQJ
x
/HQVILWWLQJDFFHSWDELOLW\
x
$EVROXWHURWDWLRQ
x
6WDELOLW\ZLWKEOLQN

0RQRFXODUYLVXDODFXLW\9$ZLOOEHDVVHVVHGZLWKWKHVWXG\OHQVHVXVLQJD6QHOOHQGLVWDQFH9$FKDUWDWDQRSWLFDO
GLVWDQFHRIIHHWWKURXJKRXWWKHVWXG\2EVHUYHGPRQRFXODU9$FROOHFWHGGXULQJSODQQHGYLVLWVZLOOEH
GLFKRWRPL]HGZKHWKHU9$ZDVµRUEHWWHU¶RUµZRUVH¶9$RIZLWKDQHJDWLYHPRGLILHUZLOOEHFRQVLGHUHG
WREHZRUVHWKDQ$GGLWLRQDOO\REVHUYHGPRQRFXODU9$ZLOOEHGLFKRWRPL]HGZKHWKHU9$ZDVµRU
EHWWHU¶RUµZRUVH¶DWILWWLQJXVLQJWKHVDPHORJLFDVWKHSUHYLRXV9$FDWHJRU\
&RQWDFWOHQVUHODWHGFRUQHDOVWDLQLQJZLOOEHDVVHVVHGYLDVOLWODPSWKURXJKRXWWKHVWXG\&RUQHDOVWDLQLQJZLOOEH
JUDGHGXVLQJDOHYHOVFDOH QRVWDLQLQJ WUDFH PLOG PRGHUDWHDQG VHYHUH2EVHUYHGFRUQHDOVWDLQLQJ
FROOHFWHGGXULQJSODQQHGDQGXQVFKHGXOHGYLVLWVZLOOEHGLFKRWRPL]HGZKHWKHUWKHFRUQHDOVWDLQLQJLVµJUDGHRU
ORZHU¶RUµ*UDGHRUKLJKHU¶
/HQVILWFKDUDFWHULVWLFVZLOOEHDVVHVVHGYLDVOLWODPSLQWHUPVRIOHQVSRVLWLRQPRYHPHQWDQGWLJKWQHVV(DFKOHQVILW
FROOHFWHGDWILWWLQJZLOOEHMXGJHGDVEHLQJHLWKHUµDFFHSWDEOH¶RUµXQDFFHSWDEOH¶EDVHGRQWKHVWDWLFDQGG\QDPLFILW
FKDUDFWHULVWLF
/HQVURWDWLRQZLOOEHDVVHVVHGYLDVOLWODPSZLWKEHDPWKDWFDQEHURWDWHG7KHURWDWLRQDOHUURUDVVXPHVKRUWHVW
GLVWDQFHDQGGLUHFWLRQEDVHWRZDUGVWKHQRVHRUEDVHGWRZDUGVWHPSOH@ZLOOEHFDOFXODWHG$EVROXWHURWDWLRQZLOO
EHGLFKRWRPL]HGZKHWKHUURWDWLRQZDVµ!GHJUHH¶RUµZRUVH¶XSRQPLQXWHSRVWLQVHUWLRQDWILWWLQJ
5RWDWLRQDOVWDELOLW\ZLWKEOLQNZLOOEHDVVHVVHGYLDVOLWODPSZLWKEHDPWKDWFDQEHURWDWHG7KHVWDELOLW\RIWKHVFULEH
PDUNURWDWLRQDOSRVLWLRQGXULQJDVHULHVRIQRUPDOXQIRUFHGEOLQNVZLOOEHREVHUYHG2EVHUYHGURWDWLRQDOVWDELOLW\
ZLWKEOLQNZLOOEHGLFKRWRPL]HGZKHWKHUVWDELOLW\ZDVµ!GHJUHH¶RUµZRUVH¶DWILWWLQJ
7KHVHFRQGDU\HQGSRLQWVDUH

x
0RQRFXODUGLVWDQFHYLVXDODFXLW\RUEHWWHU
x
6XEMHFWLYH&/8(FRPIRUWVFRUHDQG
x
6XEMHFWLYH&/8(KDQGOLQJVFRUH

6XEMHFWLYH&/8(FRPIRUWDQGKDQGOLQJVFRUHZLOOEHDVVHVVHGXVLQJWKH&RQWDFW/HQV8VHU([SHULHQFH70&/8(
TXHVWLRQQDLUH&/8(LVDYDOLGDWHGSDWLHQWUHSRUWHGRXWFRPHV352TXHVWLRQQDLUHWRDVVHVVSDWLHQWH[SHULHQFH
DWWULEXWHVRIVRIWFRQWDFWOHQVHVFRPIRUWYLVLRQKDQGOLQJDQGSDFNDJLQJLQDFRQWDFWOHQVZHDULQJSRSXODWLRQLQ
WKH86DJHV'HULYHG&/8(VFRUHVXVLQJ,WHP5HVSRQVH7KHRU\,57IROORZDQRUPDOGLVWULEXWLRQZLWKD
SRSXODWLRQDYHUDJHVFRUHRI6'ZKHUHKLJKHUVFRUHVLQGLFDWHDPRUHIDYRUDEOHSRVLWLYHUHVSRQVH$SRLQW
LQFUHDVHLQDQDYHUDJH&/8(VFRUHWUDQVODWHVLQWRVKLIWLQWKHGLVWULEXWLRQRIVFRUHVIRUSRSXODWLRQRIVRIW
GLVSRVDEOHFRQWDFWOHQVZHDUHUV
7KHIROORZLQJSULPDU\DQGVHFRQGDU\K\SRWKHVHVZLOOEHWHVWHGWKURXJKRXWWKHVWXG\XVLQJDJDWHNHHSLQJVWUDWHJ\
7KHVHFRQGDU\K\SRWKHVHVZLOOEHWHVWHGRQO\LIDOOSULPDU\K\SRWKHVHVDUHPHW2WKHUZLVHQRVHFRQGDU\K\SRWKHVHV
WHVWLQJZLOOEHSHUIRUPHG

CR-5871 Protocol v4.0
 (4) 
Page 12 of 141
CONFIDENTIAL


5$1'20,=$7,21$1'0$6.,1*
7KLVVWXG\LVDUDQGRPL]HGGRXEOHPDVNHGSDUDOOHOJURXSGHVLJQ(DFKVXEMHFWZLOOEHUDQGRPL]HGWRZHDURQHRI
WZRVWXG\OHQVHVGXULQJWKHVWXG\LQDUDWLRRIIROORZLQJWKHUDQGRPL]DWLRQVFKHPHSURYLGHGE\WKH--9&
ELRVWDWLVWLFLDQ7KHUDQGRPL]DWLRQDVVLJQPHQWZLOOEHSHUIRUPHGDWWKHILUVWYLVLWSULRUWRWKHILUVWILWWLQJ

7KHIROORZLQJPXVWKDYHRFFXUUHGSULRUWRDVVLJQPHQW
x
,QIRUPHGFRQVHQWKDVEHHQREWDLQHG
x
6XEMHFWPHHWVDOOWKHLQFOXVLRQH[FOXVLRQFULWHULD
x
6XEMHFWKLVWRU\DQGEDVHOLQHLQIRUPDWLRQKDVEHHQFROOHFWHG

7KLVZLOOEHDGRXEOHPDVNHGVWXG\7KHLGHQWLW\RIWKHVWXG\OHQVHVZLOOEHPDVNHGWRQRWRQO\WKHVXEMHFWEXWDOVR
LQYHVWLJDWRUVLQYROYHGLQWKHGDWDFROOHFWLRQ
7KHUHLVDQLQKHUHQWSRWHQWLDOULVNIRUXQPDVNLQJ+RZHYHUPDVNLQJZLOOEHPDLQWDLQHGDVPXFKDVLVORJLVWLFDOO\
IHDVLEOH8QGHUQRUPDOFLUFXPVWDQFHVWKHPDVNVKRXOGQRWEHEURNHQXQWLODOOVXEMHFWVKDYHFRPSOHWHGWKHVWXG\DQG
WKHGDWDEDVHLVILQDOL]HG2WKHUZLVHWKHPDVNVKRXOGEHEURNHQRQO\LIVSHFLILFHPHUJHQF\WUHDWPHQWFRXUVHRI
DFWLRQZRXOGEHGLFWDWHGE\NQRZLQJWKHWUHDWPHQWVWDWXVRIWKHVXEMHFW,QVXFKFDVHVWKHLQYHVWLJDWRUPD\LQDQ
HPHUJHQF\FRQWDFWWKHPHGLFDOPRQLWRU,QWKHHYHQWWKHPDVNLVEURNHQWKHVSRQVRUPXVWEHLQIRUPHGDVVRRQDV
SRVVLEOH7KHGDWHWLPHDQGUHDVRQIRUWKHXQPDVNLQJPXVWEHGRFXPHQWHGLQWKHVXEMHFWUHFRUG
6XEMHFWVZKRKDYHKDGWKHLUWUHDWPHQWDVVLJQPHQWXQPDVNHGDUHH[SHFWHGWRUHWXUQIRUDOOUHPDLQLQJVFKHGXOHG
HYDOXDWLRQV$UHSODFHPHQWVXEMHFWPD\EHHQUROOHGLIDVXEMHFWGLVFRQWLQXHVIURPWKHVWXG\SUHPDWXUHO\7KH
GHFLVLRQWRHQUROOUHSODFHPHQWVXEMHFWVZLOOEHPDGHE\WKHMRLQWDJUHHPHQWRIWKH,QYHVWLJDWRUDQG6SRQVRU

:($5$1'5(3/$&(0(176&+('8/(6,1&/8',1*)2503$&.$*,1*$1'
/$%(/,1*
:HDU6FKHGXOH'DLO\:HDU0RQWKO\UHSODFHPHQW

7HVW$UWLFOH3DFNDJLQJ'HVFULSWLRQ%OLVWHUSDFNDJLQJLQVWHULOHSDFNLQJVROXWLRQ

/DEHOLQJ,QYHVWLJDWLRQDO

 
 
 
 
 
 
 
 
CR-5871 Protocol v4.0
 (4) 
Page 16 of 141
CONFIDENTIAL


7RULF)LW(YDOXDWLRQ
$IWHUOHQVVHWWOLQJUHFRUG
x 7KHURWDWLRQDOSRVLWLRQWRWKHQHDUHVWGHJUHH
x /HQVVWDELOLW\ZLWKEOLQN
x /HQVVWDELOLW\ZLWKH\HYHUVLRQV
x 7RULFILWDFFHSWDEOHRUXQDFFHSWDEOH
7RULFOHQVILWZLOOEHXQDFFHSWDEOHLIOHQVHVURWDWHGPRUHWKDQ
GHJUHHVRUOHQVVWDELOLW\LVZRUVHWKDQGHJUHHVPRYHPHQWZLWK
EOLQN,IWRULFILWLVXQDFFHSWDEOHSURFHHGWRILQDOHYDOXDWLRQ


6XEMHFWLYHVSKHULFDO
RYHUUHIUDFWLRQ
3HUIRUPVXEMHFWLYHVSKHULFDOUHIUDFWLRQRYHUWKHVWXG\FRQWDFWOHQV
DQGUHFRUGWKHUHVXOWLQYLVXDODFXLW\IRU2'263ODQRRU'
PXVWEHDFKLHYHGWRFRQWLQXH


/HQVPRGLILFDWLRQ
LIQHHGHG
6HOHFWWKHUHDVRQVIRUOHQVFKDQJHVHOHFWDOOWKDWDSSO\
x 7KHVHWWOHGOHQVURWDWLRQLVVXFKWKDWRQHRIWKH
RWKHUDYDLODEOHOHQVF\OLQGHUD[LVZRXOGEH
EHWWHUXVH/$56UXOHWRGHWHUPLQHWKH
UHSODFHPHQWOHQVF\OLQGHUD[LV
x 7KHRYHUUHIUDFWLRQLVQRWSODQRRULQERWK
H\HV
x 2WKHUVSHFLI\UHDVRQ
,IRQHRUERWKOHQVHVDUHPRGLILHGUHSHDWVWHSVWKURXJKIRURQH
RUERWKH\HVDVDSSURSULDWH
,ISODQRRYHUUHIUDFWLRQFDQQRWEHDFKLHYHGWKHILQDOVSKHUH
VKRXOGEHWKHPRVWSOXVOHDVWPLQXVSRVVLEOHIRUEHVWYLVLRQ$
PD[LPXPRIWZROHQVPRGLILFDWLRQVLVDOORZHG
,IWKHVHFRQGLWLRQVDUHQRWPHWSURFHHGWRILQDOHYDOXDWLRQ


(7'569LVXDO
SHUIRUPDQFH
8QGHUKLJKLOOXPLQDWLRQDQGKLJKFKDUWOXPLQDQFHUHFRUGWKH
GLVWDQFHKLJKFRQWUDVWYLVXDODFXLW\IRU2'2628XVLQJ(7'56
FKDUWVDWPHWHUV


&/8(3RVW)LW
4XHVWLRQQDLUH
6XEMHFWZLOOFRPSOHWHWKH&/8(4XHVWLRQQDLUHUHJDUGLQJYLVLRQ
DQGFRPIRUW


*6,4XHVWLRQQDLUH
6XEMHFWZLOOFRPSOHWH*6,TXHVWLRQVUHJDUGLQJWKHLUH[SHULHQFHV
ZLWKWKHVWXG\OHQVHV


6XEMHFW5HSRUWHG
2FXODU6\PSWRPV
5HFRUG6XEMHFW5HSRUWHG2FXODU6\PSWRPVRU3UREOHPV

CR-5871 Protocol v4.0
 (4) 
Page 20 of 141
CONFIDENTIAL


352&('85(6)250$,17$,1,1*$1'%5($.,1*5$1'20,=$7,21&2'(6
7KHWHVWDUWLFOHPDVNVKDOOQRWEHEURNHQXQOHVVLQIRUPDWLRQFRQFHUQLQJWKHOHQVW\SHLVQHFHVVDU\IRUWKHXUJHQW
PHGLFDOWUHDWPHQWRIDVXEMHFW7KH6SRQVRUVKRXOGEHQRWLILHGEHIRUHWKHPDVNLVEURNHQ
:KHQGLVSHQVLQJWHVWDUWLFOHVWKHIROORZLQJVWHSVVKRXOGEHIROORZHGWRPDLQWDLQUDQGRPL]DWLRQFRGHV
 ,QYHVWLJDWRUZLOODVVLJQDQXQPDVNHGGHVLJQHHGRFXPHQWHGRQWKH'HOHJDWLRQ/RJZKRZLOOFRQVXOWWKH
UDQGRPL]DWLRQVFKHPHWRREWDLQWKHVWXG\WHVWDUWLFOHDVVLJQPHQWIRUWKDWVXEMHFWSULRUWRGLVSHQVLQJ
 'HVLJQHHZLOOUHFRUGWKHVXEMHFW¶VQXPEHURQWKHDSSURSULDWHOLQHRIWKHUDQGRPL]DWLRQVFKHPH
 'HVLJQHHZLOOSXOOWKHDSSURSULDWHWHVWDUWLFOHVIURPWKHVWXG\VXSSO\$OOWHVWDUWLFOHVWKDWZHUHRSHQHG
ZKHWKHUGLVSHQVHGRUQRWPXVWEHUHFRUGHGRQWKH7HVW$UWLFOH$FFRXQWDELOLW\/RJLQWKH³'LVSHQVHG´
VHFWLRQ
 'HVLJQHHZLOOUHPRYHVWXG\OHQVHVDQGSDFNLQJVROXWLRQIURPPDQXIDFWXUHU¶VEOLVWHUSDFNDQGWUDQVIHUWRD
OHQVFDVHSD\LQJSDUWLFXODUDWWHQWLRQWRWKHVWXG\OHQVWREHGLVSHQVHG2'DQG26SULRUWRHQWHULQJVWXG\
H[DPLQDWLRQURRPIRUVXEMHFWILWWLQJ

5(3257,1*352'8&748$/,7<&203/$,176
$3URGXFW4XDOLW\&RPSODLQW34&UHIHUVWRDQ\ZULWWHQHOHFWURQLFRURUDOFRPPXQLFDWLRQWKDWDOOHJHV
GHILFLHQFLHVUHODWHGWRWKHLGHQWLW\TXDOLW\GXUDELOLW\UHOLDELOLW\VDIHW\HIIHFWLYHQHVVRUSHUIRUPDQFHRIWHVWDUWLFOHV
DIWHUWKH\KDYHEHHQUHOHDVHGIRUFOLQLFDOWULDOXVH$34&LVDVVRFLDWHGZLWKDQ\LQYHVWLJDWLRQDOSURGXFWLH
SURGXFWPDQXIDFWXUHGRUVXSSOLHGVSHFLILFDOO\IRUDFOLQLFDOWULDO
&RPSODLQW+DQGOLQJ

2QFHVLWHSHUVRQQHOKDYHEHFRPHDZDUHWKDWD34&KDVRFFXUUHGLWVKDOOWKHQEHUHFRUGHGLQWKH('&V\VWHP
ZKLFKWULJJHUVDQDXWRPDWLFHPDLOQRWLILFDWLRQWRWKHDSSURSULDWH&20&5$DQG&OLQLFDO4$UHSUHVHQWDWLYH,Q
FDVHVZKHUHWKH('&V\VWHPLQXVHLVQRWFRQILJXUHGWRVHQGDXWRPDWLFQRWLILFDWLRQVWKHQWKH&20&5$LV
UHVSRQVLEOHIRUQRWLI\LQJ&OLQLFDO4$XSRQGLVFRYHU\WKDWD34&KDVRFFXUUHG
8SRQUHFHLSWRIWKH('&QRWLILFDWLRQWKH&20&5$VKDOOFRPSOHWHWKHDSSOLFDEOHVHFWLRQVRIWKH3URGXFW4XDOLW\
&RPSODLQW)RUP
RUHOHFWURQLFHTXLYDOHQW
)RUHDFKFRPSODLQWWKHIROORZLQJPLQLPXPLQIRUPDWLRQVKDOOEHUHFRUGHGE\WKH&5$&20RQWKH3URGXFW4XDOLW\
&RPSODLQW)RUP

x
'DWHWKHFRPSODLQWZDVUHFHLYHGUHFRUGHGLQWKH('&6\VWHP'DWHRI6SRQVRU$ZDUHQHVV
x
:KRUHFHLYHGWKHFRPSODLQW
x
6WXG\QXPEHU
x
,QYHVWLJDWLRQDOVLWHLQIRUPDWLRQFRQWDFWQDPHVLWH,'WHOHSKRQHQXPEHU
x
/RWQXPEHUV
x
8QLTXH6XEMHFW,GHQWLILHUV
x
,QGLFDWLRQRIZKRILUVWREVHUYHGFRPSODLQWVLWHSHUVRQQHORUVXEMHFW
x
2'26LQGLFDWLRQDORQJZLWKZKHWKHURUQRWWKHOHQVZDVLQVHUWHG
x
$Q\UHODWHG$(QXPEHULIDSSOLFDEOH
x
'HWDLOHGFRPSODLQWGHVFULSWLRQVFKHGXOHGXQVFKHGXOHGYLVLWZHDUWLPHV\PSWRPVUHVROXWLRQRI
V\PSWRPVHWF
x
(\H&DUH3URYLGHUREMHFWLYHVOLWODPSILQGLQJVLIDSSOLFDEOH
x
&RQILUPDWLRQRISURGXFWDYDLODELOLW\IRUUHWXUQDQGWUDFNLQJLQIRUPDWLRQLIDYDLODEOHRUUDWLRQDOHLI
SURGXFWLVQRWDYDLODEOHIRUUHWXUQ5HIHUWR)RUP&RQWURO1R
IRUWHVWDUWLFOHUHWXUQLQVWUXFWLRQV
CR-5871 Protocol v4.0
 (4) 
Page 31 of 141
CONFIDENTIAL

&OLQLFDO4$ZLOODVVLJQDXQLTXHQXPEHUWRWKH34&&RPSODLQWQXPEHULQJLVDVVLJQHGDVIROORZV
5'7&;;ZKHUH5'7& 5	'7HFKQLFDO&RPSODLQW;; ODVWWZRGLJLWVRIWKHFXUUHQW\HDU 
VHTXHQWLDOQXPEHULQJVWDUWLQJZLWK

:,7+'5$:$/&5,7(5,$
$VXEMHFWZLOOEHZLWKGUDZQIURPWKHVWXG\IRUDQ\RIWKHIROORZLQJUHDVRQV
x
/RVWWRIROORZXS
x
:LWKGUDZDORIFRQVHQW
x
'HDWK
x
'LVFRQWLQXDWLRQRIVWXG\WUHDWPHQWDVDUHVXOWRIWKHLQYHVWLJDWRU¶VFOLQLFDOMXGJPHQWWKDWIRUVDIHW\UHDVRQV
HJDGYHUVHHYHQWLWLVLQWKHEHVWLQWHUHVWRIWKHVXEMHFWWRVWRSWUHDWPHQW
x
7KHVXEMHFWEHFRPHVSUHJQDQW
)RUGLVFRQWLQXHGVXEMHFWVWKH,QYHVWLJDWRUZLOO
x
8SGDWHWKHHQUROOPHQWORJWRGRFXPHQWUHDVRQIRUGLVFRQWLQXDWLRQ
x
&RPSOHWHWKH³ODVW´)ROORZXS9LVLWIRUPVFKHGXOHGRUXQVFKHGXOHG
x
&RPSOHWHWKH)LQDO(YDOXDWLRQIRUPLQGLFDWLQJWKHUHDVRQWKDWWKHVXEMHFWZDVGLVFRQWLQXHGIURPWKHVWXG\
x
5HFRUGWKHVSKHURF\OLQGULFDOUHIUDFWLRQZLWKEHVWFRUUHFWHGGLVWDQFHYLVXDODFXLW\
x
&ROOHFWXVHGVWXG\OHQVHVDQGWHVWDUWLFOHVZRUQRUEURXJKWWRWKHYLVLWIURPWKHVXEMHFWDQGGLVFDUGWKHP
x
&ROOHFWDOOXQXVHGVWXG\OHQVHVDQGWHVWDUWLFOHVIURPWKHVXEMHFW
6XEMHFWVEHFRPLQJSUHJQDQWGXULQJWKHVWXG\ZLOOEHGLVFRQWLQXHG2QFHGLVFRQWLQXHGSUHJQDQWSDUWLFLSDQWVDQG
WKHLUIHWXVHVZLOOQRWEHPRQLWRUHGIRUVWXG\UHODWHGSXUSRVHV$WWKH,QYHVWLJDWRUV¶GLVFUHWLRQWKHVWXG\SDUWLFLSDQW
PD\EHIROORZHGE\WKH,QYHVWLJDWRUWKURXJKGHOLYHU\+RZHYHUWKLVGDWDZLOOQRWEHFROOHFWHGDVSDUWRIWKHFOLQLFDO
VWXG\GDWDEDVH3UHJQDQWSDUWLFLSDQWVDUHQRWGLVFRQWLQXHGIURPFRQWDFWOHQVRUVROXWLRQUHODWHGVWXGLHVIRUVDIHW\
FRQFHUQVEXWGXHWRJHQHUDOFRQFHUQVUHODWLQJWRSUHJQDQF\DQGFRQWDFWOHQVXVH6SHFLILFDOO\SUHJQDQWZRPHQDUH
GLVFRQWLQXHGGXHWRIOXFWXDWLRQVLQUHIUDFWLYHHUURUDQGRUYLVXDODFXLW\WKDWRFFXUVHFRQGDU\WRV\VWHPLFKRUPRQDO
FKDQJHVDQGQRWGXHWRXQIRUHVHHQKHDOWKULVNVWRWKHPRWKHURUIHWXV
,QFDVHVZKHUHDVXEMHFWLVORVWWRIROORZXSHYHU\SRVVLEOHHIIRUWPXVWEHPDGHWRFRQWDFWWKHVXEMHFWDQGGHWHUPLQH
WKHUHDVRQIRUGLVFRQWLQXDWLRQZLWKGUDZDO7KHPHDVXUHVWDNHQWRIROORZXSPXVWEHGRFXPHQWHGLQFOXGLQJWZR
ZULWWHQDWWHPSWVDQGDFHUWLILHGOHWWHUDVWKHILQDODWWHPSW

35(678'<$1'&21&20,7$177+(5$3<
&RQFRPLWDQWPHGLFDWLRQVZLOOEHGRFXPHQWHGGXULQJVFUHHQLQJDQGGXULQJWKHVWXG\8VHRIDQ\SUHVFULSWLRQRU
RYHUWKHFRXQWHU27&PHGLFDWLRQVWKDWPD\DIIHFWFRQWDFWOHQVZHDUIURPKRXUVSULRUWRUHFHLYLQJWKHVWXG\
SURGXFWWKURXJKRXWVWXG\SDUWLFLSDWLRQ




CR-5871 Protocol v4.0
 (4) 
Page 32 of 141
CONFIDENTIAL


021,725,1*75($70(17&203/,$1&(
-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QFUHSUHVHQWDWLYHVRUGHVLJQHHVZLOOPRQLWRUWKHVWXG\LQDPDQQHU
FRQVLVWHQWZLWK,&+*&3(7KHVWXG\PRQLWRUVZLOOPDLQWDLQFORVHFRQWDFWZLWKWKH3ULQFLSDO
,QYHVWLJDWRUDQGWKH,QYHVWLJDWRU¶VGHVLJQDWHGVWDII7KHPRQLWRU¶VUHVSRQVLELOLWLHVZLOOLQFOXGH
x
(QVXULQJWKDWWKHLQYHVWLJDWLRQLVEHLQJFRQGXFWHGDFFRUGLQJWRWKHSURWRFRO
x
(QVXULQJWKHULJKWVDQGZHOOEHLQJRIVXEMHFWVDUHSURWHFWHG
x
(QVXULQJWKDWSURWRFROGHYLDWLRQVDUHGRFXPHQWHGZLWKFRUUHFWLYHDFWLRQSODQVDVDSSOLFDEOH
x
(QVXULQJWKDWWKHVLWHKDVVXIILFLHQWWHVWDUWLFOHDQGVXSSOLHV
x
&ODULI\LQJTXHVWLRQVUHJDUGLQJWKHVWXG\
x
5HVROYLQJVWXG\LVVXHVRUSUREOHPVWKDWPD\DULVH
x
5HYLHZLQJWKHVWXG\UHFRUGVWRHQVXUHFRPSOHWHQHVVDQGDFFXUDF\
x
6WXG\DQGVXEMHFWVRXUFHGRFXPHQWUHFRUGVUHYLHZHGZLOOLQFOXGH
x
7KH,QIRUPDWLRQDQG&RQVHQW)RUPSHU&)53DUWVDQGDQGWKH+,3$$GRFXPHQWV
x
6RXUFHGRFXPHQWDWLRQLQFOXGLQJFRQVHQWLQJDQG+,3$$SURFHVVPHGLFDOKLVWRU\FRQFRPLWDQW
PHGLFDWLRQVDQGDGYHUVHHYHQWLQIRUPDWLRQDVDSSOLFDEOH7KHVRXUFHGRFXPHQWVKRXOGEH
LQLWLDOHGDQGGDWHGE\WKHVWXG\LQYHVWLJDWRUV
x
,QYHVWLJDWLRQDOSURGXFWVKLSSLQJGLVSHQVLQJDFFRXQWDELOLW\DQGUHWXUQGHVWUXFWLRQUHFRUGV
x
6WXG\UHODWHG5HJXODWRU\GRFXPHQWVDVSHU,&+(VHFWLRQ
0RQLWRULQJIRUWKLVVWXG\ZLOOEHVSHFLILHGLQWKHPRQLWRULQJSODQZKLFKZLOOEHSURYLGHGVHSDUDWHO\

816&+('8/('9,6,76
,IGXULQJWKHLQYHVWLJDWLRQDVXEMHFWH[SHULHQFHVDQ\LQYHVWLJDWLRQDOGHYLFHUHODWHGGLIILFXOWLHVDQGRUSUREOHPV
UHTXLULQJDQXQVFKHGXOHGYLVLWWRWKHFOLQLFWKHIROORZLQJLQIRUPDWLRQZLOOEHFROOHFWHGDWDPLQLPXP
x
&KLHIFRPSODLQWSURPSWLQJWKHYLVLW,IWKHUHDVRQLVDQDGYHUVHHYHQWWKHDSSOLFDEOHH&5)IRUWKHDGYHUVH
HYHQWVKRXOGEHFRPSOHWHGDQGVRXUFHGRFXPHQWDWLRQFRPSOHWHGDVDSSURSULDWH
x
'DWHDQGWLPHRIWKHYLVLWDQGDOOSURFHGXUHVFRPSOHWHGDWWKHXQVFKHGXOHGYLVLW
x
5HYLHZRIDGYHUVHHYHQWDQGFRQFRPLWDQWPHGLFDWLRQV
x
'RFXPHQWDWLRQRIDQ\LQYHVWLJDWLRQDOSURGXFWGLVSHQVHGRUFROOHFWHGIURPWKHVXEMHFW
x
6OLWODPSILQGLQJVXVLQJWKH6OLW/DPS&ODVVLILFDWLRQ6FDOH
,IWKH,QYHVWLJDWRUZLWKGUDZVDVXEMHFWIURPWKHVWXG\WKHILQDOVWXG\YLVLWFDVHUHSRUWIRUPVPXVWEHFRPSOHWHG
LQGLFDWLQJWKHUHDVRQVZK\WKHVXEMHFWZDVZLWKGUDZQ7KHVXEMHFWHQUROOPHQWORJVKRXOGEHFRPSOHWHG
GRFXPHQWLQJWKHGDWHDQGSULPDU\UHDVRQIRUZLWKGUDZDODQGWKHVWXG\&5$QRWLILHG
$Q\LQYHVWLJDWLRQDOGHYLFHUHODWHGGLIILFXOWLHVDQGRUSUREOHPVWKDWDUHRQJRLQJDWWKHWLPHRIWKHILQDOVWXG\YLVLW
ZLOOEHIROORZHGE\WKH,QYHVWLJDWRUZLWKLQOLFHQVXUHXQWLOWKH\KDYHUHWXUQHGWRSUHWUHDWPHQWVWDWXVVWDELOL]HGRU
EHHQVDWLVIDFWRULO\H[SODLQHG,IIXUWKHUWUHDWPHQWLHEH\RQGOLFHQVXUHLVUHTXLUHGWKHVXEMHFWZLOOEHUHIHUUHGWR
WKHDSSURSULDWHKHDOWKFDUHSURYLGHU

()),&$&<3$5$0(7(56
6HHVHFWLRQ

0(7+2'6)25$66(66,1*5(&25',1*$1'$1$/<=,1*()),&$&<
6HHGHWDLOHGVWXG\SURFHGXUHVLQVHFWLRQDQGDQDO\VLVSODQVLQVHFWLRQ
CR-5871 Protocol v4.0
 (4) 
Page 33 of 141
CONFIDENTIAL


6$)(7<3$5$0(7(56
7KHVDIHW\SDUDPHWHUVIRUWKLVVWXG\DUH
x
$GYHUVHHYHQWV
x
%LRPLFURVFRS\
x
2FXODUV\PSWRPV
x
$YHUDJHZHDUWLPH
x
5HDVRQVIRUGLVFRQWLQXDWLRQDQG
x
5HDVRQVIRUXQVFKHGXOHGOHQVUHSODFHPHQW
6DIHW\SDUDPHWHUVZLOOEHWDEXODWHGXVLQJIUHTXHQF\GLVWULEXWLRQWDEOHVRUDQGGHVFULSWLYHVWDWLVWLFV
$GYHUVHHYHQWVZLOOEHOLVWHGE\VXEMHFWH\H7KHUHZLOOEHVHSDUDWHVXPPDU\WDEOHVIRUDGYHUVHHYHQWVDQG
LQILOWUDWLYHDGYHUVHHYHQWV6WDWLVWLFDOPHWKRGVIRUDQDO\]LQJVDIHW\GDWDLIDQ\DUHSURYLGHGLQVHFWLRQ

$'9(56((9(176
$OO2XWFRPH±5HVROYHGRQJRLQJQRWUHVROYHGUHVROYHGZLWKVHTXHODHIDWDOUHVROYLQJDQGXQNQRZQ
$FWLRQV7DNHQ±1RQHWHPSRUDULO\GLVFRQWLQXHGSHUPDQHQWO\GLVFRQWLQXHG2WKHUDFWLRQWDNHQDGYHUVHHYHQWVZLOO
EHUHFRUGHGLQWKHVXEMHFW¶VVRXUFHGRFXPHQWGRFXPHQWHGLQWKH&5)RUDSSURSULDWHDQGHYDOXDWHGE\WKH
,QYHVWLJDWRU,QDGGLWLRQDZULWWHQUHSRUWZLOOEHVXEPLWWHGE\WKH3ULQFLSDO,QYHVWLJDWRUWRWKH,5%,(&DFFRUGLQJ
WRWKHLUUHTXLUHPHQWV6XFKDUHSRUWVKRXOGFRPPHQWZKHWKHURUQRWWKHDGYHUVHHYHQWZDVFRQVLGHUHGWREHUHODWHG
WRWKHWHVWDUWLFOH
1RQ6HULRXV$GYHUVH(YHQWV
$OOQRQVHULRXVDGYHUVHHYHQWVLQFOXGLQJQRQVHULRXVDGYHUVHGHYLFHHIIHFWVZLOOEHUHSRUWHGWRWKHVSRQVRUE\WKH
,QYHVWLJDWRUQRODWHUWKDQGD\VIURPGLVFRYHU\IRUUHYLHZE\WKH0HGLFDO0RQLWRU
6HULRXV$GYHUVH(YHQWV
7KH,QYHVWLJDWRUZLOOLQIRUPWKHVSRQVRURIDOOVHULRXVDGYHUVHHYHQWVRFFXUULQJGXULQJWKHVWXG\SHULRGDVVRRQDV
SRVVLEOHE\HPDLOID[RUWHOHSKRQHEXWQRODWHUWKDQKRXUVIROORZLQJGLVFRYHU\RIWKHHYHQW7KHLQYHVWLJDWRULV
REOLJDWHGWRSXUVXHDQGREWDLQLQIRUPDWLRQUHTXHVWHGE\WKH6SRQVRULQDGGLWLRQWRWKDWLQIRUPDWLRQUHSRUWHGRQWKH
&5)$OOVXEMHFWVH[SHULHQFLQJDVHULRXVDGYHUVHHYHQWPXVWEHIROORZHGXSDQGDOORXWFRPHVPXVWEHUHSRUWHG
:KHQPHGLFDOO\QHFHVVDU\WKHLQYHVWLJDWRUPD\EUHDNWKHUDQGRPL]DWLRQFRGHWRGHWHUPLQHWKHLGHQWLW\RIWKH
WUHDWPHQWWKDWWKHVXEMHFWUHFHLYHG7KH6SRQVRUDQGVWXG\PRQLWRUVKRXOGEHQRWLILHGSULRUWRXQPDVNLQJWKHWHVW
DUWLFOHV
,QWKHHYHQWRIDVHULRXVDGYHUVHHYHQWWKHLQYHVWLJDWRUPXVW
x
1RWLI\WKH6SRQVRULPPHGLDWHO\
x
2EWDLQDQGPDLQWDLQLQWKHVXEMHFW¶VILOHDOOSHUWLQHQWPHGLFDOUHFRUGVLQIRUPDWLRQDQGPHGLFDOMXGJPHQW
IRUFROOHDJXHVZKRDVVLVWHGLQWKHWUHDWPHQWDQGIROORZXSRIWKHVXEMHFW
x
3URYLGHWKH6SRQVRUZLWKDFRPSOHWHFDVHKLVWRU\ZKLFKLQFOXGHVDVWDWHPHQWDVWRZKHWKHUWKHHYHQWZDVRU
ZDVQRWUHODWHGWRWKHXVHRIWKHLQYHVWLJDWLRQDOWHVWDUWLFOH
x
1RWLI\WKH,5%,(&DVUHTXLUHGE\WKH,5%,(&UHSRUWLQJSURFHGXUHDFFRUGLQJWRQDWLRQDOUHJXODWLRQV


CR-5871 Protocol v4.0
 (4) 
Page 34 of 141
CONFIDENTIAL

8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW8$'(
,QWKHHYHQWRIDQ8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW8$'(WKH,QYHVWLJDWRUZLOOVXEPLWDUHSRUWRI
WKH8$'(WRWKH6SRQVRUDQG,5%,(&DVVRRQDVSRVVLEOHEXWQRODWHUWKDQKRXUVDIWHUWKH,QYHVWLJDWRUILUVW
OHDUQVRIWKHHIIHFW7KLVUHSRUWLVLQDGGLWLRQWRWKHLPPHGLDWHQRWLILFDWLRQPHQWLRQHGDERYH
7KH6SRQVRUPXVWFRQGXFWDQHYDOXDWLRQRIWKH8$'(DQGPXVWUHSRUWWKHUHVXOWVRIWKHHYDOXDWLRQWR)'$WKH
,5%,(&DQGSDUWLFLSDWLQJLQYHVWLJDWRUVZLWKLQZRUNLQJGD\VDIWHUWKH6SRQVRUILUVWUHFHLYHVQRWLILFDWLRQRIWKH
HIIHFW

$'9(56((9(17'(),1,7,216
$GYHUVH(YHQW$(±$Q$(LVDQ\XQWRZDUGXQZDQWHGPHGLFDORFFXUUHQFHLQDSDWLHQWRUFOLQLFDOLQYHVWLJDWLRQ
VXEMHFWDGPLQLVWHUHGDWHVWDUWLFOHZKHWKHURUQRWFDXVHGE\WKHWHVWDUWLFOHRUWUHDWPHQW$Q$(FDQWKHUHIRUHEHDQ\
XQIDYRUDEOHRUXQLQWHQGHGVLJQLQFOXGLQJDQDEQRUPDOILQGLQJV\PSWRPRUGLVHDVHWHPSRUDOO\DVVRFLDWHGZLWKWKH
XVHRIWKHWHVWDUWLFOHZKHWKHURUQRWUHODWHGWRWKHWHVWDUWLFOH
$Q$(LQFOXGHVDQ\FRQGLWLRQLQFOXGLQJDSUHH[LVWLQJFRQGLWLRQWKDWZDVQRWSUHVHQWSULRUWRVWXG\WUHDWPHQW
EXWDSSHDUHGRUUHDSSHDUHGIROORZLQJLQLWLDWLRQRIVWXG\WUHDWPHQWRUZDVSUHVHQWSULRUWRVWXG\WUHDWPHQWEXW
ZRUVHQHGGXULQJVWXG\WUHDWPHQW7KLVZRXOGLQFOXGHDQ\FRQGLWLRQUHVXOWLQJIURPFRQFRPLWDQWLOOQHVVHVUHDFWLRQV
WRFRQFRPLWDQWPHGLFDWLRQVRUSURJUHVVLRQRIGLVHDVHVWDWHV3UHJQDQF\VKRXOGEHGRFXPHQWHGDVDQDGYHUVHHYHQW
DQGVKRXOGEHUHSRUWHGWRWKHFOLQLFDOPRQLWRUDQGWRWKH6SRQVRULPPHGLDWHO\XSRQOHDUQLQJRIWKHHYHQW
6HULRXV$GYHUVH(YHQW6$(±$Q6$(LVDQ\XQWRZDUGPHGLFDORFFXUUHQFHWKDW
x
5HVXOWVLQGHDWK
x
,VOLIHWKUHDWHQLQJ
x
5HTXLUHVLQSDWLHQWKRVSLWDOL]DWLRQRUSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQ
x
5HVXOWVLQSHUVLVWHQWRUVLJQLILFDQWGLVDELOLW\LQFDSDFLW\LHDVLJQLILFDQWSHUVLVWHQWRUSHUPDQHQWFKDQJH
LPSDLUPHQWGDPDJHRUGLVUXSWLRQWRWKHVXEMHFW¶VERG\
x
,VDFRQJHQLWDODQRPDO\ELUWKGHIHFWRU
x
5HTXLUHVLQWHUYHQWLRQWRSUHYHQWSHUPDQHQWGDPDJHWKHXVHRIWKHLQYHVWLJDWLRQDOSURGXFWUHVXOWLQJLQD
FRQGLWLRQZKLFKUHTXLUHVPHGLFDORUVXUJLFDOLQWHUYHQWLRQWRSUHFOXGHSHUPDQHQWLPSDLUPHQWRIWKHERG\
VWUXFWXUHRUDERG\IXQFWLRQ,PSRUWDQWPHGLFDOHYHQWVWKDWPD\QRWUHVXOWLQGHDWKEHOLIHWKUHDWHQLQJRU
UHTXLUHKRVSLWDOL]DWLRQPD\EHFRQVLGHUHGDQ6$(ZKHQEDVHGXSRQDSSURSULDWHPHGLFDOMXGJPHQWWKH\
PD\MHRSDUGL]HWKHSDWLHQWRUVXEMHFWDQGPD\UHTXLUHPHGLFDORUVXUJLFDOLQWHUYHQWLRQWRSUHYHQWRQHRIWKH
RXWFRPHVOLVWHGLQWKHDERYHGHILQLWLRQ
'LDJQRVHVDQGFRQGLWLRQVWKDWDUHFRQVLGHUHG6HULRXV$GYHUVH(YHQWVLQFOXGH
x
0LFURELDO.HUDWLWLV0.
x
,ULWLV
x
3HUPDQHQWGHFUHDVHLQEHVWVSHFWDFOHFRUUHFWHGYLVXDODFXLW\HTXLYDOHQWWRDFXLW\OLQHVRUJUHDWHU
x
&HQWUDO&RUQHDO2SDFLW\
x
&HQWUDO&RUQHDO1HRYDVFXODUL]DWLRQ
x
8YHLWLV
x
(QGRSKWKDOPLWLV
x
+\SRS\RQ
x
+\SKHPD
x
3HQHWUDWLRQRI%RZPDQ¶V0HPEUDQH
CR-5871 Protocol v4.0
 (4) 
Page 35 of 141
CONFIDENTIAL

x
3HUVLVWHQW(SLWKHOLDO'HIHFW
x
/LPEDOFHOO'DPDJHOHDGLQJWR&RQMXQFWLYDOL]DWLRQ
6LJQLILFDQW$GYHUVH(YHQWV±7KRVHHYHQWVWKDWDUHXVXDOO\V\PSWRPDWLFDQGZDUUDQWGLVFRQWLQXDWLRQWHPSRUDU\RU
SHUPDQHQWRIWKHWHVWDUWLFOHH[FOXGLQJ6HULRXV$GYHUVH(YHQWV'LDJQRVHVDQGFRQGLWLRQVWKDWDUHFRQVLGHUHG
6LJQLILFDQW$GYHUVH(YHQWVLQFOXGHWKHIROORZLQJ
x
&RQWDFW/HQV,QGXFHG3HULSKHUDO8OFHU&/38
x
6LJQLILFDQW,QILOWUDWLYH(YHQWV6,(
x
6XSHULRU(SLWKHOLDO$UFXDWH/HVLRQV6($/V
x
$Q\7HPSRUDU\/RVVRI!/LQHVRI%6&9$
x
2WKHUJUDGHRUKLJKHUFRUQHDOILQGLQJVVXFKDVDEUDVLRQVRUHGHPD
x
$Q\FRUQHDOHYHQWZKLFKQHFHVVLWDWHVWHPSRUDU\OHQVGLVFRQWLQXDWLRQ!ZHHNV
x
1RQFRQWDFWOHQVUHODWHGFRUQHDOHYHQWVHJ(.&(SLGHPLF.HUDWRFRQMXQFWLYLWLV
x
$V\PSWRPDWLF&RUQHDO6FDU
1RQ6LJQLILFDQW$GYHUVH(YHQWV±7KRVHFRQGLWLRQVWKDWDUHXVXDOO\DV\PSWRPDWLFDQGXVXDOO\GRQRWZDUUDQW
GLVFRQWLQXDWLRQWHPSRUDU\RUSHUPDQHQWRIWKHWHVWDUWLFOH+RZHYHUWKH,QYHVWLJDWRUPD\FKRRVHWRWUHDWDVD
SUHFDXWLRQDU\PHDVXUH'LDJQRVHVDQGFRQGLWLRQVWKDWDUHFRQVLGHUHG1RQ6LJQLILFDQW$GYHUVH(YHQWVLQFOXGHWKH
IROORZLQJ
x
1RQVLJQLILFDQW,QILOWUDWLYH(YHQW
x
&RQWDFW/HQV3DSLOODU\&RQMXQFWLYLWLV
x
6XSHUILFLDO3XQFWDWH.HUDWLWLV
x
&RQMXQFWLYLWLV%DFWHULDO9LUDO$OOHUJLF
x
%OHSKDULWLV
x
0HLERPLDQLWLV
x
&RQWDFW'HUPDWLWLV
x
/RFDOL]HG$OOHUJLF5HDFWLRQV
x
$Q\FRUQHDOHYHQWQRWH[SOLFLWO\GHILQHGDVVHULRXVRUVLJQLILFDQWDGYHUVHHYHQWZKLFKQHFHVVLWDWHV
WHPSRUDU\OHQVGLVFRQWLQXDWLRQZHHNV
$GYHUVH'HYLFH(IIHFW$'(±$VXEVHWRI$(VDQGLQFOXGHRQO\WKRVHDGYHUVHHYHQWVWKDWDUHFDXVHE\RU
UHODWHGWRWKHLQYHVWLJDWLRQDOGHYLFHRUVWXG\SURFHGXUH

8QDQWLFLSDWHG$GYHUVH'HYLFH(IIHFW8$'(±$Q\VHULRXVDGYHUVHHIIHFWRQKHDOWKRUVDIHW\RUDQ\OLIH
WKUHDWHQLQJSUREOHPRUGHDWKFDXVHGE\RUDVVRFLDWHGZLWKWKHWHVWDUWLFOHLIWKDWHIIHFWSUREOHPRUGHDWKZDVQRW
SUHYLRXVO\LGHQWLILHGLQQDWXUHVHYHULW\RUGHJUHHRILQFLGHQFHLQWKHLQYHVWLJDWLRQDOSODQLQYHVWLJDWRU¶VEURFKXUHRU
SURWRFRORUDQ\RWKHUXQDQWLFLSDWHGVHULRXVSUREOHPDVVRFLDWHGZLWKWKHWHVWDUWLFOHWKDWUHODWHVWRWKHULJKWVVDIHW\
DQGZHOIDUHRIVXEMHFWV

&DXVDOLW\$VVHVVPHQW±$GHWHUPLQDWLRQRIWKHUHODWLRQVKLSEHWZHHQDQDGYHUVHHYHQWDQGWKHWHVWDUWLFOH7KHWHVW
DUWLFOHUHODWLRQVKLSIRUHDFKDGYHUVHHYHQWVKRXOGEHGHWHUPLQHGE\WKHLQYHVWLJDWRUXVLQJWKHVHH[SODQDWLRQV
x
1RW5HODWHG$QDGYHUVHHYHQWWKDWLVQRWUHODWHGWRWKHXVHRIWKHWHVWDUWLFOH
x
'RXEWIXO±$QDGYHUVHHYHQWIRUZKLFKDQDOWHUQDWLYHH[SODQDWLRQLVPRUHOLNHO\HJFRQFRPLWDQW
WUHDWPHQWFRQFRPLWDQWGLVHDVHVRUWKHUHODWLRQVKLSRIWLPHVXJJHVWVWKDWDFDXVDOUHODWLRQVKLSLVQRW
OLNHO\
x
3RVVLEOH±$QDGYHUVHHYHQWWKDWPLJKWEHGXHWRWKHXVHRIWKHWHVWDUWLFOH$QDOWHUQDWLYHH[SODQDWLRQHJ
FRQFRPLWDQWWUHDWPHQWFRQFRPLWDQWGLVHDVHVLVLQFRQFOXVLYH7KHUHODWLRQVKLSLQWLPHLVUHDVRQDEOH
7KHUHIRUHWKHFDXVDOUHODWLRQVKLSFDQQRWEHH[FOXGHG
CR-5871 Protocol v4.0
 (4) 
Page 36 of 141
CONFIDENTIAL

x
3UREDEOH±$QDGYHUVHHYHQWWKDWPLJKWEHGXHWRWKHXVHRIWKHWHVWDUWLFOH7KHUHODWLRQVKLSLQWLPHLV
VXJJHVWLYHHJFRQILUPHGE\GHFKDOOHQJH$QDOWHUQDWLYHH[SODQDWLRQLVOHVVOLNHO\HJFRQFRPLWDQW
WUHDWPHQWRUFRQFRPLWDQWGLVHDVHV
x
9HU\/LNHO\±$QDGYHUVHHYHQWWKDWLVOLVWHGDVDSRVVLEOHDGYHUVHHIIHFWGHYLFHRUDGYHUVHUHDFWLRQGUXJ
DQGFDQQRWEHUHDVRQDEO\H[SODLQHGE\DQDOWHUQDWLYHH[SODQDWLRQHJFRQFRPLWDQWWUHDWPHQWRI
FRQFRPLWDQWGLVHDVHV7KHUHODWLRQVKLSLQWLPHLVYHU\VXJJHVWLYHHJLWLVFRQILUPHGE\GHFKDOOHQJH
DQGUHFKDOOHQJH
6HYHULW\$VVHVVPHQW±$TXDOLWDWLYHDVVHVVPHQWRIWKHGHJUHHRILQWHQVLW\RIDQDGYHUVHHYHQWDVGHWHUPLQHGE\WKH
LQYHVWLJDWRURUUHSRUWHGWRKLPKHUE\WKHVXEMHFW7KHDVVHVVPHQWRIVHYHULW\LVPDGHLUUHVSHFWLYHRIWHVWDUWLFOH
UHODWLRQVKLSRUVHULRXVQHVVRIWKHHYHQWDQGVKRXOGEHHYDOXDWHGDFFRUGLQJWRWKHIROORZLQJVFDOH
x
0LOG±(YHQWLVQRWLFHDEOHWRWKHVXEMHFWEXWLVHDVLO\WROHUDWHGDQGGRHVQRWLQWHUIHUHZLWKWKHVXEMHFW¶V
GDLO\DFWLYLWLHV
x
0RGHUDWH±(YHQWLVERWKHUVRPHSRVVLEOHUHTXLULQJDGGLWLRQDOWKHUDS\DQGPD\LQWHUIHUHZLWKWKHVXEMHFW¶V
GDLO\DFWLYLWLHV
6HYHUH±(YHQWLVLQWROHUDEOHQHFHVVLWDWHVDGGLWLRQDOWKHUDS\RUDOWHUDWLRQRIWKHUDS\DQGLQWHUIHUHVZLWKWKH
VXEMHFW¶VGDLO\DFWLYLWLHV

0(7+2'6)25$66(66,1*5(&25',1*$1'$1$/<=,1*6$)(7<
7KHUHFRUGLQJDQGGRFXPHQWLQJRIDGYHUVHHYHQWVRFXODUDQGQRQRFXODUEHJLQZKHQWKHVXEMHFWVDUHH[SRVHGWR
WKHWHVWDUWLFOHRUVWXG\WUHDWPHQW$GYHUVHHYHQWVUHSRUWHGEHIRUHWKHXVHRIWHVWDUWLFOHRUVWDUWRIVWXG\WUHDWPHQW
VKRXOGEHUHFRUGHGDVPHGLFDOKLVWRU\8QWRZDUGPHGLFDOHYHQWVUHSRUWHGDIWHUWKHVXEMHFW¶VH[LWIURPWKHVWXG\ZLOO
EHUHFRUGHGDVDGYHUVHHYHQWVDWWKHGLVFUHWLRQRIWKH,QYHVWLJDWRU
$OODGYHUVHHYHQWVREVHUYHGE\WKH,QYHVWLJDWRUUHSRUWHGE\WKHVXEMHFWVSRQWDQHRXVO\RULQUHVSRQVHWRGLUHFW
TXHVWLRQLQJZLOOEHUHFRUGHGLQWKHVRXUFHGRFXPHQW6XFKGRFXPHQWDWLRQZLOOLQFOXGHDGHVFULSWLRQRIWKHDGYHUVH
HYHQWWLPHRIRQVHWGXUDWLRQRIHYHQWWUHDWPHQWUHJLPHQLQVWLWXWHGDQ\UHIHUUDOWRDQRWKHUKHDOWKFDUHSURYLGHULI
QHHGHGDQ\QHZFRQFRPLWDQWPHGLFDWLRQVRXWFRPHRFXODUGDPDJHLIDQ\DQGOLNHO\HWLRORJ\%HVW&RUUHFWHG
9LVXDO$FXLW\%&9$VKRXOGEHUHFRUGHGSULRUWRWKHUHSRUWRIDQDGYHUVHHYHQWDVSDUWRIWKHEDVHOLQHHYDOXDWLRQ
XSRQUHSRUWRIWKHVXEMHFW¶VUHSRUWRIWKHDGYHUVHHYHQWDQGDIWHUWKHDGYHUVHHYHQWKDVUHVROYHG$OODGYHUVHHYHQWV
ZLOOEHIROORZHGLQDFFRUGDQFHZLWKOLFHQVLQJUHTXLUHPHQWV
$OODGYHUVHHYHQWVZLOOEHGRFXPHQWHGLQWKHDSSURSULDWHVHFWLRQRIWKHVXEMHFW¶V&DVH5HSRUW)RUP&5)
,QFRQMXQFWLRQZLWKWKHPHGLFDOPRQLWRUWKH,QYHVWLJDWRUZLOOHYDOXDWHDGYHUVHHYHQWVWRHQVXUHWKHHYHQWVDUH
FDWHJRUL]HGFRUUHFWO\
(OHPHQWVRIFDWHJRUL]DWLRQZLOOLQFOXGH
6HULRXVQHVVVHHGHILQLWLRQLQ6HFWLRQ
([SHFWHGQHVV±LHLIWKHHYHQWZDVXQH[SHFWHGRUXQDQWLFLSDWHGLQWKDWLWZDVQRWSUHYLRXVO\LGHQWLILHGLQQDWXUH
VHYHULW\RUGHJUHHRILQFLGHQFHVHHGHILQLWLRQLQ6HFWLRQ
&DXVDOLW\RU5HODWHGQHVV±LHWKHUHODWLRQVKLSEHWZHHQWKHWHVWDUWLFOHDQGWKHDGYHUVHHYHQWQRWUHODWHGGRXEWIXO
SRVVLEOHSUREDEOHYHU\OLNHO\VHHGHILQLWLRQLQ6HFWLRQ
$GYHUVH(YHQW,QWHQVLW\RU&ODVVLILFDWLRQ±$GYHUVHHYHQWLQWHQVLW\LVXVHGWRDVVHVVWKHGHJUHHRILQWHQVLW\RIWKH
DGYHUVHHYHQWPLOGPRGHUDWHVHYHUHIRUDOOHYHQWV,QDGGLWLRQ$GYHUVHHYHQW&ODVVLILFDWLRQLVXVHGWRDVVHVVWKH
VHYHULW\RIRFXODUDGYHUVHHYHQWV$(QRWUHTXLULQJWUHDWPHQWQRQVLJQLILFDQWRUVLJQLILFDQWVHHGHILQLWLRQLQ6HFWLRQ

CR-5871 Protocol v4.0
 (4) 
Page 37 of 141
CONFIDENTIAL

2XWFRPH±)DWDOQRWUHVROYHGUHVROYHGUHVROYHGZLWKVHTXHODHUHVROYLQJDQGXQNQRZQ
$FWLRQV7DNHQ±1RQHWHPSRUDULO\GLVFRQWLQXHGSHUPDQHQWO\GLVFRQWLQXHG2WKHUDFWLRQWDNHQ
8SRQILQGLQJDQDGYHUVHHYHQWWKH3ULQFLSDO,QYHVWLJDWRUZLOOGRFXPHQWWKHFRQGLWLRQRQWKHIROORZXSYLVLW
ZRUNVKHHWVRXUFHGRFXPHQWDQGLQWKH&5)¶VXVLQJSKRWRVRUGUDZLQJVZKHUHDSSURSULDWHWKDWGHWDLOVL]HORFDWLRQ
DQGGHSWK+HZLOODOVRFRPSOHWHWKH$GYHUVH(YHQW&ODVVLILFDWLRQ$(&'LVFRYHU\IRUPH&5),QDGGLWLRQLIDQ
LQILOWUDWHVLVSUHVHQWKHZLOOFRPSOHWHWKH&RUQHDO,QILOWUDWH$VVHVVPHQW)RUPH&5):KHUHQHFHVVDU\DFXOWXUH
RIWKHFRUQHDOOHVLRQZLOOEHFROOHFWHGWRGHWHUPLQHLIWKHLQIHFWLRQLVPLFURELDOLQQDWXUH,IFXOWXUHVDUHFROOHFWHGD
VRXUFHGRFXPHQWQRWHVKRXOGEHFRPSOHWHGVSHFLI\LQJWKHGDWHRIFXOWXUHFROOHFWLRQDQGODERUDWRU\XWLOL]HG$Q
H&5)GRFXPHQWLQJWKLVVKRXOGEHFRPSOHWHGLQDFRPPHQWRUXQVFKHGXOHGYLVLW
&RPSOHWHGHVFULSWLRQRIDOODGYHUVHHYHQWVPXVWEHDYDLODEOHLQWKHVRXUFHGRFXPHQWV$OO$GYHUVH(YHQWVLQFOXGLQJ
ORFDODQGV\VWHPLFUHDFWLRQVQRWPHHWLQJWKHFULWHULDIRU³VHULRXVDGYHUVHHYHQWV´VKRXOGEHFDSWXUHGRQWKH
DSSURSULDWHFDVHUHSRUWIRUPRUHOHFWURQLFGDWDV\VWHP,QIRUPDWLRQWREHUHFRUGHGEDVHGRQDERYHDVVHVVPHQW
FULWHULDLQFOXGHVGDWHVLWHQRWLILHGHYHQWGHVFULSWLRQGDWHDQGWLPHRIRQVHWLQYHVWLJDWRUDVVHVVPHQWRIVHYHULW\
UHODWLRQVKLSWR6WXG\$JHQWV,QWHUYHQWLRQVDQGWLPHRIUHVROXWLRQVWDELOL]DWLRQRIWKHHYHQW$OODGYHUVHHYHQWV
RFFXUULQJZKLOHRQVWXG\PXVWEHGRFXPHQWHGDSSURSULDWHO\UHJDUGOHVVRIUHODWLRQVKLS'HILQHDWLPHIUDPHIRU&5)
FRPSOHWLRQDQGHQWU\RIWKHDGYHUVHHYHQWLQIRUPDWLRQLQWRWKHGDWDEDVHDVDSSOLFDEOH

$Q\PHGLFDOFRQGLWLRQWKDWLVSUHVHQWDWWKHWLPHWKDWWKHVXEMHFWLVVFUHHQHGVKRXOGEHFRQVLGHUHGDVEDVHOLQHDQG
QRWUHFRUGHGDVDQ$(+RZHYHULIWKHFRQGLWLRQGHWHULRUDWHVDWDQ\WLPHGXULQJWKHVWXG\LWVKRXOGEHUHFRUGHGDQG
UHSRUWHGDVDQ$(

&KDQJHVLQWKHVHYHULW\RIDQ$(VKRXOGEHGRFXPHQWHGWRDOORZDQDVVHVVPHQWRIWKHGXUDWLRQRIWKHHYHQWDWHDFK
OHYHORILQWHQVLW\WREHSHUIRUPHG$GYHUVHHYHQWVFKDUDFWHUL]HGDVLQWHUPLWWHQWUHTXLUHGRFXPHQWDWLRQRIWKHRQVHW
DQGGXUDWLRQRIHDFKHSLVRGH&KDQJHVLQWKHDVVHVVPHQWRIUHODWLRQVKLSWRWKH6WXG\$JHQWV,QWHUYHQWLRQVVKRXOG
DOVREHFOHDUO\GRFXPHQWHG
7KHLQYHVWLJDWRUZLOOQRWLI\WKH6SRQVRURIDQDGYHUVHHYHQWE\HPDLOIDFVLPLOHRUWHOHSKRQHDVVRRQDVSRVVLEOH
DQGQRODWHUWKDQKRXUVIURPGLVFRYHU\IRUDVHULRXVVLJQLILFDQWDGYHUVHHYHQWDQGGD\VIURPGLVFRYHU\IRUD
QRQVLJQLILFDQWDGYHUVHHYHQW,QDGGLWLRQDZULWWHQUHSRUWZLOOEHVXEPLWWHGE\WKH3ULQFLSDO,QYHVWLJDWRUWRWKH
,5%,(&DFFRUGLQJWRWKHLUUHTXLUHPHQWV6HFWLRQ6XFKDUHSRUWVKRXOGFRPPHQWZKHWKHURUQRWWKH
DGYHUVHHYHQWZDVFRQVLGHUHGWREHUHODWHGWRWKHWHVWDUWLFOH

$'9(56((9(176)2//2:83
,WLVWKH,QYHVWLJDWRU¶VUHVSRQVLELOLW\WRPDLQWDLQGRFXPHQWDWLRQRIHDFKUHSRUWHGDGYHUVHHYHQW$OODGYHUVHHYHQWV
ZLOOEHIROORZHGLQDFFRUGDQFHZLWKDSSOLFDEOHOLFHQVLQJUHTXLUHPHQWV6XFKGRFXPHQWDWLRQZLOOLQFOXGHWKH
IROORZLQJ
x
$GYHUVH(YHQW'LDJQRVLVQRWV\PSWRP
x
'HWDLOHGGUDZLQJVRUSKRWRJUDSKVZKHQDSSURSULDWH
x
'DWHDQGWLPHRIRQVHW
x
'DWHDQGWLPHRIUHVROXWLRQ
x
$GYHUVHHYHQWLQWHQVLW\DQGFODVVLILFDWLRQDVDSSOLFDEOH
x
7UHDWPHQWUHJLPHQLQVWLWXWHGLQFOXGLQJFRQFRPLWDQWPHGLFDWLRQVSUHVFULEHGLQDFFRUGDQFHZLWKDSSOLFDEOH
OLFHQVLQJUHTXLUHPHQWV
x
$Q\UHIHUUDOWRDQRWKHUKHDOWKFDUHSURYLGHULIQHHGHG
x
2XWFRPHRFXODUGDPDJHLIDQ\
CR-5871 Protocol v4.0
 (4) 
Page 38 of 141
CONFIDENTIAL

x
/LNHO\HWLRORJ\
x
%HVWFRUUHFWHGYLVXDODFXLW\DWWKHGLVFRYHU\RIWKHHYHQWDQGXSRQFRQFOXVLRQRIWKHHYHQW
,QDGGLWLRQLIDQLQILOWUDWHVLVSUHVHQWWKH,QYHVWLJDWRUZLOOFRPSOHWHWKH&RUQHDO,QILOWUDWH$VVHVVPHQW)RUP
H&5)
3KRWRJUDSKVRUYLGHRUHFRUGLQJVPD\EHFROOHFWHGDWWKH,QYHVWLJDWRU¶VGLVFUHWLRQIRUSXUSRVHVRIGRFXPHQWLQJ
DGYHUVHHYHQWILQGLQJV
9LVXDODFXLW\EHVWFRUUHFWHGVKRXOGEHUHFRUGHGSULRUWRWKHUHSRUWRIDQDGYHUVHHYHQWDVSDUWRIWKH%DVHOLQH
(YDOXDWLRQXSRQWKHVXEMHFW¶VUHSRUWRIWKHDGYHUVHHYHQWDQGDIWHUWKHDGYHUVHHYHQWKDVUHVROYHG
6XEMHFWVZKRSUHVHQWZLWKDQDGYHUVHHYHQWVKRXOGEHIROORZHGE\WKH,QYHVWLJDWRUZLWKLQOLFHQVXUHXQWLODOOVLJQV
DQGV\PSWRPVKDYHUHWXUQHGWRSUHWUHDWPHQWVWDWXVVWDELOL]HGRUEHHQVDWLVIDFWRULO\UHVROYHG,IIXUWKHUWUHDWPHQW
LHEH\RQGOLFHQVXUHLVUHTXLUHGWKHSDWLHQWZLOOEHUHIHUUHGWRWKHDSSURSULDWHKHDOWKFDUHSURYLGHU7KH
,QYHVWLJDWRUVKRXOGXVHKLVKHUFOLQLFDOMXGJPHQWDVWRZKHWKHURUQRWDVXEMHFWH\HUHSRUWLQJZLWKDQDGYHUVHHYHQW
VKRXOGFRQWLQXHLQWKHVWXG\,IDVXEMHFWLVGLVFRQWLQXHGIURPWKHVWXG\LWZLOOEHWKHUHVSRQVLELOLW\RIWKH
,QYHVWLJDWRUWRUHFRUGWKHUHDVRQIRUGLVFRQWLQXDWLRQ7KHLQYHVWLJDWRUZLOODOVRFRPSOHWHWKH$GYHUVH(YHQW
&ODVVLILFDWLRQ$(&2XWFRPHIRUPH&5)$Q\VXEMHFWVZLWKRQJRLQJDGYHUVHHYHQWVUHODWHGWRWKHWHVWDUWLFOHDV
RIWKHILQDOVWXG\YLVLWGDWHVKRXOGEHIROORZHGWRUHVROXWLRQRIWKHDGYHUVHHYHQWRUXQWLOUHIHUUDOWRDQDSSURSULDWH
KHDOWKFDUHSURYLGHUDVUHFRPPHQGHGE\WKH,QYHVWLJDWRU

67$7,67,&$/0(7+2'672%((03/2<('
$OOGDWDVXPPDULHVDQGVWDWLVWLFDODQDO\VHVZLOOEHSHUIRUPHGXVLQJWKH6$6VRIWZDUH9HUVLRQRUDERYH6$6
,QVWLWXWH&DU\1&7KURXJKRXWWKHDQDO\VLVRIGDWDWKHUHVXOWVIRUHDFKVXEMHFWH\HZLOOEHXVHGZKHQDYDLODEOHIRU
VXPPDUL]DWLRQDQGVWDWLVWLFDODQDO\VLV8QVFKHGXOHGYLVLWVZLOOEHVXPPDUL]HGVHSDUDWHO\DQGH[FOXGHGIURPWKH
VWDWLVWLFDODQDO\VLV
6XPPDU\WDEOHVGHVFULSWLYHVWDWLVWLFVDQGRUIUHTXHQF\WDEOHVZLOOEHSURYLGHGIRUDOOEDVHOLQHHIILFDF\DQGVDIHW\
YDULDEOHVDVDSSURSULDWH&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGZLWKGHVFULSWLYHVWDWLVWLFVLQFOXGLQJQPHDQ
VWDQGDUGGHYLDWLRQ6'PHGLDQPLQLPXPDQGPD[LPXP&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGXVLQJ
IUHTXHQF\FRXQWDQGSHUFHQWDJHRIVXEMHFWVRUH\HVZLWKLQHDFKFDWHJRU\6XPPDULHVZLOOEHSUHVHQWHGE\VWXG\OHQV
W\SHDQGZLOOEHSHUIRUPHGVHSDUDWHO\E\VWXG\SRSXODWLRQGHILQHGLQVHFWLRQ
6DIHW\YDULDEOHVZLOOEHVXPPDUL]HGGHVFULSWLYHO\IRUWKHVDIHW\SRSXODWLRQ7KHSULPDU\DQDO\VHVZLOOEHFRQGXFWHG
RQWKHVDIHW\SRSXODWLRQDQGWKHVHFRQGDU\DQDO\VHVZLOOEHFRQGXFWHGRQWKHSHUSURWRFROSRSXODWLRQGXHWRQDWXUH
RIWKHVWXG\HQGSRLQWVUHIHUWRVHFWLRQ,IWKHGURSRXWUDWHLVKLJKHUWKDQDVHQVLWLYLW\DQDO\VLVZLOOEH
FRQGXFWHGIRUWKHHIILFDF\HQGSRLQWVRQDOOUDQGRPL]HGVXEMHFWVZKRVXFFHVVIXOO\WULHGDWOHDVWRQHVWXG\OHQV
0RQRFXODU9LVXDO$FXLW\9$RUEHWWHU$QDO\VLV
(DFKH\HVXEMHFWZLOOEHFDWHJRUL]HGLQWRWZRJURXSVVXFKWKDWµUHVSRQVH ¶LIDQH\HKDGDFFHSWDEOH9$LH
9$RUEHWWHUWKURXJKRXWDOOSODQQHGYLVLWVRUµUHVSRQVH ¶RWKHUZLVH7KHJHQHUDOL]HGPL[HGPRGHOZLOOEH
XVHGWRDVVHVVWKHRYHUDOODFFHSWDEOH9$IRUHDFKOHQVW\SHVHSDUDWHO\XWLOL]LQJELQRPLDOGLVWULEXWLRQZLWKORJLW
OLQNIXQFWLRQ7KHPRGHOZLOOLQFOXGHOHQVW\SHDVDIL[HGHIIHFWDQGVLWHVXEMHFWDQGH\HQHVWHGZLWKLQVXEMHFWDV
UDQGRPHIIHFWV%DVHOLQHFKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EHDOVRLQFOXGHGLQWKHPRGHODVFRYDULDWHVLI
DSSURSULDWH
7KHPRGHOEDVHGSURSRUWLRQRIH\HVZLWKDFFHSWDEOH9$ZLWKLWVFRUUHVSRQGLQJFRQILGHQFHLQWHUYDO&,
ZLOOEHFRQVWUXFWHGIRUHDFKOHQVW\SHIURPWKHJHQHUDOL]HGOLQHDUPL[HGPRGHO2YHUDOODFFHSWDEOH9$ZLOOEH
FRQFOXGHGLIWKHORZHUOLPLWRIWKH&,LVJUHDWHUWKDQRUHTXDOWR
CR-5871 Protocol v4.0
 (4) 
Page 39 of 141
CONFIDENTIAL

/HQV)LW$FFHSWDQFH$QDO\VLV
/HQVILWDFFHSWDQFHDWILWWLQJZLOOEHHYDOXDWHGE\OHQVW\SHLIDWOHDVWRIH\HVKDYHDFFHSWDEOHOHQVILW
UHVSRQVH XVLQJWKHJHQHUDOL]HGPL[HGPRGHOZLWKELQRPLDOGLVWULEXWLRQDQGORJLWOLQNIXQFWLRQ7KHPRGHO
ZLOOLQFOXGHOHQVW\SHDVDIL[HGHIIHFWDQGVLWHVXEMHFWDQGH\HQHVWHGZLWKLQVXEMHFWDVUDQGRPHIIHFWV%DVHOLQH
FKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EHDOVRLQFOXGHGLQWKHPRGHODVFRYDULDWHVLIDSSURSULDWH
7KHPRGHOEDVHGSURSRUWLRQRIH\HVZLWKDFFHSWDEOHOHQVILWZLWKLWVFRUUHVSRQGLQJ&,ZLOOEHFRQVWUXFWHGIRU
HDFKOHQVW\SHIURPWKHJHQHUDOL]HGOLQHDUPL[HGPRGHO$FFHSWDEOHOHQVILWZLOOEHFRQFOXGHGLIWKHORZHUOLPLWRI
WKH&,LVJUHDWHUWKDQRUHTXDOWR
/HQV6WDELOLW\ZLWK%OLQN$QDO\VLV
2EVHUYHGURWDWLRQDOVWDELOLW\ZLWKEOLQNZLOOEHGLFKRWRPL]HGVXFKWKDWµUHVSRQVH ¶LIVWDELOLW\ZDVOHVVWKDQRU
HTXDOWRGHJUHHUHIHUDVµDGHTXDWHVWDELOLW\¶RUµUHVSRQVH ¶RWKHUZLVH7KHGLFKRWRPL]HGVWDELOLW\DWILWWLQJ
ZLOOEHHYDOXDWHGE\OHQVW\SHLIDWOHDVWRIH\HVKDYHDGHTXDWHVWDELOLW\UHVSRQVH 7KHJHQHUDOL]HGPL[HG
PRGHOZLOOEHXVHGWRDVVHVVDGHTXDWHVWDELOLW\IRUHDFKOHQVW\SHVHSDUDWHO\XWLOL]LQJELQRPLDOGLVWULEXWLRQZLWK
ORJLWOLQNIXQFWLRQ7KHPRGHOZLOOLQFOXGHOHQVW\SHDVDIL[HGHIIHFWVDQGVLWHVXEMHFWDQGH\HQHVWHGZLWKLQ
VXEMHFWDVUDQGRPHIIHFWV%DVHOLQHFKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EHDOVRLQFOXGHGDVFRYDULDWHVLQ
WKHPRGHOLIDSSURSULDWH
7KHPRGHOEDVHGSURSRUWLRQRIH\HVZLWKDGHTXDWHVWDELOLW\ZLWKLWVFRUUHVSRQGLQJ&,ZLOOEHFRQVWUXFWHGIRU
HDFKOHQVW\SHIURPWKHJHQHUDOL]HGOLQHDUPL[HGPRGHO$GHTXDWHVWDELOLW\ZLOOEHFRQFOXGHGLIWKHORZHUOLPLWRI
WKH&,LVJUHDWHUWKDQRUHTXDOWR
$EVROXWH5RWDWLRQ$QDO\VLV
$EVROXWHURWDWLRQZLOOEHGLFKRWRPL]HGVXFKWKDWµUHVSRQVH ¶LIDEVROXWHURWDWLRQZDVOHVVWKDQHTXDOWRGHJUHH
UHIHUDVµDFFHSWDEOHURWDWLRQ¶RUµUHVSRQVH ¶RWKHUZLVH$FFHSWDEOHDEVROXWHURWDWLRQXSRQPLQXWHSRVW
LQVHUWLRQDWILWWLQJZLOOEHHYDOXDWHGE\OHQVW\SHLIDWOHDVWRIH\HVKDYHDFFHSWDEOHDEVROXWHURWDWLRQ
UHVSRQVH XVLQJWKHJHQHUDOL]HGPL[HGPRGHOZLWKELQRPLDOGLVWULEXWLRQDQGORJLWOLQNIXQFWLRQ7KHPRGHOZLOO
LQFOXGHOHQVW\SHDVDIL[HGHIIHFWVLWHVXEMHFWDQGH\HQHVWHGZLWKLQVXEMHFWZLOOEHFRQVLGHUHGDVUDQGRPHIIHFWV
%DVHOLQHFKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EHFRQVLGHUHGDVFRYDULDWHVLQWKHPRGHOZKHQDSSURSULDWH
7KHPRGHOEDVHGSURSRUWLRQRIH\HVZLWKDFFHSWDEOHDEVROXWHURWDWLRQZLWKLWVFRUUHVSRQGLQJFRQILGHQFH
LQWHUYDO&,ZLOOEHFRQVWUXFWHGIRUHDFKOHQVW\SHIURPWKHJHQHUDOL]HGOLQHDUPL[HGPRGHO$FFHSWDEOHDEVROXWH
URWDWLRQZLOOEHFRQFOXGHGLIWKHORZHUOLPLWRIWKH&,LVJUHDWHUWKDQRUHTXDOWR
&RQWDFW/HQV5HODWHG&RUQHDO6WDLQLQJ&6$QDO\VLV
(DFKH\HVXEMHFWZLOOEHFDWHJRUL]HGLQWRWZRJURXSVVXFKWKDWµUHVSRQVH ¶LIDQH\HKDGDFFHSWDEOHFRUQHDO
VWDLQLQJ&6LH&6JUDGHRUORZHUWKURXJKRXWDOOSODQQHGDQGXQVFKHGXOHGYLVLWVRUµUHVSRQVH ¶RWKHUZLVH
7KHLQFLGHQFHUDWHRIWKH7HVWOHQVZLOOEHFRPSDUHGWRWKH&RQWUROOHQVXVLQJDJHQHUDOL]HGOLQHDUPL[HGPRGHO
ZLWKELQRPLDOGLVWULEXWLRQDQGORJLWOLQNIXQFWLRQ7KHPRGHOZLOOLQFOXGHOHQVW\SHDVDIL[HGHIIHFWDQGVLWH
VXEMHFWDQGH\HVQHVWHGZLWKLQVXEMHFWDVUDQGRPHIIHFWV%DVHOLQHFKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EH
FRQVLGHUHGDVFRYDULDWHVLQWKHPRGHOZKHQDSSURSULDWH
7KHLQFLGHQFHUDWHRI&6IRUWKH7HVWOHQVZLOOEHFRPSDUHGWRWKH&RQWUROOHQVXVLQJWKHWZRVLGHG&,
FRQVWUXFWHGIRURGGVUDWLRV7HVWRYHU&RQWURO1RGLIIHUHQFHEHWZHHQ7HVWDQG&RQWUROOHQVHVZLOOEHFRQFOXGHG
LIWKH&,RIWKHRGGVUDWLRFRQWDLQV
0RQRFXODU9LVXDO$FXLW\9$RUEHWWHU$QDO\VLV
2EVHUYHGPRQRFXODU9$ZLOOEHDOVRGLFKRWRPL]HGVXFKWKDWµUHVSRQVH ¶LI9$ZDVRUEHWWHUUHIHUDVµ
VXLWDEOH9$¶RUµUHVSRQVH ¶RWKHUZLVHDWILWWLQJ'LFKRWRPL]HG9$DWILWWLQJZLOOEHFRPSDUHGEHWZHHQWKH7HVW
DQG&RQWUROOHQVHVXVLQJDJHQHUDOL]HGOLQHDUPL[HGPRGHOZLWKELQRPLDOGLVWULEXWLRQDQGORJLWOLQNIXQFWLRQ7KH
CR-5871 Protocol v4.0
 (4) 
Page 40 of 141
CONFIDENTIAL

PRGHOZLOOLQFOXGHOHQVW\SHDVDIL[HGHIIHFWDQGVLWHVXEMHFWDQGH\HVQHVWHGZLWKLQVXEMHFWDVUDQGRPHIIHFWV
%DVHOLQHFKDUDFWHULVWLFVVXFKDVDJHDQGJHQGHUPD\EHFRQVLGHUHGDVFRYDULDWHVLQWKHPRGHOZKHQDSSURSULDWH
7KHPRGHOEDVHGSURSRUWLRQRIH\HVZLWKVXLWDEOH9$DWILWWLQJZLOOEHFRPSDUHGEHWZHHQWKH7HVWDQG&RQWURO
OHQVHVXVLQJWKHWZRVLGHG&,FRQVWUXFWHGIRURGGVUDWLRV7HVWRYHU&RQWURO1RQLQIHULRULW\ZLOOEH
FRQFOXGHGLIWKHORZHUOLPLWRIWKHWZRVLGHG&,RIWKHRGGVUDWLRLVDERYH7KHRGGVUDWLRPDUJLQRI
FRUUHVSRQGVWRDGLIIHUHQFHLQSURSRUWLRQEHWZHHQWKH7HVWDQG&RQWUROOHQVHVDVVXPLQJDUHIHUHQFHUDWHRI

&/8(6FRUH$QDO\VLV
&/8(VFRUHVLQFOXGLQJFRPIRUWYLVLRQKDQGOLQJDQGSDFNDJLQJZLOOEHDQDO\]HGVHSDUDWHO\XVLQJDOLQHDUPL[HG
PRGHODGMXVWLQJIRUEDVHOLQHYDOXHVDVDIL[HGFRYDULDWHZKHQDSSURSULDWH(DFKPRGHOZLOOLQFOXGHWKHIROORZLQJ
H[SHULPHQWDOGHVLJQIDFWRUVOHQVW\SHWLPHHYHQWLHILWWLQJDQGZHHNIROORZXSDQGOHQVW\SHE\
WLPHHYHQWLQWHUDFWLRQDVIL[HGHIIHFWVDQGVLWHDVDUDQGRPHIIHFWZKHQDSSURSULDWH%DVHOLQHFKDUDFWHULVWLFVVXFKDV
DJHDQGJHQGHUPD\EHFRQVLGHUHGDVFRYDULDWHVZKHQDSSURSULDWH7KHFRYDULDQFHEHWZHHQHUURUVIURPWKHVDPH
VXEMHFWDWGLIIHUHQWWLPHHYHQWVZLOOEHVHOHFWHGEDVHGRQWKHILQLWHVDPSOHFRUUHFWHG$NDLNH¶VLQIRUPDWLRQ&ULWHULRQ
.HVHOPDQHWDO
7KHIROORZLQJFRYDULDWHVWUXFWXUHVZLOOEHFRQVLGHUHG
x
+RPRJHQRXVFRPSRXQGV\PPHWU\&6
x
+HWHURJHQHRXVFRPSRXQGV\PPHWU\&6+
x
9DULDQFH&RPSRQHQWV9&
x
+HWHURJHQHRXV9DULDQFH&RPSRQHQW81
x
8QVWUXFWXUHG81
x
)LUVWRUGHUDXWRUHJUHVVLYH$5
x
6SDWLDO3RZHU6332:

)RU$581DQG6332:FRYDULDQFHVWUXFWXUHVVXEMHFWZLOOEHLQFOXGHGDVDUDQGRPHIIHFW)RUWKH
UHPDLQLQJFRYDULDWHVWUXFWXUHVRQO\VLWHZLOOEHLQFOXGHGDVDUDQGRPHIIHFW7KHFRYDULDWHVWUXFWXUHWKDWUHWXUQV
WKHORZHVW$NDLNH,QIRUPDWLRQ&ULWHULD&RUUHFWHG$,&&ZLOOEHFRQVLGHUHGDVWKHVWUXFWXUHEHVWILWVIRUWKHGDWD
+HWHURJHQHRXVPRGHOVDFURVVWKHVWXG\W\SHVPD\EHFRQVLGHUHGZKHQDSSURSULDWH7KHORJOLNHOLKRRGUDWLRWHVW
ZLOOEHXVHGWRWHVWIRUKRPRJHQHLW\RIYDULDQFHVDFURVVOHQVW\SHV
7KHRYHUDOO&/8(FRPIRUWVFRUHVDFURVVDOOVWXG\YLVLWVZLOOEHFRPSDUHGEHWZHHQWKHWHVWDQGFRQWUROOHQVHV
XVLQJWKHWZRVLGHG&,FRQVWUXFWHGIRUWKH/6PHDQVGLIIHUHQFHV7HVWPLQXV&RQWUROIURPWKHUHSHDWHG
PHDVXUHVDQDO\VLV7KHQRQLQIHULRULW\ZLOOEHFRQFOXGHGLIWKHORZHUOLPLWRIWKH&,IRUWKH/6PHDQ
GLIIHUHQFHLVJUHDWHUWKDQ,IWKHORZHUFRQILGHQFHOLPLWLVJUHDWHUWKDQWKHVWDWLVWLFDOVXSHULRULW\ZLOOEH
FRQFOXGHG
7KHRYHUDOO&/8(KDQGOLQJVFRUHVDFURVVDOOVWXG\YLVLWVIRUWKH7HVWOHQVZLOOEHDVVHVVHGZKHWKHUVXEMHFWLYH
KDQGOLQJVFRUHLVDGHTXDWHXVLQJDPDUJLQRI7KHDGHTXDWHVXEMHFWLYHKDQGOLQJZLOOEHFRQFOXGHGLIWKHORZHU
OLPLWRIWKH&,IRUWKH/6PHDQLVJUHDWHUWKDQ
7KH.HQZDUGDQG5RJHUPHWKRG.HQZDUGDQG5RJHUZLOOEHXVHGIRUWKHFDOFXODWLRQRIWKHGHQRPLQDWRU
GHJUHHRIIUHHGRPIRUWKHDOODERYHVWDWLVWLFDOPRGHOVLIDSSOLFDEOH,IDVSDWLDOSRZHUFRYDULDQFHVWUXFWXUHLV
VHOHFWHGWKHILUVWRUGHURSWLRQZLOOEHXVHG
,QFDVHWKHVWDWLVWLFDOPRGHOGRHVQRWFRQYHUJHIRUDQ\UHDVRQVOLNHO\GXHWRVPDOOLQFLGHQFHUDWHIRUDQ\RIWKH
SULPDU\DQDO\VHVWKH&,IRUWKHELQRPLDOSURSRUWLRQVZLOOEHFRQVWUXFWHGXVLQJWKH$JUHVWL&RXOOPHWKRG
$GGLWLRQDOSRVWKRFDQDO\VLVPD\EHFRQGXFWHGLIQHFHVVDU\DWWKHGLVFUHWLRQRIWKHSURMHFWOHDGHU
CR-5871 Protocol v4.0
 (4) 
Page 41 of 141
CONFIDENTIAL


180%(52)68%-(&76%<6,7($1'-867,),&$7,21)256$03/(6,=(
6DPSOHVL]HZDVFDOFXODWHGWRDWWDLQWKHRSWLPDOQXPEHURIVXEMHFWVWRGHPRQVWUDWHWKHVWDWLVWLFDODFFHSWDQFHRI
WKHSULPDU\DQGVHFRQGDU\K\SRWKHVHVXVLQJWKHKLVWRULFDOGDWDIURP
DQG
7KHLQFLGHQFHUDWH
RIWKHSULPDU\HQGSRLQWVIURPWKHKLVWRULFDOGDWDDUHSUHVHQWHGLQ7DEOHEHORZ
7DEOH,QFLGHQFH5DWHIURPWKH+LVWRULFDO'DWD
(QGSRLQWV
(YHQW
$WODV$
5DWH
$2$
5DWH
0RQRFXODU9LVXDO$FXLW\RUEHWWHU
2YHUDOO


&RUQHDO6WDLQLQJ*UDGH
2YHUDOO


$FFHSWDEOH/HQV)LW
)LWWLQJ


$EVROXWH5RWDWLRQZLWKLQGHJUHH
PLQ


6WDELOLW\ZLWK%OLQNZLWKLQGHJUHH
)LWWLQJ



&RUQHDOVWDLQLQJZLOOEHDVVHVVHGWRGHPRQVWUDWHQRGLIIHUHQFHEHWZHHQWKH7HVWDQG&RQWUROOHQVHV
ZKHUHDVWKHRWKHUSULPDU\HQGSRLQWVZLOOEHDVVHVVHGWRGHPRQVWUDWHVDWLVI\LQJPLQLPXPWKUHVKROGRI
WKH7HVWOHQV

3ULPDU\(QGSRLQWVZLWK7KUHVKROG
7KHFRPPRQUHIHUHQFHUDWHRIZDVVHOHFWHGIRUWKHVDPSOHVL]HFDOFXODWLRQDVWKH\DUHELQDU\LQQDWXUH
$VVXPLQJDFRUUHODWLRQRIEHWZHHQH\HVWULDOVUHSOLFDWLQJWULDOVZHUHVLPXODWHGWRDWWDLQDVDPSOH
VL]HZLWKDPLQLPXPVWDWLVWLFDOSRZHURI

3ULPDU\(QGSRLQWVZLWKQRGLIIHUHQFH
7KHLQFLGHQFHUHIHUHQFHUDWHRIZDVVHOHFWHGIRUWKHVDPSOHVL]HFDOFXODWLRQIRUQRGLIIHUHQFHEHWZHHQWZR
VWXG\OHQVHVRQFRUQHDOVWDLQLQJJUDGHRUKLJKHUXVLQJWKHIRUPXODJLYHQE\'LJJOHHWDOIRUFOXVWHUELQDU\
GDWD7KHLQFLGHQFHUDWHRIZDVVHWEDVHGRQWKHSUHYLRXV$WODVVWXGLHVERWKVSKHUHDQGDVWLJPDWLVP
LQFOXGLQJ

&5
DQG
7KHUHZHUHQRFRUQHDOVWDLQLQJJUDGHRUKLJKHU
WKURXJKRXWDOOVWXGLHVVRWKDWLWZDVGHWHUPLQHGWKDWLVDUHDVRQDEOHDVVXPSWLRQ
7KHQXPEHURIREVHUYDWLRQVSHUVXEMHFWFOXVWHUZDVVHWWRH\HVSHUVXEMHFWDQGDFRUUHODWLRQRIEHWZHHQ
H\HVZLWKLQDVXEMHFWZDVDVVXPHGWRDWWDLQDVDPSOHVL]HZLWKDPLQLPXPVWDWLVWLFDOSRZHURI

6HFRQGDU\(QGSRLQW
6DPSOHVL]HFDOFXODWLRQIRUWKHRYHUDOO&/8(FRPIRUWZDVDOVRSHUIRUPHGFRQVLGHULQJWKHHIIHFWVL]HRI7HVW
&RQWUROWRDFKLHYHDPLQLPXPVWDWLVWLFDOSRZHURI7KHWULDOVZHUHVLPXODWHGIRUWKHUHSHDWHG
PHDVXUHPHQWIURPWKHPXOWLYDULDWHQRUPDOGLVWULEXWLRQDWDVLJQLILFDQFHOHYHOXVLQJWKHIROORZLQJFRYDULDQFHV
DWWDLQHGIURPWKHKLVWRULFDOGDWD
7HVW
X 
X X 
X X X 
X X X X 
&RQWURO
X 
X X 
X X X 
X X X X 
CR-5871 Protocol v4.0
 (4) 
Page 42 of 141
CONFIDENTIAL

,WLVGHWHUPLQHGWKDWDWRWDORIVXEMHFWVSHUDUPZLOOEHVXIILFLHQWWRGHPRQVWUDWHVWDWLVWLFDODFFHSWDQFHRI
ERWKSULPDU\DQGVHFRQGDU\K\SRWKHVHV

(QGSRLQWV
3RZHU

1SHU
$UP
7RWDO1
0RQRFXODU9LVXDO$FXLW\RUEHWWHU



&RUQHDO6WDLQLQJ*UDGH



$FFHSWDEOH/HQV)LW



$EVROXWH5RWDWLRQZLWKLQGHJUHH



6WDELOLW\ZLWK%OLQNZLWKLQGHJUHH



&/8(FRPIRUW



7RWDO1LQFOXGHa'URSRXW5DWH


/(9(/2)67$7,67,&$/6,*1,),&$1&(
$OOSODQQHGDQDO\VLVIRUWKLVVWXG\ZLOOEHFRQGXFWHGZLWKDQRYHUDOOW\SH,HUURUUDWHRI
7KHSULPDU\DQDO\VHVPXOWLSOHHQGSRLQWVZLOOEHSHUIRUPHGXVLQJWKHLQWHUVHFWLRQXQLRQSULQFLSDODOOSULPDU\
K\SRWKHVHVZLOOEHVLPXOWDQHRXVO\HYDOXDWHGXVLQJĮ $OOSULPDU\K\SRWKHVHVPXVWEHPHWLQRUGHUWRFODLP
WKHVXFFHVVRIWKHVWXG\REMHFWLYHV

7KHVHFRQGDU\K\SRWKHVHVZLOOEHDVVHVVHGRQO\LIDOOWKHSULPDU\K\SRWKHVHVZHUHPHWXVLQJDJDWHNHHSLQJ
VWUDWHJ\
$GMXVWPHQWRIPXOWLSOHSDLUZLVHFRPSDULVRQVEHWZHHQ7HVWDQG&RQWURODFURVVWLPHVSRLQWVIRU&/8(VFRUHVZLOOEH
FRQGXFWHGXVLQJDVLPXODWHGEDVHGPHWKRG(GZDUGDQG%HUU\

&5,7(5,$)25678'<7(50,1$7,21
,Q DGGLWLRQ WR WKH VWRSSLQJ UXOHV GHILQHG LQ VHFWLRQ  WKH RFFXUUHQFH RI RQH RU PRUH 6HULRXV 8QDQWLFLSDWHG
$GYHUVH'HYLFH(IIHFW86$'(RUDQ\6$(ZKHUHWKHUHODWLRQVKLSWRVWXG\DJHQWFDQQRWEHUXOHGRXWPD\UHVXOW
LQVWRSSLQJIXUWKHUGLVSHQVLQJRILQYHVWLJDWLRQDOSURGXFW

,QWKHHYHQWRID86$'(RU6$(WKH6SRQVRUPD\XQPDVNWKHWUHDWPHQWUHJLPHQIRUWKHVXEMHFWVDQGPD\GLVFXVV
WKLVZLWKWKH,QYHVWLJDWRUEHIRUHDQ\IXUWKHUVXEMHFWVDUHHQUROOHG
7KHVSRQVRUPD\GHWHUPLQHZKHQDVWXG\ZLOOEHVWRSSHG7KHSULQFLSDOLQYHVWLJDWRUDOZD\VKDVWKHGLVFUHWLRQWR
LQLWLDWH VWRSSLQJ WKH VWXG\ EDVHG RQ VXEMHFW VDIHW\ RU LI LQIRUPDWLRQ LQGLFDWHV WKH VWXG\¶V UHVXOWV PD\ EH
FRPSURPLVHG

352&('85()25$&&2817,1*)250,66,1*8186('$1'6385,286'$7$
0LVVLQJRUVSXULRXVYDOXHVZLOOQRWEHLPSXWHG

352&('85()255(3257,1*'(9,$7,216)52067$7,67,&$/3/$1
7KHDQDO\VLVZLOOEHFRQGXFWHGDFFRUGLQJWRVHFWLRQ7KHUHDUHQRNQRZQUHDVRQVIRUZKLFKLWLVSODQQHGWR
GHYLDWHIURPWKHVHDQDO\VLVPHWKRGV,IIRUDQ\UHDVRQDFKDQJHLVPDGHWKHFKDQJHZLOOEHGRFXPHQWHGLQWKH
VWXG\UHSRUWDORQJZLWKDMXVWLILFDWLRQIRUWKHFKDQJH
CR-5871 Protocol v4.0
 (4) 
Page 43 of 141
CONFIDENTIAL


(9$/8$%/(68%-(&76
$FFRXQWDELOLW\GLVSRVLWLRQRIDOOHQUROOHGVXEMHFWVZLOOEHSUHVHQWHGLQHDFKRIWKHIROORZLQJ
VWDWXVVXEJURXSV
 &RPSOHWHG5DQGRPL]HGVXEMHFWVZKRDUHHOLJLEOHWRSDUWLFLSDWHLQWKHVWXG\DQGKDYHVXFFHVVIXOO\
FRPSOHWHGDOOUHTXLUHGYLVLWVLQFOXGLQJWKHILQDOYLVLW
 'LVFRQWLQXHG5DQGRPL]HGVXEMHFWVZKRDUHSUHPDWXUHO\GLVFRQWLQXHGIURPWKHVWXG\GXHWRDQ\UHDVRQV
GHVFULEHGLQ6HFWLRQ
 7RWDO'LVSHQVHG6XEMHFWVZKRDGPLQLVWHUHGWKHWHVWDUWLFOHDWOHDVWRQFHLH/HQVLQVHUWLRQRFFXUUHGLQDW
OHDVWRQHH\H
 (QUROOHG1RW'LVSHQVHG6XEMHFWVZKRZHUHLHQUROOHGLQWKHVWXG\SURYLGHGLQIRUPHGFRQVHQWEXWIDLOHG
WRVDWLVI\WKHHOLJLELOLW\FULWHULDLQFOXVLRQH[FOXVLRQFULWHULDLLUDQGRPL]HGEXWGLVFRQWLQXHGRUGURSRXW
SULRUWRDGPLQLVWHULQJWKHWHVWDUWLFOHRULLLQRWUDQGRPL]HGWRWUHDWPHQWIRUDQ\UHDVRQ
 7RWDOHQUROOHG6XEMHFWVZKRVLJQHGWKHLQIRUPHGFRQVHQWIRUPLHFRPSOHWHGGLVFRQWLQXHG(QUROOHG
QRWGLVSHQVHG

6XEMHFWVZLOOEHDOORFDWHGWRWKHIROORZLQJVWXG\SRSXODWLRQVIRUWKHDQDO\VLVSXUSRVH
 6DIHW\3RSXODWLRQ$OOVXEMHFWVZKRDUHDGPLQLVWHUHGWKHWHVWDUWLFOHVDQGKDYHDWOHDVWRQHREVHUYDWLRQRQ
DQ\VDIHW\RUDQGHIILFDF\YDULDEOHV
 3HUSURWRFRO3RSXODWLRQ$OOVXEMHFWVZKRKDYHVXFFHVVIXOO\FRPSOHWHGDOOUHTXLUHGYLVLWVZLWKRXWDQ\
PDMRUSURWRFROGHYLDWLRQVWKDWWKHFRKRUWUHYLHZFRPPLWWHHGRFXPHQWVDVLPSDFWLQJWKHDVVHVVPHQWRIWKH
K\SRWKHVHVSULRUWRWKHGDWDKDUGORFN

(/(&7521,&&$6(5(3257)250'$7$&2//(&7,21
7KH GDWD IRU WKLV VWXG\ ZLOO EH FDSWXUHG RQ HOHFWURQLF FDVH UHSRUW IRUPV H&5)V XVLQJ DQ ('& V\VWHP  ZKHQ
SRVVLEOH'HVLJQDWHGVWXG\VLWHSHUVRQQHO ZLOOHQWHUVWXG\GDWDLQWRWKHHOHFWURQLF&5)VH&5)VXVLQJWKH('&
V\VWHP'DWDFROOHFWHGRQHTXLSPHQWWKDWLVQRWSRVVLEOHWREHFDSWXUHGLQ('&ZLOOEHIRUPDWWHGWRWKHVSHFLILFDWLRQ
RIWKH--9&GDWDEDVHPDQDJHUDQGVHQWWR--9&IRUDQDO\VLV'DWDJHQHUDWHGIURPSRVWKRFPHDVXUHPHQWVHJ
&RPSRVLWLRQDO FKDUDFWHULVWLFV RI FRQWDFW OHQV OLSLG XSWDNH 0HDVXUHG WHDU ILOP SURWHFWLYH FDSDELOLW\ 0HDVXUHG
FRQWDFWOHQVVXUIDFHGHK\GUDWLRQUDWHZLOOEHFROOHFWHGRQVSHFLILF0LFURVRIW2IILFH([FHOIRUPDWZRUNVKHHWVDWWKH
FOLQLFDOVLWHDQGDWWKHFRPSOHWLRQRIWKHDQDO\VLVWUDQVIHUUHGWR--9&ELRVWDWLVWLFLDQIRUGDWDDQDO\VLVLQVXFKIRUPDW
LIDSSOLFDEOH
7KH&5)VZLOOEHUHYLHZHGIRUDFFXUDF\DQGFRPSOHWHQHVVDQGVLJQHGE\WKHLQYHVWLJDWRU8QOHVVRWKHUZLVHVWDWHG
WKHH&5)VZLOOEHFRQVLGHUHGWKHVRXUFHGRFXPHQW7KHVSRQVRURUVSRQVRUµVUHSUHVHQWDWLYHVZLOOEHDXWKRUL]HGWR
JDLQDFFHVVWRWKHVRXUFHGRFXPHQWDWLRQIRUWKHSXUSRVHVRIPRQLWRULQJDQGDXGLWLQJWKHVWXG\
(GLW FKHFNV HOHFWURQLF TXHULHV DQG DXGLW WUDLOV DUH EXLOW LQWR WKH V\VWHP WR HQVXUH DFFXUDWH DQG FRPSOHWH GDWD
FROOHFWLRQ'DWDZLOOEHWUDQVPLWWHGIURPWKHLQYHVWLJDWLRQDOVLWHWRDVHFXUHFHQWUDOGDWDEDVHDVIRUPVDUHFRPSOHWHG
RU XSGDWHG HQVXULQJ LQIRUPDWLRQ DFFXUDF\ VHFXULW\ DQG FRQILGHQWLDOLW\ $IWHU WKH ILQDO GDWDEDVH ORFN WKH
,QYHVWLJDWRUZLOOEHSURYLGHGZLWK,QGLYLGXDO3DWLHQW3URILOHV,33LQFOXGLQJWKHIXOODXGLWWUDLORQHOHFWURQLFPHGLD
LQDQRQHGLWDEOHIRUPDWIRUDOORIWKHVWXG\GDWD7KH,33VKRXOGEHUHWDLQHGLQWKHVWXG\ILOHVDVDFHUWLILHGFRS\RI
WKHVRXUFHGDWDIRUWKHVWXG\
7KHFRQWHQWDQGVWUXFWXUHRIWKH&5)VDUHFRPSOLDQWZLWK,62>@
CR-5871 Protocol v4.0
 (4) 
Page 44 of 141
CONFIDENTIAL


6285&('2&80(17$7,21
$WDPLQLPXPVRXUFHGRFXPHQWDWLRQVKRXOGEHDYDLODEOHIRUWKHIROORZLQJWRFRQILUPGDWDFROOHFWHGLQWKH&5)
VXEMHFW LGHQWLILFDWLRQ HOLJLELOLW\ DQG VWXG\ LGHQWLILFDWLRQ VWXG\ GLVFXVVLRQ SURYLVLRQ RI DQG GDWH RI LQIRUPHG
FRQVHQWYLVLWGDWHVUHVXOWVRIVDIHW\DQGHIILFDF\SDUDPHWHUVDVUHTXLUHGE\WKHSURWRFRODUHFRUGRIDOODGYHUVH
HYHQWVIROORZXSRIDGYHUVHHYHQWVFRQFRPLWDQWPHGLFDWLRQLQYHVWLJDWLRQDOSURGXFWUHFHLSWGLVSHQVLQJUHWXUQ
UHFRUGV VWXG\ LQYHVWLJDWLRQDO SURGXFW DGPLQLVWUDWLRQ LQIRUPDWLRQ GDWH RI VWXG\ FRPSOHWLRQ UHDVRQ IRU HDUO\
GLVFRQWLQXDWLRQRILQYHVWLJDWLRQDOSURGXFWRUZLWKGUDZDOIURPWKHVWXG\LIDSSOLFDEOH

7KHDXWKRURIDQHQWU\LQWKHVRXUFHGRFXPHQWVPXVWEHLGHQWLILDEOH$GYHUVHHYHQWQRWHVVKRXOGEHUHYLHZHGDQG
LQLWLDOHGE\WKH,QYHVWLJDWRU

$WDPLQLPXPWKHW\SHDQGOHYHORIGHWDLORIVRXUFHGDWDDYDLODEOHIRUDVWXG\VXEMHFWVKRXOGEHFRQVLVWHQWZLWKWKDW
FRPPRQO\UHFRUGHGDWWKHVLWHDVDEDVLVIRUVWDQGDUGPHGLFDOFDUH
6SHFLILFGHWDLOVUHTXLUHGDVVRXUFHGDWDIRUWKHVWXG\ZLOOEHUHYLHZHGZLWKWKHLQYHVWLJDWRUEHIRUHWKHVWXG\DQGZLOO
EHGHVFULEHGLQWKHPRQLWRULQJJXLGHOLQHVRURWKHUHTXLYDOHQWGRFXPHQWV

$&&(66726285&('$7$'2&80(17
7KH ,QYHVWLJDWRUV  ,QVWLWXWLRQV ZLOO SHUPLW WULDOUHODWHG PRQLWRULQJ DXGLWV ,5%,(& UHYLHZ DQG UHJXODWRU\
LQVSHFWLRQVE\SURYLGLQJGLUHFWDFFHVVWRVRXUFHGDWDGRFXPHQWV6KRXOGWKHFOLQLFDOVLWHEHFRQWDFWHGIRUDQ
DXGLWE\DQ,5%,(&RUUHJXODWRU\DXWKRULW\--9&VKRXOGEHFRQWDFWHGDQGQRWLILHGLQZULWLQJZLWKLQKRXUV



&21),'(17,$/,7<2),1)250$7,21
,QIRUPDWLRQFRQFHUQLQJWKHLQYHVWLJDWLRQDOSURGXFWDQGSDWHQWDSSOLFDWLRQSURFHVVHVVFLHQWLILFGDWDRURWKHU
SHUWLQHQWLQIRUPDWLRQLVFRQILGHQWLDODQGUHPDLQVWKHSURSHUW\RI--9&7KH,QYHVWLJDWRUPD\XVHWKLVLQIRUPDWLRQ
IRUWKHSXUSRVHVRIWKHVWXG\RQO\,WLVXQGHUVWRRGE\WKH,QYHVWLJDWRUWKDW--9&ZLOOXVHLQIRUPDWLRQGHYHORSHGLQ
WKLVFOLQLFDOVWXG\LQFRQQHFWLRQZLWKWKHGHYHORSPHQWRIWKHLQYHVWLJDWLRQDOSURGXFWDQGWKHUHIRUHPD\GLVFORVHLWDV
UHTXLUHGWRRWKHUFOLQLFDOLQYHVWLJDWRUVDQGWRUHJXODWRU\DJHQFLHV,QRUGHUWRDOORZWKHXVHRIWKHLQIRUPDWLRQ
GHULYHGIURPWKLVFOLQLFDOVWXG\WKH,QYHVWLJDWRUXQGHUVWDQGVWKDWKHVKHKDVDQREOLJDWLRQWRSURYLGHFRPSOHWHWHVW
UHVXOWVDQGDOOGDWDGHYHORSHGGXULQJWKLVVWXG\WRWKH6SRQVRU
7KH,QYHVWLJDWRUPD\QRWVXEPLWIRUSXEOLFDWLRQRUSUHVHQWDWLRQWKHUHVXOWVRIWKLVVWXG\ZLWKRXWILUVWUHFHLYLQJ
ZULWWHQDXWKRUL]DWLRQIURP--9&--9&DJUHHVWKDWEHIRUHLWSXEOLVKHVDQ\UHVXOWVRIWKHVWXG\LWVKDOOSURYLGHWKH
,QYHVWLJDWRUZLWKDWOHDVWGD\VIRUUHYLHZRIWKHSUHSXEOLFDWLRQPDQXVFULSWSULRUWRWKHVXEPLVVLRQRIWKH
PDQXVFULSWWRWKHSXEOLVKHU

'$7$48$/,7<$6685$1&(
6WHSVWREHWDNHQWRHQVXUHWKHDFFXUDF\DQGUHOLDELOLW\RIGDWDLQFOXGHWKHVHOHFWLRQRITXDOLILHGLQYHVWLJDWRUVDQG
DSSURSULDWHVWXG\VLWHVDQGUHYLHZRISURWRFROSURFHGXUHVZLWKWKHSULQFLSDOLQYHVWLJDWRU7KHSULQFLSDOLQYHVWLJDWRU
LQWXUQPXVWHQVXUHWKDWDOOVXELQYHVWLJDWRUVDQGVWXG\VWDIIDUHIDPLOLDUZLWKWKHSURWRFRODQGDOOVWXG\VSHFLILF
SURFHGXUHVDQGKDYHDSSURSULDWHNQRZOHGJHRIWKHVWXG\DUWLFOH
*XLGHOLQHVIRUFDVHUHSRUWIRUPFRPSOHWLRQZLOOEHSURYLGHGDQGUHYLHZHGZLWKVWXG\SHUVRQQHOEHIRUHWKHVWDUWRI
WKHVWXG\7KHVSRQVRU-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QFZLOOUHYLHZFDVHUHSRUWIRUPVIRUDFFXUDF\DQG
FRPSOHWHQHVVUHPRWHO\GXULQJWKHFRXUVHRIWKHVWXG\GXULQJRQVLWHPRQLWRULQJYLVLWVDQGDIWHUWUDQVPLVVLRQWRGDWD
PDQDJHPHQW$Q\GDWDGLVFUHSDQFLHVZLOOEHUHVROYHGZLWKWKHLQYHVWLJDWRURUGHVLJQHHDVDSSURSULDWH
CR-5871 Protocol v4.0
 (4) 
Page 45 of 141
CONFIDENTIAL

4XDOLW\$VVXUDQFHUHSUHVHQWDWLYHVIURP-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QFPD\YLVLWVWXG\VLWHVWRUHYLHZGDWD
SURGXFHGGXULQJWKHVWXG\DQGWRDFFHVVFRPSOLDQFHZLWKDSSOLFDEOHUHJXODWLRQVSHUWDLQLQJWRWKHFRQGXFWRIFOLQLFDO
WULDOV7KHVWXG\VLWHVZLOOSURYLGHGLUHFWDFFHVVWRVWXG\UHODWHGVRXUFHGDWDGRFXPHQWVDQGUHSRUWVIRUWKHSXUSRVH
RIPRQLWRULQJDQGDXGLWLQJE\-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QFDQGIRULQVSHFWLRQE\ORFDODQGUHJXODWRU\
DXWKRULWLHV

678'<63(&,),&'(6,*1&216,'(5$7,216
3RWHQWLDOVXEMHFWVZLOOEHIXOO\LQIRUPHGRIWKHULVNVDQGUHTXLUHPHQWVRIWKHVWXG\DQGGXULQJWKHVWXG\VXEMHFWV
ZLOOEHJLYHQDQ\QHZLQIRUPDWLRQWKDWPD\DIIHFWWKHLUGHFLVLRQWRFRQWLQXHSDUWLFLSDWLRQ7KH\ZLOOEHWROGWKDW
WKHLUFRQVHQWWRSDUWLFLSDWHLQWKHVWXG\LVYROXQWDU\DQGPD\EHZLWKGUDZQDWDQ\WLPHZLWKQRUHDVRQJLYHQDQG
ZLWKRXWSHQDOW\RUORVVRIEHQHILWVWRZKLFKWKH\ZRXOGRWKHUZLVHEHHQWLWOHG2QO\VXEMHFWVZKRDUHIXOO\DEOHWR
XQGHUVWDQGWKHULVNVEHQHILWVDQGSRWHQWLDODGYHUVHHYHQWVRIWKHVWXG\DQGSURYLGHWKHLUFRQVHQWYROXQWDULO\ZLOOEH
HQUROOHG

,19(67,*$7255(63216,%,/,7<
7KH,QYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWWKHFOLQLFDOVWXG\LVSHUIRUPHGLQDFFRUGDQFHZLWKWKHSURWRFRO
6HFWLRQRIWKH,&+(JXLGHOLQHVRQ*RRG&OLQLFDO3UDFWLFH*&3DQGDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV*&3
LVDQLQWHUQDWLRQDOHWKLFDODQGVFLHQWLILFTXDOLW\VWDQGDUGIRUGHVLJQLQJFRQGXFWLQJUHFRUGLQJDQGUHSRUWLQJVWXGLHV
WKDWLQYROYHWKHSDUWLFLSDWLRQRIKXPDQVXEMHFWV
&RPSOLDQFHZLWKWKLVVWDQGDUGSURYLGHVSXEOLFDVVXUDQFHWKDWWKHULJKWVVDIHW\DQGZHOOEHLQJRIVWXG\VXEMHFWVDUH
SURWHFWHGFRQVLVWHQWZLWKWKHSULQFLSOHVRIWKH'HFODUDWLRQRI+HOVLQNLWK:0$*HQHUDO$VVHPEO\DQGWKDW
WKHFOLQLFDOVWXG\GDWDDUHFUHGLEOH7KH,QYHVWLJDWRUPXVWPDLQWDLQFOLQLFDOVWXG\ILOHVLQDFFRUGDQFHZLWK6HFWLRQ
RIWKH,&+(JXLGHOLQHVRQ*RRG&OLQLFDO3UDFWLFH*&3DQGDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV

,1'(3(1'(17(7+,&6&200,77((25,167,787,21$/5(9,(:%2$5',(&,5%
%HIRUHWKHVWDUWRIWKHVWXG\WKH,QYHVWLJDWRURU6SRQVRUZKHQDSSOLFDEOHZLOOSURYLGHWKH,(&,5%ZLWKFXUUHQW
DQGFRPSOHWHFRSLHVRIWKHIROORZLQJGRFXPHQWVZKHUHDSSOLFDEOH
x
)LQDOSURWRFRODQGLIDSSOLFDEOHDPHQGPHQWV
x
6SRQVRUDSSURYHGLQIRUPHGFRQVHQWIRUPDQGDQ\RWKHUZULWWHQPDWHULDOVWREHSURYLGHGWRWKHVXEMHFWV
x
,QYHVWLJDWRU¶V%URFKXUHRUHTXLYDOHQWLQIRUPDWLRQDQGDPHQGPHQWV
x
6SRQVRUDSSURYHGVXEMHFWUHFUXLWPHQWPDWHULDOV
x
,QIRUPDWLRQRQFRPSHQVDWLRQIRUVWXG\UHODWHGLQMXULHVRUSD\PHQWWRVXEMHFWVIRUSDUWLFLSDWLRQLQWKH
VWXG\LIDSSOLFDEOH
x
,QYHVWLJDWRU¶VFXUULFXOXPYLWDHFOLQLFDOOLFHQVHVRUHTXLYDOHQWLQIRUPDWLRQXQOHVVQRWUHTXLUHGDV
GRFXPHQWHGE\,(&,5%
x
,QIRUPDWLRQUHJDUGLQJIXQGLQJQDPHRIWKH6SRQVRULQVWLWXWLRQDODIILOLDWLRQVRWKHUSRWHQWLDOFRQIOLFWVRI
LQWHUHVWDQGLQFHQWLYHVIRUVXEMHFWV
x
$Q\RWKHUGRFXPHQWVWKDWWKH,(&,5%UHTXHVWVWRIXOILOOLWVREOLJDWLRQ
7KLVVWXG\ZLOOEHXQGHUWDNHQRQO\DIWHU,(&,5%KDVJLYHQIXOODSSURYDORIWKHILQDOSURWRFRODPHQGPHQWVLIDQ\
WKHLQIRUPHGFRQVHQWIRUPDSSOLFDEOHUHFUXLWLQJPDWHULDOVDQGVXEMHFWFRPSHQVDWLRQSURJUDPVDQGWKH6SRQVRUKDV
UHFHLYHGDFRS\RIWKLVDSSURYDO7KLVDSSURYDOOHWWHUPXVWEHGDWHGDQGPXVWFOHDUO\LGHQWLI\WKHGRFXPHQWVEHLQJ
DSSURYHG
CR-5871 Protocol v4.0
 (4) 
Page 46 of 141
CONFIDENTIAL

'XULQJWKHVWXG\WKH,QYHVWLJDWRURU6SRQVRUZKHQDSSOLFDEOHZLOOVHQGWKHIROORZLQJGRFXPHQWVWRWKH,(&,5%
IRUWKHLUUHYLHZDQGDSSURYDOZKHUHDSSURSULDWH
x
3URWRFRODPHQGPHQWV
x
5HYLVLRQVWRLQIRUPHGFRQVHQWIRUPDQGDQ\RWKHUZULWWHQPDWHULDOVWREHSURYLGHGWRVXEMHFWV
x
,IDSSOLFDEOHQHZRUUHYLVHGVXEMHFWUHFUXLWLQJPDWHULDOVDSSURYHGE\WKH6SRQVRU
x
UHYLVLRQVWRFRPSHQVDWLRQIRUVWXG\UHODWHGLQMXULHVRUSD\PHQWWRVXEMHFWVIRUSDUWLFLSDWLRQLQWKHVWXG\LI
DSSOLFDEOH
x
,QYHVWLJDWRU¶V%URFKXUHDPHQGPHQWVRUQHZHGLWLRQV
x
6XPPDULHVRIWKHVWDWXVRIWKHVWXG\DWOHDVWDQQXDOO\RUDWLQWHUYDOVVWLSXODWHGLQJXLGHOLQHVRIWKH
,(&,5%
x
5HSRUWVRIDGYHUVHHYHQWVWKDWDUHVHULRXVXQDQWLFLSDWHGDQGDVVRFLDWHGZLWKWKHLQYHVWLJDWLRQDOSURGXFW
DFFRUGLQJWRWKH,5%¶VUHTXLUHPHQWV
x
1HZLQIRUPDWLRQWKDWPD\DGYHUVHO\DIIHFWWKHVDIHW\RIWKHVXEMHFWVRUWKHFRQGXFWRIWKHVWXG\
x
0DMRUSURWRFROGHYLDWLRQVDVUHTXLUHGE\WKH,(&,5%
x
5HSRUWRIGHDWKVRIVXEMHFWVXQGHUWKH,QYHVWLJDWRU
VFDUH
x
1RWLILFDWLRQLIDQHZLQYHVWLJDWRULVUHVSRQVLEOHIRUWKHVWXG\DWWKHVLWH
x
$Q\RWKHUUHTXLUHPHQWVRIWKH,(&,5%
)RUSURWRFRODPHQGPHQWVWKDWLQFUHDVHVXEMHFWULVNWKHDPHQGPHQWDQGDSSOLFDEOHLQIRUPHGFRQVHQWIRUPUHYLVLRQV
PXVWEHVXEPLWWHGSURPSWO\WRWKH,(&,5%IRUUHYLHZDQGDSSURYDOEHIRUHLPSOHPHQWDWLRQRIWKHFKDQJHV
$WOHDVWRQFHD\HDUWKH,(&,5%ZLOOEHDVNHGWRUHYLHZDQGUHDSSURYHWKLVFOLQLFDOVWXG\7KLVUHTXHVWVKRXOGEH
GRFXPHQWHGLQZULWLQJ
$WWKHHQGRIWKHVWXG\WKH,QYHVWLJDWRURU6SRQVRUZKHUHUHTXLUHGZLOOQRWLI\WKH,(&,5%DERXWWKHVWXG\
FRPSOHWLRQ'RFXPHQWDWLRQRIWKLVQRWLILFDWLRQPXVWEHILOHGLQWKHVWXG\,QYHVWLJDWRUELQGHUDQGDFRS\SURYLGHGWR
WKH&52RU6SRQVRUDVDSSOLFDEOH

,1)250('&216(17
(DFKVXEMHFWPXVWJLYHZULWWHQFRQVHQWDFFRUGLQJWRORFDOUHTXLUHPHQWVDIWHUWKHQDWXUHRIWKHVWXG\KDVEHHQIXOO\
H[SODLQHG7KHFRQVHQWIRUPPXVWEHVLJQHGEHIRUHSHUIRUPDQFHRIDQ\VWXG\UHODWHGDFWLYLW\7KHFRQVHQWIRUPWKDW
LVXVHGPXVWEHDSSURYHGE\ERWKWKH6SRQVRUDQGE\WKHUHYLHZLQJ,(&,5%7KHLQIRUPHGFRQVHQWVKRXOGEHLQ
DFFRUGDQFH ZLWK SULQFLSOHV WKDW RULJLQDWHG LQ WKH 'HFODUDWLRQ RI +HOVLQNL FXUUHQW ,&+ DQG *&3 JXLGHOLQHV
DSSOLFDEOHUHJXODWRU\UHTXLUHPHQWVDQGVSRQVRUSROLF\
%HIRUHHQWU\LQWRWKHVWXG\WKH,QYHVWLJDWRURUDQDXWKRUL]HGPHPEHURIWKHLQYHVWLJDWLRQDOVWDIIPXVWH[SODLQWR
SRWHQWLDO VXEMHFW WKH DLPV PHWKRGV UHDVRQDEO\ DQWLFLSDWHG EHQHILWV DQG SRWHQWLDO KD]DUGV RI WKH VWXG\ DQG DQ\
GLVFRPIRUWLWPD\HQWDLO6XEMHFWVZLOOEHLQIRUPHGWKDWWKHLUSDUWLFLSDWLRQLVYROXQWDU\DQGWKDWWKH\PD\ZLWKGUDZ
FRQVHQWWRSDUWLFLSDWHDWDQ\WLPH7KH\ZLOOEHLQIRUPHGWKDWFKRRVLQJQRWWRSDUWLFLSDWHZLOOQRWDIIHFWWKHFDUHWKH
VXEMHFWZLOOUHFHLYH)LQDOO\WKH\ZLOOEHWROGWKDWWKH,QYHVWLJDWRUZLOOPDLQWDLQDVXEMHFWLGHQWLILFDWLRQUHJLVWHUIRU
WKH SXUSRVHV RI ORQJWHUP IROORZXS LI QHHGHG DQG WKDW WKHLU UHFRUGV PD\ EH DFFHVVHG E\ KHDOWK DXWKRULWLHV DQG
DXWKRUL]HGVSRQVRUVWDIIZLWKRXWYLRODWLQJWKHFRQILGHQWLDOLW\RIWKHVXEMHFWWRWKHH[WHQWSHUPLWWHGE\WKHDSSOLFDEOH
ODZVRUUHJXODWLRQV
%\VLJQLQJWKHLQIRUPHGFRQVHQWIRUPWKHVXEMHFWLVDXWKRUL]LQJVXFKDFFHVVDQGDJUHHVWREHFRQWDFWHGDIWHUVWXG\
FRPSOHWLRQE\KHDOWKDXWKRULWLHVDQGDXWKRUL]HGVSRQVRUVWDIIIRUWKHSXUSRVHRIREWDLQLQJFRQVHQWIRUDGGLWLRQDO
VDIHW\HYDOXDWLRQVLIQHHGHG
CR-5871 Protocol v4.0
 (4) 
Page 47 of 141
CONFIDENTIAL

7KHVXEMHFWZLOOEHJLYHQVXIILFLHQWWLPHWRUHDGWKHLQIRUPHGFRQVHQWIRUPDQGWKHRSSRUWXQLW\WRDVNTXHVWLRQV
$IWHUWKLVH[SODQDWLRQDQGEHIRUHHQWU\LQWRWKHVWXG\FRQVHQWVKRXOGEHDSSURSULDWHO\UHFRUGHGE\PHDQVRIWKH
VXEMHFW
VGDWHGVLJQDWXUH$IWHUKDYLQJREWDLQHGWKHFRQVHQWDFRS\RIWKHLQIRUPHGFRQVHQWIRUPPXVWEHJLYHQWR
WKHVXEMHFW
,QWKHHYHQWDGGLWLRQDOLQYHVWLJDWRUVVLWHVDUHDGGHGWRWKHSURWRFROWKHLQIRUPHGFRQVHQWZLOOEH
PRGLILHGWRLQFOXGHWKH,QYHVWLJDWRU¶VQDPHDGGUHVVSKRQHQXPEHUDQGKRXUHPHUJHQF\QXPEHU

35,9$&<2)3(5621$/'$7$
7KHFROOHFWLRQSURFHVVLQJDQGGLVFORVXUHRISHUVRQDOGDWDDQGPHGLFDOLQIRUPDWLRQUHODWHGWRWKH6WXG\6XEMHFWDQG
SHUVRQDOGDWDUHODWHGWR3ULQFLSDO,QYHVWLJDWRUDQGDQ\LQYHVWLJDWLRQDOVWDIIHJQDPHFOLQLFDGGUHVVDQGSKRQH
QXPEHU FXUULFXOXP YLWDH LV VXEMHFW WR FRPSOLDQFH ZLWK WKH 'DWD 3URWHFWLRQ $FW RI  DQG RWKHU DSSOLFDEOH
SHUVRQDOGDWDSURWHFWLRQDQGVHFXULW\ODZVDQGUHJXODWLRQV$SSURSULDWHPHDVXUHV ZLOOEHHPSOR\HGWRVDIHJXDUG
WKHVHGDWDWRPDLQWDLQWKHFRQILGHQWLDOLW\RIWKHSHUVRQ¶VUHODWHGKHDOWKDQGPHGLFDOLQIRUPDWLRQWRSURSHUO\LQIRUP
WKHFRQFHUQHGSHUVRQVDERXWWKHFROOHFWLRQDQGSURFHVVLQJRIWKHLUSHUVRQDOGDWDWRJUDQWWKHPUHDVRQDEOHDFFHVVWR
WKHLUSHUVRQDOGDWDDQGWRSUHYHQWDFFHVVE\XQDXWKRUL]HGSHUVRQV

$OOLQIRUPDWLRQREWDLQHGGXULQJWKHFRXUVHRIWKHLQYHVWLJDWLRQZLOOEHUHJDUGHGDVFRQILGHQWLDO$OOSHUVRQDOGDWD
JDWKHUHG LQ WKLV WULDO ZLOO EH WUHDWHG LQ VWULFWHVW FRQILGHQFH E\ LQYHVWLJDWRUV PRQLWRUV 6SRQVRUV SHUVRQQHO DQG
LQGHSHQGHQWHWKLFVFRPPLWWHH1RGDWDZLOOEHGLVFORVHGWRDQ\WKLUGSDUW\ZLWKRXWWKHH[SUHVVSHUPLVVLRQRIWKH
VXEMHFWFRQFHUQHGZLWKWKHH[FHSWLRQRIVSRQVRUSHUVRQQHOPRQLWRUDXGLWRULQGHSHQGHQWHWKLFVFRPPLWWHHDQG
UHJXODWRU\RUJDQL]DWLRQVLQWKHFRQWH[WRIWKHLULQYHVWLJDWLRQUHODWHGDFWLYLWLHVWKDWDVSDUWRIWKHLQYHVWLJDWLRQZLOO
KDYHDFFHVVWRWKH&5)VDQGVRXUFHGRFXPHQWV

7KHFROOHFWLRQDQGSURFHVVLQJRISHUVRQDOGDWDIURPVXEMHFWVHQUROOHGLQWKLVVWXG\ZLOOEHOLPLWHGWRWKRVHGDWDWKDW
DUHQHFHVVDU\WRLQYHVWLJDWHWKHHIILFDF\VDIHW\TXDOLW\DQGXWLOLW\RIWKHLQYHVWLJDWLRQDOSURGXFWVXVHGLQWKLV
VWXG\

7KHVHGDWDPXVWEHFROOHFWHGDQGSURFHVVHGZLWKDGHTXDWHSUHFDXWLRQVWRHQVXUHFRQILGHQWLDOLW\DQGFRPSOLDQFHZLWK
DSSOLFDEOHGDWDSULYDF\SURWHFWLRQODZVDQGUHJXODWLRQV
7KH6SRQVRUHQVXUHVWKDWWKHSHUVRQDOGDWDZLOOEH
x
SURFHVVHGIDLUO\DQGODZIXOO\
x
FROOHFWHGIRUVSHFLILHGH[SOLFLWDQGOHJLWLPDWHSXUSRVHVDQGQRWIXUWKHUSURFHVVHGLQDZD\LQFRPSDWLEOH
ZLWKWKHVHSXUSRVHV
x
DGHTXDWHUHOHYDQWDQGQRWH[FHVVLYHLQUHODWLRQWRVDLGSXUSRVHV
x
DFFXUDWHDQGZKHUHQHFHVVDU\NHSWFXUUHQW
([SOLFLWFRQVHQWIRUWKHSURFHVVLQJRISHUVRQDOGDWDZLOOEHREWDLQHGIURPWKHSDUWLFLSDWLQJVXEMHFWEHIRUHFROOHFWLRQ
RIGDWD6XFKFRQVHQWVKRXOGDOVRDGGUHVVWKHWUDQVIHURIWKHGDWDWRRWKHUHQWLWLHVDQGWRRWKHUFRXQWULHV

7KHVXEMHFWKDVWKHULJKWWRUHTXHVWWKURXJKWKH,QYHVWLJDWRUDFFHVVWRKLVSHUVRQDOGDWDDQGWKHULJKWWRUHTXHVW
UHFWLILFDWLRQRIDQ\GDWDWKDWDUHQRWFRUUHFWRUFRPSOHWH5HDVRQDEOHVWHSVVKRXOGEHWDNHQWRUHVSRQGWRVXFKD
UHTXHVWWDNLQJLQWRFRQVLGHUDWLRQWKHQDWXUHRIWKHUHTXHVWWKHFRQGLWLRQVRIWKHVWXG\DQGWKHDSSOLFDEOHODZVDQG
UHJXODWLRQV
$SSURSULDWHWHFKQLFDODQGRUJDQL]DWLRQDOPHDVXUHVWRSURWHFWWKHSHUVRQDOGDWDDJDLQVWXQDXWKRUL]HGGLVFORVXUHVRU
DFFHVVDFFLGHQWDORUXQODZIXOGHVWUXFWLRQRUDFFLGHQWDOORVVRUDOWHUDWLRQPXVWEHSXWLQSODFH6SRQVRUSHUVRQQHO
ZKRVHUHVSRQVLELOLWLHVUHTXLUHDFFHVVWRSHUVRQDOGDWDDJUHHWRNHHSWKHLGHQWLW\RIVWXG\VXEMHFWVFRQILGHQWLDO
CR-5871 Protocol v4.0
 (4) 
Page 48 of 141
CONFIDENTIAL


'$7$+$1'/,1*$1'5(&25'.((3,1*
,QFRPSOLDQFH ZLWKWKH,&+*&3JXLGHOLQHVWKH,QYHVWLJDWRU,QVWLWXWLRQ ZLOO PDLQWDLQDOO&5)VDQGDOOVRXUFH
GRFXPHQWVWKDWVXSSRUWWKHGDWDFROOHFWHGIURPHDFKVXEMHFWDVZHOODVDOOVWXG\GRFXPHQWVDVVSHFLILHGLQ,&+*&3
6HFWLRQ(VVHQWLDO'RFXPHQWVIRUWKH&RQGXFWRID&OLQLFDO7ULDODQGDOOVWXG\GRFXPHQWVDVVSHFLILHGE\WKH
DSSOLFDEOH UHJXODWRU\ UHTXLUHPHQWV 7KH ,QYHVWLJDWRU  ,QVWLWXWLRQ ZLOO WDNH PHDVXUHV WR SUHYHQW DFFLGHQWDO RU
SUHPDWXUHGHVWUXFWLRQRIWKHVHGRFXPHQWV
(VVHQWLDOGRFXPHQWVPXVWEHUHWDLQHGXQWLODWOHDVW\HDUVDIWHUWKHODVWDSSURYDORIDPDUNHWLQJDSSOLFDWLRQLQDQ
,&+UHJLRQDQGXQWLOWKHUHDUHQRSHQGLQJRUFRQWHPSODWHGPDUNHWLQJDSSOLFDWLRQVLQDQ,&+UHJLRQRUXQWLODWOHDVW
\HDUVKDYHHODSVHGVLQFHWKHIRUPDOGLVFRQWLQXDWLRQRIFOLQLFDOGHYHORSPHQWRIWKHLQYHVWLJDWLRQDOSURGXFW7KHVH
GRFXPHQWV ZLOO EH UHWDLQHG IRU D ORQJHU SHULRG LI UHTXLUHG E\ WKH DSSOLFDEOH UHJXODWRU\ UHTXLUHPHQWV RU E\ DQ
DJUHHPHQWZLWKWKH6SRQVRU,WLVWKHUHVSRQVLELOLW\RIWKH6SRQVRUWRLQIRUPWKH,QYHVWLJDWRU,QVWLWXWLRQDVWRZKHQ
WKHVHGRFXPHQWVQRORQJHUQHHGWREHUHWDLQHG
,IWKHUHVSRQVLEOH,QYHVWLJDWRUUHWLUHVUHORFDWHVRUIRURWKHUUHDVRQVZLWKGUDZVIURPWKHUHVSRQVLELOLW\RINHHSLQJ
WKHVWXG\UHFRUGVFXVWRG\PXVWEHWUDQVIHUUHGWRDSHUVRQZKRZLOODFFHSWWKHUHVSRQVLELOLW\7KH6SRQVRUPXVWEH
QRWLILHG LQ ZULWLQJ RI WKH QDPH DQG DGGUHVV RI WKH QHZ FXVWRGLDQ 8QGHU QR FLUFXPVWDQFH VKDOO WKH ,QYHVWLJDWRU
UHORFDWHRUGLVSRVHRIDQ\VWXG\GRFXPHQWVEHIRUHKDYLQJREWDLQHGZULWWHQDSSURYDOIURPWKH6SRQVRU
,ILWEHFRPHVQHFHVVDU\IRUWKH6SRQVRURUWKHDSSURSULDWHUHJXODWRU\DXWKRULW\WRUHYLHZDQ\GRFXPHQWDWLRQUHODWLQJ
WRWKLVVWXG\WKH,QYHVWLJDWRUPXVWSHUPLWDFFHVVWRVXFKUHSRUWV
,IWKH,QYHVWLJDWRUKDVDTXHVWLRQUHJDUGLQJUHWHQWLRQRIVWXG\UHFRUGVKHVKRXOGFRQWDFW--9&5HVHDUFKDQG
'HYHORSPHQW

),1$1&,$/&216,'(5$7,216
5HPXQHUDWLRQIRUVWXG\VHUYLFHVDQGH[SHQVHVZLOOEHVHWIRUWKLQGHWDLOLQWKH,QYHVWLJDWRU¶V5HVHDUFK$JUHHPHQW
7KH5HVHDUFK$JUHHPHQWZLOOEHVLJQHGE\WKH3ULQFLSDO,QYHVWLJDWRUDQGD-RKQVRQ	-RKQVRQ9LVLRQ&DUH
PDQDJHPHQWUHSUHVHQWDWLYHSULRUWRVWXG\LQLWLDWLRQ
&DVH5HSRUW)RUPVZLOOEHFRPSOHWHGLQUHDOWLPHDFFRUGLQJWRWKHVWXG\SURFHGXUHVVSHFLILHGLQWKHVWXG\SURWRFRO
&DVH5HSRUW)RUPVVKRXOGEHFRPSOHWHGDQGUHYLHZHGDQGVLJQHGDVDSSOLFDEOHE\WKH,QYHVWLJDWRUZLWKLQGD\VRI
YLVLWFRPSOHWLRQ'DWDTXHULHVPXVWEHDGGUHVVHGZLWKFRPSOHWHUHVSRQVHVZLWKLQGD\VRIJHQHUDWLRQ-RKQVRQ	
-RKQVRQ9LVLRQ&DUHUHVHUYHVWKHULJKWWRZLWKKROGUHPXQHUDWLRQXQWLOWKHVHDFWLYLWLHVDUHDGGUHVVHG
-RKQVRQ	-RKQVRQ9LVLRQ&DUHUHVHUYHVWKHULJKWWRZLWKKROGUHPXQHUDWLRQIRUFRVWVDVVRFLDWHGZLWKSURWRFRO
YLRODWLRQVVXFKDV
x
&RQWLQXLQJDQLQHOLJLEOHVXEMHFWLQWKHVWXG\
x
6FKHGXOLQJDVWXG\YLVLWRXWVLGHWKHVXEMHFW¶VDFFHSWDEOHYLVLWUDQJH

38%/,&$7,21
7KLVVWXG\ZLOOEHUHJLVWHUHGRQ&OLQLFDO7ULDOVJRYE\WKH6SRQVRU

3$7,(175(3257('287&20(6678'<48(67,211$,5(6
$VXPPDU\RIWKHTXHVWLRQQDLUHVDUHJLYHQEHORZ

CR-5871 Protocol v4.0
 (4) 
Page 49 of 141
CONFIDENTIAL


/,672)$%%5(9,$7,216

$(
$GYHUVH(YHQW$GYHUVH([SHULHQFH
&)5
&RGHRI)HGHUDO5HJXODWLRQV
&,%
&OLQLFDO,QYHVWLJDWRU¶V%URFKXUH
&5)
&DVH5HSRUW)RUP
&52
&RQWUDFW5HVHDUFK2UJDQL]DWLRQ
)'$
)RRGDQG'UXJ$GPLQLVWUDWLRQ
*&3
*RRG&OLQLFDO3UDFWLFH
+,3$$
+HDOWK,QVXUDQFH3RUWDELOLW\DQG$FFRXQWDELOLW\$FW
,%
,QYHVWLJDWRU¶V%URFKXUH
,&)
,QIRUPHG&RQVHQW)RUP
,&+
,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ
,'(
,QYHVWLJDWLRQDO'HYLFH([HPSWLRQ
,(&
,QGHSHQGHQW(WKLFV&RPPLWWHH
,5%
,QVWLWXWLRQDO5HYLHZ%RDUG
0HG'5$
0HGLFDO'LFWLRQDU\IRU5HJXODWRU\$FWLYLWLHV
023
0DQXDORI3URFHGXUHV
1,+
1DWLRQDO,QVWLWXWHVRI+HDOWK
2+53
2IILFHIRU+XPDQ5HVHDUFK3URWHFWLRQV
2+65
2IILFHIRU+XPDQ6XEMHFWV5HVHDUFK
3+,
3URWHFWHG+HDOWK,QIRUPDWLRQ
3,
3ULQFLSDO,QYHVWLJDWRU
4$
4XDOLW\$VVXUDQFH
4&
4XDOLW\&RQWURO
6$(
6HULRXV$GYHUVH(YHQW6HULRXV$GYHUVH([SHULHQFH
623
6WDQGDUG2SHUDWLQJ3URFHGXUH
8$'(
8QDQWLFLSDWHG$GYHUVH'HYLFH(IIHFW
86$'(8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW
CR-5871 Protocol v4.0
 (4) 
Page 69 of 141
CONFIDENTIAL

3DJHRI

$WWDFKPHQW(




/LPEDODQG%XOEDU&RQMXQFWLYDO5HGQHVV
5('1(66
2'
26
1
7
,
6
1
7
,
6
/LPEDO
%XOEDU
/(9(/2)5('1(665HIHUWRWKH(IURQ*UDGLQJ6FDOH
 1RUPDO 
7UDFH

0LOG
0RGHUDWH
6HYHUH
CR-5871 Protocol v4.0
 (4) 
Page 77 of 141
CONFIDENTIAL

$33(1',;%
([SDQGHG6RGLXP)OXRUHVFHLQ&RUQHDO6WDLQLQJ

CR-5871 Protocol v4.0
 (4) 
Page 78 of 141
CONFIDENTIAL

$33(1',;&
/HQV)LWWLQJ&KDUDFWHULVWLFV

CR-5871 Protocol v4.0
 (4) 
Page 83 of 141
CONFIDENTIAL

$33(1',;'
6XEMHFW5HSRUWHG2FXODU6\PSWRPV3UREOHPV

CR-5871 Protocol v4.0
 (4) 
Page 90 of 141
CONFIDENTIAL

$33(1',;(
7UDSSHG%DFN6XUIDFH'HEULVDQG0XFLQ3OXJ*UDGLQJ3URFHGXUH

CR-5871 Protocol v4.0
 (4) 
Page 92 of 141
CONFIDENTIAL

$33(1',;)
)URQWDQG%DFN6XUIDFH/HQV'HSRVLW*UDGLQJ3URFHGXUH

CR-5871 Protocol v4.0
 (4) 
Page 99 of 141
CONFIDENTIAL

$33(1',;*
'HWHUPLQDWLRQRI'LVWDQFH6SKHURF\OLQGULFDO5HIUDFWLRQV

CR-5871 Protocol v4.0
 (4) 
Page 105 of 141
CONFIDENTIAL

$33(1',;+
%LRPLFURVFRS\6FDOH

CR-5871 Protocol v4.0
 (4) 
Page 112 of 141
CONFIDENTIAL

$33(1',;-
'LVWDQFHDQG1HDU9LVXDO$FXLW\(YDOXDWLRQ

CR-5871 Protocol v4.0
 (4) 
Page 122 of 141
CONFIDENTIAL

$33(1',;.
7RULF)LW(YDOXDWLRQ

CR-5871 Protocol v4.0
 (4) 
Page 127 of 141
CONFIDENTIAL

$33(1',;/
'LVWDQFH/RJ0$59LVXDO$FXLW\0HDVXUHPHQW3URFHGXUH

CR-5871 Protocol v4.0
 (4) 
Page 131 of 141
CONFIDENTIAL

$33(1',;0
:KLWH/LJKW/HQV6XUIDFH:HWWDELOLW\

CR-5871 Protocol v4.0
 (4) 
Page 135 of 141
CONFIDENTIAL

$33(1',;1
9LVXDO$FXLW\&KDUW/XPLQDQFHDQG5RRP,OOXPLQDWLRQ7HVWLQJ
 
CR-5871 Protocol v4.0
 (4) 
Page 137 of 141
CONFIDENTIAL