Clinical trial NCT03256526
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: Pfizer
Start date: 2017-09-27; Completion date: 2018-04-27
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Detailed description:

Arms: arm 1: None arm 2: 75 mg once daily arm 3: 300 mg once daily
Interventions: intervention 1: Placebo intervention 2: PF-06835919 Low Dose intervention 3: PF-06835919 High Dose
Intervention descriptions: intervention 1: 0 mg intervention 2: 75 mg once daily intervention 3: 300 mg once daily

Protocol documents:
Prot_000.pdf: 
3)
&
)LQDO3URWRFRO-XQH

3DJH


$3+$6($5$1'20,=(''28%/(%/,1'3/$&(%2&21752//('
$503$5$//(/*5283678'<72(9$/8$7(7+(6$)(7<
72/(5$%,/,7<$1'3+$50$&2'<1$0,&62)
3)$'0,1,67(5('21&('$,/<)25:((.6,1$'8/76:,7+
121$/&2+2/,&)$77</,9(5',6($6(

,QYHVWLJDWLRQDO3URGXFW,31XPEHU
3)
,31DPH
1RW$SSOLFDEOH 1$
8QLWHG6WDWHV86,QYHVWLJDWLRQDO1HZ
'UXJ,1'1XPEHU

(XURSHDQ&OLQLFDO7ULDOV'DWDEDVH
(XGUD&71XPEHU

3URWRFRO1XPEHU
&
3KDVH
D


090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
'RFXPHQW+LVWRU\
'RFXPHQW
9HUVLRQ'DWH
6XPPDU\ RI&KDQJHVDQG
5DWLRQDOH
2ULJLQDO SURWRFRO
-XQH
1$
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
7$%/(2)&217(176
/,672)),*85(6 
$33(1',&(6 
6&+('8/(2)$&7,9,7,(6 
,1752'8&7,21 
0HFKDQLVPRI$FWLRQ,QGLFDWLRQ 
%DFNJURXQG 
 
 
 
 
&OLQLFDO([SHULHQFHZLWK3) 
 

 
6WXG\5DWLRQDOH 
 
5DWLRQDOHIRU3RSXODWLRQ(QUROOHG 
'RVH5DWLRQDOH 
 
678'<2%-(&7,9(6$1'(1'32,176 
678'<'(6,*1 
6WXG\2YHUYLHZ 
68%-(&7(/,*,%,/,7<&5,7(5,$ 
,QFOXVLRQ&ULWHULD 
([FOXVLRQ&ULWHULD 
5DQGRPL]DWLRQ&ULWHULD 
/LIHVW\OH5HTXLUHPHQWV 
'LHW 
$OFRKRO&DIIHLQHDQG7REDFFR 
3K\VLFDO$FWLYLW\ 
&RQWUDFHSWLRQ 
6SRQVRU¶V4XDOLILHG0HGLFDO3HUVRQQHO 
CCI
CCI
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
678'<75($70(176 
$OORFDWLRQWR7UHDWPHQW 
%UHDNLQJWKH%OLQG 
6XEMHFW&RPSOLDQFH 
,QYHVWLJDWLRQDO3URGXFW6XSSOLHV 
'RVDJH)RUPVDQG3DFNDJLQJ 
3UHSDUDWLRQDQG'LVSHQVLQJ 
$GPLQLVWUDWLRQ 
,QYHVWLJDWLRQDO3URGXFW6WRUDJH 
,QYHVWLJDWLRQDO3URGXFW$FFRXQWDELOLW\ 
'HVWUXFWLRQRI,QYHVWLJDWLRQDO3URGXFW6XSSOLHV 
&RQFRPLWDQW7UHDWPHQWV 
0HGLFDWLRQVIRU*O\FHPLF&RQWURO 
/LSLGPRGLI\LQJ0HGLFDWLRQV 
$QWLK\SHUWHQVLYH0HGLFDWLRQV 
2WKHU$FFHSWDEOH&RQFRPLWDQW0HGLFDWLRQV 
2WKHU3URKLELWHG&RQFRPLWDQW0HGLFDWLRQV 
5HVFXH0HGLFDWLRQ 
678'<352&('85(6 
6FUHHQLQJ9LVLWVDQG 
5XQLQ3HULRG9LVLW 
%DVHOLQH05,3'))9LVLW 
6WXG\3HULRG 
'D\9LVLW 
'D\9LVLW 
'D\9LVLW 
'D\9LVLW 
)ROORZXS9LVLW9LVLW 
)ROORZXS&RQWDFW 
6XEMHFW:LWKGUDZDO 
$66(660(176 
&OLQLFDO/DERUDWRU\7HVWV 
3K\VLFDO([DPLQDWLRQ 
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
0HDVXUHPHQWRI:DLVW&LUFXPIHUHQFH 
%RG\:HLJKW 
OHDG(OHFWURFDUGLRJUDP 
%ORRG3UHVVXUHDQG3XOVH5DWH 
/LYHU)DW$VVHVVPHQWV 
$VVHVVPHQWRI/LYHU)DWDQG6WLIIQHVV8VLQJ)LEUR6FDQ 
$VVHVVPHQWRI/LYHU)DW8VLQJ05,3'))$FTXLVLWLRQDQG$QDO\VLV 
$QDO\VLVRI05,3')),PDJHV,QFOXGLQJ 'HWHUPLQDWLRQ RI
(OLJLELOLW\ 
0DQDJHPHQWRI,QFLGHQWDO)LQGLQJV 
3RVWKRF$QDO\VHV 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$'9(56((9(175(3257,1* 
5HTXLUHPHQWV 
$GGLWLRQDO'HWDLOV2Q5HFRUGLQJ$GYHUVH(YHQWVRQWKH&5) 
(OLFLWLQJ$GYHUVH(YHQW,QIRUPDWLRQ 
:LWKGUDZDOIURPWKH6WXG\'XHWR$GYHUVH(YHQWVVHHDOVRWKH
6XEMHFW:LWKGUDZDOVHFWLRQ 
7LPH3HULRGIRU&ROOHFWLQJ$(6$(,QIRUPDWLRQ 
5HSRUWLQJ6$(VWR3IL]HU6DIHW\ 
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
5HFRUGLQJ1RQVHULRXV$(VDQG6$(VRQWKH&5) 
&DXVDOLW\$VVHVVPHQW 
6SRQVRU¶V5HSRUWLQJ5HTXLUHPHQWVWR5HJXODWRU\$XWKRULWLHV 
'HILQLWLRQV 
$GYHUVH(YHQWV 
$EQRUPDO7HVW)LQGLQJV 
6HULRXV$GYHUVH(YHQWV 
+RVSLWDOL]DWLRQ 
6HYHULW\$VVHVVPHQW 
6SHFLDO6LWXDWLRQV 
3URWRFRO6SHFLILHG6HULRXV$GYHUVH(YHQWV 
3RWHQWLDO&DVHVRI'UXJ,QGXFHG/LYHU,QMXU\ 
([SRVXUHWRWKH,3'XULQJ 3UHJQDQF\RU%UHDVWIHHGLQJDQG
2FFXSDWLRQDO([SRVXUH 
([SRVXUH'XULQJ3UHJQDQF\ 
([SRVXUH'XULQJ%UHDVWIHHGLQJ 
2FFXSDWLRQDO([SRVXUH 
0HGLFDWLRQ(UURUV 
0HGLFDWLRQ(UURUV 
'$7$$1$/<6,667$7,67,&$/0(7+2'6 
6DPSOH6L]H'HWHUPLQDWLRQ 
(IILFDF\$QDO\VLV 
$QDO\VLVRIWKH3ULPDU\(QGSRLQW 
 
 
6DIHW\$QDO\VLV 
(OHFWURFDUGLRJUDP$QDO\VLV 
9LWDO6LJQV 
,QWHULP$QDO\VLV 
'DWD0RQLWRULQJ&RPPLWWHH 
48$/,7<&21752/$1'48$/,7<$6685$1&( 
'$7$+$1'/,1*$1'5(&25'.((3,1* 
&DVH5HSRUW)RUPV(OHFWURQLF'DWD5HFRUG 
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
5HFRUG5HWHQWLRQ 
(7+,&6 
,QVWLWXWLRQDO5HYLHZ%RDUG(WKLFV&RPPLWWHH 
(WKLFDO&RQGXFWRIWKH6WXG\ 
6XEMHFW,QIRUPDWLRQDQG&RQVHQW 
5HSRUWLQJRI6DIHW\,VVXHVDQG6HULRXV%UHDFKHVRIWKH3URWRFRORU,&+
*&3 
'(),1,7,212)(1'2)75,$/ 
(QGRI7ULDOLQ$OO3DUWLFLSDWLQJ&RXQWULHV 
6321625',6&217,18$7,21&5,7(5,$ 
38%/,&$7,212)678'<5(68/76 
&RPPXQLFDWLRQRI5HVXOWVE\3IL]HU 
3XEOLFDWLRQVE\,QYHVWLJDWRUV 
5()(5(1&(6 

/,672)7$%/(6
7DEOH 
6XPPDU\RI$OO&DXVDOLW\7($(V5HSRUWHGLQ),+6WXG\& 
7DEOH 
6XPPDU\RI3ODVPD3) 3KDUPDFRNLQHWLF3DUDPHWHUV)ROORZLQJ
6LQJOH2UDO'RVHV& 
7DEOH 
'5$)76XPPDU\RI3ODVPD3) 3KDUPDFRNLQHWLF3DUDPHWHUV
)ROORZLQJ0XOWLSOH2UDO'RVHVIRU'D\V& 
7DEOH 
'5$)76XPPDU\RI6LQJOH 'RVH3ODVPD$WRUYDVWDWLQ3KDUPDFRNLQHWLF
3DUDPHWHUVDW%DVHOLQHDQG)ROORZLQJ $GPLQLVWUDWLRQ RI
3)& 
7DEOH 
6WXG\7UHDWPHQW5HJLPHQV 
7DEOH 
&OLQLFDO/DERUDWRU\7HVWV 

/,672)),*85(6
)LJXUH 
&6WXG\'HVLJQ 

$33(1',&(6
$SSHQGL[$EEUHYLDWLRQV 

090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO3URWRFRO-XQH

3DJH
6&+('8/(2)$&7,9,7,(6
7KHVFKHGXOHRIDFWLYLWLHVWDEOHEHORZ SURYLGHVDQRYHUYLHZRIWKHSURWRFRO YLVLWVDQG
SURFHGXUHV5HIHUWR6HFWLRQDQGRIWKHSURWRFRO IRUGHWDLOHG LQIRUPDWLRQ RQHDFK
SURFHGXUHDQGDVVHVVPHQWUHTXLUHGIRUFRPSOLDQFH ZLWKWKHSURWRFRO 
7KHLQYHVWLJDWRU PD\VFKHGXOHYLVLWV XQSODQQHG YLVLWV LQDGGLWLRQ WRWKRVHOLVWHGRQWKH
VFKHGXOHRIDFWLYLWLHV WDEOHLQRUGHUWRFRQGXFWHYDOXDWLRQV RUDVVHVVPHQWVUHTXLUHGWRSURWHFW
WKHZHOOEHLQJ RIWKHVXEMHFW
9LVLW,GHQWLILHU
>IRUDEEUHYLDWLRQVUHIHUWR$SSHQGL[@
6FUHHQ
6FUHHQ
5XQ,Q%DVHOL
QH
7UHDWPHQW3KDVHD
)ROORZXS
(DUO\
7HUPLQDWLRQ
:HHN5HODWLYHWR'RVLQJRQ'D\






 E
'D\V5HODWLYHWR'RVLQJRQ'D\
r r

rrr 

9LVLWWR6LWH










,QIRUPHGFRQVHQW	GHPRJUDSK\
;










0HGLFDO	PHGLFDWLRQKLVWRU\XSGDWH
;

;

;
;
;
;
;
;
;
/LYHUIDWDQGVWLIIQHVVYLD)LEUR6FDQ
;



;
;
;
;
;

;
/LYHUIDWYLD05,3'))

;

;



;F



3K\VLFDOH[DPLQDWLRQG
;

;





;

;
&RQILUPFRQWUDFHSWLYHPHWKRG
;

;

;
;
;
;
;
;
;
6HULRXV 	QRQVHULRXV$(PRQLWRULQJ
;
o
;
o
;
;
;
;
;
;
;
%RG\ZHLJKW
;

;

;
;
;
;
;

;
6XSLQHOHDG(&*
;

;

;
;
;
;
;

;
6HDWHGYLWDOV%3	SXOVHUDWH
;

;

;
;
;
;
;

;
5DQGRPL]DWLRQLQWULDOYLD,57




;






'LVSHQVH,3YLD,57


;

;
;
;




:LWQHVVHGGRVLQJRQVLWHRI,3


;

;
;
;
;



&RPSOLDQFHYLDSLOOFRXQWRIUHWXUQHG,3




;
;
;
;


;
$GPLQLVWUDWLRQRI,3


;
o
;
o
o
;



%ORRG&ROOHFWLRQVDIWHU!KRXUIDVW











&OLQLFDOODERUDWRU\WHVWV
;

;

;
;
;
;
;

;
)6+IHPDOHV+HS%+HS&+,9
FRDJXODWLRQDDQWLWU\SVLQFHUXORSODVPLQ
;





















































































8ULQH&ROOHFWLRQV











8ULQHGUXJ WHVW
;






















8ULQDO\VLVLQFOXGLQJPLFURVFRS\
;

;

;
;
;
;
;

;
D $OOSURFHGXUHVEHIRUHPRUQLQJGRVHRI,3
E 0D\RFFXUYLDWHOHSKRQHFRQWDFWDQGPXVWRFFXUGD\VIURPDGPLQLVWUDWLRQRIWKHILQDOGRVHRIGRXEOHEOLQG,3
F 05,3'))DVVHVVPHQWWREHSHUIRUPHGZLWKLQDSSUR[LPDWHO\KRXUVSULRUWRWKH9LVLWRURQWKHVDPHGD\DV9LVLW
G ,QFOXGHVDUPDQGZDLVWFLUFXPIHUHQFHDQGKHLJKWDW9LVLWRQO\
H $EORRGVDPSOHIRU3.DQDO\VLVZLOOEHFROOHFWHGSULRUWRGRVLQJDW9LVLW$QDGGLWLRQDO3.VDPSOHZLOOEHFROOHFWHGWKH
IROORZLQJGD\ZKHQVXEMHFWVUHWXUQWRWKHVLWHWRFRPSOHWHWKHKRXUXULQHFROOHFWLRQSULRUWRGRVLQJ
I ,IQRWFROOHFWHGRQWKHGHVLJQDWHGFROOHFWLRQGD\FROOHFWDWWKHQH[WDYDLODEOHWLPHSRLQWZKHQELRVSHFLPHQVDUHEHLQJFROOHFWHG
LQFRQMXQFWLRQZLWKDVXEMHFWYLVLW
J 6XEMHFWVWRSHUIRUPWZRKRXUXULQHFROOHFWLRQVDVRXWSDWLHQWVRQFHGXULQJWKHGD\5XQ,QDQGDQRWKHUZLWKLQKRXUVRI
9LVLW'D\
CCI
CC
I
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
,1752'8&7,21
.HWRKH[RNLQDVH.+.LVDQHQ]\PHFDWDO\]LQJ WKHFRQYHUVLRQ RIIUXFWRVHDQGDGHQRVLQH
WULSKRVSKDWH $73WRIUXFWRVHSKRVSKDWH )3DQGDGHQRVLQHGLSKRVSKDWH $'3WKH
ILUVWFRPPLWWHG VWHSLQIUXFWRVHPHWDEROLVP /RVVRIIXQFWLRQ PXWDWLRQ LQ.+.NQRZQDV
(VVHQWLDO)UXFWRVXULD LVDUDUHDXWRVRPDOJHQHWLFFRQGLWLRQ 2QOLQH0HQGHOLDQ ,QKHULWDQFHLQ
0DQRU20,0 ZKLFKLVDV\PSWRPDWLF DQGLVRQO\UHFRJQL]HG E\WKHDSSHDUDQFH
RIIUXFWRVHLQWKHXULQHDIWHUIUXFWRVHFRQVXPSWLRQ 3) LVDSRWHQWUHYHUVLEOH
LQKLELWRU RIKXPDQ.+.,WLVDQWLFLSDWHGWKDWLQKLELWLRQ RI.+.ZLOO GHFUHDVHKHSDWLFGH
QRYROLSRJHQHVLV DQGVWHDWRVLVWKHUHE\DPHOLRUDWLQJ WKHSDWKRJHQHVLVRIQRQDOFRKROLF IDWW\
OLYHUGLVHDVH1$)/'DQGLWVSURJUHVVLRQ WRQRQDOFRKROLF VWHDWRKHSDWLWLV1$6+,Q
DGGLWLRQ LWLVDQWLFLSDWHGWKDW.+.LQKLELWLRQ ZLOO LPSURYHFLUFXODWLQJ OLSLG DQGOLSRSURWHLQ
SURILOHV DVZHOODVLQVXOLQ VHQVLWLYLW\
7KHSXUSRVHRIWKLVVWXG\LVWRDVVHVVVDIHW\DQGWROHUDELOLW\ DVZHOODVWKHHIIHFWRI
3) RQOLYHUIDWDQGDGGLWLRQDO SKDUPDFRG\QDPLF 3'H[SORUDWRU\SDUDPHWHUVLQ
VXEMHFWVZLWK1$)/'
0HFKDQLVPRI$FWLRQ,QGLFDWLRQ
3) LVD.+.LQKLELWRU WKDWLVFXUUHQWO\EHLQJ GHYHORSHG IRUWKHWUHDWPHQWRI
1$)/'1$6+
%DFNJURXQG
)UXFWRVHPHWDEROLVP XQOLNH JOXFRVHPHWDEROLVP LVQRWVXEMHFWWRUHJXODWRU\IHHGEDFN
LQKLELWLRQ LQQRUPDOKXPDQELRORJ\ $VDFRQVHTXHQFHRIXQUHVWUDLQHGPHWDEROLVP IUXFWRVH
UDSLGO\ JHQHUDWHVDQXPEHURIUHDFWLYHDQGVLJQDOLQJ PHWDEROLWHV WKDWFRQWULEXWH WRPHWDEROLF
GLVHDVHSURJUHVVLRQ $ORQJ ZLWKWKHODFNRIIHHGEDFNLQKLELWLRQ KHSDWLFIUXFWRVHPHWDEROLVP
KDVEHHQVKRZQWRUHGXFHOLYHU$73FRQFHQWUDWLRQVDIWHUDVLQJOH LQWUDYHQRXV,9EROXVRI
IUXFWRVH'HSOHWLRQRI$73OHDGVWRWKHDFWLYDWLRQ RIDGHQRVLQHPRQRSKRVSKDWH $03
GHDPLQDVHDQGVXEVHTXHQW LQFUHDVHVLQXULFDFLGOHYHOVWKDWKDYHEHHQVKRZQWRGLUHFWO\
UHJXODWHKHSDWLFOLSRJHQHVLV WKURXJK JHQHUDWLRQRIPLWRFKRQGULDO R[LGDWLYH VWUHVV
$GGLWLRQDOO\ SUHFOLQLFDO VWXGLHVKDYHGHPRQVWUDWHGWKDWIUXFWRVHUDSLGO\ HQULFKHVJO\FRO\WLF
PHWDEROLWH SRROV OHDGLQJ WRDFWLYDWLRQ RIWKH&DUERK\GUDWH5HVSRQVH(OHPHQW%LQGLQJ
3URWHLQ&K5(%3DKLJKO\ OLSRJHQLF WUDQVFULSWLRQ IDFWRUWKDWFDQSURPRWHERWKVWHDWRVLV
DQGLQVXOLQ UHVLVWDQFHZLWKFDUERK\GUDWHRYHUIHHGLQJ 3RVWSUDQGLDO K\SHUWULJO\FHULGHPLD LV
REVHUYHGLQERWKURGHQWVDQGKXPDQVIROORZLQJ IUXFWRVHIHHGLQJ DVIUXFWRVHERWKGHFUHDVHV
YHU\ORZGHQVLW\OLSRSURWHLQ 9/'/FOHDUDQFHDQGSURPRWHVGHQRYROLSRJHQHVLV 
([FHVVLYHIUXFWRVHFRQVXPSWLRQ KDVEHHQVKRZQWRFDXVHIHDWXUHVRIPHWDEROLF V\QGURPH
DQG1$)/',QKXPDQVVXSSOHPHQWDWLRQ RIDQRUPDOGLHWZLWKRIWKHFDORULHVDV
IUXFWRVHEXWQRWDVJOXFRVHFDXVHGK\SHUOLSLGHPLD ZLWKLQ ZHHNV$GGLWLRQDOO\ WKHVH
VXEMHFWVGHYHORSHGLQVXOLQ UHVLVWDQFHDVHYLGHQFHGE\LQFUHDVHGLQVXOLQ H[FXUVLRQ GXULQJDQ
RUDOJOXFRVHWROHUDQFHWHVW,QFUHDVHGVXJDULQWDNH LQWKHIRUPRIFDUERQDWHGEHYHUDJHVKDV
EHHQDVVRFLDWHGZLWK1$)/'LQSDWLHQWVZKRODFNRWKHUIHDWXUHVRIPHWDEROLF V\QGURPH
VXJJHVWLQJ WKDWIUXFWRVHLQWDNHLQGHSHQGHQW RIPHWDEROLF GLVHDVHFDQLQFUHDVHOLYHU IDW,Q
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
DVHSDUDWHVWXG\ZLWKVXEMHFWVFRQVXPLQJ ZHLJKWQHXWUDO GLHWVFRQWDLQLQJ RIGLHWDU\
FDORULHVDVIUXFWRVHLQFUHDVHGKHSDWLFOLSLG DQGGHFUHDVHGKHSDWLFLQVXOLQ VHQVLWLYLW\ ZHUH
REVHUYHGDIWHUGD\VRIKLJKIUXFWRVH FRQVXPSWLRQ &RQYHUVHO\ UHVWULFWLQJ GLHWDU\VXJDU
LQWDNHIURPWRIRUGD\VLPSURYHG LQVXOLQ VHQVLWLYLW\ DQGUHGXFHGKHSDWLFOLSLG LQ
REHVHDGROHVFHQWV,QDVHSDUDWHVWXG\IUXFWRVHDWRURIWKHGDLO\ FDORULF
LQWDNHVKRZHGDGRVHUHVSRQVLYH VOLJKW HOHYDWLRQ LQSODVPDWULJO\FHULGHV DQGHOHYDWLRQ LQ XULF
DFLG,QVWXGLHVZLWKPDWFKHGFDORULHVSURYLGHG DVIUHHJOXFRVHIUXFWRVHZDVXQLTXH LQLWV
DELOLW\ WRSURPRWHLQVXOLQ UHVLVWDQFHYLVFHUDOREHVLW\DQGK\SHUOLSLGHPLD &ROOHFWLYHO\
WKHVHGDWDVXJJHVWWKDWWKHIUXFWRVHQRWJOXFRVHFRPSRQHQW RIGLHWDU\VXJDULVXQLTXH LQLWV
DELOLW\ WRSURPRWHIHDWXUHVRIPHWDEROLF V\QGURPHLQFOXGLQJ VWHDWRVLVLQVXOLQ UHVLVWDQFHDQG
REHVLW\ 
1$6+LVDFOLQLFDO DQGKLVWRORJLFDO VXEVHWRI1$)/'WKDWLVDVVRFLDWHGZLWKLQFUHDVHG
DOOFDXVHPRUWDOLW\ FLUUKRVLVDQGHQGVWDJHOLYHUGLVHDVHLQFUHDVHGFDUGLRYDVFXODUPRUWDOLW\
DQGLQFUHDVHGLQFLGHQFHRIERWKOLYHUUHODWHG DQGQRQOLYHUUHODWHG FDQFHUV3UHYDOHQFHRI
1$)/'LVHVWLPDWHGDWRIWKH86SRSXODWLRQ ZKLOH SUHYDOHQFHRI1$6+LV
HVWLPDWHGDWRI86SRSXODWLRQ 5LVNIDFWRUVIRU1$6+LQFOXGH REHVLW\ LQVXOLQ
UHVLVWDQFHW\SHGLDEHWHVPHOOLWXV 7'0K\SHUWHQVLRQ DQGG\VOLSLGHPLD DVPDQLIHVWHG
E\ORZOHYHOVRIKLJKGHQVLW\OLSRSURWHLQ FKROHVWHURO +'/&DQGHOHYDWHGWULJO\FHULGHV 
7KHUHDUHQRWKHUDSLHVFXUUHQWO\DSSURYHGIRUWKHWUHDWPHQWRI1$6+DOWKRXJK DJURZLQJ
ERG\RIHYLGHQFHGHPRQVWUDWHVWKHXUJHQWQHHGIRUVXFKWKHUDSLHV1$6+LVGLDJQRVHG
FOLQLFDOO\ E\OLYHU ELRSV\GHPRQVWUDWLQJ VWHDWRVLVLQIODPPDWLRQ DQGF\WRORJLFDO EDOORRQLQJ
RIKHSDWRF\WHVRIWHQZLWKYDU\LQJGHJUHHVRIILEURVLV7KHFOLQLFDO SURJUHVVLRQ RI1$6+
LQYROYHV LQFUHDVLQJGHJUHHVRIILEURVLV ZLWKFLUUKRVLVDQGRUKHSDWRFHOOXODU FDUFLQRPD
GHYHORSLQJ LQDVXEVHWRISDWLHQWV 3DWLHQWVZLWK1$6+PD\EHDV\PSWRPDWLF RUKDYH
QRQVSHFLILF V\PSWRPVVXFKDVIDWLJXHGHVSLWHKDYLQJ VLJQLILFDQW GLVHDVHVKRZQE\OLYHU
ELRSV\ 0RUHVHYHUH1$6+LVDVVRFLDWHGZLWKHOHYDWHGULVNIRUSURJUHVVLRQ WRFLUUKRVLVDQG
OLYHUUHODWHG PRUWDOLW\
$GGLWLRQDO LQIRUPDWLRQ IRUWKLVFRPSRXQG PD\EHIRXQGLQWKHVLQJOH UHIHUHQFHVDIHW\
GRFXPHQW656'ZKLFKIRUWKLVVWXG\LVWKH,QYHVWLJDWRU¶V%URFKXUHIRU3) $
VXPPDU\RIWKHLQIRUPDWLRQ UHOHYDQWWRWKLVVWXG\ LVSUHVHQWHGEHORZ













CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH


 









 







 










 


 

 










CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH














 

















 








&OLQLFDO([SHULHQFHZLWK3)
$VRI-XQHWKHILUVWLQKXPDQ),+VWXG\& KDVEHHQFRPSOHWHG DQGWKH
RQJRLQJ PXOWLSOH DVFHQGLQJGRVHVWXG\& FRPSOHWHG ZHHNVRIGRVLQJ LQFRKRUWV
RIVXEMHFWV,QDGGLWLRQ VXEMHFWVFRPSOHWHG DGUXJGUXJ LQWHUDFWLRQ DVVHVVPHQWZLWK
DWRUYDVWDWLQ LQZKLFKGRVHVRIPJDQGPJRI3) ZHUHHDFKDGPLQLVWHUHG
IRUGD\VGD\VRIWRWDOGRVLQJ $WRWDORIKHDOWK\DGXOWVXEMHFWVDOOPDOHVKDYHEHHQ
UDQGRPL]HG LQWKHVHVWXGLHV2YHUDOO VXEMHFWVZHUHH[SRVHGWRDWOHDVWDVLQJOH
RUDOGRVHRI3) ZLWK RIWKHVHVXEMHFWVH[SRVHGWRUHSHDWHGGRVHVRI
3) 
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH



























CCI
CCI
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH


 








 


























CCI
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 




















 




 









CCI
CCI
CCI
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH







6WXG\5DWLRQDOH
7KHFXUUHQWVWXG\LVWKHILUVWWULDOGHVLJQHGWRHYDOXDWHWKHHIIHFWRIZHHNVRIRUDO
RQFHGDLO\ GRVLQJ RI3) RQOLYHUIDWDQGRWKHU3'H[SORUDWRU\ SDUDPHWHUVLQ
DGXOWVZLWK1$)/'






 




















CCI
CCI
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH




























 

















CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH

 




 















 





5DWLRQDOHIRU3RSXODWLRQ(QUROOHG
7KHSDWLHQWSRSXODWLRQ PRVWOLNHO\ WREHQHILWIURPWKHUDS\ZLWKD.+.LQKLELWRU .+.LLV
FRPSULVHGRIWKRVHZKRDUHREHVHGLDEHWLF DQGRUKDYHPHWDEROLF V\QGURPH7KHUHIRUHWKH
VWXG\SRSXODWLRQ LQFOXGHG LQWKLVVWXG\ ZLOO EHREHVHVXEMHFWVERG\PDVVLQGH[>%0,@
NJPZLWKFOLQLFDO LQGLFDWRUV RIPHWDEROLF V\QGURPH DQGRU7'0








 



CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH


 








 















'RVH5DWLRQDOH
7KLVVWXG\LVSODQQHG DVDDUP SDUDOOHO JURXS VWXG\ZLWKDFWLYH3) GRVHV
PJRQFHGDLO\>4'@DQGPJ4'DQGSODFHER WRHYDOXDWHFKDQJHVLQOLYHU IDW


















CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 






































CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH

 
678'<2%-(&7,9(6$1'(1'32,176
3ULPDU\2EMHFWLYH
3ULPDU\(QGSRLQW
7RHYDOXDWHWKHHIIHFWRIGDLO\DGPLQLVWUDWLRQRI
3)RYHUZHHNVRQOLYHUIDWLQDGXOWV
ZLWK1$)/'
3HUFHQWFKDQJHIURPEDVHOLQHLQOLYHUIDWDW:HHNDV
DVVHVVHGE\05,3'))
6HFRQGDU\2EMHFWLYHV
6HFRQGDU\(QGSRLQWV
7RHYDOXDWHWKHVDIHW\DQGWROHUDELOLW\RI
3)DGPLQLVWHUHGGDLO\RYHUZHHNV
WRDGXOWVZLWK1$)/'
$VVHVVPHQWRI7($(VFOLQLFDOODERUDWRU\WHVWVYLWDO
VLJQVDQGOHDG(&*V
























































,QDOOFDVHVEDVHOLQHGHILQHGDVUHVXOWFORVHVWSULRUWRGRVLQJDW9LVLW'D\
CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
678'<'(6,*1
6WXG\2YHUYLHZ
7KLVZLOO EHDUDQGRPL]HG GRXEOHEOLQG VWUDWLILHG SODFHERFRQWUROOHG DUPSODFHERSOXV
DFWLYHGRVHVRI3) SDUDOOHOJURXS VWXG\>UHIHUWR)LJXUH @
)LJXUH &6WXG\'HVLJQ
F/U
(V9)
(7-14 days 
post last 
dose)
Screen 1 
(V1)
Screen 2 
(V2)
MRI-PDFF
Day -14 ± 2
(V3)
Day 28±2
(V7)
Day 40±2
(V8)
MRI-PDFF*
3 
weeks 
Day 1
Randomization
(V5)
Day 14±2
(V6)
PF-06835919/placebo (V5-V8)
F/U
(V9)
(7-14 days 
post last 
dose)
Screen 1
(V1)
Screen 2
(V2)
MRI-PDFF
Day -14 ± 2
(V3)
Day 28±2
(V7)
Day 40±2
(V8)
MRI-PDFF*
3 
weeks
Day 1
Randomization
(V5)
Day 14±2
(V6)
PF-06835919/placebo (V5-V8)
Phone F/U
(28-35 days 
post last 
dose)
Placebo 
Day -4±2
(V4)
MRI-PDFF
*May occur at V8 or within 24 hours prior to the V8

'HWHUPLQDWLRQ RIHOLJLELOLW\ IRUWKLVVWXG\ZLOO RFFXUYLDDVHTXHQWLDO VWHSSURFHVVVWDUWLQJ
DWWKHILUVWVFUHHQLQJYLVLW 6FUHHQ6XEMHFWVLGHQWLILHG WREHHOLJLEOH EDVHGRQ6FUHHQ
SURFHGXUHVZLOO SURFHHGWR6FUHHQWRPHDVXUHOLYHU IDWE\05,3'))
2QFHFRQILUPHG WREHHOLJLEOH EDVHGRQUHVXOWVRI6FUHHQVXEMHFWVZLOO SURJUHVVWRD5XQLQ
SHULRG 9LVLW DWZKLFKWLPHVXEMHFWVUHFHLYHVLQJOHEOLQG SODFHERIRUDSSUR[LPDWHO\
GD\VWRHQVXUHFRPSOLDQFH ZLWKWKHDGPLQLVWUDWLRQ RI,3'XULQJWKH5XQLQ SHULRG
VXEMHFWVZLOO FRPSOHWHDKRXU XULQHFROOHFWLRQ ,QDGGLWLRQ DSSUR[LPDWHO\ GD\VSULRUWR
UDQGRPL]DWLRQ 9LVLWVXEMHFWVZLOO UHSRUWWRWKHLPDJLQJ FHQWHUWRKDYHDEDVHOLQH
05,3'))VFDQSHUIRUPHG$W9LVLW 'D\VXEMHFWVZLOO EHUDQGRPL]HG WRUHFHLYHRI
EOLQGHG ,3UHJLPHQVIRUDGXUDWLRQ RIDSSUR[LPDWHO\ ZHHNVLH rGD\V$VHFRQG
KRXUFROOHFWLRQ ZLOO EHSHUIRUPHGDURXQG9LVLW'D\ZKLFKZLOO UHTXLUHDQ
DGGLWLRQDO YLVLWWRWKHVWXG\VLWH
7KLVVWXG\LQFOXGHVDWRWDORIVFKHGXOHGRXWSDWLHQW YLVLWV WRWKHVWXG\VLWHYLVLWVWRWKH
LPDJLQJ FHQWHUDQGDVDIHW\)ROORZXS WHOHSKRQHFRQWDFW7KHWRWDOSDUWLFLSDWLRQ IURP9LVLW
6FUHHQWRWKHRQVLWH)ROORZXS YLVLW 9LVLWZLOO EHXSWRDSSUR[LPDWHO\  ZHHNV
8SWRVXEMHFWVSHUDUPZLOO EHUDQGRPL]HG DWDSSUR[LPDWHO\ VLWHVWRHQVXUHWKDWD
PLQLPXP RIDSSUR[LPDWHO\ VXEMHFWVSHUDUPFRPSOHWHWKHVWXG\7KHDSSUR[LPDWH
UDQGRPL]HG VXEMHFWVDFFRXQWIRUDSURMHFWHGSUHPDWXUHZLWKGUDZDOUDWHRI
68%-(&7(/,*,%,/,7<&5,7(5,$
7KLVVWXG\FDQIXOILOO LWVREMHFWLYHV RQO\LIDSSURSULDWHVXEMHFWVDUHHQUROOHG 7KHIROORZLQJ
HOLJLELOLW\ FULWHULDDUHGHVLJQHGWRVHOHFWVXEMHFWVIRUZKRPSDUWLFLSDWLRQ LQWKHVWXG\ LV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
FRQVLGHUHGDSSURSULDWH$OOUHOHYDQWPHGLFDODQGQRQPHGLFDO FRQGLWLRQV VKRXOG EHWDNHQLQWR
FRQVLGHUDWLRQ ZKHQGHFLGLQJ ZKHWKHUDSDUWLFXODUVXEMHFWLVVXLWDEOHIRUWKLVSURWRFRO
6XEMHFWHOLJLELOLW\ VKRXOG EHUHYLHZHGDQGGRFXPHQWHGE\DQDSSURSULDWHPHPEHURIWKH
LQYHVWLJDWRU¶V VWXG\WHDPEHIRUHVXEMHFWVDUHLQFOXGHG LQWKHVWXG\
,QFOXVLRQ&ULWHULD
6XEMHFWVPXVWPHHWDOORIWKHIROORZLQJ LQFOXVLRQ FULWHULDWREHHOLJLEOH IRUHQUROOPHQW LQWR
WKHVWXG\
 0DOHVXEMHFWVRUIHPDOHVXEMHFWV RIQRQFKLOGEHDULQJ SRWHQWLDO EHWZHHQWKHDJHVRI
DQG\HDUVLQFOXVLYH DW9LVLW6FUHHQ
x )HPDOHVXEMHFWVRIQRQFKLOGEHDULQJ SRWHQWLDO PXVWPHHWDWOHDVWRIWKHIROORZLQJ
FULWHULD
D $FKLHYHGSRVWPHQRSDXVDO VWDWXVGHILQHGDVIROORZV FHVVDWLRQRIUHJXODU
PHQVHVIRUDWOHDVWFRQVHFXWLYHPRQWKVZLWKQRDOWHUQDWLYHSDWKRORJLFDO RU
SK\VLRORJLFDO FDXVHVWDWXVVKRXOGEHFRQILUPHG ZLWKDVHUXP
IROOLFOHVWLPXODWLQJ KRUPRQH)6+OHYHOFRQILUPLQJ WKHSRVWPHQRSDXVDO
VWDWH
E +DYHXQGHUJRQHDGRFXPHQWHGK\VWHUHFWRP\DQGRUELODWHUDORRSKRUHFWRP\ 
F +DYHPHGLFDOO\ FRQILUPHG RYDULDQIDLOXUH 
$OORWKHUIHPDOHVXEMHFWVLQFOXGLQJ IHPDOHVXEMHFWVZLWKWXEDOOLJDWLRQV DUH
FRQVLGHUHGWREHRIFKLOGEHDULQJ SRWHQWLDO 
 $W9LVLW6FUHHQWRWDOERG\ZHLJKWRI!NJOEVDQGD%0,tNJP
 $W9LVLW6FUHHQD&$370tG%PYLD)LEUR6FDQ DVVHVVPHQW
 6XEMHFWVZLWKDPHGLFDO GLDJQRVLV RI7'0EHLQJWUHDWHGZLWKQRPRUHWKDQ
DFFHSWDEOHRUDODQWLGLDEHWLF GUXJVHH6HFWLRQ RU PHHWLQJtRIWKHIROORZLQJ
FULWHULD DVDVVHVVHGE\VSRQVRULGHQWLILHG FHQWUDOODERUDWRU\ ZLWKDVLQJOH UHSHDWRQ
DQ\RIWKHVHSDUDPHWHUVSHUPLWWHGWRDVVHVVHOLJLELOLW\ LIQHHGHG
D )DVWLQJSODVPDJOXFRVH !PJG/
E )DVWLQJ +'/&PJG/IRUPDOHVDQGPJG/IRUIHPDOHVRURQ
SKDUPDFRORJLFDO DJHQWVZLWKH[SOLFLWSXUSRVHWRLQFUHDVH+'/&UHIHUWR
6HFWLRQ IRUDFFHSWDEOHYHUVXVSURKLELWHG PHGLFDWLRQV 
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
F )DVWLQJWULJO\FHULGHV !PJG/ RURQSKDUPDFRORJLFDO DJHQWVZLWKH[SOLFLW
SXUSRVHWRGHFUHDVHWULJO\FHULGHV UHIHUWR6HFWLRQ IRUDFFHSWDEOHYHUVXV
SURKLELWHG PHGLFDWLRQV
G 6HDWHGV\VWROLFEORRG SUHVVXUH%3ZLWKLQ WKHUDQJHRI PP+J
LQFOXVLYH DQGVHDWHGGLDVWROLF %3ZLWKLQ WKHUDQJHRI PP+J LQFOXVLYH RU
RQSKDUPDFRORJLF DJHQWVIRUEORRG SUHVVXUH%3FRQWURO UHIHUWR6HFWLRQ 
H :DLVWFLUFXPIHUHQFH!LQFKHVIRUPDOHVDQG!LQFKHVIRUIHPDOHVZLWKD
PD[LPXP WKDWDOORZVIRUDVXEMHFWWRILWFRPIRUWDEO\ ZLWKLQ WKH05,PDFKLQH
 $W9LVLW6FUHHQOLYHU IDWtPHDVXUHGE\05,3'))DFTXLVLWLRQ SURWRFRODW
WKH6SRQVRUTXDOLILHG ,PDJLQJ IDFLOLW\ FRQILUPHGYLDDVLQJOHUHSHDWLIGHHPHG
QHFHVVDU\E\WKH6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRUUHIHUWR6HFWLRQ 
 (YLGHQFHRIDSHUVRQDOO\ VLJQHGDQGGDWHGLQIRUPHG FRQVHQWGRFXPHQWLQGLFDWLQJ WKDW
WKHVXEMHFWKDVEHHQLQIRUPHG RIDOOSHUWLQHQWDVSHFWVRIWKHVWXG\
 :LOOLQJ DQGDEOHWRFRPSO\ ZLWKVFKHGXOHGYLVLWV WUHDWPHQWSODQODERUDWRU\WHVWVDQG
RWKHUVWXG\SURFHGXUHV
([FOXVLRQ&ULWHULD
6XEMHFWVZLWKDQ\RIWKHIROORZLQJ FKDUDFWHULVWLFVFRQGLWLRQV ZLOO QRWEHLQFOXGHG LQWKH
VWXG\
 6XEMHFWVFXUUHQWO\H[SHULHQFLQJ DQ\FOLQLFDOO\ VLJQLILFDQW RUXQVWDEOHPHGLFDO
FRQGLWLRQ WKDWPLJKWOLPLW WKHLUDELOLW\ WRFRPSOHWH WKHVWXG\WRFRPSO\ ZLWKWKH
UHTXLUHPHQWVRIWKHSURWRFRO RULQWHUIHUHZLWKWKHLQWHUSUHWDWLRQ RIVWXG\UHVXOWV
ZKLFKLQWKHMXGJPHQW RIWKHLQYHVWLJDWRU ZRXOGPDNHWKHVXEMHFWLQDSSURSULDWH IRU
HQWU\LQWRWKLVVWXG\LQFOXGLQJ GHUPDWRORJLF GLVHDVHKHPDWRORJLFDO GLVHDVH
SXOPRQDU\ GLVHDVHKHSDWLFGLVHDVHJDVWURLQWHVWLQDO GLVHDVHJHQLWRXULQDU\ GLVHDVH
HQGRFULQHGLVHDVHQHXURORJLFDO GLVHDVHDQGSV\FKLDWULFGLVHDVH
 6XEMHFWVZLWKDQ\RIWKHIROORZLQJ FOLQLFDO ODERUDWRU\ DEQRUPDOLWLHV DW9LVLW6FUHHQ
DVDVVHVVHGE\VSRQVRULGHQWLILHG FHQWUDOODERUDWRU\ DQGFRQILUPHGE\DVLQJOH
UHSHDWLIGHHPHGQHFHVVDU\
x )DVWLQJWULJO\FHULGHV !PJG/
x )DVWLQJ GLUHFW/'/&!PJG/
x $67$/7RUJDPPDJOXWDP\O WUDQVIHUDVH**7![XSSHUOLPLW RIQRUPDO
8/1
x +HPRJORELQ $F+E$&!
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x )DVWLQJSODVPDJOXFRVH !PJG/
x 7RWDOELOLUXELQ ![8/1DQGGLUHFWELOLUXELQ t8/1
x $OEXPLQ ORZHUOLPLW RIQRUPDO//1
x ,QWHUQDWLRQDO QRUPDOL]HG UDWLR,15!
 +LVWRU\RIUHJXODUDOFRKRO FRQVXPSWLRQ H[FHHGLQJ GULQNVZHHNIRUIHPDOHVRU
GULQNVZHHNIRUPDOHV>GULQN RXQFHV P/RIZLQHRURXQFHV
P/RIEHHURURXQFHVP/RIKDUGOLTXRU@ ZLWKLQ WKHSUHYLRXV
PRQWKV
 $SRVLWLYH XULQHGUXJWHVWIRULOOLFLW GUXJVDWWKH6FUHHQ9LVLW 6XEMHFWVWKDWKDYH
EHHQPHGLFDOO\ SUHVFULEHGRSLDWHVRSLRLGV RUEHQ]RGLD]HSLQHV DQGUHSRUWWKHXVHRI
WKHVHGUXJVWRWKHLQYHVWLJDWRU DWWKHVFUHHQLQJYLVLWPD\EHDOORZHGWRSDUWLFLSDWHLI
DSSURYHGE\WKHVSRQVRU
 6HDWHGV\VWROLF%3tPP+JDQGRUGLDVWROLF %3t PP+JDIWHUtPLQXWHV RI
UHVW
x ,IQHHGHG%3PD\EHUHSHDWHGPRUHWLPHVDQGWKHDYHUDJHYDOXHRIWKH%3
PHDVXUHPHQWVZLOO EHXVHGWRDVVHVVHOLJLELOLW\
 6XSLQH OHDG(&*GHPRQVWUDWLQJ 47FLQWHUYDO! PVHFRUD456LQWHUYDO
! PVHF
x ,I47FLQWHUYDO H[FHHGVPVHFRU456LQWHUYDOH[FHHGV PVHFWKH(&*
VKRXOG EHUHSHDWHGPRUHWLPHVDQGWKHDYHUDJHRIWKH47FLQWHUYDOV RU456
LQWHUYDOVVKRXOG EHXVHGWRGHWHUPLQHWKHVXEMHFW¶VHOLJLELOLW\
 6XEMHFWVZLWKDQHVWLPDWHGJORPXODU ILOWUDWLRQ UDWHP/PLQ DVFDOFXODWHGE\WKH
PRGLILFDWLRQ RIGLHWLQUHQDOGLVHDVHHTXDWLRQ0'5'DQGFRQILUPHG YLDDVLQJOH
UHSHDWLIGHHPHGQHFHVVDU\
 (YLGHQFH RUGLDJQRVLV RIRWKHUIRUPVRIFKURQLFOLYHUGLVHDVHLQFOXGLQJ EXWQRW
OLPLWHG WRWKHHQWLWLHVOLVWHGEHORZHYLGHQFHPD\LQFOXGH ODERUDWRU\ WHVWVDVDVVHVVHG
E\WKH6SRQVRULGHQWLILHG FHQWUDOODERUDWRU\ ZLWKDVLQJOHUHSHDWDW9LVLW6FUHHQ
SHUPLWWHGWRDVVHVVHOLJLELOLW\ LIQHHGHG
x +HSDWLWLV %YLUXV+%9GHILQHGE\SUHVHQFHRIKHSDWLWLV%VXUIDFHDQWLJHQ
+%V$J
x +HSDWLWLV &YLUXV+&9GHILQHGE\SUHVHQFHRIKHSDWLWLV &DQWLERG\ +&9$E
DQG+&951$ZKHQUHIOH[HGEDVHGRQDSRVLWLYH UHVXOWIRU+&9$E
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x +XPDQ,PPXQRGHILFLHQF\ 9LUXV+,9LQIHFWLRQ GHILQHGDVSUHVHQFHRI+,9
DQWLERG\
x .QRZQGLDJQRVLV RISULPDU\ELOLDU\ FLUUKRVLV SULPDU\VFOHURVLQJ FKRODQJLWLV
DXWRLPPXQH KHSDWLWLV RURYHUODSV\QGURPH
x +LVWRU\RIHVRSKDJHDOYDULFHVDVFLWHVRUKHSDWLFHQFHSKDORSDWK\
x $OFRKROLF OLYHUGLVHDVH
x :LOVRQ
V GLVHDVHGHILQHGDVFHUXORSODVPLQ OHYHO//1
x .QRZQGLDJQRVLV RIKHPRFKURPDWRVLV
x ĮDQWLWU\SVLQ $$7GHILFLHQF\ GHILQHGDV$$7OHYHO//1
x 3ULRUNQRZQGUXJLQGXFHG OLYHULQMXU\
x .QRZQRUVXVSHFWHGKHSDWRFHOOXODU FDUFLQRPDRURWKHUOLYHUFDQFHU
x +LVWRU\RIOLYHUWUDQVSODQW FXUUHQWSODFHPHQWRQDOLYHUWUDQVSODQWOLVW RUFXUUHQW
PRGHORIHQGVWDJHOLYHUGLVHDVH0(/'VFRUH!
x +LVWRORJLFDO SUHVHQFHRIFLUUKRVLVRQSULRUELRSV\
 6XEMHFWVZLWKDQ\RIWKHIROORZLQJ PHGLFDO FRQGLWLRQV 
x $Q\FRQGLWLRQ SRVVLEO\ DIIHFWLQJGUXJDEVRUSWLRQ HJSULRUEDULDWULFVXUJHU\
JDVWUHFWRP\LOHDO UHVHFWLRQ
x 'LDJQRVLV RIW\SHGLDEHWHVPHOOLWXV 
x 5HFHQWLHZLWKLQ WKHSUHYLRXVPRQWKVKLVWRU\ RIFRQJHVWLYHKHDUWIDLOXUH
1HZ<RUN+HDUW$VVRFLDWLRQ 1<+$FODVV,,,RU,9RUXQVWDEOHDQJLQD
x $KLVWRU\RIP\RFDUGLDO LQIDUFWLRQ VWURNHRUWUDQVLHQWLVFKHPLFDWWDFNLQWKH
SUHYLRXVPRQWKV
x $Q\PDOLJQDQF\ QRWFRQVLGHUHGFXUHGH[FHSWEDVDOFHOOFDUFLQRPDDQGVTXDPRXV
FHOOFDUFLQRPDRIWKHVNLQDVXEMHFWLVFRQVLGHUHGFXUHGLIWKHUHKDVEHHQQR
HYLGHQFHRIFDQFHUUHFXUUHQFHLQWKHSUHYLRXV\HDUV
x $FWLYHSODFHPHQWRIPHGLFDO GHYLFHVLQRQ WKRUDFLFRUDEGRPLQDO FDYLWLHV VXFKDV
SDFHPDNHUVGHILEULOODWRUV
x 5HFHQWKLVWRU\ LHZLWKWKHSUHYLRXVPRQWKVRI!V\PSWRPDWLF XULQDU\WUDFW
LQIHFWLRQV DVGLDJQRVHGE\DPHGLFDOSURIHVVLRQDO ZKLFKZHUHSKDUPDFRORJLFDOO\
PDQDJHG
6XEMHFWV ZLWKDQ\DQDWRPLFDO RUSDWKRORJLFDO DEQRUPDOLW\ WKDWZRXOGHLWKHUSUHFOXGH
RUWHQGWRFRQIRXQG WKHDQDO\VLVRIVWXG\GDWDLQFOXGLQJ DQ\FOLQLFDOO\ VLJQLILFDQW
DEQRUPDOILQGLQJV RQ05,REWDLQHG DW9LVLW6FUHHQE\WKH6SRQVRULGHQWLILHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
FHQWUDOLPDJLQJ YHQGRU RUVXEMHFWVPHHWLQJFULWHULDIRUFRQWUDLQGLFDWLRQ IRU05,
LQFOXGLQJ WKHIROORZLQJ
x +LVWRU\RIVHYHUHFODXVWURSKRELD LPSDFWLQJ DELOLW\ WRSHUIRUP05,GXULQJ WKH
VWXG\GHVSLWHPLOG VHGDWLRQWUHDWPHQWZLWKDQDQ[LRO\WLF
x 6XEMHFWVZLWKPHWDOLPSODQWV GHYLFHVSDUDPDJQHWLFREMHFWVFRQWDLQHG ZLWKLQ WKH
ERG\ DQGH[FHVVLYHRUPHWDOFRQWDLQLQJ WDWWRRV
x 6XEMHFWVXQDEOHWROLHVWLOO ZLWKLQ WKHHQYLURQPHQW RIWKH05,VFDQQHURUPDLQWDLQ
DEUHDWKKROGIRUWKHUHTXLUHGSHULRGWRDFTXLUHLPDJHV GHVSLWHPLOG
VHGDWLRQWUHDWPHQW ZLWKDQDQ[LRO\WLF
x 6XEMHFWVZLWKDEGRPLQDO JLUWKJUHDWHUWKDQWKHERUHVL]HRIWKHVLWH¶V05,V\VWHP
6XEMHFWVRQDQ\SURKLELWHG FRQFRPLWDQW PHGLFDWLRQV RUWKRVHXQZLOOLQJXQDEOH WR
VZLWFKWRSHUPLWWHG FRQFRPLWDQWPHGLFDWLRQV >UHIHUWR6HFWLRQ @
:HLJKWORVVRItZLWKLQ PRQWKSULRUWR9LVLW6FUHHQ
3DUWLFLSDWLRQ LQRWKHUVWXGLHVLQYROYLQJ LQYHVWLJDWLRQDO GUXJVZLWKLQ GD\VSULRUWR
9LVLW6FUHHQDQGXSWR9LVLWRQVLWH)ROORZXS
0DOHVXEMHFWVZLWKSDUWQHUVZKRDUHFXUUHQWO\SUHJQDQWDVZHOODVPDOHVXEMHFWVZKR
DUHXQZLOOLQJ RUXQDEOHWRXVHKLJKO\ HIIHFWLYHPHWKRGVRIFRQWUDFHSWLRQDVRXWOLQHG
LQWKLVSURWRFRO 6HFWLRQIRUWKHGXUDWLRQ RIWKHVWXG\DQGIRUDWOHDVWGD\V
DIWHUWKHODVWGRVHRIGRXEOHEOLQG ,3
%ORRGGRQDWLRQ H[FOXGLQJ SODVPDGRQDWLRQV RIDSSUR[LPDWHO\ SLQWP/RU
PRUHZLWKLQ GD\VSULRUWR9LVLW6FUHHQRUGXULQJ WKHVWXG\XQWLO 9LVLW
RQVLWH)ROORZXS
6XEMHFWVZLWKNQRZQSULRUSDUWLFLSDWLRQ LQDWULDOLQYROYLQJ 3) LHUHFHLYHG
DWOHDVWGRVHRI,3
,QYHVWLJDWRUVLWHVWDIIPHPEHUVGLUHFWO\ LQYROYHG LQWKHFRQGXFWRIWKHVWXG\DQGWKHLU
IDPLO\ PHPEHUVVLWHVWDIIPHPEHUVRWKHUZLVHVXSHUYLVHGE\WKHLQYHVWLJDWRU RU
VXEMHFWVZKRDUH3IL]HUHPSOR\HHV LQFOXGLQJ WKHLUIDPLO\PHPEHUVGLUHFWO\ LQYROYHG
LQWKHFRQGXFWRIWKHVWXG\
$W9LVLW6FUHHQRWKHUDFXWHRUFKURQLFPHGLFDO RUSV\FKLDWULFFRQGLWLRQ
LQFOXGLQJ UHFHQWZLWKLQ WKHSDVW\HDURUDFWLYHVXLFLGDO LGHDWLRQ RUEHKDYLRU RU
ODERUDWRU\DEQRUPDOLW\ WKDWPD\LQFUHDVHWKHULVNDVVRFLDWHGZLWKVWXG\SDUWLFLSDWLRQ
RU,3DGPLQLVWUDWLRQ RUPD\LQWHUIHUHZLWKWKHLQWHUSUHWDWLRQ RIVWXG\UHVXOWVDQGLQ
WKHMXGJPHQW RIWKHLQYHVWLJDWRU ZRXOGPDNHWKHVXEMHFWLQDSSURSULDWH IRUHQWU\LQWR
WKLVVWXG\
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
5DQGRPL]DWLRQ&ULWHULD
$W9LVLW 'D\LQWHUDFWLYHUHVSRQVHWHFKQRORJ\ ,57ZLOO EHXVHGWRDVVLJQHDFKHOLJLEOH
VXEMHFWDUDQGRPL]DWLRQ QXPEHUZLWKWKLVQXPEHU UHFRUGHGRQWKHHOHFWURQLF&DVH5HSRUW
)RUPH&5)$FRPSXWHUJHQHUDWHG UDQGRPL]DWLRQ FRGHXVLQJWKHPHWKRGRIUDQGRP
SHUPXWHGEORFNVZLOO EHXWLOL]HG WRUDQGRPL]H VXEMHFWV SODFHERDQGRIDFWLYHGRVHV
RI3) SULRUWRWKHILUVWGRVHRIWKHGRXEOHEOLQG ,3SURYLGHG VXEMHFWVVDWLVI\DOORI
WKHHOLJLELOLW\ FULWHULDRXWOLQHG LQ6HFWLRQDQG6HFWLRQ 
6XEMHFWVPXVWEHtFRPSOLDQW EDVHGRQSLOO FRXQWGXULQJ WKHZHHNUXQLQSHULRG DV
DVVHVVHGSULRUWRUDQGRPL]DWLRQ RQ'D\LHVXEMHFWVFDQQRWPLVVPRUHWKDQGRVH
$QDWWHPSWZLOO EHPDGHWRHTXDOO\ EDODQFHWKHQXPEHURIVXEMHFWVDVVLJQHGWRUHFHLYH
3) YHUVXVSODFHERZLWKLQ HDFKVWUDWXPE\XWLOL]LQJ DWLHUHGVWUDWLILFDWLRQ VFKHPH
6XEMHFWV ZLOO EHVWUDWLILHGDWUDQGRPL]DWLRQ 9LVLWEDVHGRQWKHSUHVHQFHRUDEVHQFHRI
7'0DQGE\WKH05,3'))OLYHUIDWPHDVXUHPHQWGHWHUPLQHG E\WKH6SRQVRULGHQWLILHG
FHQWUDOLPDJLQJ YHQGRURILPDJHVREWDLQHG GXULQJ 9LVLW6FUHHQ
x 6FUHHQLQJOLYHUIDWtDQG
x 6FUHHQLQJOLYHUIDWt
/LIHVW\OH5HTXLUHPHQWV
$IWHUFRQILUPDWLRQ RIHOLJLELOLW\ DW9LVLW6FUHHQDQGVWDUWLQJDW9LVLW5XQLQ
VXEMHFWVZLOO EHLQVWUXFWHGWRPDLQWDLQ WKHJXLGHOLQHV GHVFULEHGEHORZIRUWKHGXUDWLRQ RI
SDUWLFLSDWLRQ LQWKHVWXG\7KHVHJXLGHOLQHV PXVWEHUHLWHUDWHGDW9LVLW'D\
'LHW
x 6XEMHFWVPXVWDEVWDLQIURPDOOIRRGDQGGULQNH[FHSWZDWHUDWOHDVWEXWSUHIHUDEO\
KRXUVSULRUWRDQ\EORRG VDPSOHFROOHFWLRQV IRUFOLQLFDO ODERUDWRU\ WHVWV
x 6XEMHFWVPXVWDEVWDLQIURPDOOIRRGDQGGULQNH[FHSWZDWHUIRUtKRXUVSULRUWR
DVVHVVPHQWRIOLYHUIDWHLWKHUYLD)LEUR6FDQ RU05,3'))
x %OLQGHG ,3VKRXOG EHDGPLQLVWHUHG HYHU\GD\ZLWKWKHPRUQLQJ PHDO
x 6XEMHFWVZLOO EHLQVWUXFWHGWRPDLQWDLQ WKHLUQRUPDO GLHWWKURXJKRXW SDUWLFLSDWLRQ LQ
WKHVWXG\LH WKURXJK 9LVLW 
$OFRKRO&DIIHLQHDQG7REDFFR
x ,QWDNHRIDOFRKRO LVSHUPLWWHGLQPRGHUDWLRQ DVGHILQHGLQ6HFWLRQ 
x &RQVXPSWLRQ RIFDIIHLQDWHGGULQNV DQGQLFRWLQHFRQWDLQLQJ SURGXFWV LVSHUPLWWHG
GXULQJ SDUWLFLSDWLRQ LQWKHVWXG\KRZHYHUWKHUHPD\EHDQHHGIRUEULHILQWHUUXSWLRQ
ZKLOHDWWKHVLWHDQGRU,PDJLQJ IDFLOLW\ GHSHQGLQJ RQORFDOSROLF\
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
3K\VLFDO$FWLYLW\
x 6XEMHFWVZLOO EHDVNHGWRQRWHQJDJHLQSK\VLFDOO\ VWUHQXRXVH[HUFLVHIRUH[DPSOH
KHDY\OLIWLQJ ZHLJKWWUDLQLQJ FDOLVWKHQLFV DQGDHURELFVZLWKLQ KRXUVEHIRUH
EORRG VDPSOHFROOHFWLRQV IRUFOLQLFDO ODERUDWRU\WHVWV
x 6XEMHFWVZLOO EHDGYLVHGWRDYRLGGLUHFWVXQOLJKW H[SRVXUHRUDQ\KLJK LQWHQVLW\ 89
OLJKW H[SRVXUHIURPWKHILUVWGD\RIGRVLQJ ZLWK VLQJOHEOLQG ,39LVLWDQGFRQWLQXH
XQWLO WKHRQVLWH)ROORZXS YLVLW 9LVLW ,QDGGLWLRQ VXEMHFWVZLOO EHLQVWUXFWHGWR
DSSO\VXQFUHDPORWLRQ ZLWKVXQSURWHFWLRQ IDFWRU63)RIRUKLJKHU
&RQWUDFHSWLRQ
$OOIHUWLOHPDOHVXEMHFWVZKRDUHLQWKHRSLQLRQ RIWKHLQYHVWLJDWRU VH[XDOO\DFWLYHDQGDWULVN
IRUSUHJQDQF\ZLWKWKHLUSDUWQHUVPXVWDJUHHWRXVHDKLJKO\ HIIHFWLYHPHWKRGRI
FRQWUDFHSWLRQFRQVLVWHQWO\ DQGFRUUHFWO\IRUWKHGXUDWLRQRIWKHDFWLYHWUHDWPHQWSHULRGDQG
IRUDWOHDVWGD\VDIWHUWKHODVWGRVHRILQYHVWLJDWLRQDO SURGXFW7KHLQYHVWLJDWRU RUKLVRU
KHUGHVLJQHHLQFRQVXOWDWLRQ ZLWKWKHVXEMHFWZLOO FRQILUPWKDWWKHVXEMHFWKDVVHOHFWHGDQ
DSSURSULDWHPHWKRGRIFRQWUDFHSWLRQIRUWKHLQGLYLGXDO VXEMHFWDQGKLVSDUWQHUVIURPWKH
SHUPLWWHGOLVWRIFRQWUDFHSWLRQPHWKRGVVHHEHORZDQGZLOO FRQILUP WKDWWKHVXEMHFWKDV
EHHQLQVWUXFWHGLQLWVFRQVLVWHQWDQGFRUUHFWXVH$WWLPHSRLQWV LQGLFDWHGLQWKH6FKHGXOHRI
$FWLYLWLHV WKHLQYHVWLJDWRU RUGHVLJQHHZLOO LQIRUP WKHVXEMHFWRIWKHQHHGWRXVHKLJKO\
HIIHFWLYHFRQWUDFHSWLRQ FRQVLVWHQWO\ DQGFRUUHFWO\DQGGRFXPHQWWKHFRQYHUVDWLRQDQGWKH
VXEMHFW¶VDIILUPDWLRQ LQWKHVXEMHFW¶VFKDUWVXEMHFWVQHHGWRDIILUPWKHLUFRQVLVWHQWDQG
FRUUHFWXVHRIDWOHDVWRIWKHVHOHFWHGPHWKRGVRIFRQWUDFHSWLRQ,QDGGLWLRQ WKH
LQYHVWLJDWRU RUGHVLJQHHZLOO LQVWUXFWWKHVXEMHFWWRFDOOLPPHGLDWHO\ LIWKHVHOHFWHG
FRQWUDFHSWLRQPHWKRGLVGLVFRQWLQXHG RULISUHJQDQF\LVNQRZQRUVXVSHFWHGLQWKHVXEMHFWRU
SDUWQHU
+LJKO\ HIIHFWLYHPHWKRGVRIFRQWUDFHSWLRQ DUHWKRVHWKDWDORQHRULQFRPELQDWLRQ UHVXOWLQD
IDLOXUHUDWHRIOHVVWKDQSHU\HDUZKHQXVHGFRQVLVWHQWO\ DQGFRUUHFWO\LHSHUIHFWXVHDQG
LQFOXGH WKHIROORZLQJ
 (VWDEOLVKHG XVHRIKRUPRQDO PHWKRGVRIFRQWUDFHSWLRQDVVRFLDWHGZLWKLQKLELWLRQ RI
RYXODWLRQ HJRUDOLQVHUWHGLQMHFWHG LPSODQWHG WUDQVGHUPDO SURYLGHG WKHVXEMHFWRU
PDOHVXEMHFW¶VIHPDOHSDUWQHUSODQVWRUHPDLQRQWKHVDPHWUHDWPHQWWKURXJKRXW WKH
HQWLUHVWXG\DQGKDVEHHQXVLQJ WKDWKRUPRQDO FRQWUDFHSWLYHIRUDQDGHTXDWHSHULRGRI
WLPHWRHQVXUHHIIHFWLYHQHVV
 &RUUHFWO\SODFHGFRSSHUFRQWDLQLQJ LQWUDXWHULQH GHYLFH,8'RULQWUDXWHULQHV\VWHP
 0DOHFRQGRPRUIHPDOHFRQGRP XVHG:,7+DVHSDUDWHVSHUPLFLGH SURGXFWLHIRDP
JHOILOP FUHDPRUVXSSRVLWRU\ )RUFRXQWULHVZKHUHVSHUPLFLGHLVQRWDYDLODEOH RU
FRQGRPSOXVVSHUPLFLGHLVQRWDFFHSWHGDVKLJKO\ HIIHFWLYHFRQWUDFHSWLRQ WKLVRSWLRQ
LVQRWDSSURSULDWH
 0DOHVWHULOL]DWLRQ ZLWKDEVHQFHRIVSHUPLQWKHSRVWYDVHFWRP\HMDFXODWH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 %LODWHUDOWXEDOOLJDWLRQELODWHUDO VDOSLQJHFWRP\ RUELODWHUDO WXEDORFFOXVLYH SURFHGXUH
SURYLGHG WKDWRFFOXVLRQ KDVEHHQFRQILUPHG LQDFFRUGDQFHZLWKWKHGHYLFH¶VODEHO
127(6H[XDODEVWLQHQFHGHILQHGDVFRPSOHWHO\ DQGSHUVLVWHQWO\ UHIUDLQLQJ IURPDOO
KHWHURVH[XDOLQWHUFRXUVHLQFOXGLQJ GXULQJ WKHHQWLUHSHULRGRIULVNDVVRFLDWHGZLWKWKHVWXG\
WUHDWPHQWVPD\REYLDWHWKHQHHGIRUFRQWUDFHSWLRQ21/<LIWKLVLVWKHSUHIHUUHGDQGXVXDO
OLIHVW\OH RIWKHVXEMHFW
$OOVH[XDOO\ DFWLYHPDOHVXEMHFWVPXVWDJUHHWRSUHYHQWSRWHQWLDO WUDQVIHUWRDQGH[SRVXUHRI
SDUWQHUVWRGUXJWKURXJKHMDFXODWHE\XVLQJDFRQGRPFRQVLVWHQWO\ DQGFRUUHFWO\EHJLQQLQJ
ZLWKWKHILUVWGRVHRI,3DQGFRQWLQXLQJ IRUDWOHDVWGD\VDIWHUWKHODVWGRVHRIGRXEOHEOLQG
,3
6SRQVRU¶V4XDOLILHG0HGLFDO3HUVRQQHO
7KHFRQWDFWLQIRUPDWLRQ IRUWKHVSRQVRU
VDSSURSULDWHO\ TXDOLILHG PHGLFDOSHUVRQQHOIRUWKH
VWXG\LVGRFXPHQWHGLQWKHVWXG\FRQWDFWOLVW ORFDWHGLQWKHVWXG\SRUWDO
7RIDFLOLWDWH DFFHVVWRDSSURSULDWHO\ TXDOLILHG PHGLFDOSHUVRQQHORQVWXG\UHODWHGPHGLFDO
TXHVWLRQVRUSUREOHPV VXEMHFWVDUHSURYLGHG ZLWKDFRQWDFWFDUG7KHFRQWDFWFDUGFRQWDLQV
DWDPLQLPXP SURWRFRO DQG,3LGHQWLILHUV VXEMHFWVWXG\QXPEHUVFRQWDFWLQIRUPDWLRQ IRUWKH
LQYHVWLJDWRU VLWHDQGFRQWDFWGHWDLOVIRUDFRQWDFWFHQWHULQWKHHYHQWWKDWWKHLQYHVWLJDWRU VLWH
VWDIIFDQQRWEHUHDFKHGWRSURYLGHDGYLFHRQDPHGLFDO TXHVWLRQRUSUREOHPRULJLQDWLQJ IURP
DQRWKHUKHDOWKFDUHSURIHVVLRQDO QRWLQYROYHG LQWKHVXEMHFW¶VSDUWLFLSDWLRQ LQWKHVWXG\7KH
FRQWDFWQXPEHUFDQDOVREHXVHGE\LQYHVWLJDWRU VWDIILIWKH\DUHVHHNLQJDGYLFHRQPHGLFDO
TXHVWLRQVRUSUREOHPVKRZHYHULWVKRXOGEHXVHGRQO\ LQWKHHYHQWWKDWWKHHVWDEOLVKHG
FRPPXQLFDWLRQ SDWKZD\VEHWZHHQWKHLQYHVWLJDWRU VLWHDQGWKHVWXG\WHDPDUHQRWDYDLODEOH 
,WLVWKHUHIRUHLQWHQGHGWRDXJPHQW EXWQRWUHSODFHWKHHVWDEOLVKHG FRPPXQLFDWLRQ SDWKZD\V
EHWZHHQWKHLQYHVWLJDWRU VLWHDQGWKHVWXG\WHDPIRUDGYLFHRQPHGLFDO TXHVWLRQVRUSUREOHPV
WKDWPD\DULVHGXULQJ WKHVWXG\7KHFRQWDFWQXPEHULVQRWLQWHQGHGIRUXVHE\WKHVXEMHFW
GLUHFWO\ DQGLIDVXEMHFWFDOOVWKDWQXPEHUKHRUVKHZLOO EHGLUHFWHGEDFNWRWKHLQYHVWLJDWRU
VLWH
678'<75($70(176
)RUWKHSXUSRVHVRIWKLVVWXG\ DQGSHU,QWHUQDWLRQDO &RQIHUHQFHRQ+DUPRQLVDWLRQ ,&+
JXLGHOLQHV ,3LVGHILQHGDVDSKDUPDFHXWLFDO IRUPRIDQDFWLYHLQJUHGLHQW RUSODFHEREHLQJ
WHVWHGRUXVHGDVDUHIHUHQFHFRPSDUDWRULQDFOLQLFDO WULDOLQFOXGLQJ DSURGXFWZLWKD
PDUNHWLQJ DXWKRUL]DWLRQ ZKHQXVHGRUDVVHPEOHGIRUPXODWHG RUSDFNDJHGLQDZD\GLIIHUHQW
IURPWKHDSSURYHGIRUPRUZKHQXVHGIRUDQXQDSSURYHG LQGLFDWLRQ RUZKHQXVHGWRJDLQ
IXUWKHULQIRUPDWLRQ DERXWDQDSSURYHGXVH,&+(
)RUWKLVVWXG\WKH,3LV3) DQGLWVPDWFKLQJSODFHERDQGZLOO EHSURYLGHG DV
WDEOHWVIRURUDODGPLQLVWUDWLRQ $Q,3PDQXDOZLOO EHSURYLGHG WRWKHVLWHVSULRUWRWKH
LQLWLDWLRQ RIUDQGRPL]DWLRQ RIVXEMHFWVLQWRWKHVWXG\
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$OORFDWLRQWR7UHDWPHQW
7KH,57V\VWHPZLOO EHXVHGWRVHTXHQWLDOO\ DVVLJQDXQLTXH GLJLW VXEMHFWLGHQWLILFDWLRQ
QXPEHUWRHDFKVXEMHFWZKRKDVVLJQHGWKHLQIRUPHGFRQVHQWGRFXPHQW,&'7KLV
LGHQWLI\LQJ QXPEHUZLOO EHUHWDLQHGWKURXJKRXW WKHGXUDWLRQ RIVWXG\SDUWLFLSDWLRQ 
$OORFDWLRQ RIVXEMHFWVWRGRVLQJ UHJLPHQVZLOO SURFHHGWKURXJKWKHXVHRIWKH,57V\VWHP
7KHVLWHSHUVRQQHO VWXG\FRRUGLQDWRU RUVSHFLILHGGHVLJQHHZLOO EHUHTXLUHGWRHQWHURUVHOHFW
LQIRUPDWLRQ LQFOXGLQJ EXWQRWOLPLWHG WRWKHXVHU¶VLGHQWLILFDWLRQ ,'DQGSDVVZRUGWKH
SURWRFRO QXPEHUDQGWKHVXEMHFWQXPEHU7KHVLWHSHUVRQQHO ZLOO WKHQEHSURYLGHG ZLWK D
WUHDWPHQWDVVLJQPHQW UDQGRPL]DWLRQ QXPEHU DQGGLVSHQVDEOH XQLW'8RUFRQWDLQHUQXPEHU
ZKHQ,3LVEHLQJVXSSOLHG YLDWKH,57V\VWHP7KH,57V\VWHPZLOO SURYLGH DFRQILUPDWLRQ
UHSRUWFRQWDLQLQJ WKHVXEMHFWQXPEHUUDQGRPL]DWLRQ QXPEHU DQG'8RUFRQWDLQHUQXPEHU
DVVLJQHG7KHFRQILUPDWLRQ UHSRUWPXVWEHVWRUHGLQWKHVLWH¶VILOHV7KHVWXG\VSHFLILF ,57
UHIHUHQFHPDQXDOZLOO EHSURYLGHG SULRUWRILUVWGRVHDQGZLOO FRQWDLQ WKHFRQWDFWLQIRUPDWLRQ
DQGIXUWKHUGHWDLOVRQWKHXVHRIWKH,57V\VWHP
$FRPSXWHUJHQHUDWHGUDQGRPL]DWLRQ VFKHGXOHZLOO EHXVHGWRDVVLJQDSSUR[LPDWHO\
VXEMHFWVWRRQHRIWKHWUHDWPHQWJURXSVGHVFULEHGLQ 7DEOHLQDUDQGRPL]DWLRQ UDWLRRI
 7KHUDQGRPL]DWLRQ QXPEHUZLOO EHUHFRUGHGLQWKHFDVHUHSRUWIRUP&5)7KH
VXEMHFWZLOO UHFHLYHWKHDSSURSULDWHVWXG\PHGLFDWLRQ DVVLJQHGE\WKH,57V\VWHP
7DEOH
6WXG\7UHDWPHQW5HJLPHQV
5HJLPHQ
'RVH
PJWDEOHWV
3)
PJWDEOHWV
3)
PJPDWFKLQJ
SODFHERWDEOHWV
$
3ODFHER



%
PJ



&
PJ




,QRUGHUWRPDLQWDLQ WKHGRXEOHEOLQG GHVLJQ
x PJ PJDQGPDWFKLQJSODFHERWDEOHWVZLOO EHWKHVDPHVL]HDQGVKDSH
x (DFKPRUQLQJ GRVHZLOO FRQVLVWRIRIIZKLWHWDEOHWVUHSUHVHQWLQJ
3)PDWFKLQJ SODFHER
%UHDNLQJWKH%OLQG
7KHVWXG\ZLOO EHVXEMHFWDQGLQYHVWLJDWRU EOLQGHG
$WWKHLQLWLDWLRQ RIWKHVWXG\WKHLQYHVWLJDWRU VLWHZLOO EHLQVWUXFWHGRQWKHPHWKRGIRU
EUHDNLQJWKHEOLQG 7KHPHWKRGZLOO EHDQHOHFWURQLFSURFHVV%OLQGLQJ FRGHVVKRXOG EH
EURNHQRQO\ LQH[FHSWLRQDO FLUFXPVWDQFHVZKHQNQRZOHGJH RIWKHDFWXDOWUHDWPHQWFRGHLV
DEVROXWHO\ HVVHQWLDOIRUIXUWKHUPDQDJHPHQWRIWKHVXEMHFW,QYHVWLJDWRUVDUHHQFRXUDJHGWR
GLVFXVVZLWKDPHPEHURIWKHVWXG\WHDPLIWKH\EHOLHYHWKDWXQEOLQGLQJ LVQHFHVVDU\:KHQ
WKHEOLQGLQJ FRGHLVEURNHQWKHUHDVRQPXVWEHIXOO\ GRFXPHQWHGDQGHQWHUHGRQWKH&5)
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
6XEMHFW&RPSOLDQFH
&RPSOLDQFH RIVLQJOHEOLQG SODFHERDGPLQLVWUDWLRQ GXULQJ WKH5XQLQSHULRGZLOO EHDVVHVVHG
E\SLOO FRXQWRQ'D\9LVLWIRUWKHSXUSRVHRILQFOXVLRQ LQWRWKHVWXG\$FFHSWDEOH
FRPSOLDQFH ZLOO EHGHILQHGDVVHOIDGPLQLVWUDWLRQ E\WKHVXEMHFWVRI
x tRIWKHVWXG\VXSSOLHG EOLQGHG SODFHERWDNHQE\WKHVXEMHFWGXULQJ WKH5XQ,Q
SHULRGLH9LVLW WR9LVLW RQO\ GRVHLVSHUPLWWHGWREHPLVVHG
&RPSOLDQFH RIVWXG\PHGLFDWLRQ DGPLQLVWUDWLRQ ZLOO EHDVVHVVHGGXULQJWKHWUHDWPHQWSKDVH
RIWKHVWXG\E\WKHQXPEHURIWDEOHWVUHWXUQHGE\WKHVXEMHFWVDW9LVLW 9LVLW DQG9LVLW
x !FRPSOLDQFH ZLWKVHOIDGPLQLVWUDWLRQ RIWKHVWXG\PHGLFDWLRQ LVH[SHFWHGIURP
'D\9LVLWWR'D\9LVLWLQYHVWLJDWRUV PXVWFORVHO\PRQLWRU QRQFRPSOLDQW
VXEMHFWVLQRUGHUWRHQKDQFHWKHLUDGKHUHQFHWRWKHVWXG\WUHDWPHQW
3ULRUWRWKHILUVWGRVHRIVLQJOHEOLQG ,3VXEMHFWVPD\EHSURYLGHG ZLWKDGRVLQJ GLDU\ DQG
LQVWUXFWHGWRUHFRUGWKHGDWHDQGWLPHRIHDFKGDLO\ GRVH
,QYHVWLJDWLRQDO3URGXFW6XSSOLHV
'RVDJH)RUPVDQG3DFNDJLQJ
3) ZLOO EHVXSSOLHG E\WKH6SRQVRU DVPJDQGPJWDEOHWVIRURUDO
DGPLQLVWUDWLRQ 0DWFKLQJSODFHERWDEOHWVZLOO DOVREHSURYLGHG ,QYHVWLJDWLRQDO SURGXFWZLOO
EHVXSSOLHG LQ ERWWOHV DQGODEHOHGDFFRUGLQJWRORFDOUHJXODWRU\ UHTXLUHPHQWV 
3UHSDUDWLRQDQG'LVSHQVLQJ
,QYHVWLJDWLRQDO SURGXFWLVWREHGLVSHQVHGWRVXEMHFWVE\TXDOLILHG VLWHVWXG\VWDIIDWHDFK
FOLQLF YLVLW IURP9LVLWWR9LVLWH[FOXGLQJ 9LVLW6XEMHFWVZLOO UHFHLYHWKHLUILUVWERWWOHRI
,3DW9LVLWVLQJOHEOLQG DQGZLOO UHFHLYHDQHZERWWOHRI,3DWHDFKFOLQLF YLVLW WKURXJK
9LVLWH[FOXGLQJ 9LVLWGRXEOHEOLQG 'RVLQJLQVWUXFWLRQV ZLOO EHSURYLGHG WRWKHVLWHV
DQGLQGLYLGXDO VXEMHFWV8SRQUHFHLSWRIWKHQHZERWWOH WKHXVHGERWWOH ZLOO EHUHWXUQHG
6XEMHFWVZLOO EHLQVWUXFWHGWRVWRUHWKHVWXG\GUXJDWURRPWHPSHUDWXUHDQGRXWRIWKHUHDFKRI
VPDOOFKLOGUHQ
$GPLQLVWUDWLRQ
7RPDLQWDLQ WKHEOLQG DGPLQLVWUDWLRQ RI,3ZLOO XVHDVWUDWHJ\VRWKDWDOOVXEMHFWVZLOO UHFHLYH
DQHTXDOQXPEHURIWDEOHWVUHJDUGOHVVRIZKLFKGRVHWKH\DUHDVVLJQHG7DEOHWVZLOO EHDFWLYH
GUXJPJRUPJRUSODFHER
6XEMHFWVZLOO WDNHDWRWDORIWDEOHWVRI3) DQGRUSODFHERDWDSSUR[LPDWHO\ WKH
VDPHWLPHHDFKGD\DQGUHFRPPHQGHGWREHWDNHQZLWKWKHPRUQLQJ PHDO6XEMHFWVZLOO
VZDOORZWKHVWXG\PHGLFDWLRQ ZKROH DQGZLOO QRWPDQLSXODWH RUFKHZWKHPHGLFDWLRQ SULRUWR
VZDOORZLQJ 6XEMHFWGRVLQJ ZLOO EHZLWQHVVHGE\WKHLQYHVWLJDWRU VLWHVWDIIDW9LVLW 9LVLW 
9LVLW 9LVLW DQG9LVLW 6XEMHFWVZLOO EHLQVWUXFWHGWRGHOD\VHOIDGPLQLVWUDWLRQ RI,3RQ
VFKHGXOHGYLVLWGD\VXQWLO WKH\DUULYHIRUWKHLURXWSDWLHQWFOLQLF YLVLW $WYLVLWV ZKHQVXEMHFWV
UHSRUWWRWKHLPDJLQJ FHQWHUGRVLQJ VKRXOG EHGHOD\HGXQWLO FRPSOHWLRQ RIWKH05,3'))
SURFHGXUH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
6XEMHFWVVKRXOGEHLQVWUXFWHGWKDWLIWKH\IRUJHWWRWDNHWKHLUPRUQLQJ GRVHDWWKHLUXVXDOWLPH
WKH\VKRXOGWDNHWKHPLVVHGGRVHDVVRRQDVSRVVLEOH RQWKHGD\LWZDVPLVVHGKRZHYHUWKHUH
PXVWEHDWOHDVWDQKRXULQWHUYDO EHWZHHQWKHPLVVHGGRVHDQGWKHQH[WGRVH,IWKHVXEMHFW
UHPHPEHUVPLVVLQJ DGRVHWKHQH[WGD\RUODWHUWKH\VKRXOG EHLQVWUXFWHG127WRWDNH
GRVHVLQWKHVDPHGD\
,QYHVWLJDWLRQDO3URGXFW6WRUDJH
7KHLQYHVWLJDWRU RUDQDSSURYHGUHSUHVHQWDWLYHHJSKDUPDFLVWZLOO HQVXUHWKDWDOO ,3VDUH
VWRUHGLQDVHFXUHGDUHDZLWKFRQWUROOHG DFFHVVXQGHUUHTXLUHG VWRUDJHFRQGLWLRQV DQGLQ
DFFRUGDQFHZLWKDSSOLFDEOH UHJXODWRU\UHTXLUHPHQWV
,3VVKRXOG EHVWRUHGLQWKHLU RULJLQDO FRQWDLQHUVDQGLQDFFRUGDQFHZLWKWKHODEHOV
$Q\VWRUDJHFRQGLWLRQV VWDWHGLQWKH656'ZLOO EHVXSHUVHGHGE\WKHVWRUDJHFRQGLWLRQV
VWDWHGRQWKHSURGXFWODEHO
6LWHV\VWHPVPXVWEHFDSDEOHRIPHDVXULQJDQGGRFXPHQWLQJ IRUH[DPSOHYLDDORJDWD
PLQLPXP GDLO\ PLQLPXP DQGPD[LPXP WHPSHUDWXUHVIRUDOOVLWHVWRUDJHORFDWLRQV DV
DSSOLFDEOH LQFOXGLQJ IUR]HQUHIULJHUDWHG DQGRUURRPWHPSHUDWXUHSURGXFWV7KLVVKRXOG
EHFDSWXUHGIURPWKHWLPHRI,3UHFHLSWWKURXJKRXW WKHVWXG\(YHQIRU
FRQWLQXRXVPRQLWRULQJ V\VWHPVDORJRUVLWHSURFHGXUHWKDWHQVXUHVDFWLYHHYDOXDWLRQ IRU
H[FXUVLRQVVKRXOG EHDYDLODEOH7KHLQWHQWLVWRHQVXUHWKDWWKHPLQLPXP DQGPD[LPXP
WHPSHUDWXUHLVFKHFNHGHDFKEXVLQHVVGD\WRFRQILUPWKDWQRH[FXUVLRQRFFXUUHGVLQFHWKHODVW
HYDOXDWLRQ DQGWRSURYLGH WKHVLWHZLWKWKHFDSDELOLW\ WRVWRUHRUYLHZWKHPLQLPXPPD[LPXP
WHPSHUDWXUHIRUDOOQRQZRUNLQJ GD\VXSRQUHWXUQWRQRUPDORSHUDWLRQV7KHRSHUDWLRQRIWKH
WHPSHUDWXUHPRQLWRULQJ GHYLFHDQGVWRUDJHXQLWIRUH[DPSOH UHIULJHUDWRUDVDSSOLFDEOH
VKRXOG EHUHJXODUO\ LQVSHFWHGWRHQVXUHWKH\DUHPDLQWDLQHG LQZRUNLQJRUGHU
$Q\H[FXUVLRQVIURPWKHSURGXFWODEHOVWRUDJHFRQGLWLRQV VKRXOG EHUHSRUWHGWR3IL]HUXSRQ
GLVFRYHU\ 7KHVLWHVKRXOG DFWLYHO\SXUVXHRSWLRQV IRUUHWXUQLQJ WKHSURGXFWWRWKHVWRUDJH
FRQGLWLRQV GHVFULEHGLQWKHODEHOLQJ DVVRRQDVSRVVLEOH 'HYLDWLRQV IURPWKHVWRUDJH
UHTXLUHPHQWV LQFOXGLQJ DQ\DFWLRQVWDNHQPXVWEHGRFXPHQWHGDQGUHSRUWHGWR3IL]HU
2QFHDQH[FXUVLRQLVLGHQWLILHG WKH,3PXVWEHTXDUDQWLQHG DQGQRWXVHGXQWLO 3IL]HUSURYLGHV
SHUPLVVLRQ WRXVHWKH,3,WZLOO QRWEHFRQVLGHUHGDSURWRFRO GHYLDWLRQ LI3IL]HUDSSURYHVWKH
XVHRIWKH,3DIWHUWKHWHPSHUDWXUHH[FXUVLRQ8VHRIWKH,3SULRUWR3IL]HUDSSURYDOZLOO EH
FRQVLGHUHGDSURWRFRO GHYLDWLRQ 6SHFLILFGHWDLOVUHJDUGLQJLQIRUPDWLRQ WKHVLWHVKRXOG UHSRUW
IRUHDFKH[FXUVLRQ ZLOO EHSURYLGHG WRWKHVLWH
5HFHLSWRIPDWHULDOVGRRURSHQLQJ DQGFORVLQJ DQGRWKHUURXWLQHKDQGOLQJ RSHUDWLRQV ZKHUH
WKHSURGXFWVDUHEULHIO\RXWRIWKHWHPSHUDWXUHUDQJHGHVFULEHGLQWKHODEHOLQJ DUHQRW
FRQVLGHUHGH[FXUVLRQV
6LWHVWDIIZLOO LQVWUXFWVXEMHFWVRQWKHSURSHUVWRUDJHUHTXLUHPHQWVIRUWDNHKRPH,3V7KH
VLWHVWDIIVKRXOG UHIHUWRWKH,30DQXDOIRUDGGLWLRQDO JXLGDQFHRQVWRUDJHFRQGLWLRQV DQG
DFWLRQVWREHWDNHQZKHQFRQGLWLRQV DUHRXWVLGHRIWKHVSHFLILHGUDQJH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
,QYHVWLJDWLRQDO3URGXFW$FFRXQWDELOLW\
7KHLQYHVWLJDWRU VLWHPXVWPDLQWDLQ DGHTXDWHUHFRUGVGRFXPHQWLQJ WKHUHFHLSWXVHORVVRU
RWKHUGLVSRVLWLRQ RIWKH,3VXSSOLHV$OO ,3ZLOO EHDFFRXQWHGIRUXVLQJDGUXJDFFRXQWDELOLW\
IRUPUHFRUG
$OO ERWWOHVRIEOLQGHG ,3PXVWEHUHWXUQHGWRWKHLQYHVWLJDWRU E\WKHVXEMHFWDWHYHU\YLVLW XS
WR9LVLWUHIHUWR6FKHGXOHRI$FWLYLWLHV
'HVWUXFWLRQRI,QYHVWLJDWLRQDO3URGXFW6XSSOLHV
7KHVSRQVRURUGHVLJQHHZLOO SURYLGH JXLGDQFHRQWKHGHVWUXFWLRQ RIXQXVHG,3HJDWWKH
VLWH,IGHVWUXFWLRQLVDXWKRUL]HG WRWDNHSODFHDWWKHLQYHVWLJDWRU VLWHWKHLQYHVWLJDWRU PXVW
HQVXUHWKDWWKHPDWHULDOVDUHGHVWUR\HGLQFRPSOLDQFH ZLWKDSSOLFDEOH HQYLURQPHQWDO
UHJXODWLRQV LQVWLWXWLRQDO SROLF\ DQGDQ\VSHFLDOLQVWUXFWLRQV SURYLGHG E\3IL]HU DQGDOO
GHVWUXFWLRQPXVWEHDGHTXDWHO\GRFXPHQWHG
&RQFRPLWDQW7UHDWPHQWV
$OOFRQFRPLWDQW PHGLFDWLRQV WDNHQGXULQJ WKHVWXG\PXVWEHUHFRUGHGZLWKLQGLFDWLRQ GDLO\
GRVHDQGVWDUWDQGVWRSGDWHVRIDGPLQLVWUDWLRQ $WWHPSWVPXVWEHPDGHWRQRWDOWHUWKH
GRVHVDQGUHJLPHQVRIFKURQLFEDFNJURXQG PHGLFDWLRQV DIWHUUDQGRPL]DWLRQ DQGIRUWKH
GXUDWLRQ RISDUWLFLSDWLRQ LQWKLVVWXG\$Q\FKDQJHVPDGHWREDFNJURXQG PHGLFDWLRQV PXVW
EHFDSWXUHGLQWKH&5)$OOVXEMHFWVPXVWEHTXHVWLRQHG DERXWFRQFRPLWDQW PHGLFDWLRQ DW
HDFKRXWSDWLHQW YLVLW WRWKHFOLQLFDO VLWH
0HGLFDWLRQV WDNHQEHIRUH9LVLW'D\ZLOO EHGRFXPHQWHGDVSULRUPHGLFDWLRQV 
0HGLFDWLRQV WDNHQDIWHUGRVLQJ RIGRXEOHEOLQG ,3DW9LVLW'D\DQGXQWLO WKHQG
)ROORZXS WHOHSKRQHFRQWDFWRUYLVLW ZLOO EHGRFXPHQWHGDVFRQFRPLWDQW PHGLFDWLRQV
0HGLFDWLRQVIRU*O\FHPLF&RQWURO
6XEMHFWV ZLWKDGLDJQRVLV RI7'0DUHSHUPLWWHGWREHRQVWDEOHGRVHVRIRUDODJHQWIRU
JO\FHPLFFRQWUROVWDUWLQJDWtZHHNVSULRUWR9LVLW6FUHHQDQGXQWLO 9LVLWRQVLWH
)ROORZXS LQFOXGLQJ EXWQRWOLPLWHG WRWKHIROORZLQJ DSSURYHGFODVVHVRIDJHQWV
x %LJXDQLGH VXFKDVPHWIRUPLQ 
x 6XOIRQ\OXUHDV VXFKDVJO\EXULGH DFHWRKH[DPLGHFKORUSURSDPLGH WROD]DPLGH
WROEXWDPLQH JOLPHSLULGH JOLSL]LGH
x 'LSHSWLG\O SHSWLGDVH '33LLQKLELWRUV VXFKDVVLWDJOLSWLQ VD[DJOLSWLQ
YLOGDJOLSWLQ
x DJOXFRVLGDVHLQKLELWRUV VXFKDVDFDUERVHPLJOLWRO
7KHXVHRIWKHIROORZLQJ FODVVHVRIDJHQWVLVQRWSHUPLWWHG ZLWKLQ WKHWLPHIUDPHVLQGLFDWHG
EHORZ
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x 7='VVXFKDVSLRJOLWD]RQH DQGURVLJOLWD]RQH ZLWKLQ ZHHNVSULRUWR9LVLWDQGXQWLO
9LVLWRQVLWH)ROORZXS 
x 6XEFXWDQHRXVO\ DGPLQLVWHUHG DJHQWVIRUJO\FHPLF FRQWUROHJLQVXOLQ H[HQDWLGH
OLUDJOXWLGH SUDPOLQWLGH ZLWKLQ ZHHNVSULRUWR9LVLWDQGXQWLO 9LVLWRQVLWH
)ROORZXS
x 6RGLXPJOXFRVH FRWUDQVSRUWHULQKLELWRUV VXFKDVFDQDJOLIOR]LQ GDSDJOLIOR]LQ
HPSDJOLIOR]LQ ZLWKLQ ZHHNVSULRUWR9LVLWDQGXQWLO 9LVLWRQVLWH)ROORZXS
/LSLGPRGLI\LQJ 0HGLFDWLRQV
6XEMHFWVDUHSHUPLWWHGWREHRQVWDEOHGRVHVRIWKHIROORZLQJ OLSLGPRGLI\LQJ DJHQWVVWDUWLQJ
DWtZHHNVSULRUWR9LVLW6FUHHQDQGXQWLO 9LVLWRQVLWH)ROORZXS LQFOXGLQJ EXW
QRWOLPLWHG WRWKHIROORZLQJ 
x %LOHDFLGVHTXHVWUDQWVVXFKDVFKROHVW\UDPLQH FROHVWLSRO FROHVHYDODP
x )HQRILEUDWH
x 1LFRWLQLF DFLGQLDFLQ
7KHXVHRIWKHIROORZLQJ FODVVHVRIDJHQWVLVQRWSHUPLWWHG ZLWKLQ WKHWLPHOLQHV VSHFLILHG 
x 6WDWLQVVXFKDVDWRUYDVWDWLQ VLPYDVWDWLQ URVXYDVWDWLQ IOXYDVWDWLQ SLWDYDVWDWLQ
SUDYDVWDWLQ ZLWKLQ ZHHNVSULRUWR9LVLWDQGXQWLO 9LVLWRQVLWH)ROORZXS 
x (]HWLPLEH 2$73VXEVWUDWHDQGJHPILEUR]LO 2$73LQKLELWRU ZLWKLQ ZHHNVSULRU
WR9LVLWDQGXQWLO 9LVLWRQVLWH)ROORZXS
x 0RQRFORQDO DQWLERGLHV LQKLELWLQJ SURSURWHLQ FRQYHUWDVHVXEWLOLVLQNH[LQ W\SH
3&6.VXFKDVDOLURFXPDE DQGHYRORFXPDE ZLWKLQ ZHHNVSULRUWR9LVLW RU
ZLWKLQ KDOIOLYHV RIGRVHDGPLQLVWHUHG ZKLFKHYHULVORQJHU DQGXQWLO 9LVLW
RQVLWH)ROORZXS
$QWLK\SHUWHQVLYH0HGLFDWLRQV
8VHRIEDFNJURXQG DQWLK\SHUWHQVLYH DJHQWVLVSHUPLWWHGXQOHVVQRWHGEHORZLQ
6HFWLRQ ,ISRVVLEOH GRVHVRIDQWLK\SHUWHQVLYH DJHQWVVKRXOGEHVWDEOHIRUtZHHNV
SULRUWR9LVLWDQGIRUWKHGXUDWLRQ RIWKHVWXG\KRZHYHUVWDUWLQJDW9LVLW5XQLQ VRPH
%3PHGLFDWLRQV PD\EHFKDQJHGDVQHFHVVDU\WRDYRLGDQWLK\SHUWHQVLYH PHGLFDWLRQV QRW
DOORZHGLQWKLVVWXG\
2WKHU$FFHSWDEOH&RQFRPLWDQW0HGLFDWLRQV
$Q\VXEMHFWRQWKHIROORZLQJ OLVWRIPHGLFDWLRQV PXVWEHRQVWDEOHGRVHV>LHtZHHNVSULRU
WR9LVLW 6FUHHQDQGXQWLO 9LVLW RQVLWH)ROORZXS LISRVVLEOH@
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x 1RQVWHURLGDO DQWLLQIODPPDWRU\ PHGLFDWLRQV 16$,'VVXFKDVLEXSURIHQ
NHWRSURIHQGLFORIHQDF QDSUR[HQ LQGRPHWKDFLQ PHOR[LFDP DQGFHOHFR[LE
,QWHUPLWWHQW XVHRIWKHVHPHGLFDWLRQV LVDOVRSHUPLWWHG
x ,QWHUPLWWHQW XVHRIDFHWDPLQRSKHQSDUDFHWDPRO DWGRVHVRIXSWRJUDPSHUGD\
x ,QKDOHGDQGWRSLFDO FRUWLFRVWHURLGV
x 7K\URLG UHSODFHPHQWWKHUDS\DQGKRUPRQHUHSODFHPHQWWKHUDS\LQHOLJLEOH IHPDOH
VXEMHFWV
x $QWLSV\FKRWLF PHGLFDWLRQV VXFKDVRODQ]DSLQH ULVSHULGRQH
x $QWLGHSUHVVDQWPHGLFDWLRQV VXFKDVWULF\FOLF DJHQWVVHOHFWLYHVHURWRQLQ UHXSWDNH
LQKLELWRUV DQGVHURWRQLQQRUHSLQHSKULQH UHXSWDNHLQKLELWRUV
x 9LWDPLQ (LQFOXGLQJ KLJKGRVHVVRORQJDVWKHUHJLPHQLVVWDEOH
x &HUWDLQKHUEDOVXSSOHPHQWV EXWRQO\IROORZLQJ FRQVXOWDWLRQ ZLWK6SRQVRU
x /LPLWHG XVHRIQRQSUHVFULSWLRQ PHGLFDWLRQV WKDWDUHQRWEHOLHYHGWRDIIHFWVXEMHFW
VDIHW\RUWKHRYHUDOOUHVXOWVRIWKHVWXG\PD\EHSHUPLWWHGRQDFDVHE\FDVHEDVLV
IROORZLQJ DSSURYDOE\WKH6SRQVRU
2WKHU3URKLELWHG&RQFRPLWDQW0HGLFDWLRQV
6XEMHFWVPXVWDEVWDLQIURPXVLQJWKHIROORZLQJ PHGLFDWLRQV IRUtZHHNVSULRUWR
9LVLW 6FUHHQDQGXQWLO 9LVLW RQVLWH)ROORZXS
x 8VHRIPHGLFDWLRQV WKDWDUHNQRZQ2$73LQKLELWRUV LQFOXGLQJ
x 5LIDPSLQ JHPILEUR]LO F\FORVSRULQH HU\WKURP\FLQ DQGFODULWKURP\FLQ 
x &KURQLFXVHRIV\VWHPLFJOXFRFRUWLFRLGV VXFKDVSUHGQLVRQH GH[DPHWKDVRQH
WULDPFLQRORQH EXGHVRQLGH EHWDPHWKDVRQHDQGLPPXQRVXSSUHVVDQWV VXFKDV
WDFUROLPXV
x 3KDUPDFRORJLFDO DJHQWVZLWKDSSURYHGLQGLFDWLRQ IRUZHLJKWORVVVXFKDVRUOLVWDWDQG
VLEXWUDPLQH 
x 2YHUWKHFRXQWHUDSSHWLWHVLPXODQW RUDSSHWLWHVXSSUHVVDQW DVDGYHUWLVHG 
x 0HGLFDOJUDGHPDULMXDQD UHJDUGOHVVRIPHGLFDO LQGLFDWLRQ
x 6SHFLILFFODVVHVRIDJHQWVJLYHQFXUUHQWVWXG\LVVWVWXG\LQSDWLHQWSRSXODWLRQ
x &RXPDGLQW\SH DQWLFRDJXODQWV RURWKHUDQWLFRDJXODQWV HJGDELJDWUDQ
WKRXJKDVSLULQDWGRVHVPJGD\LVSHUPLWWHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x $QWLFRQYXOVDQWV
x $QWLDUUK\WKPLFV H[FHSWIRUEHWDEORFNHUVRUFDOFLXP FKDQQHOEORFNHUVLIXVHG
IRUWKHPDQDJHPHQWRIFRQGLWLRQV RWKHUWKDQDUU\WKPLDV
x 0HGLFDWLRQV KLVWRULFDOO\ DVVRFLDWHGZLWKIDWW\OLYHUDUHSURKLELWHG LIXVHGIRU
tZHHNVRIFRQWLQXRXVXVHLQWKHSUHYLRXVPRQWKVSULRUWR9LVLW 6FUHHQ
H[DPSOHVLQFOXGH 
x DPLRGDURQH PHWKRWUH[DWHWHWUDF\FOLQHVWDPR[LIHQ HVWURJHQVDWGRVHVJUHDWHU
WKDQWKRVHXVHGIRUKRUPRQH UHSODFHPHQWDQDEROLF VWHURLGVYDOSURLF DFLG
RWKHUNQRZQKHSDWRWR[LQV
5HVFXH0HGLFDWLRQ
7KHUHLVQRUHVFXHWKHUDS\WRUHYHUVH$(VREVHUYHGZLWKDGPLQLVWUDWLRQ RI,3VWDQGDUG
PHGLFDOVXSSRUWLYH FDUHPXVWEHSURYLGHG WRPDQDJHWKH$(V
678'<352&('85(6
$VLJQHGDQGGDWHG,&'ZLOO EHREWDLQHGIURPHDFKVXEMHFWDW9LVLW 6FUHHQEHIRUH
SHUIRUPLQJ DQ\SURWRFROVSHFLILF SURFHGXUHV$OOUHTXLUHPHQWVDQGSURFHGXUHVRIWKHWULDO
ZLOO EHWKRURXJKO\ UHYLHZHGZLWKDOOVXEMHFWV7KHUHVXOWVRIWKHFOLQLFDO ODERUDWRU\
DVVHVVPHQWVDQGDOOVFUHHQLQJSURFHGXUHVZLOO EHHYDOXDWHGZLWKUHVSHFWWRLQFOXVLRQ DQG
H[FOXVLRQ FULWHULDWRGHWHUPLQHWKHVXEMHFW¶VHOLJLELOLW\ ,IDVXEMHFWGRHVQRWTXDOLI\ IRUWKH
WULDO KHRUVKHZLOO EHFRQVLGHUHGDVFUHHQIDLOXUH$GYHUVH(YHQW$(UHSRUWLQJ
LQFOXGLQJ6HULRXV$GYHUVH(YHQW6$(UHSRUWLQJZLOOEHJLQIURPWKHWLPHWKH,&'LV
VLJQHGDW9LVLW6FUHHQ
)RUWKHSURFHGXUHVGHVFULEHGEHORZ ZKHUHPXOWLSOH SURFHGXUHVDUHVFKHGXOHGDWWKHVDPH
WLPHSRLQWV UHODWLYHWRGRVLQJ WKHIROORZLQJ FKURQRORJ\ RIHYHQWVVKRXOG EHDGKHUHGWRDV
PXFKDVSRVVLEOH
x OHDG(&*REWDLQSULRUWRYLWDOVLJQVDVVHVVPHQWEORRG VDPSOHVDQGSULRUWRGRVLQJ
>UHIHUWR6HFWLRQ @
x 9LWDO6LJQV%3SXOVHUDWHREWDLQDIWHUOHDG(&*FROOHFWLRQ EXWSULRUWRREWDLQLQJ
EORRG VDPSOHVDQGSULRUWRGRVLQJ >UHIHUWR6HFWLRQ @
x )DVWLQJEORRGVDPSOHVLQFOXGLQJ3.DIWHUDVVHVVPHQWRIOHDG(&*DQGYLWDO VLJQV
EXWSULRUWRGRVLQJ
x 2WKHUSUHGRVHSURFHGXUHVVKRXOGEHREWDLQHGSHUIRUPHG DVFORVHDVSRVVLEOH WRWKH
VFKHGXOHGWLPHEXWPD\EHREWDLQHG EHIRUHRUDIWHUEORRG VSHFLPHQFROOHFWLRQ
x 'RVLQJRIEOLQGHG,3PXVWRFFXUDIWHUDQ\SUHGRVHEORRG VDPSOH FROOHFWLRQV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
6FUHHQLQJ9LVLWVDQG
)RU9LVLWVXEMHFWVZLOO EHLQVWUXFWHGWRDUULYHDWWKHVWXG\VLWHDIWHUDWOHDVWDQKRXU EXW
SUHIHUDEO\KRXU IDVWH[FHSWZDWHU
$IWHUREWDLQLQJ LQIRUPHG FRQVHQWIRUDOOVXEMHFWVDW6FUHHQOLYHU IDWZLOO EHHVWLPDWHGE\
)LEUR6FDQ,IDVXEMHFW¶V&$370PHDVXUHPHQWLV G%PWKHVXEMHFWZLOO EHGHHPHG
LQHOLJLEOH DQGQRWXQGHUJRDQ\DGGLWLRQDO VFUHHQLQJDVVHVVPHQWV,IWKHVXEMHFWKDVD&$3 70
YDOXH! G%PDOOVWXG\SURFHGXUHVRXWOLQHG LQWKH6FKHGXOHRI$FWLYLWLHV VKRXOG EH
FRPSOHWHGIRU9LVLW 
6FUHHQ9LVLW ZLOO RFFXURQO\ DIWHUVXEMHFWVDUHLGHQWLILHG WREHHOLJLEOH IRUWKHVWXG\
IROORZLQJ DVVHVVPHQWVFRQGXFWHGDW6FUHHQ6XEMHFWVZLOO EHLQVWUXFWHGWRUHSRUWWRWKH
,PDJLQJ IDFLOLW\ DIWHUDPLQLPXP KRXUIDVWWRXQGHUJROLYHUIDWDVVHVVPHQWYLD05,3'))
,QUDUHFDVHVVXEMHFWVPD\EHUHVFUHHQHGKRZHYHUWKLVLVSHUPLWWHGRQO\ ZKHQGXHWR
ORJLVWLFDO FRQVWUDLQWVWKHPD[LPXP SHULRG EHWZHHQ9LVLWWR9LVLW LH6FUHHQWR'D\
H[FHHGVZHHNV,QVXFKFDVHVDOOVFUHHQLQJSURFHGXUHVPXVWEHUHSHDWHGDQGWKHVXEMHFW
DVVLJQHGDQHZGLJLW VWXG\VSHFLILF VXEMHFWLGHQWLILFDWLRQ QXPEHU 66,'QXPEHU6XEMHFWV
PXVWEHGHHPHGWRPHHWDOOWKHHOLJLELOLW\ FULWHULDLQFOXGLQJ DVVHVVPHQWRIOLYHUIDWYLD
05,3'))DW6FUHHQYLVLW XQGHUWKHQHZGLJLW 66,'QXPEHU
5XQLQ3HULRG9LVLW
$IWHUWKHLQYHVWLJDWRU KDVGHWHUPLQHGHOLJLELOLW\ FULWHULDKDYHEHHQVDWLVILHG DSSUR[LPDWHO\
ZHHNIROORZLQJ 9LVLW VXEMHFWVZLOO UHWXUQWRWKHVLWHDIWHUDPLQLPXP KRXU EXW
SUHIHUDEO\KRXU IDVWH[FHSWZDWHU7KH5XQLQSHULRGZLOO VHUYHWRIDPLOLDUL]H WKH
VXEMHFWZLWK WKHVWXG\WUHDWPHQWUHJLPHQDQGH[FOXGHVXEMHFWVZKRDUHQRWFRPSOLDQW ZLWK
GRVLQJ 7KLVYLVLWZLOO RFFXUr GD\VSULRUWRWKHSODQQHGGDWHRIUDQGRPL]DWLRQ 9LVLW
'D\
)RUDOOVXEMHFWVUHIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREH
FRPSOHWHGDWWKH5XQLQYLVLW9LVLW
)ROORZLQJ FRPSOHWLRQ RIWKHDERYHSURFHGXUHVVLQJOHEOLQG ,3ZLOO EHVHOIDGPLQLVWHUHG
ZKLOHZLWQHVVHGE\DGHTXDWHO\WUDLQHGVLWHVWDII6XEMHFWVZLOO WKHQEHGLVFKDUJHGIURPWKH
VLWHZLWKHQRXJK ,3WRODVWXQWLO 'D\9LVLW 
'XULQJWKHDSSUR[LPDWH GD\5XQLQ SHULRG WLPLQJ GHSHQGHQWRQVLWHDQGVXEMHFW
ORJLVWLFV VXEMHFWVZLOO FRPSOHWHDKRXUXULQHFROOHFWLRQ WRPHDVXUHIUXFWRVHH[FUHWLRQ
UHIHUWR6HFWLRQ 6XEMHFWV ZLOO UHSRUWWRWKHVWXG\VLWHDQGEHLQVWUXFWHGWRIXOO\
HPSW\WKHLUEODGGHUV DQGWKHQEHSURYLGHG ZLWKFRQWDLQHUV DQGLQVWUXFWLRQV WRFROOHFW$//RI
WKHLUXULQH GXULQJ WKHVXEVHTXHQWKRXUV6XEMHFWVZLOO UHWXUQWRWKHVWXG\VLWH
DSSUR[LPDWHO\ KRXUVODWHUWRHPSW\WKHLU EODGGHUVDQGFRPSOHWHWKHXULQHFROOHFWLRQ
%DVHOLQH05,3'))9LVLW
%HWZHHQWRGD\VLQFOXVLYH SULRUWR9LVLW'D\VXEMHFWVZLOO EHLQVWUXFWHGWRUHSRUW
WRWKH,PDJLQJ IDFLOLW\ IROORZLQJ DKRXUIDVWDQGZLWKLQ KRXUVRIWKH9LVLWWLPHWR
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
XQGHUJROLYHUIDWDVVHVVPHQWYLD05,3'))6XEMHFWVVKRXOG VHOIDGPLQLVWHU VLQJOHEOLQG ,3
SRVW05,3'))

6WXG\3HULRG
'D\9LVLW
$SSUR[LPDWHO\ GD\VIURP9LVLWVXEMHFWVZLOO UHWXUQWRWKHVLWHDIWHUDPLQLPXP RIDQ
KRXUEXWSUHIHUDEO\KRXUIDVWDQGZLWKLQ KRXUVRIWKH9LVLW WLPH6XEMHFWVZLOO EH
DVNHGWRUHWXUQ,3GLVSHQVHGDW9LVLW IRUDQDVVHVVPHQWRIWKHSLOO FRXQW6XEMHFWVPXVWEH
DWOHDVWFRPSOLDQW ZLWKWKHSODFHERUXQLQ ,3LQRUGHUWREHUDQGRPL]HG 
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGSULRUWR
DGPLQLVWUDWLRQRI,3RQ'D\%HVXUHWRFROOHFWDJHQRPLF EDQNHGELRVSHFLPHQ ,I
PLVVHGFROOHFWDWWKHQH[WDYDLODEOH WLPHSRLQW ZKHQELRVSHFLPHQV DUHEHLQJFROOHFWHGLQ
FRQMXQFWLRQ ZLWKDVXEMHFWYLVLW 
6XEMHFWVZKRPHHWDOOHQWU\FULWHULDZLOO EHUDQGRPL]HG WRGRXEOHEOLQG VWXG\WUHDWPHQWRQ
'D\6LWHVZLOO FRQWDFWWKH,57V\VWHPIRUDVVLJQPHQWRIGRXEOHEOLQG WUHDWPHQW
)ROORZLQJ ZLWQHVVHGGRVLQJ RI,3DQDSSUR[LPDWH ZHHNVXSSO\RIGRXEOHEOLQG ,3ZLOO EH
GLVSHQVHG DQGVXEMHFWVZLOO EHGLVFKDUJHGIURPWKHVLWH
'D\9LVLW
$WGD\VIURP9LVLW VXEMHFWVZLOO UHWXUQWRWKHVWXG\VLWHDIWHUDPLQLPXP RIDQ
KRXUEXWSUHIHUDEO\KRXUIDVWDQGZLWKLQ KRXUVRIWKH9LVLWWLPH
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGSULRUWR
DGPLQLVWUDWLRQRI,3RQ'D\
)ROORZLQJ FRPSOHWLRQ RIWKHDERYHSURFHGXUHVGRXEOHEOLQG ,3ZLOO EHGLVSHQVHGWRVXEMHFWV
YLD,57DQGVHOIDGPLQLVWHUHG 6XEMHFWVZLOO WKHQEHGLVFKDUJHGIURPWKHVWXG\VLWHZLWKDQ
DSSUR[LPDWH ZHHNVXSSO\RIGRXEOHEOLQG ,3
'D\9LVLW
$WGD\VIURP9LVLW VXEMHFWVZLOO UHWXUQWRWKHVWXG\VLWHDIWHUDPLQLPXP RIDQ
KRXUEXWSUHIHUDEO\KRXUIDVWDQGZLWKLQ KRXUVRIWKH9LVLWWLPH:LWKLQ KRXUV
RIWKLVYLVLW VXEMHFWVZLOO FRPSOHWHDKRXU XULQHFROOHFWLRQ WRPHDVXUHIUXFWRVHH[FUHWLRQ
UHIHUWR6HFWLRQ 6XEMHFWVZLOO EHLQVWUXFWHGWRIXOO\ HPSW\WKHLUEODGGHUV DQGZLOO
WKHQEHSURYLGHG ZLWKFRQWDLQHUVDQGLQVWUXFWLRQV WRFROOHFW$//RIWKHLUXULQHGXULQJ WKH
VXEVHTXHQWKRXUV6XEMHFWVZLOO UHWXUQWRWKHVWXG\VLWHDSSUR[LPDWHO\ KRXUVODWHUWR
HPSW\WKHLUEODGGHUV FRPSOHWHWKHXULQHFROOHFWLRQ DQGKDYHDEORRG VDPSOHFROOHFWHGIRU
3.DQDO\VLVSULRUWRGRVLQJ ,WVKRXOG EHQRWHGWKDW3.VDPSOHVZLOO EHFROOHFWHGDURXQG
WKLVYLVLW RQHDWDSSUR[LPDWHO\ WKHVWDUWRIWKHXULQHFROOHFWLRQ DQGDVHFRQGRQHDW
DSSUR[LPDWHO\ WKHHQGRIWKHXULQHFROOHFWLRQ KRXUVODWHU,IQHFHVVDU\IRUORJLVWLFV LWLV
DFFHSWDEOHIRUVXEMHFWVWRUHSRUWWRWKHVWXG\VLWHKRXUVSULRU WRWKHQRPLQDO 'D\YLVLW WR
EHJLQWKHXULQHFROOHFWLRQ DQGWKHQFRPSOHWHLWDWWKH'D\YLVLW
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGSULRUWR
DGPLQLVWUDWLRQRI,3RQ'D\
)ROORZLQJ FRPSOHWLRQ RIWKHDERYHSURFHGXUHVGRXEOHEOLQG ,3ZLOO EHGLVSHQVHGWRVXEMHFWV
YLD,57DQGVHOIDGPLQLVWHUHG 6XEMHFWVZLOO WKHQEHGLVFKDUJHGIURPWKHVWXG\VLWHZLWKDQ
DSSUR[LPDWH ZHHNVXSSO\RIGRXEOHEOLQG ,3
'D\9LVLW
:LWKLQ DSSUR[LPDWHO\ KRXUVSULRUWRWKH'D\YLVLW RURQWKHGD\RIWKH'D\YLVLW
VXEMHFWVZLOO EHLQVWUXFWHGWRUHSRUWWRWKH,PDJLQJ IDFLOLW\ IROORZLQJ DKRXUIDVWDQG
ZLWKLQ KRXUVRIWKH9LVLWWLPHWRXQGHUJROLYHUIDWDVVHVVPHQWYLD05,3'))6XEMHFWV
VKRXOG VHOIDGPLQLVWHU GRXEOHEOLQG ,3SRVW05,3'))
$WGD\VIURP9LVLW VXEMHFWVZLOO UHWXUQWRWKHVWXG\VLWHDIWHUDPLQLPXP RIDQ
KRXUEXWSUHIHUDEO\KRXUIDVWDQGZLWKLQ KRXUVRIWKH9LVLWWLPH
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGSULRUWR
DGPLQLVWUDWLRQRI,3RQ'D\
)ROORZLQJ FRPSOHWLRQ RIWKHDERYHSURFHGXUHVVXEMHFWVZLOO UHFHLYHWKHLUILQDO GRVHRI
GRXEOHEOLQG ,3IURPWKHVXSSO\ GLVSHQVHGDWWKHSUHYLRXVYLVLW 6XEMHFWVZLOO WKHQEH
GLVFKDUJHGIURPWKHVWXG\VLWH
)ROORZXS9LVLW9LVLW
$WtGD\VDQGdGD\VIROORZLQJ WKHODVWGRVHRIGRXEOHEOLQG ,3VXEMHFWVZLOO UHWXUQWR
WKHVWXG\VLWHIRUDIROORZXS YLVLW DIWHUDPLQLPXP KRXUEXWSUHIHUDEO\KRXUIDVWDQG
ZLWKLQ KRXUVRIWKH9LVLW
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGDWWKLVYLVLW
)ROORZXS&RQWDFW
$)ROORZXS FRQWDFWYLDWHOHSKRQH RIDOOVXEMHFWVZLOO EHFRPSOHWHGDWOHDVWFDOHQGDUGD\V
DQGXSWRFDOHQGDUGD\VDIWHUWKHODVWDGPLQLVWUDWLRQ RIGRXEOHEOLQG ,3
5HIHUWRWKH6FKHGXOHRI$FWLYLWLHVIRUWKHVWXG\SURFHGXUHVWREHFRPSOHWHGGXULQJWKLV
FRQWDFW
x 127(WKLVFRQWDFWFDQEHFRQVLGHUHGDVRQVLWHLQRUGHUWRSHUPLWIROORZXS RIRSHQ
$(VDQGRUDEQRUPDOODERUDWRU\WHVWVIURPSULRUYLVLWV DVQHHGHG
6XEMHFW:LWKGUDZDO 
,QWKLV VWXG\ DQ\VXEMHFWZKRGLVFRQWLQXHV SDUWLFLSDWLRQ LQWKHWULDO DQ\WLPHSULRUWR
DGPLQLVWUDWLRQ RIGRXEOHEOLQG ,3ZLOO KDYHQRDGGLWLRQDO SURFHGXUHVFRPSOHWHG+RZHYHU
DQHDUO\WHUPLQDWLRQ YLVLWLVWREHFRQVLGHUHG IRUDOOVXEMHFWVZKRZHUHUDQGRPL]HG DQG
UHFHLYHGDWOHDVWGRVHRIWKHGRXEOHEOLQG ,3DQGWKHQDUHSUHPDWXUHO\ZLWKGUDZQIURPWKH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
VWXG\6XEMHFWVVKRXOG UHWXUQWRWKHVLWHIRUILQDOVDIHW\DVVHVVPHQWVWREHVFKHGXOHGDVHDUO\
DVSUDFWLFDOO\ IHDVLEOHIROORZLQJ WKHGHFLVLRQ WRZLWKGUDZEXWdGD\VDIWHUODVWGRVHRI
GRXEOHEOLQG ,36XEMHFWVVKRXOG EHTXHVWLRQHG UHJDUGLQJWKHLUUHDVRQIRUZLWKGUDZDO$WWKH
HDUO\ZLWKGUDZDOYLVLW HYHU\HIIRUWPXVWEHPDGHWRFRPSOHWHWKHDVVHVVPHQWVRXWOLQHG LQWKH
6FKHGXOHRI$FWLYLWLHV /DFNRIFRPSOHWLRQ RIDOORUDQ\RIWKHHDUO\WHUPLQDWLRQ SURFHGXUHV
ZLOO QRWEHYLHZHGDVSURWRFRO GHYLDWLRQV VRORQJ DVWKHVXEMHFW¶VVDIHW\ZDVSUHVHUYHG
:LWKGUDZDO RIFRQVHQW
6XEMHFWVZKRUHTXHVWWRGLVFRQWLQXH UHFHLSWRIVWXG\WUHDWPHQWZLOO UHPDLQLQWKHVWXG\DQG
PXVWFRQWLQXHWREHIROORZHG IRUSURWRFRO VSHFLILHG IROORZXS SURFHGXUHV7KHRQO\
H[FHSWLRQWRWKLVLVZKHQDVXEMHFWVSHFLILFDOO\ ZLWKGUDZVFRQVHQWIRUDQ\IXUWKHUFRQWDFW
ZLWKKLP RUKHURUSHUVRQVSUHYLRXVO\ DXWKRUL]HG E\WKHVXEMHFWWRSURYLGH WKLVLQIRUPDWLRQ 
6XEMHFWVVKRXOGQRWLI\ WKHLQYHVWLJDWRU LQZULWLQJ RIWKHGHFLVLRQ WRZLWKGUDZFRQVHQWIURP
IXWXUHIROORZXS ZKHQHYHUSRVVLEOH 7KHZLWKGUDZDORIFRQVHQWVKRXOG EHH[SODLQHG LQ
GHWDLOLQWKHPHGLFDOUHFRUGVE\WKHLQYHVWLJDWRU DVWRZKHWKHUWKHZLWKGUDZDOLVRQO\ IURP
IXUWKHUUHFHLSWRI,3RUDOVRIURPVWXG\SURFHGXUHVDQGRUSRVWWUHDWPHQWVWXG\IROORZXS DQG
HQWHUHGRQWKHDSSURSULDWH&5)SDJH,QWKHHYHQWWKDWYLWDO VWDWXVZKHWKHUWKHVXEMHFWLV
DOLYHRUGHDGLVEHLQJPHDVXUHGSXEOLFO\ DYDLODEOH LQIRUPDWLRQ VKRXOG EHXVHGWRGHWHUPLQH
YLWDOVWDWXVRQO\ DVDSSURSULDWHO\ GLUHFWHGLQDFFRUGDQFHZLWKORFDOODZ
/RVWWRIROORZXS
$OOUHDVRQDEOHHIIRUWVPXVWEHPDGHWRORFDWHVXEMHFWVWRGHWHUPLQHDQGUHSRUWWKHLURQJRLQJ
VWDWXV7KLVLQFOXGHV IROORZXS ZLWKSHUVRQVDXWKRUL]HG E\WKHVXEMHFWDVQRWHGDERYH/RVW
WRIROORZXS LVGHILQHGE\WKHLQDELOLW\ WRUHDFKWKHVXEMHFWDIWHUDPLQLPXP RIGRFXPHQWHG
SKRQHFDOOVID[HVRUHPDLOVDVZHOODVODFNRIUHVSRQVHE\WKHVXEMHFWWRUHJLVWHUHGPDLO
OHWWHU$OODWWHPSWVVKRXOGEHGRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDOUHFRUGV,ILWLV
GHWHUPLQHGWKDWWKHVXEMHFWKDVGLHGWKHVLWHZLOO XVHORFDOO\ SHUPLVVLEOH PHWKRGVWRREWDLQ
WKHGDWHDQGFDXVHRIGHDWK,IWKHLQYHVWLJDWRU¶V XVHRIDWKLUGSDUW\ UHSUHVHQWDWLYHWRDVVLVW
LQWKHIROORZXS SRUWLRQ RIWKHVWXG\KDVEHHQLQFOXGHG LQWKHVXEMHFW¶VLQIRUPHG FRQVHQW
WKHQWKHLQYHVWLJDWRU PD\XVHDVSRQVRUUHWDLQHG WKLUGSDUW\ UHSUHVHQWDWLYHWRDVVLVWVLWHVWDII
ZLWKREWDLQLQJ WKHVXEMHFW¶VFRQWDFWLQIRUPDWLRQ RURWKHUSXEOLF YLWDOVWDWXVGDWDQHFHVVDU\WR
FRPSOHWHWKHIROORZXS SRUWLRQ RIWKHVWXG\7KHVLWHVWDIIDQGUHSUHVHQWDWLYHZLOO FRQVXOW
SXEOLFO\ DYDLODEOH VRXUFHVVXFKDVSXEOLF KHDOWKUHJLVWULHVDQGGDWDEDVHVLQRUGHUWRREWDLQ
XSGDWHGFRQWDFWLQIRUPDWLRQ ,IDIWHUDOODWWHPSWVWKHVXEMHFWUHPDLQVORVWWRIROORZXS WKHQ
WKHODVWNQRZQDOLYH GDWHDVGHWHUPLQHGE\WKHLQYHVWLJDWRU VKRXOG EHUHSRUWHGDQG
GRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDOUHFRUGV
6XEMHFWVPD\ZLWKGUDZIURPWKHVWXG\DWDQ\WLPHDWWKHLURZQUHTXHVWRUWKH\PD\EH
ZLWKGUDZQDWDQ\WLPHDWWKHGLVFUHWLRQ RIWKHLQYHVWLJDWRU RUVSRQVRUIRUVDIHW\VHHDOVR
6HFWLRQ RUEHKDYLRUDO UHDVRQVRUWKHLQDELOLW\ RIWKHVXEMHFWWRFRPSO\ ZLWKWKH
SURWRFROUHTXLUHG VFKHGXOHRIVWXG\YLVLWV RUSURFHGXUHVDWDJLYHQVWXG\VLWH
,IDVXEMHFWGRHVQRWUHWXUQIRUDVFKHGXOHGYLVLW HYHU\HIIRUWVKRXOG EHPDGHWRFRQWDFWWKH
VXEMHFW$OODWWHPSWVWRFRQWDFWWKHVXEMHFWDQGLQIRUPDWLRQ UHFHLYHGGXULQJFRQWDFWDWWHPSWV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
PXVWEHGRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDO UHFRUG,QDQ\FLUFXPVWDQFHHYHU\HIIRUW
VKRXOG EHPDGHWRGRFXPHQWVXEMHFWRXWFRPH LISRVVLEOH7KHLQYHVWLJDWRU VKRXOGLQTXLUH
DERXWWKHUHDVRQIRUZLWKGUDZDO UHTXHVWWKDWWKHVXEMHFWUHWXUQDOO XQXVHG,3UHTXHVWWKDWWKH
VXEMHFWUHWXUQIRUDILQDO YLVLW LIDSSOLFDEOH DQGIROORZ XSZLWKWKHVXEMHFWUHJDUGLQJDQ\
XQUHVROYHG $(V
,IWKHVXEMHFWZLWKGUDZVIURPWKHVWXG\DQGDOVRZLWKGUDZVFRQVHQWIRUGLVFORVXUHRIIXWXUH
LQIRUPDWLRQ QRIXUWKHUHYDOXDWLRQV VKRXOGEHSHUIRUPHGDQGQRDGGLWLRQDO GDWDVKRXOG EH
FROOHFWHG7KHVSRQVRUPD\UHWDLQDQGFRQWLQXHWRXVHDQ\GDWDFROOHFWHGEHIRUHVXFK
ZLWKGUDZDORIFRQVHQW
$66(660(176
(YHU\HIIRUWVKRXOGEHPDGHWRHQVXUHWKDWWKHSURWRFROUHTXLUHG WHVWVDQGSURFHGXUHVDUH
FRPSOHWHGDVGHVFULEHG+RZHYHULWLVDQWLFLSDWHGWKDWIURPWLPHWRWLPHWKHUHPD\EH
FLUFXPVWDQFHVRXWVLGHRIWKHFRQWURORIWKHLQYHVWLJDWRU WKDWPD\PDNHLWXQIHDVLEOH WR
SHUIRUPWKHWHVW,QWKHVHFDVHVWKHLQYHVWLJDWRU ZLOO WDNHDOOVWHSVQHFHVVDU\WRHQVXUHWKH
VDIHW\DQGZHOOEHLQJ RIWKHVXEMHFW:KHQDSURWRFROUHTXLUHG WHVWFDQQRWEHSHUIRUPHGWKH
LQYHVWLJDWRU ZLOO GRFXPHQWWKHUHDVRQIRUWKLVDQGDQ\FRUUHFWLYHDQGSUHYHQWLYHDFWLRQVWKDW
KHRUVKHKDVWDNHQWRHQVXUHWKDWQRUPDO SURFHVVHVDUHDGKHUHGWRDVVRRQDVSRVVLEOH 7KH
VWXG\WHDPZLOO EHLQIRUPHG RIWKHVHLQFLGHQWV LQDWLPHO\ PDQQHU
)RUVDPSOHVEHLQJFROOHFWHGDQGVKLSSHG GHWDLOHGFROOHFWLRQ SURFHVVLQJ VWRUDJHDQG
VKLSPHQW LQVWUXFWLRQV DQGFRQWDFWLQIRUPDWLRQ ZLOO EHSURYLGHG WRWKHLQYHVWLJDWRU VLWHSULRU
WRLQLWLDWLRQ RIWKHVWXG\
&OLQLFDO/DERUDWRU\7HVWV
7KHIROORZLQJ FOLQLFDO ODERUDWRU\WHVWVZLOO EHSHUIRUPHGDWWLPHVRXWOLQHG LQWKH6FKHGXOHRI
$FWLYLWLHV $GGLWLRQDO ODERUDWRU\ UHVXOWVPD\EHUHSRUWHGRQWKHVHVDPSOHVDVDUHVXOWRIWKH
PHWKRGRIDQDO\VLVRUWKHW\SHRIDQDO\]HUXVHGE\WKHFOLQLFDO ODERUDWRU\RUDVGHULYHGIURP
FDOFXODWHGYDOXHV7KHVHDGGLWLRQDO WHVWVZRXOGQRWUHTXLUHDGGLWLRQDO FROOHFWLRQ RIEORRG 
8QVFKHGXOHGFOLQLFDO ODEVPD\EHREWDLQHG DWDQ\WLPHGXULQJ WKHVWXG\WRDVVHVVDQ\
SHUFHLYHGVDIHW\FRQFHUQV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
7DEOH
&OLQLFDO/DERUDWRU\7HVWV
+HPDWRORJ\
&KHPLVWU\
8ULQDO\VLV
2WKHU
í+HPRJORELQ
í+HPDWRFULW
í5%&FRXQW
í0&9
í0&+
í0&+&
í3ODWHOHWFRXQW
í:%&FRXQW
í7RWDOQHXWURSKLOV
$EV
í(RVLQRSKLOV$EV
í0RQRF\WHV$EV
í%DVRSKLOV$EV
í/\PSKRF\WHV$EV
í%81
í&UHDWLQLQH
í3ODVPDJOXFRVHIDVWLQJ
í&DOFLXP
í6RGLXP
í3RWDVVLXP
í&KORULGH
í7RWDO&2%LFDUERQDWH
í$67
í$/7
í**7
í$ONDOLQHSKRVSKDWDVH
í7RWDO%LOLUXELQ
í'LUHFWFRQMXJDWHGELOLUXELQD
í,QGLUHFWXQFRQMXJDWHG
ELOLUXELQD
í8ULFDFLG
í$OEXPLQ
í7RWDOSURWHLQ
íS+
í*OXFRVHTXDO
í3URWHLQTXDO
í%ORRGTXDO
í.HWRQHV
í1LWULWHV
í/HXNRF\WH
HVWHUDVH
í8URELOLQRJHQ
í8ULQHELOLUXELQ
í0LFURVFRS\
$W6FUHHQRQO\
í&RDJXODWLRQ37,15
D377
í6HUXP)6+IHPDOHV
í8ULQHGUXJWHVWE
í6HURORJ\+%V$J
+&9$EDQGLI
SRVLWLYHUHIOH[+&9
51$+,9
í$$7
í&HUXORSODVPLQ


$GGLWLRQDO7HVWV1HHGHGIRULQVWDQFHVRIVXVSHFWHG+\¶VODZ


í $67$/7UHSHDW
í 7RWDOELOLUXELQUHSHDW
í $OEXPLQUHSHDW
í $ONDOLQHSKRVSKDWDVH
UHSHDW
í 'LUHFWELOLUXELQ
í ,QGLUHFWELOLUXELQ
í &UHDWLQHNLQDVH
í **7
í 37,15
í 7RWDOELOHDFLGV
í $FHWDPLQRSKHQGUXJOHYHOV
í $QGRUSURWHLQDGGXFWOHYHO


D 'LUHFWDQGLQGLUHFWELOLUXELQ PHDVXUHGRQO\ZKHQWRWDOELOLUXELQLV!8/1
E 0LQLPXPUHTXLUHPHQWIRUXULQHGUXJWHVWLQFOXGHFRFDLQHWHWUDK\GURFDQQDELQRO7+&RSLDWHVRSLRLGV
EHQ]RGLD]HSLQHVDQGDPSKHWDPLQHV
)RUOLVWRIDEEUHYLDWLRQVUHIHUWR$SSHQGL[
$GGLWLRQDO ODERUDWRU\UHVXOWVPD\EHUHSRUWHGRQWKHVHVDPSOHVDVDUHVXOWRIWKHPHWKRGRI
DQDO\VLV RUWKHW\SHRIDQDO\]HUXVHGE\WKH6SRQVRULGHQWLILHG FHQWUDOODERUDWRU\ RU
VHFRQGDU\ODERUDWRU\ RUDVGHULYHGIURPFDOFXODWHGYDOXHV7KHVHDGGLWLRQDO WHVWVZRXOG QRW
UHTXLUHDGGLWLRQDO FROOHFWLRQ RIEORRG 
8QVFKHGXOHGFOLQLFDO ODERUDWRU\WHVWVIRUVXEMHFWVDIHW\PD\EHREWDLQHG DWDQ\WLPHGXULQJ
WKHVWXG\WRDVVHVVDQ\SHUFHLYHGVDIHW\FRQFHUQVDQGVKLSSHGWRWKH6SRQVRULGHQWLILHG
FHQWUDOODERUDWRU\IRUDQDO\VLV
$GGLWLRQDO GHWDLOVUHJDUGLQJVDPSOHFROOHFWLRQ SURFHVVLQJ DQGVKLSPHQW ZLOO EHSURYLGHG LQ
WKHVWXG\VSHFLILF FHQWUDOODERUDWRU\PDQXDOWREHSURYLGHG SULRUWRWKHVWDUWRIWKHVWXG\
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
3K\VLFDO([DPLQDWLRQ
,QWKLVVWXG\SK\VLFDOH[DPLQDWLRQV DUHWREHSHUIRUPHGDWQRPLQDO WLPHSRLQWVVSHFLILHGLQ
WKH6FKHGXOHRI$FWLYLWLHV 3K\VLFDOH[DPLQDWLRQV PD\EHFRQGXFWHGE\DSK\VLFLDQ WUDLQHG
SK\VLFLDQ
V DVVLVWDQWRUQXUVHSUDFWLWLRQHUDVDFFHSWDEOHDFFRUGLQJWRORFDOUHJXODWLRQ $IXOO
SK\VLFDO H[DPLQDWLRQ ZLOO LQFOXGH KHDGHDUVH\HVQRVHPRXWK VNLQ KHDUWDQGOXQJ
H[DPLQDWLRQV O\PSK QRGHVJDVWURLQWHVWLQDO PXVFXORVNHOHWDO DQGQHXURORJLFDO V\VWHPV
+HLJKWZLOO DOVREHPHDVXUHGDVSDUWRIWKHSK\VLFDO H[DPLQDWLRQ DW6FUHHQ9LVLW$
OLPLWHG SK\VLFDO H[DPLQDWLRQ ZLOO EHIRFXVHGRQJHQHUDODSSHDUDQFHWKHUHVSLUDWRU\DQG
FDUGLRYDVFXODUV\VWHPVDVZHOODVWRZDUGVVXEMHFWUHSRUWHGV\PSWRPV
0HDVXUHPHQWRI:DLVW&LUFXPIHUHQFH
$VSDUWRIWKHSK\VLFDO H[DPLQDWLRQ DW6FUHHQRQO\ ZDLVWFLUFXPIHUHQFHZLOO EHPHDVXUHG
XVLQJDIOH[LEOH DQWKURSRPHWULF WDSHDQGLGHDOO\ UHSRUWLQJ WKHPHDVXUHPHQWLQFHQWLPHWHUV
ZLWKDFFXUDF\WRWKHQHDUHVWFHQWLPHWHU0HDVXUHPHQWZLOO EHXQGHUWDNHQDVIROORZV 
x :KLOHVXEMHFWLVLQDVWDQGLQJ SRVLWLRQ ZLWKDUPVUHVWLQJFRPIRUWDEO\ DWWKHVLGH
x 8QGHUVWDQGDUGFRQGLWLRQV LQFOXGLQJ SRVWYRLG ZLWKWKHWDSHWRXFKLQJ WKHVNLQQRW
FORWKLQJ
x $WWKHHQGRIDQRUPDO H[SLUDWLRQ ZKHQOXQJVDUHDWWKHLUUHVLGXDOFDSDFLW\
7KHPHDVXUHPHQWZLOO FRQVLGHUWKHIROORZLQJ DQDWRPLFDOIHDWXUHVDVEHQFKPDUNV 
x &LUFXPIHUHQFHRIWKHQDUURZHVWSDUWRIWKHWRUVRDVYLHZHGIURPWKHDQWHULRUDVSHFWRU
x ,IWKHQDUURZHVWSDUWRIWKHWRUVRFDQQRWEHLGHQWLILHG WKHPHDVXUHPHQWPXVWEHPDGHRI
WKHVPDOOHVWKRUL]RQWDO FLUFXPIHUHQFHLQWKHDUHDEHWZHHQWKHULEVDQGWKHLOLDFFUHVW
%RG\:HLJKW
,QWKLVVWXG\DVVHVVPHQWRIERG\ZHLJKWZLOO RFFXUDWWKHQRPLQDO WLPHSRLQWVVSHFLILHGLQ
WKH6FKHGXOHRI$FWLYLWLHV SHUWKHIROORZLQJ VSHFLILFDWLRQV 
x :HLJKWZLOO EHUHFRUGHGXVLQJDVFDOHSODFHGRQDVWDEOHIODWVXUIDFH
x 6DPHVFDOHDVPXFKDVSUDFWLFDOO\ SRVVLEOH ZLOO EHXVHGZLWKWKHVFDOHUHSRUWLQJ ZHLJKW
LQNLORJUDPV RUSRXQGV DQGDFFXUDF\WRWKHQHDUHVWNJRUSRXQGV LHWKHGHYLFH
XVHGIRUWKLVVWXG\PXVWEHDEOHWRGLVWLQJXLVK DGLIIHUHQFHEHWZHHQNJDQGNJ
x 0HDVXUHPHQWPXVWEHXQGHUWDNHQ
x $WDSSUR[LPDWHO\ WKHVDPHWLPHRIWKHGD\DWHDFKQRPLQDO WLPHSRLQW
x $IWHUWKHVXEMHFWKDVEHHQDVNHGWRYRLGLHIRUFHGYRLG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x 8QGHUVWDQGDUGFRQGLWLRQV HJVXEMHFWVPXVWZHDUOLJKW FORWKLQJ ZLWKFRQWHQWRIWKHLU
SRFNHWVHPSWLHG RUKRVSLWDO JRZQDQGQRWEHZHDULQJVKRHVRUEXON\ OD\HUVRI
FORWKLQJMDFNHWV
OHDG(OHFWURFDUGLRJUDP
,QWKLVVWXG\OHDG(&*VZLOO EHFROOHFWHGDWWKHQRPLQDO WLPHSRLQWVVSHFLILHGLQ WKH
6FKHGXOHRI$FWLYLWLHV SHUWKHIROORZLQJ VSHFLILFDWLRQV
x $OOVFKHGXOHGOHDG(&*VVKRXOG EHSHUIRUPHGDIWHUWKHVXEMHFWKDVUHVWHGTXLHWO\ IRU
tPLQXWHVLQDVXSLQHSRVLWLRQ
x )XUWKHU(&*PRQLWRULQJ ZLOO RFFXULIDDSRVWGRVH47FLQWHUYDOLVLQFUHDVHGE\
tPVHFIURPWKHEDVHOLQHDQGLV!PVHFRUEDQDEVROXWH47FYDOXHLVt PVHF
IRUDQ\VFKHGXOHG(&*,IHLWKHURIWKHVHFRQGLWLRQV RFFXUVWKHQDGGLWLRQDO (&*VZLOO
EHFROOHFWHG DSSUR[LPDWHO\ WRPLQXWHVDSDUWWRFRQILUP WKHRULJLQDO PHDVXUHPHQW,I
WKH47FYDOXHVIURPWKHVHUHSHDWHG(&*VUHPDLQVDERYHWKHWKUHVKROG YDOXHWKHQD
VLQJOH (&*PXVWEHUHSHDWHGDWOHDVWKRXUO\XQWLO 47FYDOXHVIURPVXFFHVVLYH(&*V
IDOOEHORZWKHWKUHVKROG YDOXHWKDWWULJJHUHGWKHUHSHDWPHDVXUHPHQW
,QVRPHFDVHVLWPD\EHDSSURSULDWHWRUHSHDWDEQRUPDO OHDG(&*VWRUXOHRXWLPSURSHU
OHDGSODFHPHQWDVFRQWULEXWLQJ WRWKH(&*DEQRUPDOLW\ ,WLVLPSRUWDQW WKDWOHDGVDUHSODFHG
LQWKHVDPHSRVLWLRQV HDFKWLPHLQRUGHUWRDFKLHYHSUHFLVH(&*UHFRUGLQJV,ID
PDFKLQHUHDG47FYDOXHLVSURORQJHG DVGHILQHGDERYHUHSHDWPHDVXUHPHQWVPD\QRWEH
QHFHVVDU\LIDTXDOLILHG SK\VLFLDQ¶V LQWHUSUHWDWLRQ GHWHUPLQHVWKDWWKH47FYDOXHVDUHLQWKH
DFFHSWDEOHUDQJH
%ORRG3UHVVXUHDQG3XOVH5DWH
,QWKLVVWXG\DVVHVVPHQWRIYLWDO VLJQVLQFOXGLQJ VHDWHG%3DQGSXOVHUDWHZLOO RFFXUDWWKH
QRPLQDO WLPHSRLQWV VSHFLILHGLQWKH6FKHGXOHRI$FWLYLWLHV SHUWKHIROORZLQJ VSHFLILFDWLRQV
x $WWKH6FUHHQYLVLW RQO\ WKHVXEMHFW¶VDUPFLUFXPIHUHQFHVKRXOG EHPHDVXUHGDWWKH
PLGSRLQW RIWKHOHQJWKRIWKHXSSHUDUPXVLQJDIOH[LEOH DQWKURSRPHWULF WDSHWRVHOHFWWKH
DSSURSULDWHFXIIWREHXVHGWKURXJKRXW WKHVWXG\WRPHDVXUH%3SXOVHUDWHYLDDQ
DXWRPDWHGGHYLFHXVLQJDQRVFLOORPHWULF PHWKRGQRWDXVFXOWDWLRQ
x 6XEMHFWVZLWKDUPFLUFXPIHUHQFHJUHDWHUWKDQWKHODUJHVWFXIIVL]HDYDLODEOH DWHDFK
VWXG\VLWHDUHQRWHOLJLEOH
x 6HDWHG%3SXOVHUDWHZLOO EHPHDVXUHGZLWKWKHVXEMHFW¶VDUPVXSSRUWHGDWWKHOHYHORIWKH
KHDUWDQGUHFRUGHGWRWKHQHDUHVWPP+JIROORZLQJ DUHVWRItPLQXWHV
x 6DPHDUPSUHIHUDEO\WKHGRPLQDQW DUPZLOO EHXVHGIRU%3SXOVHUDWHDVVHVVPHQW
WKURXJKRXW WKHVWXG\
x 6XEMHFWVVKRXOGEHLQVWUXFWHG QRWWRVSHDNGXULQJ %3SXOVHUDWHPHDVXUHPHQWV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$GGLWLRQDO FROOHFWLRQ WLPHVRUFKDQJHVWRFROOHFWLRQ WLPHVRI%3SXOVHUDWHZLOO EHSHUPLWWHG
DVQHFHVVDU\WRHQVXUHDSSURSULDWHFROOHFWLRQ RIVDIHW\GDWD
/LYHU)DW$VVHVVPHQWV
$VVHVVPHQWRI/LYHU)DWDQG6WLIIQHVV8VLQJ)LEUR6FDQ
,QWKLVVWXG\ HVWLPDWLRQ RIOLYHUIDWDQGVWLIIQHVVXVLQJ)LEUR6FDQ ZLOO RFFXUDWVFKHGXOHG
YLVLWVRXWOLQHG LQWKH6FKHGXOHRI$FWLYLWLHV (DFKDFTXLVLWLRQ ZLOO WDNHDSSUR[LPDWHO\
PLQXWHVDQGUHTXLUHWKHVXEMHFWVWREHLQDVXSLQHSRVLWLRQ ZLWKWKHULJKW DUPSODFHGIODW
DERYHWKHKHDG$FTXLVLWLRQ UHVXOWVGRQRWQHHGLQGHSHQGHQW RYHUUHDGEXWVWHSVWRHQVXUH
WKHDFTXLVLWLRQ ZDVFRPSOHWHDQGDFFXUDWHDUHUHTXLUHG DVSHUWUDLQLQJ WREHSURYLGHG E\
(FKR6HQVYHQGRUVXSSRUWLQJ WKHGHYLFHDWWKHVWDUWRIWKHVWXG\$VPXFKDVSUDFWLFDOO\
SRVVLEOH DWWHPSWVZLOO EHPDGHWRHQVXUHHDFKLQGLYLGXDO VXEMHFWV¶DVVHVVPHQWLVSHUIRUPHG
E\WKHVDPHVLWHVWDII
&RPSOHWHGHWDLOVUHJDUGLQJDFTXLVLWLRQV XVLQJ)LEUR6FDQWRDVVHVV&$370DQG/60ZLOO EH
SURYLGHG E\(FKR6HQVEHIRUHLQLWLDWLRQ RIWKLVVWXG\$OOLPDJHVDFTXLUHGPXVWEHVDYHGE\
WKHVWXG\VLWHXQWLO WKHFRQFOXVLRQ RIWKHVWXG\WKHVXPPDU\RIQXPHULFDOUHVXOWVLQFOXGLQJ
TXDOLW\UHODWHG RXWSXWVPXVWEHSULQWHGDQGVDYHGE\WKHVWXG\VLWHRU,PDJLQJ IDFLOLW\ DV
DSSOLFDEOH DVSDUWRIHDFKVXEMHFW¶VVRXUFHGRFXPHQWV 
$VVHVVPHQWRI/LYHU)DW8VLQJ05,3'))$FTXLVLWLRQDQG$QDO\VLV
$WVFKHGXOHGYLVLWV UHIHUWRWKH6FKHGXOHRI$FWLYLWLHV OLYHUIDWDQGVWLIIQHVVZLOO EH
DVVHVVHGYLD05,XVLQJ WKH3'))DFTXLVLWLRQ SURWRFRO 
$FURVVWKHVWXG\VLWHVVHOHFWHGIRUWKLVVWXG\WKH6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRU
ZLOO WUDLQWKHVWDIIDWWKH,PDJLQJ IDFLOLW\ RQWKH05,3'))DFTXLVLWLRQ SURWRFRO RQ
MXVWLQWLPH UHYLHZRIWKHDFTXLUHGLPDJHVIRUDVVHVVPHQWRILPDJHVEHLQJGHHPHGHYDOXDEOH
DQGRQWUDQVIHUSUHIHUDEO\HOHFWURQLFDOO\ RIWKHLPDJHVWRWKH6SRQVRULGHQWLILHG FHQWUDO
LPDJLQJ YHQGRUIRUDQDO\VLVDQGTXDQWLILFDWLRQ RIOLYHU IDW2QO\WKHVWDIIPHPEHUVDWWKH
,PDJLQJIDFLOLW\ ZKRDUHWUDLQHGE\WKH6SRQVRULGHQWLILHGFHQWUDOLPDJLQJYHQGRUDUH
SHUPLWWHGWRDFTXLUHLPDJHVLQWKHVXEMHFWVZKRFRQVHQWIRUWKLVVWXG\KRZHYHULQ
UDUHOLPLWHG VLWXDWLRQV H[FHSWLRQVPD\EHJUDQWHGZLWKZULWWHQDSSURYDO RIWKH6SRQVRU
&RPSOHWHGHWDLOVRQWKH05,3'))DFTXLVLWLRQ SURWRFRO GHWHUPLQDWLRQ RITXDOLW\ RILPDJHV
DQGWUDQVPLVVLRQ RIGDWDWR6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRUZLOO EHSURYLGHG LQDQ
,PDJLQJ 0DQXDORIIHUHGWRWKHVWXG\VLWHVSULRUWRWKHVWDUWRIWKHVWXG\
$VPXFKDVSUDFWLFDOO\SRVVLEOHDQDO\VLVRIWKH05,3'))LPDJHVDFTXLUHGIURPEDVHOLQH
9LVLW WR9LVLW :HHNZLOO EHXQGHUWDNHQE\DVLQJOH FROOHDJXHDWWKH
6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRUZKRZLOO EHEOLQGHG WRLQGLYLGXDO VXEMHFW¶V
FOLQLFDO GDWDDVZHOODVUDQGRPL]DWLRQ DQGVWUDWLILFDWLRQ DVVLJQPHQW 
$QDO\VLVRI05,3')),PDJHV,QFOXGLQJ'HWHUPLQDWLRQRI(OLJLELOLW\ 
$VXEMHFW¶VHOLJLELOLW\ IRUWKLVVWXG\EDVHGRQOLYHU IDWDVDVVHVVHGYLD05,3'))DW6FUHHQ
ZLOO EHPDGHE\WKH6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRU RQO\7KHLQGLYLGXDO
VXEMHFW¶VOLYHUIDWZLOO QRWEHFRPPXQLFDWHG WRWKHVWXG\VLWHRQO\WKHVWUDWXPWRZKLFKWKH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
VXEMHFWLVDVVLJQHGWKRXJK UHVXOWVIURP6FUHHQZLOO EHNQRZQWRWKH6SRQVRU,QWKHFDVH
RIWKH05,DW6FUHHQVWXG\VLWHVZLOO RQO\ EHLQIRUPHGZKHWKHUDVXEMHFWPHHWVHOLJLELOLW\
FULWHULDRULIWKHVFUHHQLQJ05,VKRXOG EHUHSHDWHGRQFHDVGHWHUPLQHGE\WKH
6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRU)RUDOO VXEVHTXHQWO\ VFKHGXOHG05,3'))
DVVHVVPHQWVVWXG\VLWHVZLOO RQO\EHLQIRUPHG ZKHWKHUWKHLPDJHVDUHGHHPHGHYDOXDEOHRU
QRW2IQRWHVXEMHFWVZLWKQRQHYDOXDEOH EDVHOLQHLPDJHV DVGHWHUPLQHGE\WKH
6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRUPD\EHZLWKGUDZQ SULRUWRRUDIWHU
UDQGRPL]DWLRQ DWWKHGLVFUHWLRQ RIWKH6SRQVRU 
0DQDJHPHQWRI,QFLGHQWDO)LQGLQJV
$QLQFLGHQWDO ILQGLQJ LVRQHXQNQRZQ WRWKHVXEMHFWWKDWKDVSRWHQWLDO KHDOWKRUUHSURGXFWLYH
LPSRUWDQFH ZKLFKLVGLVFRYHUHGXQH[SHFWHGO\ LQWKHFRXUVHRIDUHVHDUFKVWXG\EXWLV
XQUHODWHGWRWKHSXUSRVHDQGEH\RQGWKHDLPVRIWKHVWXG\
7KH05,VZLOO EHUHYLHZHGE\WKH6SRQVRULGHQWLILHG FHQWUDOLPDJLQJ YHQGRU 7KHSXUSRVH
RIWKLVUHYLHZLVWRHYDOXDWHLPDJHVIRUWKHDPRXQWRIIDWLQWKHOLYHU&HQWUDOLPDJHUHYLHZLV
QRWDFRPSOHWHPHGLFDOUHYLHZRIWKHVXEMHFW,IGXULQJ WKHFHQWUDOUHYLHZSURFHVVDQ
XQH[SHFWHGREVHUYDWLRQ LVLGHQWLILHG DQGWKLVILQGLQJ FRXOG LQWKHRSLQLRQ RIWKHFHQWUDO
UHYLHZHUKDYHDVLJQLILFDQW KHDOWKRUUHSURGXFWLYH FRQVHTXHQFHWKLVILQGLQJ PD\EHVKDUHG
ZLWKWKHVWXG\6SRQVRUIRUGLVFORVXUHWRWKHSULQFLSDO LQYHVWLJDWRU $OOIROORZXS WHVWLQJDQG
ILQDOGLDJQRVLV ZLOO EHOHIWWRWKHGLVFUHWLRQ RIWKHPHGLFDOSURIHVVLRQDOV DWWKHVWXG\VLWHRU
WKRVHZLWKDQH[LVWLQJ SK\VLFLDQSDWLHQW UHODWLRQVKLS 7KHSULQFLSDO LQYHVWLJDWRU ZLOO EH
UHVSRQVLEOH IRUUHSRUWLQJ DQ\$(VLGHQWLILHG IURPLQFLGHQWDO ILQGLQJV DVGHVFULEHGLQWKH
$GYHUVH(YHQW5HSRUWLQJ VHFWLRQ,GHQWLILFDWLRQ RIVXFKLQFLGHQWDO ILQGLQJV GXULQJ WKH
FHQWUDOUHYLHZSURFHVVVKRXOG QRWEHH[SHFWHGDQGWKHVWXG\VLWHPDLQWDLQV UHVSRQVLELOLW\ IRU
SHUIRUPLQJ DJHQHUDOVDIHW\UHYLHZRIDOOLPDJHVDVSHUVWXG\VLWHSURWRFROV 
3RVWKRF$QDO\VHV
$VDPHDQVWRXQGHUVWDQGWKHSHUIRUPDQFHRI&$370YLD)LEUR6FDQ 05,3'))DQGHDFK
RIWKHVHOLYHUDVVHVVPHQWWHFKQLTXHVUHODWLYH WRWKHRWKHUWKH6SRQVRUDQGRUGHOHJDWHPD\
XQGHUWDNHSRVWKRFDQDO\VHVRIWKHVXEMHFWOHYHO FRGHGGDWDDFTXLUHGLQWKLVVWXG\$Q\VXFK
DQDO\VHVZLOO QRWEHLQFOXGHG LQWKHFOLQLFDO VWXG\UHSRUWEXWDVHSDUDWHVXSSOHPHQWDO UHSRUW
ZLOO EHZULWWHQWRFDSWXUHWKLVZRUNLIXQGHUWDNHQ





 




CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 


 


 







 



 

 





















CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH













 







 













CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH












 







 












 




CCI
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH





















 



 





 








CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH



$'9(56((9(175(3257,1*
5HTXLUHPHQWV
7KHWDEOHEHORZVXPPDUL]HV WKHUHTXLUHPHQWVIRUUHFRUGLQJVDIHW\HYHQWVRQWKH&5)DQGIRU
UHSRUWLQJ VDIHW\HYHQWVRQWKH&OLQLFDO 7ULDO&76HULRXV$GYHUVH(YHQW6$(5HSRUW)RUP
WR3IL]HU6DIHW\7KHVHUHTXLUHPHQWVDUHGHOLQHDWHG IRUW\SHVRIHYHQWV6$(V
QRQVHULRXV DGYHUVHHYHQWV$(VDQGH[SRVXUHWRWKH,3XQGHUVWXG\GXULQJ SUHJQDQF\
RUEUHDVWIHHGLQJ DQGRFFXSDWLRQDO H[SRVXUH
6DIHW\(YHQW
5HFRUGHGRQWKH&5)
5HSRUWHGRQWKH&76$(
5HSRUW)RUPWR3IL]HU6DIHW\
:LWKLQ+RXUVRI$ZDUHQHVV
6$(
$OO
$OO
1RQVHULRXV$(
$OO
1RQH
([SRVXUHWRWKH,3XQGHU
VWXG\GXULQJ SUHJQDQF\RU
EUHDVWIHHGLQJDQG
RFFXSDWLRQDO H[SRVXUH
$OOUHJDUGOHVVRIZKHWKHU
DVVRFLDWHGZLWKDQ$(
H[FHSWRFFXSDWLRQDO
H[SRVXUH
([SRVXUHGXULQJ SUHJQDQF\
H[SRVXUHYLDEUHDVWIHHGLQJ
RFFXSDWLRQDO H[SRVXUH
UHJDUGOHVVRIZKHWKHUDVVRFLDWHG
ZLWKDQ$(
$OOREVHUYHGRUYROXQWHHUHG HYHQWVUHJDUGOHVVRIWUHDWPHQWJURXSRUVXVSHFWHGFDXVDO
UHODWLRQVKLS WRWKH,3VZLOO EHUHSRUWHGDVGHVFULEHGLQWKHIROORZLQJ SDUDJUDSKV
(YHQWVOLVWHGLQWKHWDEOHDERYHWKDWUHTXLUHUHSRUWLQJ WR3IL]HU6DIHW\RQWKH&76$(5HSRUW
)RUPZLWKLQ KRXUVRIDZDUHQHVVRIWKHHYHQWE\WKHLQYHVWLJDWRU DUHWREHUHSRUWHG
UHJDUGOHVVRIZKHWKHUWKHHYHQWLVGHWHUPLQHGE\WKHLQYHVWLJDWRUWREHUHODWHGWRDQ,3
XQGHUVWXG\,QSDUWLFXODU LIWKH6$(LVIDWDORUOLIHWKUHDWHQLQJ QRWLILFDWLRQ WR3IL]HU
6DIHW\PXVWEHPDGHLPPHGLDWHO\ LUUHVSHFWLYHRIWKHH[WHQWRIDYDLODEOH HYHQWLQIRUPDWLRQ 
7KLVWLPHIUDPHDOVRDSSOLHV WRDGGLWLRQDO QHZIROORZXS LQIRUPDWLRQ RQSUHYLRXVO\
IRUZDUGHGUHSRUWV,QWKHUDUHVLWXDWLRQ WKDWWKHLQYHVWLJDWRU GRHVQRWEHFRPHLPPHGLDWHO\
DZDUHRIWKHRFFXUUHQFHRIDQHYHQWWKHLQYHVWLJDWRU PXVWUHSRUWWKHHYHQWZLWKLQ KRXUV
DIWHUOHDUQLQJ RILWDQGGRFXPHQWWKHWLPHRIKLVKHUILUVWDZDUHQHVVRIWKHHYHQW
)RUHDFKHYHQWWKHLQYHVWLJDWRU PXVWSXUVXHDQGREWDLQDGHTXDWHLQIRUPDWLRQ ERWKWR
GHWHUPLQHWKHRXWFRPHDQGWRDVVHVVZKHWKHULWPHHWVWKHFULWHULDIRUFODVVLILFDWLRQ DVDQ6$(
VHHWKH6HULRXV$GYHUVH(YHQWVVHFWLRQEHORZ,QDGGLWLRQ WKHLQYHVWLJDWRU PD\EH
UHTXHVWHGE\3IL]HU6DIHW\WRREWDLQVSHFLILFIROORZXS LQIRUPDWLRQ LQDQH[SHGLWHG IDVKLRQ
7KLVLQIRUPDWLRQ LVPRUHGHWDLOHG WKDQWKDWUHFRUGHGRQWKH&5),QJHQHUDOWKLVZLOO LQFOXGH
DGHVFULSWLRQ RIWKHHYHQWLQVXIILFLHQWGHWDLOWRDOORZIRUDFRPSOHWHPHGLFDODVVHVVPHQWRI
WKHFDVHDQGLQGHSHQGHQW GHWHUPLQDWLRQ RISRVVLEOH FDXVDOLW\$Q\LQIRUPDWLRQ UHOHYDQWWR
WKHHYHQWVXFKDVFRQFRPLWDQWPHGLFDWLRQV DQGLOOQHVVHV PXVWEHSURYLGHG ,QWKHFDVHRID
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
VXEMHFWGHDWKDVXPPDU\RIDYDLODEOH DXWRSV\ILQGLQJV PXVWEHVXEPLWWHG DVVRRQDVSRVVLEOH
WR3IL]HU6DIHW\$Q\SHUWLQHQWDGGLWLRQDO LQIRUPDWLRQ PXVWEHUHSRUWHGRQWKH&76$(
5HSRUW)RUPDGGLWLRQDO VRXUFHGRFXPHQWVHJPHGLFDOUHFRUGV&5)ODERUDWRU\GDWDDUHWR
EHVHQWWR3IL]HU6DIHW\21/<XSRQUHTXHVW
$VSDUWRIRQJRLQJ VDIHW\UHYLHZVFRQGXFWHGE\WKHVSRQVRUDQ\QRQVHULRXV $(WKDWLV
GHWHUPLQHGE\WKHVSRQVRUWREHVHULRXVZLOO EHUHSRUWHGE\WKHVSRQVRUDVDQ6$(7RDVVLVW
LQWKHGHWHUPLQDWLRQ RIFDVHVHULRXVQHVVIXUWKHULQIRUPDWLRQ PD\EHUHTXHVWHGIURPWKH
LQYHVWLJDWRU WRSURYLGH FODULW\DQGXQGHUVWDQGLQJ RIWKHHYHQWLQWKHFRQWH[WRIWKHFOLQLFDO
VWXG\
$GGLWLRQDO'HWDLOV2Q5HFRUGLQJ$GYHUVH(YHQWVRQWKH&5)
$OOHYHQWVGHWDLOHGLQWKHWDEOHDERYHZLOO EHUHFRUGHGRQWKH$(SDJHVRIWKH&5),W
VKRXOG EHQRWHGWKDWWKH&76$(5HSRUW)RUPIRUUHSRUWLQJ RI6$(LQIRUPDWLRQ LVQRWWKH
VDPHDVWKH$(SDJHRIWKH&5):KHQWKHVDPHGDWDDUHFROOHFWHGWKHIRUPVPXVWEH
FRPSOHWHGLQDFRQVLVWHQWPDQQHU$(VVKRXOGEHUHFRUGHGXVLQJ FRQFLVHPHGLFDO
WHUPLQRORJ\ DQGWKHVDPH$(WHUPVKRXOG EHXVHGRQERWKWKH&5)DQGWKH&76$(5HSRUW
)RUPIRUUHSRUWLQJ RI6$(LQIRUPDWLRQ
(OLFLWLQJ$GYHUVH(YHQW,QIRUPDWLRQ
7KHLQYHVWLJDWRU LVWRUHFRUGRQWKH&5)DOOGLUHFWO\REVHUYHG$(VDQGDOO$(VVSRQWDQHRXVO\
UHSRUWHGE\WKHVWXG\VXEMHFW,QDGGLWLRQ HDFKVWXG\VXEMHFWZLOO EHTXHVWLRQHG DERXWWKH
RFFXUUHQFHRI$(VLQDQRQOHDGLQJ PDQQHU
:LWKGUDZDO IURPWKH6WXG\'XHWR$GYHUVH(YHQWVVHHDOVRWKH6XEMHFW
:LWKGUDZDO VHFWLRQ
:LWKGUDZDO GXHWR$(VVKRXOG EHGLVWLQJXLVKHG IURPZLWKGUDZDO GXHWRRWKHUFDXVHV
DFFRUGLQJWRWKHGHILQLWLRQ RI$(QRWHGEHORZDQGUHFRUGHGRQWKH&5)
:KHQDVXEMHFWZLWKGUDZVIURPWKHVWXG\EHFDXVHRIDQ6$(WKH6$(PXVWEHUHFRUGHGRQ
WKH&5)DQGUHSRUWHGDVDSSURSULDWH RQWKH&76$(5HSRUW)RUPLQDFFRUGDQFHZLWKWKH
5HTXLUHPHQWV VHFWLRQDERYH
7LPH3HULRGIRU&ROOHFWLQJ$(6$(,QIRUPDWLRQ
7KHWLPHSHULRG IRUDFWLYHO\HOLFLWLQJ DQGFROOHFWLQJ $(VDQG6$(V³DFWLYHFROOHFWLRQ
SHULRG´IRUHDFKVXEMHFWEHJLQVIURPWKHWLPHWKHVXEMHFWSURYLGHVLQIRUPHG FRQVHQWZKLFK
LVREWDLQHGEHIRUHWKHVXEMHFW¶VSDUWLFLSDWLRQ LQWKHVWXG\LHEHIRUHXQGHUJRLQJ DQ\
VWXG\UHODWHGSURFHGXUHDQGRUUHFHLYLQJ ,3WKURXJK DQGLQFOXGLQJ DPLQLPXP RI
FDOHQGDUGD\VDIWHUWKHODVWDGPLQLVWUDWLRQ RIWKH,3
)RUVXEMHFWVZKRDUHVFUHHQIDLOXUHV WKHDFWLYHFROOHFWLRQ SHULRGHQGVZKHQVFUHHQIDLOXUH
VWDWXVLVGHWHUPLQHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
5HSRUWLQJ6$(VWR3IL]HU6DIHW\
$OO6$(VRFFXUULQJLQDVXEMHFWGXULQJ WKHDFWLYHFROOHFWLRQ SHULRGDUHUHSRUWHGWR3IL]HU
6DIHW\RQWKH&76$(5HSRUW)RUP
6$(VRFFXUULQJLQDVXEMHFWDIWHUWKHDFWLYHFROOHFWLRQ SHULRGKDVHQGHGDUHUHSRUWHGWR3IL]HU
6DIHW\LIWKHLQYHVWLJDWRU EHFRPHVDZDUHRIWKHPDWDPLQLPXP DOO6$(VWKDWWKH
LQYHVWLJDWRU EHOLHYHVKDYHDWOHDVWDUHDVRQDEOHSRVVLELOLW\ RIEHLQJUHODWHGWR,3PXVWEH
UHSRUWHGWR3IL]HU6DIHW\
)ROORZ XSE\WKHLQYHVWLJDWRU FRQWLQXHV WKURXJKRXW DQGDIWHUWKHDFWLYHFROOHFWLRQ SHULRGDQG
XQWLO WKHHYHQWRULWVVHTXHODHUHVROYHRUVWDELOL]H DWDOHYHODFFHSWDEOHWRWKHLQYHVWLJDWRU DQG
3IL]HUFRQFXUVZLWKWKDWDVVHVVPHQW
5HFRUGLQJ1RQVHULRXV$(VDQG6$(VRQWKH&5)
'XULQJWKHDFWLYHFROOHFWLRQ SHULRG ERWKQRQVHULRXV $(VDQG6$(VDUHUHFRUGHGRQWKH
&5)
)ROORZXS E\WKHLQYHVWLJDWRU PD\EHUHTXLUHGXQWLO WKHHYHQWRULWVVHTXHODHUHVROYHRU
VWDELOL]H DWDOHYHODFFHSWDEOHWRWKHLQYHVWLJDWRU DQG3IL]HUFRQFXUVZLWKWKDWDVVHVVPHQW
&DXVDOLW\$VVHVVPHQW
7KHLQYHVWLJDWRU¶V DVVHVVPHQWRIFDXVDOLW\PXVWEHSURYLGHG IRUDOO$(VVHULRXVDQG
QRQVHULRXV WKHLQYHVWLJDWRU PXVWUHFRUGWKHFDXVDOUHODWLRQVKLS RQWKH&5)DQGUHSRUWVXFK
DQDVVHVVPHQWLQDFFRUGDQFHZLWKWKH6$(UHSRUWLQJUHTXLUHPHQWV LIDSSOLFDEOH $Q
LQYHVWLJDWRU¶V FDXVDOLW\DVVHVVPHQWLVWKHGHWHUPLQDWLRQ RIZKHWKHUWKHUHH[LVWVDUHDVRQDEOH
SRVVLELOLW\ WKDWWKH,3FDXVHGRUFRQWULEXWHG WRDQ$(JHQHUDOO\WKHIDFWVHYLGHQFHRU
DUJXPHQWVWRVXJJHVWDFDXVDOUHODWLRQVKLS VKRXOGEHSURYLGHG ,IWKHLQYHVWLJDWRU GRHVQRW
NQRZZKHWKHURUQRWWKH,3FDXVHGWKHHYHQWWKHQWKHHYHQWZLOO EHKDQGOHGDV³UHODWHGWR,3´
IRUUHSRUWLQJ SXUSRVHVDVGHILQHGE\WKHVSRQVRU,IWKHLQYHVWLJDWRU
V FDXVDOLW\ DVVHVVPHQWLV
³XQNQRZQ EXWQRWUHODWHG´WR,3WKLVVKRXOG EHFOHDUO\GRFXPHQWHGRQVWXG\UHFRUGV
,QDGGLWLRQ LIWKHLQYHVWLJDWRU GHWHUPLQHVWKDWDQ6$(LVDVVRFLDWHGZLWKVWXG\SURFHGXUHV
WKHLQYHVWLJDWRU PXVWUHFRUGWKLVFDXVDOUHODWLRQVKLS LQWKHVRXUFHGRFXPHQWVDQG&5)DQG
UHSRUWVXFKDQDVVHVVPHQWLQWKHGHGLFDWHGVHFWLRQRIWKH&76$(5HSRUW)RUPDQGLQ
DFFRUGDQFHZLWKWKH6$(UHSRUWLQJ UHTXLUHPHQWV
6SRQVRU¶V5HSRUWLQJ5HTXLUHPHQWVWR5HJXODWRU\$XWKRULWLHV
$(UHSRUWLQJ LQFOXGLQJ VXVSHFWHGXQH[SHFWHGVHULRXVDGYHUVHUHDFWLRQVZLOO EHFDUULHGRXW
LQDFFRUGDQFHZLWKDSSOLFDEOH ORFDOUHJXODWLRQV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
'HILQLWLRQV
$GYHUVH(YHQWV
$Q$(LVDQ\XQWRZDUGPHGLFDO RFFXUUHQFHLQDVWXG\VXEMHFWDGPLQLVWHUHG DSURGXFWRU
PHGLFDOGHYLFHWKHHYHQWQHHGQRWQHFHVVDULO\KDYHDFDXVDOUHODWLRQVKLS ZLWKWKH
WUHDWPHQWRUXVDJH([DPSOHVRI$(VLQFOXGH EXWDUHQRWOLPLWHG WR
x $EQRUPDO WHVWILQGLQJV
x &OLQLFDOO\ VLJQLILFDQW VLJQVDQGV\PSWRPV
x &KDQJHVLQSK\VLFDO H[DPLQDWLRQ ILQGLQJV
x +\SHUVHQVLWLYLW\
x 3URJUHVVLRQZRUVHQLQJ RIXQGHUO\LQJ GLVHDVH
x 'UXJDEXVH
x 'UXJGHSHQGHQF\
$GGLWLRQDOO\ $(VPD\LQFOXGH VLJQVDQGV\PSWRPV UHVXOWLQJ IURP
x 'UXJRYHUGRVH
x 'UXJZLWKGUDZDO
x 'UXJPLVXVH
x 'UXJLQWHUDFWLRQV
x ([WUDYDVDWLRQ
x ([SRVXUHGXULQJ SUHJQDQF\('3
x ([SRVXUHYLDEUHDVWIHHGLQJ
x 0HGLFDWLRQ HUURU
x 2FFXSDWLRQDO H[SRVXUH
$EQRUPDO7HVW)LQGLQJV
$EQRUPDO REMHFWLYHWHVWILQGLQJV VKRXOG EHUHFRUGHGDV$(VZKHQDQ\RIWKHIROORZLQJ
FRQGLWLRQV DUHPHW 
x 7HVWUHVXOWLVDVVRFLDWHGZLWKDFFRPSDQ\LQJ V\PSWRPV DQGRU
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x 7HVWUHVXOWUHTXLUHVDGGLWLRQDO GLDJQRVWLF WHVWLQJRUPHGLFDOVXUJLFDO LQWHUYHQWLRQ
DQGRU
x 7HVWUHVXOWOHDGVWRDFKDQJHLQVWXG\GRVLQJ RXWVLGHRIDQ\SURWRFROVSHFLILHG GRVH
DGMXVWPHQWVRUGLVFRQWLQXDWLRQ IURPWKHVWXG\VLJQLILFDQW DGGLWLRQDO FRQFRPLWDQW
GUXJWUHDWPHQWRURWKHUWKHUDS\DQGRU
x 7HVWUHVXOWLVFRQVLGHUHGWREHDQ$(E\WKHLQYHVWLJDWRU RUVSRQVRU
0HUHO\UHSHDWLQJDQDEQRUPDOWHVWLQWKHDEVHQFHRIDQ\RIWKHDERYHFRQGLWLRQV GRHVQRW
FRQVWLWXWHDQ$($Q\DEQRUPDOWHVWUHVXOWWKDWLVGHWHUPLQHGWREHDQHUURUGRHVQRWUHTXLUH
UHFRUGLQJDVDQ$(
6HULRXV$GYHUVH(YHQWV
$VHULRXVDGYHUVHHYHQWLVDQ\XQWRZDUGPHGLFDORFFXUUHQFHDWDQ\GRVHWKDW
x 5HVXOWVLQGHDWK
x ,VOLIHWKUHDWHQLQJ LPPHGLDWH ULVNRIGHDWK
x 5HTXLUHVLQSDWLHQW KRVSLWDOL]DWLRQ RUSURORQJDWLRQ RIH[LVWLQJ KRVSLWDOL]DWLRQ
x 5HVXOWVLQSHUVLVWHQWRUVLJQLILFDQW GLVDELOLW\LQFDSDFLW\ VXEVWDQWLDO GLVUXSWLRQ RIWKH
DELOLW\ WRFRQGXFWQRUPDOOLIHIXQFWLRQV
x 5HVXOWVLQFRQJHQLWDO DQRPDO\ELUWK GHIHFW
2UWKDWLVFRQVLGHUHGWREH
x $QLPSRUWDQW PHGLFDOHYHQW
0HGLFDODQGVFLHQWLILF MXGJPHQW LVH[HUFLVHGLQGHWHUPLQLQJ ZKHWKHUDQHYHQWLVDQ
LPSRUWDQW PHGLFDOHYHQW$QLPSRUWDQW PHGLFDOHYHQWPD\QRWEHLPPHGLDWHO\
OLIHWKUHDWHQLQJ DQGRUUHVXOWLQGHDWKRUKRVSLWDOL]DWLRQ +RZHYHULILWLVGHWHUPLQHGWKDW
WKHHYHQWPD\MHRSDUGL]H WKHVXEMHFWRUPD\UHTXLUHLQWHUYHQWLRQ WRSUHYHQWRQHRIWKH
RWKHU$(RXWFRPHVWKHLPSRUWDQW PHGLFDO HYHQWVKRXOG EHUHSRUWHGDVVHULRXV
x ([DPSOHVRIVXFKHYHQWVDUHLQWHQVLYHWUHDWPHQWLQDQHPHUJHQF\URRPRUDWKRPHIRU
DOOHUJLF EURQFKRVSDVPEORRG G\VFUDVLDVRUFRQYXOVLRQV WKDWGRQRWUHVXOWLQ
KRVSLWDOL]DWLRQ RUGHYHORSPHQW RIGUXJGHSHQGHQF\RUGUXJDEXVH
+RVSLWDOL]DWLRQ
+RVSLWDOL]DWLRQ LVGHILQHGDVDQ\LQLWLDO DGPLVVLRQ HYHQOHVVWKDQKRXUVLQDKRVSLWDO
RUHTXLYDOHQW KHDOWKFDUHIDFLOLW\ RUDQ\SURORQJDWLRQ RIDQH[LVWLQJ DGPLVVLRQ 
$GPLVVLRQ DOVRLQFOXGHVWUDQVIHUZLWKLQ WKHKRVSLWDO WRDQDFXWHLQWHQVLYHFDUHXQLWHJ
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
IURPWKHSV\FKLDWULF ZLQJWRDPHGLFDOIORRU PHGLFDOIORRUWRDFRURQDU\FDUHXQLW RU
QHXURORJLFDO IORRUWRDWXEHUFXORVLV XQLW$QHPHUJHQF\URRPYLVLW GRHVQRWQHFHVVDULO\
FRQVWLWXWHDKRVSLWDOL]DWLRQ KRZHYHUWKHHYHQWOHDGLQJ WRWKHHPHUJHQF\URRPYLVLWLV
DVVHVVHGIRUPHGLFDOLPSRUWDQFH
x +RVSLWDOL]DWLRQ GRHVQRWLQFOXGHWKHIROORZLQJ
x 5HKDELOLWDWLRQ IDFLOLWLHV
x +RVSLFHIDFLOLWLHV
x 5HVSLWHFDUHHJFDUHJLYHUUHOLHI
x 6NLOOHG QXUVLQJ IDFLOLWLHV
x 1XUVLQJKRPHV
x 6DPHGD\VXUJHULHVDVRXWSDWLHQWVDPHGD\DPEXODWRU\ SURFHGXUHV
+RVSLWDOL]DWLRQ RUSURORQJDWLRQ RIKRVSLWDOL]DWLRQ LQWKHDEVHQFHRIDSUHFLSLWDWLQJ FOLQLFDO
$(LVQRWLQLWVHOIDQ6$(([DPSOHVLQFOXGH
x $GPLVVLRQ IRUWUHDWPHQWRIDSUHH[LVWLQJ FRQGLWLRQ QRWDVVRFLDWHGZLWKWKH
GHYHORSPHQW RIDQHZ$(RUZLWKDZRUVHQLQJ RIWKHSUHH[LVWLQJ FRQGLWLRQ HJIRU
ZRUNXSRIDSHUVLVWHQWSUHWUHDWPHQWODERUDWRU\DEQRUPDOLW\
x 6RFLDODGPLVVLRQ HJVXEMHFWKDVQRSODFHWRVOHHS
x $GPLQLVWUDWLYH DGPLVVLRQ HJIRU\HDUO\SK\VLFDO H[DPLQDWLRQ
x 3URWRFROVSHFLILHG DGPLVVLRQ GXULQJ DVWXG\HJIRUDSURFHGXUHUHTXLUHGE\WKHVWXG\
SURWRFRO
x 2SWLRQDO DGPLVVLRQ QRWDVVRFLDWHGZLWK DSUHFLSLWDWLQJ FOLQLFDO $(HJIRUHOHFWLYH
FRVPHWLFVXUJHU\
x +RVSLWDOL]DWLRQ IRUREVHUYDWLRQZLWKRXW DPHGLFDO $(
x 3UHSODQQHGWUHDWPHQWVRUVXUJLFDOSURFHGXUHV7KHVHVKRXOGEHQRWHGLQWKHEDVHOLQH
GRFXPHQWDWLRQ IRUWKHHQWLUHSURWRFRO DQGRUIRUWKHLQGLYLGXDO VXEMHFW
'LDJQRVWLF DQGWKHUDSHXWLFQRQLQYDVLYH DQGLQYDVLYH SURFHGXUHVVXFKDVVXUJHU\VKRXOG QRW
EHUHSRUWHGDV6$(V+RZHYHUWKHPHGLFDOFRQGLWLRQ IRUZKLFKWKHSURFHGXUHZDV
SHUIRUPHGVKRXOG EHUHSRUWHGLILWPHHWVWKHGHILQLWLRQ RIDQ6$()RUH[DPSOHDQDFXWH
DSSHQGLFLWLV WKDWEHJLQVGXULQJ WKHUHSRUWLQJ SHULRGVKRXOG EHUHSRUWHGLIWKH6$(
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
UHTXLUHPHQWVDUHPHWDQGWKHUHVXOWLQJ DSSHQGHFWRP\VKRXOG EHUHFRUGHGDVWUHDWPHQWRIWKH
$(
6HYHULW\$VVHVVPHQW
,IUHTXLUHGRQWKH$(SDJHRIWKH&5)WKHLQYHVWLJDWRU ZLOO XVHWKHDGMHFWLYHV0,/'
02'(5$7(RU6(9(5(WRGHVFULEHWKHPD[LPXP LQWHQVLW\ RIWKH$()RUSXUSRVHVRI
FRQVLVWHQF\WKHVHLQWHQVLW\ JUDGHVDUHGHILQHGDVIROORZV
0,/'
'RHVQRWLQWHUIHUHZLWKVXEMHFW
VXVXDOIXQFWLRQ
02'(5$7(
,QWHUIHUHVWRVRPHH[WHQWZLWKVXEMHFW
VXVXDOIXQFWLRQ
6(9(5(
,QWHUIHUHVVLJQLILFDQWO\ ZLWKVXEMHFW
VXVXDOIXQFWLRQ
1RWHWKHGLVWLQFWLRQ EHWZHHQWKHVHYHULW\DQGWKHVHULRXVQHVVRIDQ$($VHYHUHHYHQWLVQRW
QHFHVVDULO\DQ6$()RUH[DPSOH DKHDGDFKHPD\EHVHYHUHLQWHUIHUHVVLJQLILFDQWO\ ZLWK
WKHVXEMHFW
VXVXDOIXQFWLRQ EXWZRXOGQRWEHFODVVLILHGDVVHULRXVXQOHVVLWPHWRQHRIWKH
FULWHULDIRU6$(VOLVWHGDERYH
6SHFLDO6LWXDWLRQV
3URWRFRO6SHFLILHG6HULRXV$GYHUVH(YHQWV
7KHUHDUHQRSURWRFROVSHFLILHG 6$(VLQWKLVVWXG\$OO6$(VZLOO EHUHSRUWHGWR3IL]HU
6DIHW\E\WKHLQYHVWLJDWRU DVGHVFULEHGLQSUHYLRXV VHFWLRQVDQGZLOO EHKDQGOHGDV6$(VLQ
WKHVDIHW\GDWDEDVH
3RWHQWLDO&DVHVRI'UXJ,QGXFHG/LYHU,QMXU\
+XPDQVH[SRVHGWRDGUXJZKRVKRZQRVLJQRIOLYHU LQMXU\ DVGHWHUPLQHGE\HOHYDWLRQV
LQWUDQVDPLQDVHVDUHWHUPHG³WROHUDWRUV´ZKLOHWKRVHZKRVKRZWUDQVLHQWOLYHULQMXU\ EXW
DGDSWDUHWHUPHG³DGDSWRUV´,QVRPHVXEMHFWVWUDQVDPLQDVHHOHYDWLRQVDUHDKDUELQJHURI
DPRUHVHULRXVSRWHQWLDO RXWFRPH7KHVHVXEMHFWVIDLOWRDGDSWDQGWKHUHIRUHDUH
VXVFHSWLEOH WRSURJUHVVLYHDQGVHULRXVOLYHULQMXU\ FRPPRQO\ UHIHUUHGWRDV
GUXJLQGXFHG OLYHULQMXU\ ',/,6XEMHFWVZKRH[SHULHQFHDWUDQVDPLQDVHHOHYDWLRQ
DERYHWLPHVWKHXSSHUOLPLW RIQRUPDO î8/1VKRXOGEHPRQLWRUHG PRUHIUHTXHQWO\ WR
GHWHUPLQHLIWKH\DUHDQ³DGDSWRU´RUDUH³VXVFHSWLEOH´
x ,QWKHPDMRULW\ RI',/,FDVHVHOHYDWLRQV LQDVSDUWDWHDPLQRWUDQVIHUDVH$67DQGRU
DODQLQHDPLQRWUDQVIHUDVH$/7SUHFHGHWRWDOELOLUXELQ 7%LOL HOHYDWLRQV!î8/1
E\VHYHUDOGD\VRUZHHNV7KHLQFUHDVHLQ7%LOL W\SLFDOO\ RFFXUVZKLOH$67$/7
LVDUHVWLOO HOHYDWHGDERYHî8/1LH$67$/7DQG7%LOL YDOXHVZLOO EHHOHYDWHG
ZLWKLQ WKHVDPHODEVDPSOH,QUDUHLQVWDQFHVE\WKHWLPH7%LOL HOHYDWLRQV DUH
GHWHFWHG$67$/7YDOXHVPLJKW KDYHGHFUHDVHG7KLVRFFXUUHQFHLVVWLOO UHJDUGHGDV
DSRWHQWLDO ',/,7KHUHIRUHDEQRUPDO HOHYDWLRQVLQHLWKHU$6725$/7LQDGGLWLRQ
WR7%LOL WKDWPHHWWKHFULWHULDRXWOLQHG EHORZDUHFRQVLGHUHGSRWHQWLDO ',/,DVVHVVHG
SHU+\¶VODZFULWHULDFDVHVDQGVKRXOG DOZD\VEHFRQVLGHUHGLPSRUWDQW PHGLFDO
HYHQWVHYHQEHIRUHDOORWKHUSRVVLEOH FDXVHVRIOLYHU LQMXU\ KDYHEHHQH[FOXGHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
x 7KHWKUHVKROG RIODERUDWRU\DEQRUPDOLWLHV IRUDSRWHQWLDO ',/,FDVHGHSHQGVRQWKH
VXEMHFW¶VLQGLYLGXDO EDVHOLQHYDOXHVDQGXQGHUO\LQJ FRQGLWLRQV 6XEMHFWVZKRSUHVHQW
ZLWKWKHIROORZLQJ ODERUDWRU\DEQRUPDOLWLHV VKRXOG EHHYDOXDWHGIXUWKHUDVSRWHQWLDO
',/,+\¶VODZFDVHVWRGHILQLWLYHO\ GHWHUPLQHWKHHWLRORJ\ RIWKHDEQRUPDO
ODERUDWRU\YDOXHV
x 6XEMHFWVZLWK$67$/7DQG7%LOL EDVHOLQHYDOXHVZLWKLQ WKHQRUPDO UDQJHZKR
VXEVHTXHQWO\ SUHVHQWZLWK$6725$/7YDOXHV!î8/1$1'D7%LOL YDOXH
!î8/1ZLWKQRHYLGHQFHRIKHPRO\VLV DQGDQDONDOLQH SKRVSKDWDVHYDOXH
î8/1RUQRWDYDLODEOH
x )RUVXEMHFWVZLWKEDVHOLQH$6725$/7257%LOL YDOXHVDERYHWKH8/1WKH
IROORZLQJ WKUHVKROG YDOXHVDUHXVHGLQWKHGHILQLWLRQ PHQWLRQHG DERYHDVQHHGHG
GHSHQGLQJ RQZKLFKYDOXHVDUHDERYHWKH8/1DWEDVHOLQH
x 3UHH[LVWLQJ$67RU$/7EDVHOLQHYDOXHVDERYHWKHQRUPDOUDQJH$67RU$/7
YDOXHV!WLPHVWKHEDVHOLQHYDOXHV$1'!î8/1RU!î8/1ZKLFKHYHULV
VPDOOHU
x 3UHH[LVWLQJYDOXHVRI7%LOL DERYHWKHQRUPDOUDQJH7%LOL OHYHOLQFUHDVHGIURP
EDVHOLQHYDOXHE\DQDPRXQWRIDWOHDVWî8/1RULIWKHYDOXHUHDFKHV!î
8/1ZKLFKHYHULVVPDOOHU
5LVHVLQ$67$/7DQG7%LOL VHSDUDWHGE\PRUHWKDQDIHZZHHNVVKRXOG EHDVVHVVHG
LQGLYLGXDOO\ EDVHGRQFOLQLFDO MXGJPHQW DQ\FDVHZKHUHXQFHUWDLQW\UHPDLQVDVWRZKHWKHULW
UHSUHVHQWVDSRWHQWLDO +\¶VODZFDVHVKRXOGEHUHYLHZHGZLWKWKHVSRQVRU
7KHVXEMHFWVKRXOG UHWXUQWRWKHLQYHVWLJDWRU VLWHDQGEHHYDOXDWHGDVVRRQDVSRVVLEOH
SUHIHUDEO\ZLWKLQ KRXUVIURPDZDUHQHVVRIWKHDEQRUPDOUHVXOWV7KLVHYDOXDWLRQ VKRXOG
LQFOXGH ODERUDWRU\WHVWVGHWDLOHG KLVWRU\ DQGSK\VLFDO DVVHVVPHQW
,QDGGLWLRQ WRUHSHDWLQJPHDVXUHPHQWVRI$67DQG$/7DQG7%LOL ODERUDWRU\WHVWVVKRXOG
LQFOXGH DOEXPLQ FUHDWLQHNLQDVH&.GLUHFWDQGLQGLUHFW ELOLUXELQ JDPPDJOXWDP\O
WUDQVIHUDVH**7SURWKURPELQ WLPH37LQWHUQDWLRQDO QRUPDOL]HG UDWLR,15WRWDOELOH
DFLGVDONDOLQH SKRVSKDWDVHDQGDFHWDPLQRSKHQ GUXJDQGRUSURWHLQDGGXFWOHYHOV
&RQVLGHUDWLRQ VKRXOG DOVREHJLYHQ WRGUDZLQJDVHSDUDWHWXEHRIFORWWHGEORRGDQGDQ
DQWLFRDJXODWHG WXEHRIEORRG IRUIXUWKHUWHVWLQJDVQHHGHGIRUIXUWKHUFRQWHPSRUDQHRXV
DQDO\VHVDWWKHWLPHRIWKHUHFRJQL]HGLQLWLDO DEQRUPDOLWLHV WRGHWHUPLQHHWLRORJ\ $GHWDLOHG
KLVWRU\ LQFOXGLQJ UHOHYDQWLQIRUPDWLRQ VXFKDVUHYLHZRIHWKDQRO DFHWDPLQRSKHQHLWKHUE\
LWVHOIRUDVDFRIRUPXODWHGSURGXFWLQSUHVFULSWLRQ RURYHUWKHFRXQWHUPHGLFDWLRQV
UHFUHDWLRQDOGUXJVXSSOHPHQWKHUEDOXVHDQGFRQVXPSWLRQ IDPLO\ KLVWRU\ VH[XDOKLVWRU\
WUDYHOKLVWRU\ KLVWRU\RIFRQWDFWZLWKDMDXQGLFHG SHUVRQVXUJHU\EORRG WUDQVIXVLRQ KLVWRU\
RIOLYHURUDOOHUJLFGLVHDVHDQGSRWHQWLDO RFFXSDWLRQDO H[SRVXUHWRFKHPLFDOVVKRXOG EH
FROOHFWHG)XUWKHUWHVWLQJIRUDFXWHKHSDWLWLV$%&'DQG(LQIHFWLRQ DQGOLYHULPDJLQJ
HJELOLDU\ WUDFWPD\EHZDUUDQWHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$OOFDVHVGHPRQVWUDWHGRQUHSHDWWHVWLQJDVPHHWLQJWKHODERUDWRU\ FULWHULDRI$67$/7DQG
7%LOL HOHYDWLRQ GHILQHGDERYHVKRXOG EHFRQVLGHUHGSRWHQWLDO ',/,+\¶VODZFDVHVLIQR
RWKHUUHDVRQIRUWKH/)7DEQRUPDOLWLHV KDV\HWEHHQIRXQG6XFKSRWHQWLDO',/,+\¶VODZ
FDVHVDUHWREHUHSRUWHGDV6$(VLUUHVSHFWLYHRIDYDLODELOLW\RIDOOWKHUHVXOWVRIWKH
LQYHVWLJDWLRQVSHUIRUPHGWRGHWHUPLQHHWLRORJ\RIWKH/)7DEQRUPDOLWLHV
$SRWHQWLDO ',/,+\¶VODZFDVHEHFRPHVDFRQILUPHGFDVHRQO\DIWHUDOOUHVXOWVRI
UHDVRQDEOHLQYHVWLJDWLRQV KDYHEHHQUHFHLYHGDQGKDYHH[FOXGHGDQDOWHUQDWLYHHWLRORJ\
([SRVXUHWRWKH,3'XULQJ3UHJQDQF\RU%UHDVWIHHGLQJDQG2FFXSDWLRQDO
([SRVXUH
([SRVXUHWRWKH,3XQGHUVWXG\GXULQJ SUHJQDQF\RUEUHDVWIHHGLQJDQGRFFXSDWLRQDO H[SRVXUH
DUHUHSRUWDEOHWR3IL]HU6DIHW\ZLWKLQ KRXUVRILQYHVWLJDWRU DZDUHQHVV
([SRVXUH'XULQJ3UHJQDQF\
)RUERWKXQDSSURYHGXQOLFHQVHG SURGXFWVDQGIRUPDUNHWHGSURGXFWV DQH[SRVXUHGXULQJ
SUHJQDQF\('3RFFXUVLI
x $IHPDOHEHFRPHVRULVIRXQGWREHSUHJQDQWHLWKHUZKLOHUHFHLYLQJ RUKDYLQJ EHHQ
H[SRVHGHJEHFDXVHRIWUHDWPHQWRUHQYLURQPHQWDO H[SRVXUHWRWKH,3RUWKHIHPDOH
EHFRPHVRULVIRXQGWREHSUHJQDQWDIWHUGLVFRQWLQXLQJ DQGRUEHLQJH[SRVHGWRWKH
,3
x $QH[DPSOHRIHQYLURQPHQWDO H[SRVXUHZRXOGEHDFDVHLQYROYLQJ GLUHFWFRQWDFW
ZLWKD3IL]HUSURGXFWLQDSUHJQDQWZRPDQHJDQXUVHUHSRUWVWKDWVKHLVSUHJQDQW
DQGKDVEHHQH[SRVHGWRFKHPRWKHUDSHXWLFSURGXFWV
x $PDOHKDVEHHQH[SRVHGHJEHFDXVHRIWUHDWPHQWRUHQYLURQPHQWDO H[SRVXUHWRWKH
,3SULRU WRRUDURXQGWKHWLPHRIFRQFHSWLRQDQGRULVH[SRVHGGXULQJ KLVSDUWQHU¶V
SUHJQDQF\
,IDVXEMHFWRUVXEMHFW¶VSDUWQHUEHFRPHVRULVIRXQGWREHSUHJQDQWGXULQJ WKHVXEMHFW¶V
WUHDWPHQWZLWKWKH,3WKHLQYHVWLJDWRU PXVWUHSRUWWKLVLQIRUPDWLRQ WR3IL]HU6DIHW\RQWKH
&76$(5HSRUW)RUPDQGDQ('3VXSSOHPHQWDO IRUPUHJDUGOHVVRIZKHWKHUDQ6$(KDV
RFFXUUHG,QDGGLWLRQ WKHLQYHVWLJDWRU PXVWVXEPLW LQIRUPDWLRQ UHJDUGLQJ HQYLURQPHQWDO
H[SRVXUHWRD3IL]HUSURGXFWLQDSUHJQDQWZRPDQHJDVXEMHFWUHSRUWVWKDWVKHLV
SUHJQDQWDQGKDVEHHQH[SRVHGWRDF\WRWR[LF SURGXFWE\LQKDODWLRQ RUVSLOODJH WR3IL]HU
6DIHW\XVLQJWKH('3VXSSOHPHQWDO IRUP7KLVPXVWEHGRQHLUUHVSHFWLYHRIZKHWKHUDQ
$(KDVRFFXUUHGDQGZLWKLQ KRXUVRIDZDUHQHVVRIWKHH[SRVXUH7KHLQIRUPDWLRQ
VXEPLWWHG VKRXOG LQFOXGH WKHDQWLFLSDWHGGDWHRIGHOLYHU\ VHHEHORZIRULQIRUPDWLRQ
UHODWHGWRWHUPLQDWLRQ RISUHJQDQF\
x )ROORZXS LVFRQGXFWHGWRREWDLQJHQHUDOLQIRUPDWLRQ RQWKHSUHJQDQF\DQGLWV
RXWFRPHIRUDOO('3UHSRUWVZLWKDQXQNQRZQ RXWFRPH7KHLQYHVWLJDWRU ZLOO IROORZ
WKHSUHJQDQF\XQWLO FRPSOHWLRQ RUXQWLO SUHJQDQF\WHUPLQDWLRQ DQGQRWLI\3IL]HU
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
6DIHW\RIWKHRXWFRPHDVDIROORZXS WRWKHLQLWLDO ('3VXSSOHPHQWDO IRUP,QWKH
FDVHRIDOLYHELUWK WKHVWUXFWXUDOLQWHJULW\ RIWKHQHRQDWHFDQEHDVVHVVHGDWWKHWLPH
RIELUWK,QWKHHYHQWRIDWHUPLQDWLRQ WKHUHDVRQVIRUWHUPLQDWLRQ VKRXOGEH
VSHFLILHGDQGLIFOLQLFDOO\ SRVVLEOH WKHVWUXFWXUDOLQWHJULW\ RIWKHWHUPLQDWHGIHWXV
VKRXOG EHDVVHVVHGE\JURVVYLVXDO LQVSHFWLRQ XQOHVVSUHSURFHGXUHWHVWILQGLQJV DUH
FRQFOXVLYH IRUDFRQJHQLWDO DQRPDO\DQGWKHILQGLQJV DUHUHSRUWHG
x ,IWKHRXWFRPHRIWKHSUHJQDQF\PHHWVWKHFULWHULDIRUDQ6$(LHHFWRSLFSUHJQDQF\
VSRQWDQHRXVDERUWLRQ LQWUDXWHULQH IHWDOGHPLVHQHRQDWDOGHDWKRUFRQJHQLWDO DQRPDO\
>LQDOLYHERUQ EDE\DWHUPLQDWHGIHWXVDQLQWUDXWHULQH IHWDOGHPLVHRUDQHRQDWDO
GHDWK@WKHLQYHVWLJDWRU VKRXOGIROORZ WKHSURFHGXUHVIRUUHSRUWLQJ 6$(V
x $GGLWLRQDO LQIRUPDWLRQ DERXWSUHJQDQF\RXWFRPHVWKDWDUHUHSRUWHGWR3IL]HU6DIHW\
DV6$(VIROORZV 
x 6SRQWDQHRXVDERUWLRQ LQFOXGHV PLVFDUULDJHDQGPLVVHGDERUWLRQ
x 1HRQDWDOGHDWKVWKDWRFFXUZLWKLQ PRQWKRIELUWKVKRXOG EHUHSRUWHGZLWKRXW UHJDUG
WRFDXVDOLW\ DV6$(V,QDGGLWLRQ LQIDQWGHDWKVDIWHUPRQWKVKRXOG EHUHSRUWHGDV
6$(VZKHQWKHLQYHVWLJDWRU DVVHVVHVWKHLQIDQWGHDWKDVUHODWHGRUSRVVLEO\ UHODWHGWR
H[SRVXUHWRWKH,3
$GGLWLRQDO LQIRUPDWLRQ UHJDUGLQJ WKH('3PD\EHUHTXHVWHGE\WKHVSRQVRU)XUWKHU
IROORZXS RIELUWKRXWFRPHVZLOO EHKDQGOHG RQDFDVHE\FDVHEDVLVHJIROORZXS RQ
SUHWHUPLQIDQWVWRLGHQWLI\ GHYHORSPHQWDO GHOD\V,QWKHFDVHRISDWHUQDOH[SRVXUHWKH
LQYHVWLJDWRU ZLOO SURYLGHWKHVXEMHFWZLWKWKH3UHJQDQW3DUWQHU5HOHDVHRI,QIRUPDWLRQ )RUP
WRGHOLYHU WRKLVSDUWQHU7KHLQYHVWLJDWRU PXVWGRFXPHQWLQWKHVRXUFHGRFXPHQWVWKDWWKH
VXEMHFWZDVJLYHQWKH3UHJQDQW3DUWQHU5HOHDVHRI,QIRUPDWLRQ )RUPWRSURYLGH WRKLV
SDUWQHU
([SRVXUH'XULQJ%UHDVWIHHGLQJ
6FHQDULRVRIH[SRVXUHGXULQJ EUHDVWIHHGLQJPXVWEHUHSRUWHGLUUHVSHFWLYHRIWKHSUHVHQFHRI
DQDVVRFLDWHG6$(WR3IL]HU6DIHW\ZLWKLQ KRXUVRIWKHLQYHVWLJDWRU¶V DZDUHQHVVXVLQJWKH
&76$(5HSRUW)RUP$QH[SRVXUHGXULQJ EUHDVWIHHGLQJUHSRUWLVQRWFUHDWHGZKHQD3IL]HU
GUXJVSHFLILFDOO\ DSSURYHGIRUXVHLQEUHDVWIHHGLQJZRPHQHJYLWDPLQV LVDGPLQLVWHUHG LQ
DFFRUGZLWKDXWKRUL]HG XVH+RZHYHULIWKHLQIDQWH[SHULHQFHVDQ6$(DVVRFLDWHGZLWKVXFK
DGUXJ¶VDGPLQLVWUDWLRQ WKH6$(LVUHSRUWHGWRJHWKHUZLWKWKHH[SRVXUHGXULQJEUHDVWIHHGLQJ
2FFXSDWLRQDO([SRVXUH
$QRFFXSDWLRQDO H[SRVXUHRFFXUVZKHQGXULQJ WKHSHUIRUPDQFHRIMREGXWLHVDSHUVRQ
ZKHWKHUDKHDOWKFDUHSURIHVVLRQDO RURWKHUZLVHJHWVLQXQSODQQHG GLUHFWFRQWDFWZLWKWKH
SURGXFWZKLFKPD\RUPD\QRWOHDGWRWKHRFFXUUHQFHRIDQ$(
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$QRFFXSDWLRQDO H[SRVXUHLVUHSRUWHGWR3IL]HU6DIHW\ZLWKLQ KRXUVRIWKHLQYHVWLJDWRU¶V
DZDUHQHVVXVLQJWKH&76$(5HSRUW)RUPUHJDUGOHVVRIZKHWKHUWKHUHLVDQDVVRFLDWHG
6$(6LQFHWKHLQIRUPDWLRQ GRHVQRWSHUWDLQWRDVXEMHFWHQUROOHG LQWKHVWXG\WKH
LQIRUPDWLRQ LVQRWUHFRUGHGRQD&5)KRZHYHUDFRS\RIWKHFRPSOHWHG&76$(5HSRUW
)RUPLVPDLQWDLQHG LQWKHLQYHVWLJDWRU VLWHILOH
0HGLFDWLRQ(UURUV
2WKHUH[SRVXUHVWRWKH,3XQGHUVWXG\PD\RFFXULQFOLQLFDO WULDOVHWWLQJV VXFKDVPHGLFDWLRQ
HUURUV
6DIHW\(YHQW
5HFRUGHGRQWKH&5)
5HSRUWHGRQWKH&76$(5HSRUW
)RUPWR3IL]HU6DIHW\:LWKLQ
+RXUVRI$ZDUHQHVV
0HGLFDWLRQ HUURUV
$OOUHJDUGOHVVRIZKHWKHU
DVVRFLDWHGZLWKDQ$(
2QO\LIDVVRFLDWHGZLWKDQ6$(
0HGLFDWLRQ(UURUV
0HGLFDWLRQ HUURUVPD\UHVXOWIURPWKHDGPLQLVWUDWLRQ RUFRQVXPSWLRQ RIWKH,3E\WKH
ZURQJVXEMHFWRUDWWKHZURQJWLPHRUDWWKHZURQJGRVDJHVWUHQJWK
x 0HGLFDWLRQ HUURUVLQFOXGH
x 0HGLFDWLRQ HUURUVLQYROYLQJ VXEMHFWH[SRVXUHWRWKH,3
x 3RWHQWLDOPHGLFDWLRQ HUURUVRUXVHVRXWVLGHRIZKDWLVIRUHVHHQLQWKHSURWRFRO WKDWGR
RUGRQRWLQYROYH WKHSDUWLFLSDWLQJ VXEMHFW
6XFKPHGLFDWLRQ HUURUVRFFXUULQJWRDVWXG\SDUWLFLSDQW DUHWREHFDSWXUHGRQWKHPHGLFDWLRQ
HUURUSDJHRIWKH&5)ZKLFKLVDVSHFLILFYHUVLRQRIWKH$(SDJH
,QWKHHYHQWRIDPHGLFDWLRQ GRVLQJHUURUWKHVSRQVRUVKRXOG EHQRWLILHG LPPHGLDWHO\
:KHWKHURUQRWWKHPHGLFDWLRQ HUURULVDFFRPSDQLHGE\DQ$(DVGHWHUPLQHGE\WKH
LQYHVWLJDWRU WKHPHGLFDWLRQ HUURULVUHFRUGHGRQWKHPHGLFDWLRQ HUURUSDJHRIWKH&5)DQGLI
DSSOLFDEOH DQ\DVVRFLDWHG$(VVHULRXVDQGQRQVHULRXV DUHUHFRUGHGRQDQ$(SDJHRIWKH
&5)
0HGLFDWLRQ HUURUVVKRXOG EHUHSRUWHGWR3IL]HU6DIHW\ZLWKLQ KRXUVRQD&76$(5HSRUW
)RUPRQO\ZKHQDVVRFLDWHGZLWKDQ6$(
'$7$$1$/<6,667$7,67,&$/0(7+2'6
'HWDLOHGPHWKRGRORJ\ IRUVXPPDU\DQGVWDWLVWLFDODQDO\VHVRIWKHGDWDFROOHFWHGLQWKLVVWXG\
LVRXWOLQHG KHUHDQGIXUWKHUGHWDLOHG LQD6$3ZKLFKZLOO EHPDLQWDLQHG E\WKH6SRQVRU7KH
6$3PD\PRGLI\ ZKDWLVRXWOLQHG LQWKHSURWRFRO ZKHUHDSSURSULDWHKRZHYHUDQ\PDMRU
PRGLILFDWLRQV RIWKHSULPDU\HQGSRLQW GHILQLWLRQV RUWKHLUDQDO\VHVZLOO DOVREHUHIOHFWHGLQD
SURWRFRO DPHQGPHQW
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
6DPSOH6L]H'HWHUPLQDWLRQ
$SSUR[LPDWHO\ VXEMHFWVSHUDUPDUHSODQQHG WREHHQUROOHG LQWKLV VWXG\IRUDWRWDORI
DSSUR[LPDWHO\ VXEMHFWV7KLVDVVXPHVDQDSSUR[LPDWH GURSRXWUDWHUHVXOWLQJ LQ
FRPSOHWHUVSHUDUP:LWKWKLVVDPSOHVL]HWKHSRZHUWRGHWHFWDPHDQUHGXFWLRQ LQ
05,3'))FRPSDUHGWRSODFHER LVDWOHDVWXVLQJ DVDPSOHWWHVWDQGDVLGHG 7\SH,
HUURUUDWHRI7KLVFDOFXODWLRQ DVVXPHVWKHSRROHG VWDQGDUGGHYLDWLRQ 6'WRYDU\IURP
EDVHGRQVWXG\1&7 WREDVHGRQDQLQWHUQDO VWXG\7KHSRZHUZLOO EH
DWOHDVWLIWKH6'LVLQWKHUDQJHRI
(IILFDF\$QDO\VLV
7KHSULPDU\DQDO\VLVSRSXODWLRQ IRUDOOHIILFDF\DQDO\VHVZLOO LQFOXGH DOOUDQGRPL]HG VXEMHFWV
ZKRUHFHLYHGDWOHDVWGRVHRIVWXG\PHGLFDWLRQ )XOO $QDO\VLVVHW
$QDO\VLVRIWKH3ULPDU\ (QGSRLQW
7KHSULPDU\HQGSRLQW ZLOO EHWKHSHUFHQWFKDQJHIURPEDVHOLQHDW:HHNLQ05,3'))
%DVHOLQHZLOO EHWKHFORVHVWPHDVXUHPHQWSULRUWRILUVWGRVHRQ'D\$QDQDO\VLVRI
FRYDULDQFH$1&29$ZLOO EHSHUIRUPHGZLWKWUHDWPHQWDVDIDFWRUEDVHOLQH05,3'))
YDOXHDQGEDVHOLQHGLDEHWHVVWDWXVDVFRYDULDWHV%DVHOLQHIUXFWRVHH[FUHWLRQDQGLWV
LQWHUDFWLRQ ZLWKWUHDWPHQWZLOO EHFRQVLGHUHGWREHLQFOXGHG DVWKHDGGLWLRQDO FRYDULDWHV
(VWLPDWHVRIWKHPHDQGLIIHUHQFHVEHWZHHQHDFKDFWLYHGRVHDQGSODFHERDW:HHNDQGWKH
FRUUHVSRQGLQJ &,ZLOO EHREWDLQHGIURPWKHPRGHO%RWKFRPSDULVRQV RI
3)GRVHVZLWKWKHSODFHERZLOO EHSHUIRUPHG DWD7\SH,HUURUUDWHRIVLGHG 
1RDGMXVWPHQW IRUPXOWLSOH FRPSDULVRQVZLOO EHPDGH
'HVFULSWLYHVXPPDULHVRIWKHREVHUYHGYDOXHVFKDQJHDQGSHUFHQWFKDQJHIURPEDVHOLQHLQ
05,3'))LQHDFKWUHDWPHQWJURXSZLOO DOVREHSURGXFHG






 












CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH




 


6DIHW\$QDO\VLV
$OOVXEMHFWVZKRUHFHLYHDWOHDVWGRVHRIGRXEOHEOLQG ,3ZLOO EHLQFOXGHG LQWKHVDIHW\
DQDO\VHVDQGOLVWLQJV 
$GYHUVHHYHQWVLQFOXGLQJ 6$(V(&*V%3SXOVHUDWHDQGFOLQLFDO ODERUDWRU\GDWDZLOO EH
UHYLHZHGDQGVXPPDUL]HG RQDQRQJRLQJ EDVLVGXULQJWKHVWXG\WRHYDOXDWHWKHVDIHW\RI
VXEMHFWV6DIHW\GDWDZLOO EHSUHVHQWHGLQWDEXODUDQGRUJUDSKLFDO IRUPDWDQGVXPPDUL]HG
GHVFULSWLYHO\ DFFRUGLQJWR6SRQVRU¶VUHSRUWLQJ VWDQGDUGV
3K\VLFDOH[DPLQDWLRQ LQIRUPDWLRQ FROOHFWHGGXULQJ WKHFRXUVHRIWKHVWXG\ZLOO QRWEH
FDSWXUHGIRULQFOXVLRQ LQWRWKHVWXG\GDWDEDVHYLDWKH&5)'&7GDWDFROOHFWLRQ WRRO SDJH
+RZHYHUDQ\XQWRZDUGILQGLQJV LGHQWLILHG RQSK\VLFDO H[DPLQDWLRQV FRQGXFWHGDIWHUWKH
DGPLQLVWUDWLRQ RIWKHILUVWGRVHRI,3ZLOO EHFDSWXUHGDVDQ$(LIWKRVHILQGLQJV PHHWWKH
GHILQLWLRQ RIDQ$(
(OHFWURFDUGLRJUDP$QDO\VLV
7KHKHDUWUDWH3545647DQG47FLQWHUYDOVZLOO EHUHFRUGHGDWHDFKDVVHVVPHQWWLPH
LQGLFDWHG LQWKH6FKHGXOHRI$FWLYLWLHV 47F)ZLOO EHGHULYHGXVLQJ)ULGHULFLD¶V KHDUWUDWH
FRUUHFWLRQIRUPXOD
7KHPD[LPXP YDOXHSRVWGRVHDQGWKHPD[LPXP LQFUHDVHIURPEDVHOLQHIRU47F)35DQG
456ZLOO EHGHWHUPLQHGIURPRYHUDOOPHDVXUHPHQWVWDNHQSRVWGRVH7KHVHGDWDZLOO EH
VXPPDUL]HG GHVFULSWLYHO\ E\WUHDWPHQWXVLQJ FDWHJRULHVDVGHILQHGLQWKHVWDWLVWLFDODQDO\VLV
SODQ1XPEHUVDQGSHUFHQWDJHVRIVXEMHFWVPHHWLQJWKHFDWHJRULFDOFULWHULDZLOO EHSURYLGHG
DQGLQGLYLGXDO YDOXHVOLVWHGLQWKHVWXG\UHSRUW
1RIRUPDOLQIHUHQWLDO VWDWLVWLFVZLOO EHDSSOLHG WRWKH(&*GDWD
9LWDO6LJQV
6HDWHG%3DQGSXOVH UDWHZLOO EHUHFRUGHGDWHDFKDVVHVVPHQWWLPHLQGLFDWHGLQWKH6FKHGXOH
RI$FWLYLWHV
%DVHOLQHZLOO EHWKHSUHGRVHPHDVXUHPHQWSULRUWRILUVWGRVHRQ'D\0D[LPXP YDOXHV
DQGPD[LPXP FKDQJHVIURPWLPHPDWFKHGEDVHOLQHIRUYLWDO VLJQVZLOO EHVXPPDUL]HG
GHVFULSWLYHO\ E\WUHDWPHQWXVLQJ FDWHJRULHVDVGHILQHGLQWKHVWDWLVWLFDODQDO\VLVSODQ
1XPEHUVDQGSHUFHQWDJHVRIVXEMHFWVPHHWLQJFDWHJRULFDOFULWHULDRXWOLQHG LQWKH6$3ZLOO EH
CCI
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
SURYLGHG DQGLQGLYLGXDO YDOXHVOLVWHGLQWKHVWXG\UHSRUW1RIRUPDOLQIHUHQWLDO VWDWLVWLFVZLOO
EHDSSOLHG WRWKHYLWDO VLJQVGDWD'HVFULSWLYHVXPPDULHVRIWKHREVHUYHGYDOXHVDQGFKDQJH
IURPEDVHOLQHDWHDFKWLPHSRLQW LQHDFKWUHDWPHQWJURXSZLOO DOVREHSURGXFHG
,QWHULP$QDO\VLV
1RLQWHULP DQDO\VLVZLOO EHFRQGXFWHGLQWKLVVWXG\
'DWD0RQLWRULQJ&RPPLWWHH
7KLVVWXG\ZLOO QRWXVHDGDWDPRQLWRULQJ FRPPLWWHH 
48$/,7<&21752/$1'48$/,7<$6685$1&(
3IL]HURULWVDJHQWZLOO FRQGXFWSHULRGLF PRQLWRULQJ YLVLWV GXULQJ VWXG\FRQGXFWWRHQVXUHWKDW
WKHSURWRFRO DQG*RRG&OLQLFDO 3UDFWLFHV*&3VDUHEHLQJIROORZHG 7KHPRQLWRUV PD\
UHYLHZVRXUFHGRFXPHQWVWRFRQILUPWKDWWKHGDWDUHFRUGHGRQ&5)VDUHDFFXUDWH7KH
LQYHVWLJDWRU DQGLQVWLWXWLRQ ZLOO DOORZ3IL]HUPRQLWRUVDXGLWRUV RULWVDJHQWVDQGDSSURSULDWH
UHJXODWRU\DXWKRULWLHV GLUHFWDFFHVVWRVRXUFHGRFXPHQWVWRSHUIRUPWKLVYHULILFDWLRQ 7KLV
YHULILFDWLRQ PD\DOVRRFFXUDIWHUVWXG\FRPSOHWLRQ
'XULQJVWXG\FRQGXFWDQGRUDIWHUVWXG\FRPSOHWLRQ WKHLQYHVWLJDWRU VLWHPD\EHVXEMHFWWR
UHYLHZE\WKH,5%(&DQGRUWRTXDOLW\ DVVXUDQFHDXGLWVSHUIRUPHGE\3IL]HURUFRPSDQLHV
ZRUNLQJ ZLWKRURQEHKDOIRI3IL]HUDQGRUWRLQVSHFWLRQ E\DSSURSULDWHUHJXODWRU\
DXWKRULWLHV
7KHLQYHVWLJDWRUV ZLOO QRWLI\3IL]HURULWVDJHQWVLPPHGLDWHO\ RIDQ\UHJXODWRU\ LQVSHFWLRQ
QRWLILFDWLRQ LQUHODWLRQ WRWKHVWXG\)XUWKHUPRUH WKHLQYHVWLJDWRU ZLOO FRRSHUDWHZLWK3IL]HU
RULWVDJHQWVWRSUHSDUHWKHLQYHVWLJDWRU VLWHIRUWKHLQVSHFWLRQ DQGZLOO DOORZ3IL]HURULWV
DJHQWZKHQHYHUIHDVLEOHWREHSUHVHQWGXULQJWKHLQVSHFWLRQ 7KHLQYHVWLJDWRU VLWHDQG
LQYHVWLJDWRU ZLOO SURPSWO\ UHVROYHDQ\GLVFUHSDQFLHVWKDWDUHLGHQWLILHG EHWZHHQWKHVWXG\
GDWDDQGWKHVXEMHFW
VPHGLFDOUHFRUGV7KHLQYHVWLJDWRU ZLOO SURPSWO\ SURYLGH FRSLHVRIWKH
LQVSHFWLRQ ILQGLQJV WR3IL]HURULWVDJHQW%HIRUHUHVSRQVHVXEPLVVLRQ WRWKHUHJXODWRU\
DXWKRULWLHV WKHLQYHVWLJDWRU ZLOO SURYLGH3IL]HURULWVDJHQWVZLWKDQRSSRUWXQLW\ WRUHYLHZ
DQGFRPPHQWRQUHVSRQVHVWRDQ\VXFKILQGLQJV
,WLVLPSRUWDQW WKDWWKHLQYHVWLJDWRUV DQGWKHLUUHOHYDQWSHUVRQQHODUHDYDLODEOH GXULQJ WKH
PRQLWRULQJ YLVLWV DQGSRVVLEOH DXGLWVRULQVSHFWLRQV DQGWKDWVXIILFLHQW WLPHLVGHYRWHGWRWKH
SURFHVV
'$7$+$1'/,1*$1'5(&25'.((3,1*
&DVH5HSRUW)RUPV(OHFWURQLF'DWD5HFRUG
$VXVHGLQWKLVSURWRFRO WKHWHUP&5)VKRXOG EHXQGHUVWRRGWRUHIHUWRHLWKHUDSDSHUIRUPRU
DQHOHFWURQLFGDWDUHFRUGRUERWKGHSHQGLQJ RQWKHGDWDFROOHFWLRQ PHWKRGXVHGLQWKLVVWXG\
$&5)LVUHTXLUHGDQGVKRXOGEHFRPSOHWHGIRUHDFKLQFOXGHG VXEMHFW7KHFRPSOHWHG
RULJLQDO &5)VDUHWKHVROHSURSHUW\RI3IL]HUDQGVKRXOG QRWEHPDGHDYDLODEOH LQDQ\IRUPWR
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
WKLUGSDUWLHVH[FHSWIRUDXWKRUL]HG UHSUHVHQWDWLYHVRI3IL]HURUDSSURSULDWHUHJXODWRU\
DXWKRULWLHV ZLWKRXWZULWWHQSHUPLVVLRQ IURP3IL]HU
7KHLQYHVWLJDWRU KDVXOWLPDWH UHVSRQVLELOLW\ IRUWKHFROOHFWLRQ DQGUHSRUWLQJ RIDOOFOLQLFDO
VDIHW\DQGODERUDWRU\GDWDHQWHUHGRQWKH&5)VDQGDQ\RWKHUGDWDFROOHFWLRQ IRUPVVRXUFH
GRFXPHQWVDQGHQVXULQJ WKDWWKH\DUHDFFXUDWHDXWKHQWLFRULJLQDO DWWULEXWDEOH FRPSOHWH
FRQVLVWHQWOHJLEOH WLPHO\ FRQWHPSRUDQHRXV HQGXULQJ DQGDYDLODEOH ZKHQUHTXLUHG7KH
&5)VPXVWEHVLJQHGE\WKHLQYHVWLJDWRU RUE\DQDXWKRUL]HG VWDIIPHPEHUWRDWWHVWWKDWWKH
GDWDFRQWDLQHGRQWKH&5)VDUHWUXH$Q\FRUUHFWLRQVWRHQWULHVPDGHLQWKH&5)VRUVRXUFH
GRFXPHQWVPXVWEHGDWHGLQLWLDOHG DQGH[SODLQHG LIQHFHVVDU\DQGVKRXOG QRWREVFXUHWKH
RULJLQDO HQWU\
,QPRVWFDVHVWKHVRXUFHGRFXPHQWVDUHWKHKRVSLWDO RUWKHSK\VLFLDQ VXEMHFWFKDUW,QWKHVH
FDVHVGDWDFROOHFWHGRQWKH&5)VPXVWPDWFKWKHGDWDLQWKRVHFKDUWV
,QVRPHFDVHVWKH&5)PD\DOVRVHUYHDVWKHVRXUFHGRFXPHQW,QWKHVHFDVHVDGRFXPHQW
VKRXOG EHDYDLODEOH DWWKHLQYHVWLJDWRU VLWHDQGDW3IL]HUWKDWFOHDUO\ LGHQWLILHV WKRVHGDWDWKDW
ZLOO EHUHFRUGHGRQWKH&5)DQGIRUZKLFKWKH&5)ZLOO VWDQGDVWKHVRXUFHGRFXPHQW
5HFRUG5HWHQWLRQ
7RHQDEOHHYDOXDWLRQV DQGRULQVSHFWLRQVDXGLWV IURPUHJXODWRU\DXWKRULWLHV RU3IL]HUWKH
LQYHVWLJDWRU DJUHHVWRNHHSUHFRUGVLQFOXGLQJ WKHLGHQWLW\ RIDOOSDUWLFLSDWLQJ VXEMHFWV
VXIILFLHQWLQIRUPDWLRQ WROLQN UHFRUGVHJ&5)VDQGKRVSLWDO UHFRUGVDOORULJLQDO VLJQHG
LQIRUPHG FRQVHQWGRFXPHQWV FRSLHVRIDOO&5)VVDIHW\UHSRUWLQJ IRUPVVRXUFHGRFXPHQWV
DQGGHWDLOHG UHFRUGVRIWUHDWPHQWGLVSRVLWLRQ DQGDGHTXDWHGRFXPHQWDWLRQ RIUHOHYDQW
FRUUHVSRQGHQFHHJOHWWHUVPHHWLQJPLQXWHV DQGWHOHSKRQHFDOOUHSRUWV7KHUHFRUGVVKRXOG
EHUHWDLQHGE\WKHLQYHVWLJDWRU DFFRUGLQJWRWKH,&+JXLGHOLQHV DFFRUGLQJWRORFDO
UHJXODWLRQV RUDVVSHFLILHGLQWKHFOLQLFDO VWXG\DJUHHPHQW&6$ZKLFKHYHULVORQJHU
,IWKHLQYHVWLJDWRU EHFRPHVXQDEOHIRUDQ\UHDVRQWRFRQWLQXH WRUHWDLQVWXG\UHFRUGVIRUWKH
UHTXLUHGSHULRGHJUHWLUHPHQW UHORFDWLRQ 3IL]HUVKRXOGEHSURVSHFWLYHO\ QRWLILHG 7KH
VWXG\UHFRUGVPXVWEHWUDQVIHUUHGWRDGHVLJQHHDFFHSWDEOHWR3IL]HUVXFKDVDQRWKHU
LQYHVWLJDWRU DQRWKHULQVWLWXWLRQ RUDQLQGHSHQGHQW WKLUGSDUW\DUUDQJHGE\3IL]HU
,QYHVWLJDWRUUHFRUGVPXVWEHNHSWIRUDPLQLPXP RI\HDUVDIWHUFRPSOHWLRQ RU
GLVFRQWLQXDWLRQ RIWKHVWXG\RUIRUORQJHULIUHTXLUHGE\DSSOLFDEOH ORFDOUHJXODWLRQV 
7KHLQYHVWLJDWRU PXVWREWDLQ3IL]HU
VZULWWHQSHUPLVVLRQ EHIRUHGLVSRVLQJ RIDQ\UHFRUGV
HYHQLIUHWHQWLRQUHTXLUHPHQWVKDYHEHHQPHW
(7+,&6
,QVWLWXWLRQDO5HYLHZ%RDUG(WKLFV&RPPLWWHH
,WLVWKHUHVSRQVLELOLW\ RIWKHLQYHVWLJDWRU WRKDYHSURVSHFWLYHDSSURYDO RIWKHVWXG\SURWRFRO
SURWRFRO DPHQGPHQWVLQIRUPHG FRQVHQWGRFXPHQWV DQGRWKHUUHOHYDQWGRFXPHQWV HJ
UHFUXLWPHQWDGYHUWLVHPHQWVLIDSSOLFDEOH IURPWKH,5%(&$OOFRUUHVSRQGHQFHZLWKWKH
,5%(&VKRXOG EHUHWDLQHGLQWKHLQYHVWLJDWRU ILOH&RSLHVRI,5%(&DSSURYDOVVKRXOG EH
IRUZDUGHGWR3IL]HU
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
7KHRQO\FLUFXPVWDQFHLQZKLFKDQDPHQGPHQWPD\EHLQLWLDWHG SULRUWR,5%(&DSSURYDOLV
ZKHUHWKHFKDQJHLVQHFHVVDU\WRHOLPLQDWH DSSDUHQWLPPHGLDWH KD]DUGVWRWKHVXEMHFWV,Q
WKDWHYHQWWKHLQYHVWLJDWRU PXVWQRWLI\WKH,5%(&DQG3IL]HULQZULWLQJ LPPHGLDWHO\ DIWHU
WKHLPSOHPHQWDWLRQ
(WKLFDO&RQGXFWRIWKH6WXG\
7KHVWXG\ZLOO EHFRQGXFWHGLQDFFRUGDQFHZLWK WKHSURWRFRO OHJDODQGUHJXODWRU\
UHTXLUHPHQWV DQGWKHJHQHUDOSULQFLSOHV VHWIRUWKLQWKH,QWHUQDWLRQDO (WKLFDO*XLGHOLQHV IRU
%LRPHGLFDO 5HVHDUFK,QYROYLQJ +XPDQ6XEMHFWV&RXQFLO IRU,QWHUQDWLRQDO 2UJDQL]DWLRQV RI
0HGLFDO6FLHQFHV ,&+*XLGHOLQH IRU*RRG&OLQLFDO 3UDFWLFHDQGWKH'HFODUDWLRQRI
+HOVLQNL
6XEMHFW,QIRUPDWLRQDQG&RQVHQW
$OOSDUWLHVZLOO HQVXUHSURWHFWLRQRIVXEMHFWSHUVRQDOGDWDDQGZLOO QRWLQFOXGH VXEMHFWQDPHV
RURWKHULGHQWLILDEOH GDWDLQDQ\UHSRUWVSXEOLFDWLRQV RURWKHUGLVFORVXUHV H[FHSWZKHUH
UHTXLUHGE\ODZ
:KHQVWXG\GDWDDUHFRPSLOHG IRUWUDQVIHUWR3IL]HUDQGRWKHUDXWKRUL]HG SDUWLHVVXEMHFW
QDPHVDGGUHVVHVDQGRWKHULGHQWLILDEOH GDWDZLOO EHUHSODFHGE\QXPHULFDO FRGHVEDVHGRQD
QXPEHULQJ V\VWHPSURYLGHG E\3IL]HULQRUGHUWRGHLGHQWLI\ VWXG\ VXEMHFWV7KHLQYHVWLJDWRU
VLWHZLOO PDLQWDLQ DFRQILGHQWLDO OLVWRIVXEMHFWVZKRSDUWLFLSDWHGLQWKHVWXG\ OLQNLQJ HDFK
VXEMHFW¶VQXPHULFDO FRGHWRKLVRUKHUDFWXDOLGHQWLW\ ,QFDVHRIGDWDWUDQVIHU3IL]HUZLOO
PDLQWDLQ KLJK VWDQGDUGVRIFRQILGHQWLDOLW\ DQGSURWHFWLRQRIVXEMHFWV¶SHUVRQDOGDWDFRQVLVWHQW
ZLWKDSSOLFDEOH SULYDF\ODZV
7KHLQIRUPHG FRQVHQWGRFXPHQWVDQGDQ\VXEMHFWUHFUXLWPHQWPDWHULDOV PXVWEHLQ
FRPSOLDQFH ZLWK,&+*&3ORFDOUHJXODWRU\ UHTXLUHPHQWV DQGOHJDOUHTXLUHPHQWV LQFOXGLQJ
DSSOLFDEOH SULYDF\ODZV
7KHLQIRUPHG FRQVHQWGRFXPHQWVXVHGGXULQJ WKHLQIRUPHG FRQVHQWSURFHVVDQGDQ\VXEMHFW
UHFUXLWPHQWPDWHULDOV PXVWEHUHYLHZHGDQGDSSURYHGE\3IL]HUDSSURYHGE\WKH,5%(&
EHIRUHXVHDQGDYDLODEOH IRULQVSHFWLRQ 
7KHLQYHVWLJDWRU PXVWHQVXUHWKDWHDFKVWXG\VXEMHFWLVIXOO\ LQIRUPHG DERXWWKHQDWXUHDQG
REMHFWLYHV RIWKHVWXG\DQGSRVVLEOHULVNVDVVRFLDWHGZLWKSDUWLFLSDWLRQ 
7KHLQYHVWLJDWRU RUDSHUVRQGHVLJQDWHGE\WKHLQYHVWLJDWRU ZLOO REWDLQZULWWHQLQIRUPHG
FRQVHQWIURPHDFKVXEMHFWEHIRUHDQ\VWXG\VSHFLILF DFWLYLW\ LVSHUIRUPHG7KHLQYHVWLJDWRU
ZLOO UHWDLQWKHRULJLQDO RIHDFKVXEMHFW
VVLJQHGFRQVHQWGRFXPHQW
5HSRUWLQJRI6DIHW\,VVXHVDQG6HULRXV%UHDFKHVRIWKH3URWRFRORU,&+*&3
,QWKHHYHQWRIDQ\SURKLELWLRQ RUUHVWULFWLRQLPSRVHG LHFOLQLFDO KROG E\DQDSSOLFDEOH
UHJXODWRU\ DXWKRULW\ LQDQ\DUHDRIWKHZRUOG RULIWKHLQYHVWLJDWRU LVDZDUHRIDQ\QHZ
LQIRUPDWLRQ WKDWPLJKW LQIOXHQFHWKHHYDOXDWLRQ RIWKHEHQHILWVDQGULVNVRIWKH,33IL]HU
VKRXOG EHLQIRUPHGLPPHGLDWHO\ 
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
,QDGGLWLRQ WKHLQYHVWLJDWRU ZLOO LQIRUP3IL]HULPPHGLDWHO\ RIDQ\XUJHQWVDIHW\PHDVXUHV
WDNHQE\WKHLQYHVWLJDWRU WRSURWHFWWKHVWXG\VXEMHFWVDJDLQVWDQ\LPPHGLDWH KD]DUGDQGRI
DQ\VHULRXVEUHDFKHVRIWKLVSURWRFRORURI,&+*&3WKDWWKHLQYHVWLJDWRU EHFRPHVDZDUHRI
'(),1,7,212)(1'2)75,$/
(QGRI7ULDOLQ$OO3DUWLFLSDWLQJ&RXQWULHV
(QGRIWULDOLQDOOSDUWLFLSDWLQJ FRXQWULHVLVGHILQHG DVODVWVXEMHFWODVWYLVLW /6/9±WKHGDWH
WKHLQYHVWLJDWRU UHYLHZVWKHODVWVXEMHFW¶VILQDOVDIHW\GDWDDQGGHWHUPLQHVWKDWQRIXUWKHU
HYDOXDWLRQ LVUHTXLUHGIRUWKHVXEMHFWVWRFRPSOHWHWKHWULDO
6321625',6&217,18$7,21&5,7(5,$
3UHPDWXUHWHUPLQDWLRQ RIWKLVVWXG\PD\RFFXUEHFDXVHRIDUHJXODWRU\DXWKRULW\ GHFLVLRQ
FKDQJHLQRSLQLRQ RIWKH,5%(&RU,3VDIHW\SUREOHPV RUDWWKHGLVFUHWLRQRI3IL]HU,Q
DGGLWLRQ 3IL]HUUHWDLQVWKHULJKWWRGLVFRQWLQXH GHYHORSPHQW RI3) DWDQ\WLPH
,IDVWXG\LVSUHPDWXUHO\WHUPLQDWHG 3IL]HUZLOO SURPSWO\ QRWLI\ WKHLQYHVWLJDWRU $IWHU
QRWLILFDWLRQ WKHLQYHVWLJDWRU PXVWFRQWDFWDOOSDUWLFLSDWLQJ VXEMHFWVDQGWKHKRVSLWDO SKDUPDF\
LIDSSOLFDEOH ZLWKLQ GD\V$VGLUHFWHGE\3IL]HUDOOVWXG\PDWHULDOVPXVWEHFROOHFWHGDQG
DOO&5)VFRPSOHWHGWRWKHJUHDWHVWH[WHQWSRVVLEOH
38%/,&$7,212)678'<5(68/76
&RPPXQLFDWLRQRI5HVXOWVE\3IL]HU
3IL]HUIXOILOOV LWVFRPPLWPHQW WRSXEOLFO\ GLVFORVHFOLQLFDO WULDOUHVXOWVWKURXJKSRVWLQJ WKH
UHVXOWVRIVWXGLHVRQZZZFOLQLFDOWULDOVJRY &OLQLFDO7ULDOVJRY WKH(XURSHDQ&OLQLFDO 7ULDOV
'DWDEDVH(XGUD&7DQGRUZZZSIL]HUFRP DQGRWKHUSXEOLF UHJLVWULHVLQDFFRUGDQFHZLWK
DSSOLFDEOH ORFDOODZVUHJXODWLRQV 
,QDOOFDVHVVWXG\UHVXOWVDUHUHSRUWHGE\3IL]HULQDQREMHFWLYH DFFXUDWHEDODQFHGDQG
FRPSOHWHPDQQHUDQGDUHUHSRUWHGUHJDUGOHVVRIWKHRXWFRPHRIWKHVWXG\RUWKHFRXQWU\LQ
ZKLFKWKHVWXG\ZDVFRQGXFWHG
ZZZFOLQLFDOWULDOVJRY
3IL]HUSRVWVFOLQLFDO WULDO 86%DVLF5HVXOWVRQZZZFOLQLFDOWULDOVJRY IRU3IL]HUVSRQVRUHG
LQWHUYHQWLRQDO VWXGLHVFRQGXFWHGLQSDWLHQWV WKDWHYDOXDWHWKHVDIHW\DQGRUHIILFDF\RID
3IL]HUSURGXFWUHJDUGOHVVRIWKHJHRJUDSKLFDO ORFDWLRQ LQZKLFKWKHVWXG\LVFRQGXFWHG86
%DVLF5HVXOWVDUHVXEPLWWHG IRUSRVWLQJ ZLWKLQ \HDURIWKHSULPDU\ FRPSOHWLRQ GDWH3&'
IRUVWXGLHVLQDGXOWSRSXODWLRQV RUZLWKLQ PRQWKVRIWKH3&'IRUVWXGLHVLQSHGLDWULF
SRSXODWLRQV
3&'LVGHILQHGDVWKHGDWHWKDWWKHILQDOVXEMHFWZDVH[DPLQHGRUUHFHLYHGDQLQWHUYHQWLRQ IRU
WKHSXUSRVHVRIILQDO FROOHFWLRQ RIGDWDIRUWKHSULPDU\RXWFRPHZKHWKHUWKHFOLQLFDO VWXG\
FRQFOXGHGDFFRUGLQJWRWKHSUHVSHFLILHGSURWRFRO RUZDVWHUPLQDWHG
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
(XGUD&7
3IL]HUSRVWV(XURSHDQ8QLRQ (8%DVLF5HVXOWVRQ(XGUD&7IRUDOO3IL]HUVSRQVRUHG
LQWHUYHQWLRQDO VWXGLHVWKDWDUHLQVFRSHRI(8UHTXLUHPHQWV(8%DVLF5HVXOWVDUHVXEPLWWHG
IRUSRVWLQJ ZLWKLQ \HDURIWKH3&'IRUVWXGLHVLQDGXOWSRSXODWLRQV RUZLWKLQ PRQWKVRI
WKH3&'IRUVWXGLHVLQSHGLDWULFSRSXODWLRQV
ZZZSIL]HUFRP
3IL]HUSRVWV3XEOLF'LVFORVXUH6\QRSVHVFOLQLFDO VWXG\UHSRUWV\QRSVHVLQZKLFKDQ\GDWD
WKDWFRXOGEHXVHGWRLGHQWLI\ LQGLYLGXDO SDWLHQWVKDVEHHQUHPRYHGRQZZZSIL]HUFRPIRU
3IL]HUVSRQVRUHGLQWHUYHQWLRQDO VWXGLHV DWWKHVDPHWLPHWKH86%DVLF5HVXOWVGRFXPHQWLV
SRVWHGWRZZZFOLQLFDOWULDOVJRY
3XEOLFDWLRQVE\,QYHVWLJDWRUV
3IL]HUVXSSRUWVWKHH[HUFLVHRIDFDGHPLFIUHHGRPDQGKDVQRREMHFWLRQ WRSXEOLFDWLRQ E\WKH
SULQFLSDO LQYHVWLJDWRU 3,RIWKHUHVXOWVRIWKHVWXG\EDVHGRQLQIRUPDWLRQ FROOHFWHGRU
JHQHUDWHGE\WKH3,ZKHWKHURUQRWWKHUHVXOWVDUHIDYRUDEOHWRWKH3IL]HUSURGXFW+RZHYHU
WRHQVXUHDJDLQVWLQDGYHUWHQWGLVFORVXUHRIFRQILGHQWLDO LQIRUPDWLRQ RUXQSURWHFWHG
LQYHQWLRQV WKHLQYHVWLJDWRU ZLOO SURYLGH3IL]HUDQRSSRUWXQLW\ WRUHYLHZDQ\SURSRVHG
SXEOLFDWLRQ RURWKHUW\SHRIGLVFORVXUH RIWKHUHVXOWVRIWKHVWXG\FROOHFWLYHO\ ³SXEOLFDWLRQ´
EHIRUHLWLVVXEPLWWHG RURWKHUZLVHGLVFORVHG
7KHLQYHVWLJDWRU ZLOO SURYLGH DQ\SXEOLFDWLRQ WR3IL]HUDWOHDVWGD\VEHIRUHLWLVVXEPLWWHG
IRUSXEOLFDWLRQ RURWKHUZLVHGLVFORVHG ,IDQ\SDWHQWDFWLRQLVUHTXLUHGWRSURWHFWLQWHOOHFWXDO
SURSHUW\ULJKWV WKHLQYHVWLJDWRU DJUHHVWRGHOD\WKHGLVFORVXUHIRUDSHULRGQRWWRH[FHHGDQ
DGGLWLRQDO GD\V
7KHLQYHVWLJDWRU ZLOO RQUHTXHVWUHPRYHDQ\SUHYLRXVO\ XQGLVFORVHG FRQILGHQWLDO
LQIRUPDWLRQ EHIRUHGLVFORVXUH H[FHSWIRUDQ\VWXG\RU3IL]HUSURGXFWUHODWHGLQIRUPDWLRQ
QHFHVVDU\WRWKHDSSURSULDWHVFLHQWLILFSUHVHQWDWLRQRUXQGHUVWDQGLQJ RIWKHVWXG\UHVXOWV
,IWKHVWXG\LVSDUWRIDPXOWLFHQWHU VWXG\ WKHLQYHVWLJDWRU DJUHHVWKDWWKHILUVWSXEOLFDWLRQ LV
WREHDMRLQW SXEOLFDWLRQ FRYHULQJDOO LQYHVWLJDWRU VLWHVDQGWKDWDQ\VXEVHTXHQWSXEOLFDWLRQV
E\WKH3,ZLOO UHIHUHQFHWKDWSULPDU\ SXEOLFDWLRQ +RZHYHULIDMRLQW PDQXVFULSWKDVQRW
EHHQVXEPLWWHG IRUSXEOLFDWLRQ ZLWKLQ PRQWKVRIFRPSOHWLRQ RUWHUPLQDWLRQ RIWKHVWXG\DW
DOOSDUWLFLSDWLQJ VLWHVWKHLQYHVWLJDWRU LVIUHHWRSXEOLVK VHSDUDWHO\VXEMHFWWRWKHRWKHU
UHTXLUHPHQWVRIWKLVVHFWLRQ
)RUDOOSXEOLFDWLRQV UHODWLQJ WRWKHVWXG\ WKHLQVWLWXWLRQ ZLOO FRPSO\ ZLWKUHFRJQL]HG HWKLFDO
VWDQGDUGVFRQFHUQLQJ SXEOLFDWLRQV DQGDXWKRUVKLS LQFOXGLQJ 6HFWLRQ,,³(WKLFDO
&RQVLGHUDWLRQV LQWKH&RQGXFWDQG5HSRUWLQJ RI5HVHDUFK´RIWKH8QLIRUP5HTXLUHPHQWVIRU
0DQXVFULSWV6XEPLWWHG WR%LRPHGLFDO -RXUQDOVKWWSZZZLFPMHRUJLQGH[KWPODXWKRUVKLS
HVWDEOLVKHGE\WKH,QWHUQDWLRQDO &RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
3XEOLFDWLRQ RIVWXG\UHVXOWVLVDOVRSURYLGHG IRULQWKH&6$EHWZHHQ3IL]HUDQGWKH
LQVWLWXWLRQ ,QWKLVVHFWLRQHQWLWOHG 3XEOLFDWLRQV E\,QYHVWLJDWRUV WKHGHILQHGWHUPVVKDOOKDYH
WKHPHDQLQJVJLYHQWRWKHPLQWKH&6$
,IWKHUHLVDQ\FRQIOLFWEHWZHHQWKH&6$DQGDQ\DWWDFKPHQWVWRLWWKHWHUPVRIWKH&6$
FRQWURO,IWKHUHLVDQ\FRQIOLFW EHWZHHQWKLVSURWRFRO DQGWKH&6$WKLVSURWRFRO ZLOO FRQWURO
DVWRDQ\LVVXHUHJDUGLQJWUHDWPHQWRIVWXG\VXEMHFWVDQGWKH&6$ZLOO FRQWURODVWRDOORWKHU
LVVXHV
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
5()(5(1&(6

2QOLQH 0HQGHOLDQ,QKHULWDQFHLQ0DQ20,0-RKQV+RSNLQV 8QLYHUVLW\ %DOWLPRUH
0'0,01XPEHU^` ^-XQH` :RUOG:LGH:HE85/KWWSRPLPRUJ

6DFKV%6WHUQIHOG/.UDXV*(VVHQWLDOIUXFWRVXULD ,WVSDWKRSK\VLRORJ\ $P-'LV
&KLOG 

%RHVLJHU3%XFKOL 50HLHU'HWDO&KDQJHVRIOLYHU PHWDEROLWH FRQFHQWUDWLRQVLQ
DGXOWVZLWKGLVRUGHUVRIIUXFWRVHPHWDEROLVP DIWHULQWUDYHQRXV IUXFWRVHE\ 3PDJQHWLF
UHVRQDQFHVSHFWURVFRS\3HGLDWU5HV

$EGHOPDOHN 0)/D]R0+RUVND$HWDO)DWW\/LYHU6XEJURXS RI/RRN$5*
+LJKHUGLHWDU\IUXFWRVHLVDVVRFLDWHGZLWKLPSDLUHG KHSDWLFDGHQRVLQHWULSKRVSKDWH
KRPHRVWDVLVLQREHVHLQGLYLGXDOV ZLWKW\SHGLDEHWHV+HSDWRORJ\

0DHQSDD3+5DLYLR .2.HNRPDNL 03/LYHUDGHQLQHQXFOHRWLGHV IUXFWRVHLQGXFHG
GHSOHWLRQ DQGLWVHIIHFWRQSURWHLQV\QWKHVLV6FLHQFH

/DQDVSD0$6DQFKH]/R]DGD/*&KRL<-HWDO8ULFDFLGLQGXFHVKHSDWLFVWHDWRVLVE\
JHQHUDWLRQRIPLWRFKRQGULDO R[LGDWLYH VWUHVVSRWHQWLDO UROHLQIUXFWRVHGHSHQGHQWDQG
LQGHSHQGHQW IDWW\OLYHU-%LRO&KHP

(ULRQ'03RSRY9+VLDR--HWDO7KHUROHRIWKHFDUERK\GUDWHUHVSRQVH
HOHPHQWELQGLQJ SURWHLQLQPDOHIUXFWRVHIHGUDWV(QGRFULQRORJ\ 

6RIWLF6&RKHQ'(.DKQ&55ROHRIGLHWDU\IUXFWRVHDQGKHSDWLFGHQRYROLSRJHQHVLV
LQIDWW\OLYHUGLVHDVH'LJ'LV6FL

6WDQKRSH./6FKZDU]-0.HLP1/HWDO&RQVXPLQJ IUXFWRVHVZHHWHQHGQRW
JOXFRVHVZHHWHQHGEHYHUDJHVLQFUHDVHVYLVFHUDODGLSRVLW\ DQGOLSLGV DQGGHFUHDVHV
LQVXOLQ VHQVLWLYLW\ LQRYHUZHLJKWREHVH KXPDQV-&OLQ,QYHVW
 $ELG$7DKD21VHLU:HWDO6RIWGULQNFRQVXPSWLRQ LVDVVRFLDWHGZLWKIDWW\OLYHU
GLVHDVHLQGHSHQGHQW RIPHWDEROLF V\QGURPH-+HSDWRO
 $VV\11DVVHU*.DPD\VH,HWDO6RIWGULQNFRQVXPSWLRQ OLQNHG ZLWKIDWW\OLYHULQ
WKHDEVHQFHRIWUDGLWLRQDO ULVNIDFWRUV&DQ-*DVWURHQWHURO
 6FKZDU]-01RZRUROVNL 60:HQ0-HWDO(IIHFWRIDKLJKIUXFWRVHZHLJKW
PDLQWDLQLQJ GLHWRQOLSRJHQHVLV DQGOLYHUIDW-&OLQ (QGRFULQRO 0HWDE

 /XVWLJ50XOOLJDQ .1RZRUROVNL 60HWDO,VRFDORULFIUXFWRVHUHVWULFWLRQ DQG
PHWDEROLF LPSURYHPHQW LQFKLOGUHQ ZLWKREHVLW\DQGPHWDEROLF V\QGURPH2EHVLW\

090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 6WDQKRSH./0HGLFL9%UHPHU$$HWDO$GRVHUHVSRQVHVWXG\RIFRQVXPLQJ KLJK
IUXFWRVHFRUQV\UXSVZHHWHQHGEHYHUDJHVRQOLSLGOLSRSURWHLQ ULVNIDFWRUVIRU
FDUGLRYDVFXODUGLVHDVHLQ\RXQJDGXOWV$P-&OLQ 1XWU
 6DQ\DO$-)ULHGPDQ6/0F&XOORXJK $-HWDO$PHULFDQ$VVRFLDWLRQIRUWKH6WXG\RI
/LYHU'LVHDVHV8QLWHG6WDWHV)RRGDQG'UXJ$GPLQLVWUDWLRQ &KDOOHQJHV DQG
RSSRUWXQLWLHV LQGUXJDQGELRPDUNHUGHYHORSPHQW IRUQRQDOFRKROLF VWHDWRKHSDWLWLV
ILQGLQJV DQGUHFRPPHQGDWLRQV IURPDQ$PHULFDQ$VVRFLDWLRQ IRUWKH6WXG\RI/LYHU
'LVHDVHV86)RRGDQG'UXJ$GPLQLVWUDWLRQ -RLQW:RUNVKRS +HSDWRORJ\ 

 ,VKLPRWR 7/DQDVSD0$/H07HWDO2SSRVLQJ HIIHFWVRIIUXFWRNLQDVH&DQG$
LVRIRUPVRQIUXFWRVHLQGXFHG PHWDEROLFV\QGURPHLQPLFH3URF1DWO$FDG6FL86$

 ,VKLPRWR 7/DQDVSD0$5LYDUG&-HWDO+LJKIDWDQGKLJKVXFURVHZHVWHUQGLHW
LQGXFHVVWHDWRKHSDWLWLVWKDWLVGHSHQGHQWRQIUXFWRNLQDVH+HSDWRORJ\ 
 'XDQ3=KDR3=KDQJ/3K\VLRORJLFDOO\ EDVHGSKDUPDFRNLQHWLF 3%3.PRGHOLQJ RI
SLWDYDVWDWLQ DQGDWRUYDVWDWLQWRSUHGLFWGUXJGUXJ LQWHUDFWLRQV'',V(XU-'UXJ0HWDE
3KDUPDFRNLQHW1RY
 1RXUHGGLQ 0/DP-3HWHUVRQ05HWDO8WLOLW\ RIPDJQHWLFUHVRQDQFHLPDJLQJ YHUVXV
KLVWRORJ\ IRUTXDQWLI\LQJ FKDQJHVLQOLYHUIDWLQQRQDOFRKROLF IDWW\OLYHUGLVHDVHWULDOV 
+HSDWRORJ\ 
 /H7$&KHQ-&KDQTFKLHQ&HWDO(IIHFWRIFROHVHYHODPRQOLYHUIDWTXDQWLILHG E\
PDJQHWLFUHVRQDQFHLQ QRQDOFRKROLF VWHDWRKHSDWLWLV DUDQGRPL]HG FRQWUROOHG WULDO
+HSDWRORJ\   
 /RRPED 56LUOLQ &%$QJ%HWDO(]HWLPLEH IRUWKHWUHDWPHQWRIQRQDOFRKROLF
VWHDWRKHSDWLWLV DVVHVVPHQWE\QRYHOPDJQHWLFUHVRQDQFHLPDJLQJ DQGPDJQHWLF
UHVRQDQFHHODVWRJUDSK\LQDUDQGRPL]HG WULDO02=$577ULDO +HSDWRORJ\

 6WDQKRSH./6FKZDU]-0.HLP1/HWDO&RQVXPLQJ IUXFWRVHVZHHWHQHGQRW
JOXFRVHVZHHWHQHGEHYHUDJHVLQFUHDVHVYLVFHUDODGLSRVLW\ DQGOLSLGV DQGGHFUHDVHV
LQVXOLQ VHQVLWLYLW\ LQRYHUZHLJKWREHVH KXPDQV-&OLQ,QYHVW 
 &KDODVDQL1<RXQRVVL =/DYLQH-(HWDO7KHGLDJQRVLV DQGPDQDJHPHQWRI
QRQDOFRKROLF IDWW\OLYHU GLVHDVHSUDFWLFH*XLGHOLQH E\WKH$PHULFDQ$VVRFLDWLRQIRU
WKH6WXG\RI/LYHU'LVHDVHV$PHULFDQ&ROOHJH RI*DVWURHQWHURORJ\ DQGWKH$PHULFDQ
*DVWURHQWHURORJLFDO $VVRFLDWLRQ+HSDWRORJ\ 
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
 3HWLW-0&HUFXHLO-3/RIIUR\5HWDO(IIHFWRIOLUDJOXWLGH WKHUDS\RQOLYHUIDWFRQWHQW
LQSDWLHQWVZLWKLQDGHTXDWHO\ FRQWUROOHG W\SHGLDEHWHV7KH/LUD1$)/'VWXG\-&OLQ
(QGRFULQRO 0HWDEGRLMF
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$SSHQGL[$EEUHYLDWLRQV
7KLVIROORZLQJ LVDOLVWRIDEEUHYLDWLRQV WKDWPD\EHXVHGLQWKHSURWRFRO 
$EEUHYLDWLRQ
7HUP
$$7
ĮDQWLWU\SVLQ
$EV
DEVROXWH
$'3
DGHQRVLQHGLSKRVSKDWH
$(
DGYHUVHHYHQW
$/3
DONDOLQH SKRVSKDWDVH
$/7
DODQLQHDPLQRWUDQVIHUDVH
$03
DGHQRVLQHPRQRSKRVSKDWH
$1&29$
DQDO\VLVRIFRYDULDQFH
$SR%
DSROLSRSURWHLQ %
$SR&
DSROLSRSURWHLQ &
D377
DFWLYDWHGSDUWLDOWKURPERSODVWLQ WLPH
$67
DVSDUWDWHDPLQRWUDQVIHUDVH
$73
DGHQRVLQHWULSKRVSKDWH
$8&
DUHDXQGHUWKHFXUYH
$8&
V\VWHPLFH[SRVXUHRYHUKRXUV
$8(&
DUHDXQGHUWKHHIIHFWFXUYHRYHUKRXUV
%%6
%LRVSHFLPHQ %DQNLQJ 6\VWHP
%&53
EUHDVWFDQFHUUHVLVWDQFHSURWHLQ
%0,
ERG\PDVVLQGH[
%3
EORRG SUHVVXUH
%81
EORRG XUHDQLWURJHQ
&$3
FRQWUROOHG DWWHQXDWLRQSDUDPHWHU
&K5(%3
FDUERK\GUDWHUHVSRQVLYH HOHPHQWELQGLQJ SURWHLQ
&,
FRQILGHQFHLQWHUYDO
&.
FUHDWLQHNLQDVH
&/S
SODVPDFOHDUDQFH
&PD[
PD[LPXP FRQFHQWUDWLRQ
&2
FDUERQGLR[LGH ELFDUERQDWH
&5)
FDVHUHSRUWIRUP
&6$
FOLQLFDO VWXG\DJUHHPHQW
&65
FOLQLFDO VWXG\UHSRUW
&7
FOLQLFDO WULDO
&7$
FOLQLFDO WULDODSSOLFDWLRQ
&7&$(
&RPPRQ 7HUPLQRORJ\ &ULWHULDIRU$GYHUVH(YHQWV
&<3
F\WRFKURPH3
G%P
GHFLEHOVSHUPHWHU
'&7
GDWDFROOHFWLRQ WRRO
'',
GUXJGUXJ LQWHUDFWLRQ
',/,
GUXJLQGXFHG OLYHULQMXU\
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$EEUHYLDWLRQ
7HUP
'0&
GDWDPRQLWRULQJ FRPPLWWHH
'1$
GHR[\ULERQXFOHLF DFLG
'33L
GLSHSWLG\O SHSWLGDVHLQKLELWRUV
'8
GLVSHQVDEOH XQLW
(&
RIWKHPD[LPXP HIIHFW
(&
HWKLFVFRPPLWWHH
(&*
HOHFWURFDUGLRJUDP
H&5)
HOHFWURQLFFDVHUHSRUWIRUP
('0&
H[WHUQDOGDWDPRQLWRULQJ FRPPLWWHH 
('3
H[SRVXUHGXULQJ SUHJQDQF\
()'
HPEU\RIHWDOGHYHORSPHQW
(PD[
HIILFDF\
(8
(XURSHDQ8QLRQ
(XGUD&7
(XURSHDQ&OLQLFDO 7ULDOV'DWDEDVH
)3
IUXFWRVHSKRVSKDWH
)
ELRDYDLODELOLW\
),+
ILUVWLQKXPDQ
)6+
IROOLFOHVWLPXODWLQJ KRUPRQH
IX
XQERXQG SODVPDIUDFWLRQ
*&3
*RRG&OLQLFDO 3UDFWLFH
**7
JDPPDJOXWDP\O WUDQVIHUDVH
*/3
*RRG/DERUDWRU\3UDFWLFH
*/3U
JOXFDJRQOLNH SHSWLGHUHFHSWRU
+E$F
KHPRJORELQ $&
+%V$J
KHSDWLWLV %VXUIDFHDQWLJHQ
+%9
KHSDWLWLV %YLUXV
+&&
KHSDWLFFHOOXODU FDUFLQRPD
+&9
KHSDWLWLV &YLUXV
+&9$E
KHSDWLWLV &DQWLERG\
+'/&
KLJKGHQVLW\ OLSRSURWHLQ FKROHVWHURO
+(.
KXPDQHPEU\RQLFNLGQH\
+HS%
KHSDWLWLV %
+HS&
KHSDWLWLV &
K(5*
KXPDQ(WKHUDJRJRUHODWHGJHQH
+,9
KXPDQLPPXQRGHILFLHQF\ YLUXV
+20$,5
KRPHRVWDWLFPRGHODVVHVVPHQWRILQVXOLQ UHVLVWDQFH
KV&53
KLJKVHQVLWLYLW\ &UHDFWLYHSURWHLQ
,&
RIWKHLQKLELWLRQ FRQFHQWUDWLRQ
,&'
LQIRUPHG FRQVHQWGRFXPHQW
,&+
,QWHUQDWLRQDO &RQIHUHQFHRQ+DUPRQLVDWLRQ
,'
LGHQWLILFDWLRQ
,'/
LQWHUPHGLDWHGHQVLW\ OLSRSURWHLQ
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$EEUHYLDWLRQ
7HUP
,/
LQWHUOHXNLQ 
,1'
LQYHVWLJDWLRQDO QHZGUXJDSSOLFDWLRQ
,15
LQWHUQDWLRQDO QRUPDOL]HG UDWLR
,3
LQYHVWLJDWLRQDO SURGXFW
,5%
LQVWLWXWLRQDO UHYLHZERDUG
,5&
LQWHUQDO UHYLHZFRPPLWWHH
,57
LQWHUDFWLYHUHVSRQVHWHFKQRORJ\
,8'
LQWUDXWHULQH GHYLFH
,9
LQWUDYHQRXV
,:5
LQWHUDFWLYHZHEUHVSRQVH
.('7$
GLSRWDVVLXP HWK\OHQHGLDPLQHWHWUDDFHWLF DFLG
.+.
NHWRKH[RNLQDVH
.L
LQKLELWRU\ FRQVWDQW
N3D
NLORSDVFDOV
/'/&
ORZGHQVLW\ OLSRSURWHLQ FKROHVWHURO
//1
ORZHUOLPLW RIQRUPDO
/)7
OLYHUIXQFWLRQ WHVW
/6/9
ODVWVXEMHFWODVWYLVLW 
/60
OLYHUVWLIIQHVVPHDVXUH
0&+
PHDQFRUSXVFXODUKHPRJORELQ
0&+&
PHDQFRUSXVFXODUKHPRJORELQ FRQFHQWUDWLRQ
0&9
PHDQFRUSXVFXODUYROXPH
0'5'
PRGLILFDWLRQ RIGLHWLQUHQDOGLVHDVH
0(/'
PRGHORIHQGVWDJHOLYHUGLVHDVH
0050
PL[HGPRGHOUHSHDWHGPHDVXUHV
02$
PHFKDQLVPRIDFWLRQ
05,
PDJQHWLFUHVRQDQFHLPDJLQJ
1$
QRWDSSOLFDEOH
1$)/'
QRQDOFRKROLF IDWW\OLYHU GLVHDVH
1$6+
QRQDOFRKROLF VWHDWRKHSDWLWLV
1'
QRWGHWHUPLQHG
12$(/
QRREVHUYHGDGYHUVHHIIHFWOHYHO
12(/
QRREVHUYHGHIIHFWOHYHO
16$,'
QRQVWHURLGDO DQWLLQIODPPDWRU\
1<+$
1HZ<RUN+HDUW$VVRFLDWLRQ
2$7
RUJDQLFDQLRQWUDQVSRUWHU
2$73
RUJDQLFDQLRQWUDQVSRUWLQJ SRO\SHSWLGH
20,0
2QOLQH 0HQGHOLDQ,QKHULWDQFHLQ0DQ
3&'
SULPDU\FRPSOHWLRQ GDWH
3&6.
SURSURWHLQ FRQYHUWDVHVXEWLOLVLQNH[LQ W\SH
3'
SKDUPDFRG\QDPLFV
3'(
SKRVSKRGLHVWHUDVH
090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


3)
&
)LQDO 3URWRFRO -XQH



3DJH
$EEUHYLDWLRQ
7HUP
3'))
SURWRQGHQVLW\ IDWIUDFWLRQ
3JS
3JO\FRSURWHLQ
3*[
SKDUPDFRJHQRPLFV
3,
SULQFLSDO LQYHVWLJDWRU
3.
SKDUPDFRNLQHWLF
37
SURWKURPELQ WLPH
4'
RQFHGDLO\
5%&
UHGEORRG FHOO
51$
ULERQXFOHLF DFLG
6$(
VHULRXVDGYHUVHHYHQW
6$3
VWDWLVWLFDODQDO\VLVSODQ
6&
VXEFXWDQHRXV
6'
VWDQGDUGGHYLDWLRQ
6(0
VWDQGDUGHUURURIWKHPHDQ
6*27
VHUXPJOXWDPLF R[DORDFHWLFWUDQVDPLQDVH
6*37
VHUXPJOXWDPLF S\UXYLFWUDQVDPLQDVH
623
VWDQGDUGRSHUDWLQJSURFHGXUH
63)
VXQSURWHFWLRQIDFWRU
656'
VLQJOH UHIHUHQFHVDIHW\GRFXPHQW
66,'
VWXG\VSHFLILF VXEMHFWLGHQWLILFDWLRQ QXPEHU
686$5
VXVSHFWHGXQH[SHFWHGVHULRXVDGYHUVHUHDFWLRQ
Wò
WHUPLQDO KDOIOLIH
7'0
7\SH'LDEHWHV0HOOLWXV
7%LOL
WRWDOELOLUXELQ
7($(
WUHDWPHQWHPHUJHQWDGYHUVHHYHQW
7+&
WHWUDK\GURFDQQDELQRO
7PD[
WLPHWRUHDFKPD[LPXP FRQFHQWUDWLRQ
75/3
WULJO\FHULGHULFK OLSRSURWHLQ SDUWLFOHV
7='
WKLD]ROLGLQHGLRQHV
8*7
XULGLQH GLSKRVSKDWHJOXFXURQRV\OWUDQVIHUDVH
8/1
XSSHUOLPLW RIQRUPDO
86
8QLWHG6WDWHV
89
XOWUDYLROHW
9/'/
YHU\ORZGHQVLW\ OLSRSURWHLQ
9&7(
YLEUDWLRQ FRQWUROOHG WUDQVLHQWHODVWRJUDSK\
9VV
YROXPH RIGLVWULEXWLRQ
:%&
ZKLWHEORRG FHOOV

090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)

SAP_001.pdf: 
Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 1 
 
TMF Doc ID: 98.03 
 
 
 
 
 
PROTOCOL C1061003 
 
 
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
3-ARM, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY, 
TOLERABILITY, AND PHARMACODYNAMICS OF 
PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH 
NONALCOHOLIC FATTY LIVER DISEASE 
 
 
 
STATISTICAL ANALYSIS PLAN  
(SAP) 
 
 
Version: 
1 
Date:  
07-NOV-2017 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
7$%/(2)&217(176
/,672)7$%/(6
/,672)),*85(6
9(56,21+,6725<
,1752'8&7,21
6WXG\2EMHFWLYHV
6WXG\'HVLJQ
(1'32,176$1'%$6(/,1(9$5,$%/(6'(),1,7,216$1'
&219(17,216
3ULPDU\(QGSRLQW
6HFRQGDU\(QGSRLQWV

%DVHOLQH9DULDEOHV
6DIHW\(QGSRLQWV
$GYHUVH(YHQWV
/DERUDWRU\'DWD
9LWDOV
(&*V
$1$/<6,66(76
)XOO$QDO\VLV6HW
3HU3URWRFRO$QDO\VLV6HW
6DIHW\$QDO\VLV6HW

*(1(5$/0(7+2'2/2*<$1'&219(17,216
+\SRWKHVHVDQG'HFLVLRQ5XOHV
*HQHUDO0HWKRGV
0HWKRGVWR0DQDJH0LVVLQJ'DWD
$1$/<6(6$1'6800$5,(6
3ULPDU\(QGSRLQW:KROH/LYHU3'))
3ULPDU\$QDO\VLV
6HQVLWLYLW\5REXVWQHVV$QDO\VHV
6XSSOHPHQWDU\$QDO\VLV
CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
6HFRQGDU\(QGSRLQWV


6XEVHW$QDO\VHV
%DVHOLQHDQG2WKHU6XPPDULHVDQG$QDO\VHV
6DIHW\6XPPDULHVDQG$QDO\VHV
$GYHUVH(YHQWV
/DERUDWRU\'DWD
9LWDO6LJQV
(OHFWURFDUGLRJUDP
,17(5,0$1$/<6(6
5()(5(1&(6
$33(1',;

/,672)7$%/(6
7DEOH
6XPPDU\RI0DMRU&KDQJHVLQ6$3$PHQGPHQWV
7DEOH
([SORUDWRU\(QGSRLQWV'HVFULSWLYH6XPPDU\
7DEOH
([SORUDWRU\(QGSRLQWV0RGHOLQJ'HWDLOV
7DEOH
)LJXUHVIRU([SORUDWRU\(QGSRLQWV

/,672)),*85(6
)LJXUH
&6WXG\'HVLJQ
CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
9(56,21+,6725<
7KLV6WDWLVWLFDO $QDO\VLV 3ODQ6$3IRUVWXG\ & LVEDVHGRQWKHSURWRFRO GDWHG
-81 
7DEOH
6XPPDU\ RI0DMRU&KDQJHVLQ6$3$PHQGPHQWV
6$39HUVLRQ
&KDQJH
5DWLRQDOH

1RW$SSOLFDEOH 1RW$SSOLFDEOH

,1752'8&7,21
7KLV6$3SURYLGHVWKHGHWDLOHGPHWKRGRORJ\ IRUVXPPDU\DQGVWDWLVWLFDODQDO\VHVRIWKHGDWD
FROOHFWHGLQVWXG\ & 7KLVGRFXPHQWPD\PRGLI\ WKHSODQVRXWOLQHG LQWKHSURWRFRO
KRZHYHUDQ\PDMRUPRGLILFDWLRQV RIWKHSULPDU\HQGSRLQW GHILQLWLRQ RULWVDQDO\VLVZLOO DOVR
EHUHIOHFWHGLQDSURWRFRO DPHQGPHQW
6WXG\2EMHFWLYHV
3ULPDU\2EMHFWLYH
3ULPDU\(QGSRLQW
7RHYDOXDWHWKHHIIHFWRIGDLO\DGPLQLVWUDWLRQRI
3)RYHUZHHNVRQOLYHUIDWLQDGXOWV
ZLWK1$)/'
3HUFHQWFKDQJHIURPEDVHOLQHLQOLYHUIDWDW:HHNDV
DVVHVVHGE\05,3'))
6HFRQGDU\2EMHFWLYHV
6HFRQGDU\(QGSRLQWV
7RHYDOXDWHWKHVDIHW\DQGWROHUDELOLW\RI
3)DGPLQLVWHUHGGDLO\RYHUZHHNVWR
DGXOWVZLWK1$)/'
$VVHVVPHQWRI7($(VFOLQLFDOODERUDWRU\WHVWVYLWDO
VLJQVDQGOHDG(&*V









































CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'














,QDOOFDVHVEDVHOLQHGHILQHGDVUHVXOWFORVHVWSULRUWRGRVLQJDW9LVLW'D\

6WXG\'HVLJQ
7KLVZLOO EHDUDQGRPL]HG GRXEOHEOLQG VWUDWLILHG SODFHERFRQWUROOHG DUPSODFHERSOXV
DFWLYHGRVHVRI3) SDUDOOHOJURXS VWXG\>UHIHUWR)LJXUH @
)LJXUH &6WXG\'HVLJQ
F/U
(V9)
(7-14 days 
post last 
dose)
Screen 1 
(V1)
Screen 2 
(V2)
MRI-PDFF
Day -14 ± 2
(V3)
Day 28±2
(V7)
Day 40±2
(V8)
MRI-PDFF*
3 
weeks 
Day 1
Randomization
(V5)
Day 14±2
(V6)
PF-06835919/placebo (V5-V8)
F/U
(V9)
(7-14 days 
post last 
dose)
Screen 1 
(V1)
Screen 2
(V2)
MRI-PDFF
Day -14 ± 2
(V3)
Day 28±2
(V7)
Day 40±2
(V8)
MRI-PDFF*
3 
weeks
Day 1
Randomization
(V5)
Day 14±2
(V6)
PF-06835919/placebo (V5-V8)
Phone F/U
(28-35 days 
post last 
dose)
Placebo 
Day -4±2
(V4)
MRI-PDFF
*May occur at V8 or within 24 hours prior to the V8

'HWHUPLQDWLRQ RIHOLJLELOLW\ IRUWKLVVWXG\ZLOO RFFXUYLDDVHTXHQWLDO VWHSSURFHVVVWDUWLQJ
DWWKHILUVWVFUHHQLQJYLVLW6FUHHQ6XEMHFWVLGHQWLILHG WREHHOLJLEOH EDVHGRQ
6FUHHQSURFHGXUHVZLOO SURFHHGWR6FUHHQWRPHDVXUHOLYHUIDWE\PDJQHWLFUHVRQDQFH
LPDJLQJSURWRQ GHQVLW\IDWIUDFWLRQ05,3'))
2QFHFRQILUPHG WREHHOLJLEOH EDVHGRQUHVXOWVRI6FUHHQVXEMHFWVZLOO SURJUHVVWRD5XQLQ
SHULRG9LVLWDWZKLFKWLPHVXEMHFWVUHFHLYHVLQJOHEOLQG SODFHERIRUDSSUR[LPDWHO\
GD\VWRHQVXUHFRPSOLDQFH ZLWKWKHDGPLQLVWUDWLRQ RI,3'XULQJWKH5XQLQ SHULRG
VXEMHFWVZLOO FRPSOHWHDKRXU XULQHFROOHFWLRQ ,QDGGLWLRQ DSSUR[LPDWHO\ GD\VSULRUWR
UDQGRPL]DWLRQ 9LVLWVXEMHFWVZLOO UHSRUWWRWKHLPDJLQJ FHQWHUWRKDYHDEDVHOLQH
05,3'))VFDQSHUIRUPHG$W9LVLW'D\VXEMHFWVZLOO EHUDQGRPL]HG WRUHFHLYHRI
EOLQGHG ,3UHJLPHQVIRUDGXUDWLRQ RIDSSUR[LPDWHO\ ZHHNVLHrGD\V$VHFRQG
KRXU XULQH FROOHFWLRQ ZLOO EHSHUIRUPHGDURXQG9LVLW'D\ZKLFKZLOO UHTXLUHDQ
DGGLWLRQDO YLVLWWRWKHVWXG\VLWH
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
7KLVVWXG\LQFOXGHVDWRWDORIVFKHGXOHGRXWSDWLHQW YLVLWV WRWKHVWXG\VLWHYLVLWVWRWKH
LPDJLQJ FHQWHUDQGDVDIHW\)ROORZXS WHOHSKRQHFRQWDFW7KHWRWDOSDUWLFLSDWLRQ IURP9LVLW
6FUHHQWRWKHRQVLWH)ROORZXS YLVLW 9LVLWZLOO EHXSWRDSSUR[LPDWHO\  ZHHNV
8SWRVXEMHFWVSHUDUPZLOO EHUDQGRPL]HG DWDSSUR[LPDWHO\ VLWHVWRHQVXUHWKDWD
PLQLPXP RIDSSUR[LPDWHO\ VXEMHFWVSHUDUPFRPSOHWHWKHVWXG\7KHDSSUR[LPDWH
UDQGRPL]HG VXEMHFWVDFFRXQWIRUDSURMHFWHGSUHPDWXUHZLWKGUDZDOUDWHRI
(1'32,176$1'%$6(/,1(9$5,$%/(6'(),1,7,216$1'
&219(17,216
3ULPDU\ (QGSRLQW
3HUFHQWFKDQJHIURPEDVHOLQHLQOLYHUIDWDW:HHNDVDVVHVVHGE\05,3'))%DVHOLQHLV
GHILQHGDVWKHUHVXOWFORVHVWSULRUWRGRVLQJDW9LVLW'D\
7KHOLYHUIDWRUWKHZKROH OLYHU 3'))LVFDOFXODWHGIURPWKHSUHGHILQHGLQGLYLGXDO VHJPHQWDO
3'))VODEHOHG 6HJPHQW,,,,,,,9D,9E99,9,,DQG9,,,DVIROORZV
:KROH /LYHU3')) 3'))VIRU6HJPHQW,6HJPHQW,,6HJPHQW,,,6HJPHQW,9D
6HJPHQW,9E6HJPHQW96HJPHQW9,6HJPHQW9,,6HJPHQW9,,,QXPEHURI
VHJPHQWVDVVHVVHG
$PLQLPXP RIQRQPLVVLQJ VHJPHQWVLVQHHGHGLQRUGHUWRFDOFXODWHZKROHOLYHU 3'))
$OOVHJPHQWVDUHHTXDOO\ZHLJKWHG
:KLOHGHULYLQJ WKHSHUFHQWFKDQJHIURPEDVHOLQH WKHVDPHVHJPHQWVDUHWREHXVHGDWERWK
EDVHOLQHDQGSRVWEDVHOLQH WLPHSRLQWVLQWKHFDOFXODWLRQ RIZKROHOLYHU3')))RUH[DPSOH
LIDWEDVHOLQH3'))VIURPDOOVHJPHQWVDUHDYDLODEOH EXW DW:HHNRQO\VHJPHQWVKDYH
QRQPLVVLQJ UHVXOWVZKROHOLYHU3'))ZLOO EHFDOFXODWHGXVLQJWKHPDWFKLQJ LQGLYLGXDO
VHJPHQWDO 3'))VDWERWKEDVHOLQHDQG:HHN
6XSSOHPHQW WRWKHSULPDU\HQGSRLQW WKHSHUFHQWFKDQJHIURPEDVHOLQHLQHDFKRIWKH
VHJPHQWDO3'))VDW:HHNZLOO DOVREHDQDO\VHG%DVHOLQHLVGHILQHGDVWKHUHVXOWFORVHVW
SULRUWRGRVLQJ DW9LVLW'D\
6HFRQGDU\(QGSRLQWV
7KHVHFRQGDU\HQGSRLQWV LQFOXGH WKHVWDQGDUGVDIHW\HQGSRLQWV QDPHO\DGYHUVHHYHQWV
$(VFOLQLFDO ODERUDWRU\ WHVWVYLWDOVLJQVLQFOXGLQJ EORRG SUHVVXUHDQGSXOVHUDWHDQG
OHDGHOHFWURFDUGLRJUDP (&*7KHVHZLOO EHIXUWKHUGHVFULEHGLQ 6HFWLRQ





CCI
C
C
I
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'


 






























CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'










%DVHOLQH9DULDEOHV
%DVHOLQHYDULDEOHVDUHWKRVHFROOHFWHGRQ'D\SULRUWRGRVLQJRUEHIRUH'D\7KH
GHPRJUDSKLF GDWDRIDJHUDFHZHLJKW DQGERG\PDVVLQGH[ZLOO EHVXPPDUL]HG E\VH[DW
ELUWKDQGWUHDWPHQWLQDFFRUGDQFHZLWKWKHVSRQVRUUHSRUWLQJ VWDQGDUGV(WKQLFLW\ ZLOO QRWEH
VXPPDUL]HG 7KHQXPEHUDQGSURSRUWLRQ RIVXEMHFWVHQUROOHG LQHDFKVWXG\VLWHZLOO DOVREH
SUHVHQWHG
,QWKLVVWXG\VXEMHFWVZLOO EHVWUDWLILHGDWUDQGRPL]DWLRQ 9LVLWEDVHGRQWKHSUHVHQFHRU
DEVHQFHRI7\SH'LDEHWHV0HOOLWXV 7'0DQGE\WKH05,3'))OLYHUIDWFDWHJRULHV
REWDLQHGGXULQJ 9LVLW6FUHHQOLVWHG EHORZ
x 6FUHHQLQJOLYHUIDWtDQG
x 6FUHHQLQJOLYHUIDWt
%RWKRIWKHVHVWUDWLILFDWLRQ YDULDEOHVZLOO EHXVHGDVFRYDULDWHVLQWKHHIILFDF\DQDO\VLV)RU
EDVHOLQHGLDEHWLFVWDWXVGDWDZLOO EHREWDLQHGIURPWKHFDVHUHSRUWIRUPV&5)V(YHQ
WKRXJKEDVHOLQHOLYHU IDWZDVXVHGDVDELQDU\YDULDEOHIRUVWUDWLILFDWLRQ SXUSRVHVLWZLOO EH
XVHGDVDFRQWLQXRXV FRYDULDWHLQWKHHIILFDF\DQDO\VLVLQRUGHUWRPD[LPL]H WKHXWLOLW\ RI
LQIRUPDWLRQ %DVHOLQHIUXFWRVHH[FUHWLRQZLOO EHFRQVLGHUHG WREHLQFOXGHG DVDSRWHQWLDO
FRYDULDWH,IWKHUHLVVXEVWDQWLDO LPEDODQFH LQWKHQXPEHURIVXEMHFWVHQUROOHG LQHDFKVLWH
WKHQVWXG\VLWHZLOO EHFRQVLGHUHG WREHLQFOXGHG DVDSRWHQWLDO FRYDULDWH,ILQFOXGHG DVD
FRYDULDWHVLWHVHQUROOLQJ OHVVWKDQVXEMHFWVZLOO EHSRROHG 
6DIHW\(QGSRLQWV
7KHIROORZLQJ GDWDDUHFRQVLGHUHGLQVWDQGDUGVDIHW\VXPPDULHVVHHSURWRFRO IRUFROOHFWLRQ
GD\VDQGOLVWRISDUDPHWHUV
x $(V
x ODERUDWRU\GDWD
x YLWDOVLJQV GDWD
x (&*UHVXOWV
C
C
I
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 9 
 
TMF Doc ID: 98.03 
2.5.1. Adverse Events 
For serious adverse events (SAEs), the reporting period to Pfizer or its designated 
representative begins from the time that the subject provides informed consent, which is 
obtained prior to the subject’s participation in the study, ie, prior to undergoing any 
study-related procedure and/or receiving investigational product, through and including 
28 calendar days after the last administration of the investigational product. 
Similarly,the time period for collecting AEs (“active collection period”) for each subject 
begins from the time the subject provides informed consent.  The AEs occurring following 
start of the double-blind randomized treatment will be counted as treatment emergent.  The 
AEs occurring prior to the double-blind randomized treatment intake but during the 
single-blind placebo administration will be listed and summarized as baseline symptoms. 
The 3-Tier approach will not be used to summarize the AEs due to the small size of the 
study. 
2.5.2. Laboratory Data 
Safety laboratory tests will be performed as described in the protocol. 
To determine if there are any clinically significant laboratory abnormalities, the 
haematological, clinical chemistry (serum) and urinalysis safety tests will be assessed against 
the criteria specified in the sponsor reporting standards.  The assessment will take into 
account whether each subject’s baseline test result is within or outside the laboratory 
reference range for the particular laboratory parameter. 
Baseline is defined as the result closest prior to dosing at Visit 5 (Day 1).  
2.5.3. Vitals  
Seated blood pressure and pulse rate measurements will be taken at time points detailed in 
the Schedule of Activities given in the protocol.  
Baseline is defined as the result closest prior to dosing at Visit 5 (Day 1).  The following 
vital signs endpoints will be determined for each subject: 
 The maximum decrease and increase from baseline over all measurements taken post 
dose for systolic and diastolic blood pressures; 
 The maximum increase and decrease from baseline over all measurements taken post 
dose for pulse rate. 
The maximum increase from baseline will be calculated by first subtracting the baseline 
value from each post dose measurement to give the change from baseline.  The maximum of 
these values over the respective period will then be selected, except in the case where a 
subject does not show an increase.  In such an instance, the minimum decrease should be 
taken.  Similarly, the maximum decrease from baseline will be determined by selecting the 
largest negative value of the changes from baseline.  In cases where a subject does not show 
a decrease, the minimum increase should be taken. 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
(&*V
6LQJOH OHDG(&*VZLOO EHREWDLQHG RQDOOVXEMHFWVDWWLPHVGHWDLOHGLQWKH6FKHGXOHRI
$FWLYLWLHV JLYHQLQWKHSURWRFRO%DVHOLQHLVGHILQHGDVWKHUHVXOWFORVHVWSULRUWRGRVLQJ DW
9LVLW'D\
7KH4747F)KHDUWUDWH456DQG35ZLOO EHUHFRUGHGDWHDFKDVVHVVPHQWWLPH,IQRW
VXSSOLHG 47F)ZLOO EHGHULYHGXVLQJ)ULGHULFLD¶V KHDUWUDWHFRUUHFWLRQIRUPXOD
47F) 4755 
ZKHUH55 +5LI55LVQRWSURYLGHG
7KHPD[LPXP DEVROXWHYDOXHSRVWGRVHDQGWKHPD[LPXP LQFUHDVHIURPEDVHOLQHIRU47F)
KHDUWUDWH35DQG456ZLOO EHGHWHUPLQHGE\VWXG\GD\IRUHDFKVXEMHFW
7KHPD[LPXP LQFUHDVHIURPEDVHOLQHZLOO EHFDOFXODWHGE\ILUVWO\VXEWUDFWLQJ WKHEDVHOLQH
YDOXHIURPHDFKSRVWGRVHPHDVXUHPHQWWRJLYHWKHFKDQJHIURPEDVHOLQH7KHPD[LPXP RI
WKHVHYDOXHVRYHUWKHUHVSHFWLYHSHULRGZLOO WKHQEHVHOHFWHGH[FHSWLQWKHFDVHZKHUHD
VXEMHFWGRHVQRWVKRZDQLQFUHDVH,QVXFKDQLQVWDQFHWKHPLQLPXP GHFUHDVHVKRXOGEH
WDNHQSUHVHUYLQJWKHVLJQRIFKDQJH
$1$/<6,66(76
'DWDIRUDOOVXEMHFWVZLOO EHDVVHVVHGWRGHWHUPLQHLIVXEMHFWVPHHWWKHFULWHULDIRULQFOXVLRQ LQ
HDFKDQDO\VLVSRSXODWLRQ SULRUWRXQEOLQGLQJ DQGUHOHDVLQJWKHGDWDEDVHDQGFODVVLILFDWLRQV
ZLOO EHGRFXPHQWHG SHUVWDQGDUGRSHUDWLQJSURFHGXUHV
)XOO$QDO\VLV6HW
7KH)XOO $QDO\VLV6HW)$6LVGHILQHGDVDOOUDQGRPL]HG VXEMHFWV ZKRUHFHLYHGDWOHDVW
GRVHRIUDQGRPL]HG WUHDWPHQWVXEMHFWVDUHDVVLJQHGWRWKHUDQGRPL]HG WUHDWPHQWUHJDUGOHVV
RIZKDWWUHDWPHQWZDVUHFHLYHG7KLVZRXOGEHWKHSULPDU\ DQDO\VLVSRSXODWLRQ IRUDOO
HIILFDF\DQDO\VHV
3HU3URWRFRO$QDO\VLV6HW
7KLVZLOO QRWEHXVHGLQWKHFXUUHQWVWXG\
6DIHW\$QDO\VLV6HW
$OOVXEMHFWVZKRUHFHLYHDWOHDVWGRVHRILQYHVWLJDWLRQDO SURGXFWSRVWUDQGRPL]DWLRQ LH
VWDUWLQJIURP9ZLOO EHLQFOXGHG LQWKHVDIHW\DQDO\VHVDQGOLVWLQJV $OOVDIHW\HQGSRLQWV
ZLOO EHDQDO\]HGE\WKHWUHDWPHQWWKDWWKHVXEMHFWVDFWXDOO\UHFHLYHIRUWKHPDMRULW\ RIWKH
VWXG\GXUDWLRQ UHJDUGOHVVRIZKLFKWUHDWPHQWJURXSWKH\DUHUDQGRPL]HG $UDQGRPL]HG EXW
QRWWUHDWHGVXEMHFWZLOO EHH[FOXGHGIURPWKHVDIHW\DQDO\VHV$WUHDWHGEXWQRWUDQGRPL]HG
VXEMHFWZLOO EHUHSRUWHGXQGHUWKHWUHDWPHQWDFWXDOO\ UHFHLYHG



CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
*(1(5$/0(7+2'2/2*<$1'&219(17,216
7KHDQDO\VLVZLOO EHSHUIRUPHGDIWHUGDWDEDVHUHOHDVHIROORZLQJ ODVWVXEMHFWODVWYLVLW
+\SRWKHVHVDQG'HFLVLRQ5XOHV
7KHIROORZLQJ QXOO K\SRWKHVHVZLOO EHWHVWHGIRUHDFKHQGSRLQW
 3) PJGLVHTXDOLQ HIIHFWWRSODFHER
 3) PJGLVHTXDOLQHIIHFWWRSODFHER
7KHDOWHUQDWLYHK\SRWKHVHVFRUUHVSRQGLQJ WRWKHDERYHQXOO K\SRWKHVHVZLOO EHWKHIROORZLQJ
VLGHGK\SRWKHVHV
 7KHHIIHFWRI3)  PJGLVGLIIHUHQWIURPWKHHIIHFWRISODFHER
 7KHHIIHFWRI3) PJGLVGLIIHUHQWIURPWKHHIIHFWRISODFHER
7KH7\SH,HUURUUDWHDOHYHOXVHGZLWKWKHGHFLVLRQUXOHIRUWKHSULPDU\REMHFWLYH LV
VLGHG1RDGMXVWPHQW IRUPXOWLSOH FRPSDULVRQV ZLOO EHPDGH
1RLQWHULP DQDO\VLVZLOO EHFRQGXFWHGLQWKLVVWXG\
*HQHUDO0HWKRGV
'HVFULSWLYH6WDWLVWLFV
'HVFULSWLYHVWDWLVWLFVLQFOXGLQJ WKHVDPSOHVL]HPHDQVWDQGDUGGHYLDWLRQ PHGLDQ
PLQLPXP DQGPD[LPXP YDOXHV ZLOO EHSURYLGHG IRUFRQWLQXRXV HQGSRLQWV6RPHPHDVXUHV
ZLOO EHVXPPDUL]HG XVLQJJUDSKLFDO UHSUHVHQWDWLRQVE\WUHDWPHQWDQGYLVLW ZKHUH
DSSURSULDWH


 

 



 






 




CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
$QDO\VLVRI&RYDULDQFH$1&29$
7KH$1&29$PRGHOZLOO EHXVHGZLWKFRQWLQXRXV HQGSRLQWV IRUODQGPDUNVLQJOH WLPH
SRLQW DQDO\VHV7KHPRGHOZLOO LQFOXGH WUHDWPHQWJURXSDVIL[HGHIIHFWVEDVHOLQHYDOXHDQG
EDVHOLQHGLDEHWHVVWDWXVDVDFRYDULDWH%DVHOLQHIUXFWRVHH[FUHWLRQDQGLWVLQWHUDFWLRQ ZLWK
WUHDWPHQWZLOO EHLQFOXGHG DVWKHDGGLWLRQDO FRYDULDWHVIRUWKHDQDO\VLVRISULPDU\ HQGSRLQW
RQO\,IWKHUHLVVXEVWDQWLDO LPEDODQFHLQWKHQXPEHURIVXEMHFWVHQUROOHG LQHDFKVLWHWKHQ
VWXG\VLWHDQGWKHLQWHUDFWLRQ RIVWXG\VLWHZLWKWUHDWPHQWZLOO EHFRQVLGHUHGWREHLQFOXGHG DV
SRWHQWLDO FRYDULDWHVIRUWKHDQDO\VLVRISULPDU\ HQGSRLQW RQO\,ILQFOXGHG DVDFRYDULDWH
VLWHVHQUROOLQJ OHVVWKDQVXEMHFWVZLOO EHSRROHG7KH QXPEHURIFRYDULDWHVPD\EHUHGXFHG
WRLPSURYH PRGHOILW(VWLPDWHVRIWUHDWPHQWHIIHFWVZLOOEHDVVHVVHGXVLQJ /60VDQG&,V
(VWLPDWHVRIWKHPHDQGLIIHUHQFHVEHWZHHQHDFKDFWLYHGRVHDQGSODFHERDW:HHNDQGWKH
FRUUHVSRQGLQJ &,ZLOO EHREWDLQHGIURPWKHPRGHO%RWKFRPSDULVRQV RI
3)GRVHVZLWKWKHSODFHERZLOO EHSHUIRUPHG DWD7\SH,HUURUUDWHRIVLGHG 
,IWKHUHDUHPDMRUGHYLDWLRQV IURPWKHVWDWLVWLFDODVVXPSWLRQV XQGHUO\LQJ WKLVPRGHOWKHQ
DOWHUQDWLYHWUDQVIRUPDWLRQV HJORJRUQRQSDUDPHWULFDQDO\VHVPD\EHSUHVHQWHG
-XVWLILFDWLRQ IRUDQ\DOWHUQDWLYHWRWKHSODQQHGDQDO\VLV ZLOO EHJLYHQLQWKHVWXG\UHSRUW
1RQ3DUDPHWULF$QDO\VLV
,IWKHGDWDKDYHPDQ\RXWOLHUVHYHQDIWHUWKHORJWUDQVIRUPDWLRQ WKHIROORZLQJ QRQSDUDPHWULF
DQDO\VLVZLOO EHSHUIRUPHGLQVWHDG RIWKHOLQHDUPRGHO$QRXWOLHUZLOO EHGHILQHGDVDQ\
GDWDSRLQW IDOOLQJ RXWVLGH RI[VWDQGDUGGHYLDWLRQV WKHPHGLDQ $GGLWLRQDO HYDOXDWLYH
VWDWLVWLFVZLOO EHFRQGXFWHGWRH[SORUHWKHQDWXUHRIWKHRXWOLHUVLQRUGHUWRGHWHUPLQHWKH
DSSURSULDWHQHVVRIDSDUDPHWULFDQDO\VLV 
)RUJURXSPHGLDQV &,VZLOO EHSUHVHQWHG,QDGGLWLRQ WKH&,VZLOO DOVREH
SUHVHQWHGIRUGLIIHUHQFHVLQJURXSPHGLDQVIURPSODFHERJURXSPHGLDQ7KHPHWKRGRI
0F*LOO 7XNH\DQG/DUVRQZLOO EHHPSOR\HG WRFDOFXODWHWKHFRQILGHQFHLQWHUYDO IRUWKH
GLIIHUHQFHLQWUHDWPHQWJURXSPHGLDQV 





0HWKRGVWR0DQDJH0LVVLQJ'DWD

)RUWKH
DQDO\VLVRIVDIHW\HQGSRLQWV WKHVSRQVRUGDWDVWDQGDUGUXOHVIRULPSXWDWLRQ ZLOO EHDSSOLHG 
,QFDVHRIELRPDUNHUV LIWKHFRQFHQWUDWLRQVDUHDERYHWKHOLPLWV RITXDQWLILFDWLRQ VXFKYDOXHV
ZLOO EHWUXQFDWHGDWWKHOLPLW RITXDQWLILFDWLRQ LQDOOVXPPDU\WDEOHV,IWKHFRQFHQWUDWLRQV DUH
EHORZWKHOLPLWV RITXDQWLILFDWLRQ VXFKYDOXHVZLOO EHLPSXWHG E\//4ZKHUH//4LVWKH
ORZHUOLPLW RITXDQWLILFDWLRQ +RZHYHULQOLVWLQJV WKH\ZLOO DSSHDUDVUHSRUWHG
CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'







 







1RWHWKDWVXPPDU\ VWDWLVWLFVZLOO QRWEHSUHVHQWHGDWDSDUWLFXODUWLPHSRLQWLIPRUHWKDQ
RIWKHGDWDDUHPLVVLQJ
$1$/<6(6$1'6800$5,(6
3ULPDU\ (QGSRLQW:KROH/LYHU3'))
3ULPDU\ $QDO\VLV
x $QDO\VLV HQGSRLQW :KROHOLYHU 3'))
x $QDO\VLVWLPHSRLQWV :HHN
x $QDO\VLVSRSXODWLRQ )XOO $QDO\VLV VHW
x $QDO\VLVPHWKRGRORJ\ &KDQJHIURPEDVHOLQHWR:HHNLQZKROHOLYHU 3'))ZLOO
EHDQDO\]HGXVLQJ WKH$1&29$7KHPRGHOZLOO LQFOXGH EDVHOLQH ZKROHOLYHU 3'))
GLDEHWHVVWDWXV%DVHOLQHIUXFWRVHH[FUHWLRQDQGLWVLQWHUDFWLRQ ZLWKWUHDWPHQWZLOO EH
FRQVLGHUHGWREHLQFOXGHG
5HSRUWLQJ5HVXOWV
x 5DZGDWD7KHVDPSOHVL]HPHDQVWDQGDUGGHYLDWLRQ PHGLDQ PLQLPXP DQG
PD[LPXP DWEDVHOLQHDQG:HHNYLVLW ZLOO EHSUHVHQWHGIRUHDFKWUHDWPHQWDUP
x &KDQJHIURPEDVHOLQH&%/7KHVDPSOHVL]HPHDQVWDQGDUGGHYLDWLRQ
PHGLDQ PLQLPXP DQGPD[LPXP ZLOO EHSUHVHQWHGIRUHDFKWUHDWPHQWDUPDW:HHN
7KH/60V&,IRUWKH/60VGLIIHUHQFHEHWZHHQWKH/60RIHDFKWUHDWPHQW
JURXSDQGWKHSODFHERJURXSDQGWKHFRUUHVSRQGLQJ &,DQGWKHVLGHGSYDOXHV
ZLOO EHSUHVHQWHGIRUZKROHOLYHU3'))RQO\
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 14 
 
TMF Doc ID: 98.03 
Figures 
 Whole liver PDFF - A line plot of the model-derived least square means for all 
treatment groups including the placebo group with 90% CI will be provided for 
Week 6 with dose on the X-axis; 
 Whole liver PDFF - Box and whisker plots for individual percent change from 
baseline versus treatment will be presented and overlaid with arithmetic means.  
5.1.2. Sensitivity/Robustness Analyses  
 Analysis endpoint: Whole liver PDFF; 
 Analysis time points: Week 6; 
 Analysis population: Full Analysis set; 
 Analysis methodology: Natural log-transformed individual relative change (RC) from 
baseline to Week 6 in whole liver PDFF will be analyzed using the ANCOVA.  
Log-transformed baseline will be the covariate.  The model will include natural 
log-transformed baseline whole liver PDFF, diabetes status.  Natural log-transformed 
baseline fructose excretion and its interaction with treatment will be considered to be 
included. 
Reporting Results: 
The LSMs and their 90% CI will be exponentiated to provide estimates of the RC which 
will be converted to percent change as follows: 
Percent change = 100* (RC - 1). 
The LSMs of the percent change from baseline with the 90%CIs for each treatment group 
and the LSMs of the percent change from placebo with the 90% CIs for each of the 
PF-06835919 groups and the 2-sided p-values will be presented. 
5.1.3. Supplementary Analysis 
 Analysis endpoint: 9 Segmental PDFFs; 
 Analysis time points: Week 6; 
 Analysis population: Full Analysis set; 
 Analysis methodology: Descriptive statistics. 
Reporting Results: 
 Raw data:  For each of the 9 segmental PDFFs the sample size, mean, standard 
deviation, median, minimum and maximum at baseline and Week 6 visit will be 
presented for each treatment arm; 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'
x &KDQJHIURPEDVHOLQH&%/)RUHDFKRIWKHVHJPHQWDO3'))VWKHVDPSOH
VL]HPHDQVWDQGDUGGHYLDWLRQ PHGLDQPLQLPXP DQGPD[LPXP ZLOO EHSUHVHQWHGIRU
HDFKWUHDWPHQWDUPDW:HHN
)LJXUHV
x )RUHDFKVHJPHQWER[DQGZKLVNHUSORWVIRULQGLYLGXDO SHUFHQWFKDQJHIURPEDVHOLQH
3'))YHUVXVWUHDWPHQWZLOO EHSUHVHQWHGDQGRYHUODLG ZLWKDULWKPHWLF PHDQV7KLV
ZLOO EHDSDQHOSORWZLWKSDQHOVLQILJXUH ZKHUHWKHSDQHOVFRUUHVSRQGWRWKH
VHJPHQWV
6HFRQGDU\(QGSRLQWV
7KHDQDO\VHVRIVWDQGDUGVDIHW\HQGSRLQWV ZLOO EHGHVFULEHGLQ 6HFWLRQ






CCI
CCI
CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'





CCI
CCI
CCI
CCI
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


3URWRFRO&3)6WDWLVWLFDO$QDO\VLV3ODQ


3DJH

70)'RF,'





 







6XEVHW$QDO\VHV
,IWKHDQDO\VHVZLWKEDVHOLQHGLDEHWHVVWDWXVLQGLFDWHVLJQLILFDQW FRYDULDWHHIIHFWVXEVHW
DQDO\VHVE\EDVHOLQHGLDEHWHVVWDWXVPD\EHFRQGXFWHG,IDQ\VLWHHQUROOV RUPRUHRIWKH
WRWDOQXPEHURIVXEMHFWVLQWKHVWXG\VLWHVSHFLILFDQDO\VLVPD\EHFRQGXFWHG
%DVHOLQHDQG2WKHU6XPPDULHVDQG$QDO\VHV
$EUHDNGRZQRIGHPRJUDSKLF GDWDZLOO EHSURYLGHG IRUDJHUDFHZHLJKW DQGERG\PDVV
LQGH[ (DFKZLOO EHVXPPDUL]HG E\VH[DWELUWK DQGWUHDWPHQWLQDFFRUGDQFHZLWKWKHVSRQVRU
UHSRUWLQJ VWDQGDUGV%DVHOLQHVXPPDU\RISDUDPHWHUVRIPHWDEROLF V\QGURPHQDPHO\
WULJO\FHULGHV +'/&ZDLVWFLUFXPIHUHQFHV\VWROLF DQGGLDVWROLF EORRG SUHVVXUHV$67$/7
DQGZKROHOLYHU3'))ZLOO EHSUHVHQWHGIRUHDFKWUHDWPHQWJURXSDQGRYHUDOO %DVHOLQH
VXPPDU\RIVWUDWLILFDWLRQ IDFWRUVQDPHO\GLDEHWHVVWDWXVSUHVHQFHRUDEVHQFH05,3'))
FDWHJRULHVRUtDQGEDVHOLQHIUXFWRVHH[FUHWLRQZLOO DOVREHSURYLGHG 7KH
QXPEHUDQGSURSRUWLRQ RIVXEMHFWVHQUROOHG LQHDFKVWXG\VLWHZLOO DOVREHSUHVHQWHG
6XEMHFWHYDOXDWLRQ JURXSVZLOO VKRZHQGRIVWXG\VXEMHFWGLVSRVLWLRQ DQGZLOO VKRZZKLFK
VXEMHFWVZHUHDQDO\]HGIRUSKDUPDFRG\QDPLF )$6DQGSKDUPDFRNLQHWLFV 3.DVZHOODV
IRUVDIHW\DGYHUVHHYHQWVDQGODERUDWRU\GDWD)UHTXHQF\FRXQWVZLOO EHVXSSOLHG IRU
VXEMHFWGLVFRQWLQXDWLRQV E\WUHDWPHQW,IWKHSURSRUWLRQ RIGLVFRQWLQXDWLRQV LVPRUHWKDQ
WKHQWDEOHZLWKVXEMHFWGLVSRVLWLRQ E\YLVLWZLOO EHSURGXFHG'DWDZLOO EHUHSRUWHGLQ
DFFRUGDQFHZLWKWKHVSRQVRUUHSRUWLQJ VWDQGDUGV
6DIHW\6XPPDULHVDQG$QDO\VHV
$VHWRIVXPPDU\WDEOHVVSOLWE\WUHDWPHQWZLOO EHSURGXFHGWRHYDOXDWHDQ\SRWHQWLDO ULVN
DVVRFLDWHGZLWKWKHVDIHW\DQGWROHUDWLRQ RIDGPLQLVWHULQJ 3) 
1RIRUPDODQDO\VHVDUHSODQQHG IRUVDIHW\GDWD7KHVDIHW\HQGSRLQWV GHWDLOHG LQ
6HFWLRQ ZLOO EHOLVWHGDQGVXPPDUL]HG LQDFFRUGDQFHZLWKVSRQVRUUHSRUWLQJ VWDQGDUGV
ZKHUHWKHUHVXOWLQJ GDWDSUHVHQWDWLRQVZLOO FRQVLVWRIVXEMHFWVIURPWKHVDIHW\DQDO\VLVVHWV
CCI
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 18 
 
TMF Doc ID: 98.03 
Any untoward findings identified on physical examinations conducted during the active 
collection period will be captured as AEs, if those findings meet the definition of an AE.  
Data collected at screening that are used for inclusion/exclusion criteria, such as laboratory 
data, ECGs, and vital signs, will be considered source data, and will not be required to be 
reported, unless otherwise noted.  
5.6.1. Adverse Events 
Adverse events will be summarized by treatment and in accordance with current Pfizer data 
standards.  The AEs will be sorted alphabetically within a system organ class.  Summary 
tables will be provided separately for TEAEs and baseline symptoms. 
The 3-Tier approach will not be used to summarize the AEs due to the small sample size. 
5.6.2. Laboratory Data 
All planned, quantitative, standard safety laboratory data presented in Table 6 of the protocol 
and non-standard safety laboratory data that are not reported independently will be listed and 
summarized at each planned collection time point by treatment in accordance with the 
sponsor reporting standards as applicable.  Summary tables will present the number of 
observations, median, minimum and maximum.  Baseline is as defined in Section 2.5.2. 
5.6.3. Vital Signs 
Absolute values and changes from baseline in supine systolic and diastolic blood pressure 
and pulse rate will be summarized by treatment and time postdose, according to sponsor 
reporting standards.  Tables will be paged by parameter.  Baseline is as defined in  
Section 2.5.3. 
Mean changes from baseline for systolic and diastolic blood pressure and pulse rate will be 
plotted against time post doses.  On each plot there will be 1 line for each treatment, all 
treatments on the same plot including the placebo.  Corresponding individual plots of 
changes from baseline will also be produced for each treatment. 
For baseline subtracted seated systolic and diastolic blood pressure and pulse rate, the 
differences between each dose and placebo (dose – placebo) will be summarized (N, mean, 
90% CI) and plotted (mean, 90% CI) for each dose and day.  
Maximum absolute values and maximum changes from baseline for vital signs, over all 
measurements taken post dose will also be tabulated by treatment using categories as defined 
in the Appendix.  Numbers and percentages of subjects meeting the categorical criteria will 
be provided.  All planned and unplanned post dose time points will be counted in these 
categorical summaries.  All values meeting the criteria of potential clinical concern will be 
listed. 
Maximum decrease and increase from baseline for seated systolic and diastolic blood 
pressures, and maximum increase from baseline for seated pulse rate will be summarized by 
treatment, according to sponsor reporting standards. 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 19 
 
TMF Doc ID: 98.03 
Changes from baseline in vital signs will also be plotted separately against drug 
concentrations for each time point of collection (Weeks 2, 4 and 6).  These will be scatter 
plots for all observations where vital signs and drug concentration are recorded.  Placebo data 
will also be included (with drug concentration set to zero).  Different symbols will be used 
for each treatment. 
5.6.4. Electrocardiogram 
Absolute values and changes from baseline in QT, heart rate, QTcF, PR, RR and QRS will be 
summarized by treatment and day using sponsor reporting standards.  Tables will be paged 
by parameter.  Baseline is as defined in Section 2.5.4. 
Mean changes from baseline in QT, heart rate and QTcF will be plotted against time 
postdose.  On each plot there will be 1 line for each treatment, all treatments on the same plot 
including the placebo.  Corresponding individual plots of changes from baseline will also be 
produced for each treatment. 
In addition for baseline subtracted QT, heart rate and QTcF, the differences between each 
dose and placebo (dose – placebo) will be summarized (N, mean, 90% CI) and plotted 
(mean) for each dose and day (Weeks 2, 4, 6 and follow-up). 
Changes from baseline in QTcF will also be plotted separately against drug concentrations 
for each time point of collection (Weeks 2, 4 and 6).  These will be scatter plots for all 
observations where QTcF and drug concentration are recorded.  Placebo data will also be 
included (with drug concentration set to zero).  Different symbols will be used for each 
treatment. 
ECG endpoints and changes from baseline (QTcF, PR and QRS) will also be summarized 
descriptively by treatment using categories as defined in the Appendix (for QTc these 
correspond to ICH E14).  Numbers and percentages of subjects meeting the categorical 
criteria will be provided.  All planned and unplanned postdose timepoints will be counted in 
these categorical summaries.  All values meeting the criteria of potential clinical concern will 
be listed. 
Maximum absolute value (post dose) and the maximum increase from baseline for QTcF, PR 
and QRS will be summarized by treatment according to sponsor reporting standards.  
Listings of subjects with any single post dose value 500 msec will also be produced for 
QTcF.  
6. INTERIM ANALYSES 
No interim analysis will be conducted in this study. 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 20 
 
TMF Doc ID: 98.03 
7. REFERENCES  
1. 
McGill, R., John W. Tukey and W. A. Larsen. 1978. "Variations of Box Plots." 
American Statistician 32:12-16 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 21 
 
TMF Doc ID: 98.03 
8. APPENDIX 
Categorical Classes for ECG and Vital Signs  
Categories for QTcF 
QTcF (ms) 
450≤ max. <480 
480≤ max.<500 
max. ≥500 
QTcF (ms) 
increase from 
baseline 
30≤ max. <60 
max. ≥60 
 
 
Categories for PR and QRS 
PR (ms) 
max. ≥300 
 
PR (ms) increase 
from baseline 
Baseline 
>200 and max. 
≥25% increase 
Baseline ≤200 and 
max. ≥50% 
increase 
QRS (ms) 
max. ≥140 
 
QRS (ms) 
increase from 
baseline 
≥50% increase 
 
 
Categories for Vital Signs 
Systolic BP (mm Hg) 
min. <90 
 
Systolic BP (mm Hg) 
change from baseline 
max. decrease ≥30 
max. increase ≥30 
Diastolic BP (mm Hg) 
min. <50 
 
Diastolic BP (mm Hg) 
change from baseline 
max. decrease ≥20 
max. increase ≥20 
Seated pulse rate (bpm) 
min. <40 
max. >120 
 
 Measurements that fulfill these criteria are to be listed in the report. 
 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)