Safety and Effectiveness Evaluation of the Peregrine Drivable ENT Scope for Office Endoscopy of the Paranasal Sinuses in Patients Who Underwent ESS
Phase: NA
Conditions: Sinus Problem
Sponsor: Emory University


170HGLFDO&RQILGHQWLDO

3DJHRI


&OLQLFDO3URWRFRO

9HUVLRQ1XPEHU

9HUVLRQ'DWH
1RYHPEHU
$PHQGPHQW1R

3URWRFRO1XPEHU
3*
3URWRFRO7LWOH
6DIHW\DQG(IIHFWLYHQHVV(YDOXDWLRQRIWKH3HUHJULQH'ULYDEOH
(176FRSHIRU2IILFH(QGRVFRS\RIWKH3DUDQDVDO6LQXVHVLQ
3DWLHQWVZKRXQGHUZHQW(66
1&71XPEHU
1&7
$SSURYDOV
6LWH
6SRQVRU

BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB
3ULQFLSDO,QYHVWLJDWRU'DWH
6LJQDWXUH

BBBBBBBBBBBBBBBBBBBBBBBBBBBBBB
(KXG%HQGRU\'DWH
&(2
170(',&$/



170HGLFDO&RQILGHQWLDO

3DJHRI


$6WXG\WR(YDOXDWHWKH6DIHW\DQG(IIHFWLYHQHVV(YDOXDWLRQRIWKH3HUHJULQH'ULYDEOH(17
6FRSHIRU2IILFH(QGRVFRS\RIWKH3DUDQDVDO6LQXVHVLQ3DWLHQWVZKRXQGHUZHQW(66


7KH,QGLFDWLRQVIRU8VHIRUWKHLQYHVWLJDWLRQDOVWXG\GHYLFHVDUH±
 7KH3HUHJULQHHQGRVFRS\V\VWHPLVLQWHQGHGWRYLVXDOL]HWKHLQWHUQDOFDYLWLHVRIWKHHDUDLUZD\V
QRVHDQGVLQXVFDYLWLHVGXULQJGLDJQRVWLFDQGWKHUDSHXWLFHQGRVFRSHSURFHGXUHV

3URWRFRO1XPEHU
3*
'DWH
1RYHPEHU


170HGLFDO
+DPHODFKD6W32%
5RVK+D¶D\LQ
,VUDHO


170HGLFDO&RQILGHQWLDO

3DJHRI


7DEOHRI&RQWHQW

/,672)$%%5(9,$7,216 

6<1236,6 

%$&.*5281' 
 
1DVDO(QGRVFRS\ 
 
7KH3HUHJULQH'ULYDEOH(176FRSH 
 
&OLQLFDO([SHULHQFHZLWK170HGLFDO¶V(QGRVFRS\V\VWHP(UURU%RRNPDUNQRWGHILQHG 
(UURU%RRNPDUNQRWGHILQHG 

2%-(&7,9(6 
 
6DIHW\DVVHVVPHQW 
 
3HUIRUPDQFHDVVHVVPHQW 
 
6WXG\(QG3RLQWV 

'(6&5,37,21 2)3$7,(173238/$7,21 
 
3DWLHQW6HOHFWLRQ 
 
6XEMHFW(QUROOPHQW 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 

,19(67,*$7,213/$1 
 
6WXG\'HVLJQ 
 
6WXG\3URFHGXUHV 
 
0HWKRGVDQG7LPLQJIRUDVVHVVPHQWV 

67$7,67,&$/&216,'(5$7,216$1'6$03/(6,=( 
6WDWLVWLFDO&RQVLGHUDWLRQV 
6DPSOH6L]H 

5,6.$1$/<6,6 
 
3RWHQWLDOULVNV±3HUHJULQH 
 
'HILQLWLRQVRI$GYHUVH'HYLFH(YHQWVDQG$GYHUVH(YHQWV 
 
'HILQLWLRQVRI6HULRXV$GYHUVH'HYLFH(IIHFWVDQGGHYLFHGHILFLHQFLHV 
 
8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW86$'( 
 
$GYHUVH(IIHFWVDQG3UHFDXWLRQV 
 
$GYHUVH(YHQW5HSRUWLQJ 

'$7$0$1$*(0(17 


170HGLFDO&RQILGHQWLDO

3DJHRI



021,725,1*3/$1 

,19(67,*$7255(63216,%,/,7,(6 

$0(1'0(176727+(35272&2/ 

'(9,$7,21)5207+(678'<3/$1 

'(9,&($&&2817$%,/,7< 

98/1(5$%/(3238/$7,21 

68%-(&7&21),'(17,$/,7< 

68%-(&7:,7+'5$:$/25',6&217,18$7,21 

6863(16,212535(0$785(7(50,1$7,212)7+(678'< 

38%/,&$7,2132/,&< 

5()5(1&(6 

$33(1',&(6(UURU%RRNPDUNQRWGHILQHG 


170HGLFDO&RQILGHQWLDO

3DJHRI



/,672)$%%5(9,$7,216

$(
$GYHUVH(YHQW
&5)
&DVH5HSRUW)RUP
&56
&KURQLF5KLQRVLQXVLWLV
&9
&XUULFXOXP9LWDH
(&
(WKLF&RPPLWWHH
(17
(DU1RVHDQG7KURDW
(66
(QGRVFRSLF6LQXV6XUJHU\
)(66
)XQFWLRQDO(QGRVFRSLF6LQXV6XUJHU\
,'
,GHQWLILFDWLRQ
,5%
,QVWLWXWLRQDO5HYLHZ%RDUG
56
5KLQRVLQXVLWLV
6$(
6HULRXV$GYHUVH(YHQW
623
6WDQGDUG2SHUDWLQJ3URFHGXUHV


170HGLFDO&RQILGHQWLDO

3DJHRI



6<1236,6
3URWRFRO
1XPEHU
3*
3URWRFRO7LWOH
6DIHW\DQG(IIHFWLYHQHVV(YDOXDWLRQRIWKH3HUHJULQH70'ULYDEOH(176FRSHIRU
2IILFH(QGRVFRS\RIWKH3DUDQDVDO6LQXVHVLQ3DWLHQWVZKRXQGHUZHQW(66
3DUWLFLSDWLQJ
&HQWHUV
(PRU\8QLYHUVLW\$WODQWD*$
&OLQLFDO3KDVH
2SHQVLQJOHFHQWHUSURVSHFWLYH
,QYHVWLJDWLRQDO
6WXG\'HYLFH
3HUHJULQH70'ULYDEOH(176FRSHE\170HGLFDO
6WXG\
3URFHGXUHV

8SWR3DWLHQWVRXWRIZKLFKDUHDWOHDVWVDPSOHVSHUHDFKRIWKHIURQWDO
PD[LOODU\DQGVSKHQRLGVLQXVHVZKRKDYHKDGSULRU(66DQGDUHVFKHGXOHGIRU
QDVDOHQGRVFRS\LQWKHRIILFHDVSDUWRIDURXWLQHSRVWRSHUDWLYHRIILFHYLVLWRUGXHWR
UHFXUUHQFHRIV\PSWRPVZLOOEHHYDOXDWHGZLWK3HUHJULQH(QGRVFRSH7KHSDWLHQWV
ZLOODWWHQGWKHIROORZLQJYLVLWV

 9LVLW6FUHHQLQJDQG(QUROOPHQW±DVSDUWRIDUHJXODURIILFH YLVLW
 9LVLW6LQRQDVDOHQGRVFRS\±HYDOXDWLRQZLWK3HUHJULQHDQGVWDQGDUG
HQGRVFRSHV

9LVLWVDQGFDQEHFRPELQHGLQWRDVLQJOHYLVLW
6WXG\
3RSXODWLRQ
3DWLHQWVZKRKDYHKDGSULRU(66
6WXG\3XUSRVH
7RDVVHVVWKHVDIHW\DQGHIIHFWLYHQHVVRI3HUHJULQHHQGRVFRSHLQSDWLHQWVLQWKH
RIILFHVHWWLQJLQWHUPVRIDFFHVVLQWRDQGYLVXDOL]DWLRQRIWKHSDUDQDVDOVLQXV
DQDWRP\LPDJHTXDOLW\SDWLHQWWROHUDELOLW\DQGFOLQLFDOXWLOLW\
6WXG\(QGSRLQWV
3ULPDU\±3HUIRUPDQFHDQG6DIHW\(QGSRLQWV
x
7RFRPSDUHYLVXDOL]DWLRQVXFFHVVUDWHVRIWKHSDUDQDVDOVLQXVDQDWRP\E\
3HUHJULQHDQGE\DVWDQGDUGHQGRVFRSHXVHGLQWKHRIILFHVHWWLQJ
x
'HYLFHUHODWHGDGYHUVHHYHQWV
6HFRQGDU\±3HUIRUPDQFH(QGSRLQWV
x
7RDVVHVVWKHDGHTXDF\RIWKHLPDJHTXDOLW\RI3HUHJULQHIRUHQGRVFRS\
SURFHGXUHVLQWKHRIILFH
x
7RHYDOXDWHSDWLHQWWROHUDELOLW\DQGSDLQ
x
7RHYDOXDWHWKHLPSDFWRIH[WHQGHGYLVXDOL]DWLRQE\3HUHJULQHRQFOLQLFDO
ZRUNIORZ


170HGLFDO&RQILGHQWLDO

3DJHRI


6WXG\0HWKRGV
RI$SSUDLVDO

0HWKRGV
'XULQJWKHVWXG\WKHVXEMHFWVZLOOEHHYDOXDWHGZLWK
D 0DQGDWRU\±3HUHJULQH(QGRVFRSHWKHVWXG\GHYLFH
E0DQGDWRU\±$6WDQGDUGPPHQGRVFRSH
F 2SWLRQDO±$6WDQGDUGPPHQGRVFRSH
G2SWLRQDO±$VWDQGDUG)OH[LEOH(QGRVFRSH

6DIHW\DVVHVVPHQW
6DIHW\DVVHVVPHQWZLOOEHEDVHGXSRQPRQLWRULQJWKH$GYHUVHGHYLFHHYHQWVZKLFK
ZLOOEHFROOHFWHGWKURXJKRXWWKHSURFHGXUHVLQZKLFK3HUHJULQHZDVXVHG

3HUIRUPDQFHDVVHVVPHQW
x (YDOXDWLRQRIDELOLW\RI3HUHJULQHDQGWKHFRPSDULVRQHQGRVFRSHDVWDQGDUG
HQGRVFRSHWRDFFHVVDQGYLVXDOL]HVLQXVDQDWRP\1RRIVXFFHVVHV
GLYLGHGE\1RRIDWWHPSWV
x $QDWRPLFODQGPDUNV±0D[LOODU\RVWLXPDQWHULRUZDOOODWHUDODVSHFW
IORRU)URQWDORVWLXPSRVWHULRUZDOODQWHULRUZDOOODWHUDOUHFHVV
6SKHQRLGRVWLXPVHOODIORRUODWHUDOUHFHVV
x 9LVXDOL]DWLRQVXFFHVVUDWHVZLOOEHFRQILUPHGE\GLUHFWYLVXDOL]DWLRQ
x /HYHORISULRUUHVHFWLRQZLOOEHUHFRUGHG±DQWHULRURUSRVWHULRU
HWKPRLGHFWRP\GUDI,,DGUDI,,EXQFLQHFWRP\DQWURVWRP\
PD[LOOHFWRP\VSKHQRLGRWRP\GLODWLRQ
x ,PDJHTXDOLW\±ZLOOEHDVVHVVHGWKURXJKD\HVQRVWDWHPHQWUHJDUGLQJ
DGHTXDF\RI3HUHJULQHLPDJHTXDOLW\IRURIILFHHQGRVFRS\SURFHGXUHVLQ
FRPSDULVRQWRWKHVWDQGDUGHQGRVFRSH
x 3DWLHQWSDLQDQGWROHUDELOLW\ZLOOEHDVVHVVHGWKURXJKYDOLGDWHG9$6IRUERWK
3HUHJULQHDQGWKHFRPSDULVRQHQGRVFRSH
x ,PSDFWRI3HUHJULQH
VH[WHQGHGYLVXDOL]DWLRQFDSDELOLW\RQFOLQLFDOZRUNIORZ
ZLOOEHHYDOXDWHGWKURXJKDVHULHVRITXHVWLRQVUHJDUGLQJLGHQWLILFDWLRQRI
SDWKRORJ\HYDOXDWLRQRIPXFRVDFKDQJHLQPHGLFDOPDQDJHPHQWQHHGIRU
DGGLWLRQDO&7VFDQLQGLFDWLRQIRUUHYLVLRQVXUJHU\HWF
x 3HUHJULQHHDVHRIXVHZLOOEHHYDOXDWHGWKURXJKDXVHUTXHVWLRQQDLUH
x ,UULJDWLRQWKURXJK3HUHJULQHZRUNLQJFKDQQHOZLOOEHGRFXPHQWHG
SHUIRUPHGQRWSHUIRUPHGZKHQSHUIRUPHG
,QFOXVLRQ
([FOXVLRQ
&ULWHULD
,QFOXVLRQ&ULWHULD
 $PDOHRUIHPDOHSDWLHQWZKRKDVKDGSULRU(66DQGZKRLVLQGLFDWHGIRURIILFH
HQGRVFRS\E\WKH(17VSHFLDOLVW
 3DWLHQWDJHDGXOW!\HDUVROG
 $SDWLHQWZKRLVDEOHWRXQGHUVWDQGWKHUHTXLUHPHQWVRIWKHVWXG\LVZLOOLQJWR
FRPSO\ZLWKLWVLQVWUXFWLRQVDQGVFKHGXOHVDQGDJUHHVWRVLJQWKHLQIRUPHG
FRQVHQW

([FOXVLRQ&ULWHULD


170HGLFDO&RQILGHQWLDO

3DJHRI


 $Q\PHGLFDOGLVRUGHUZKLFKLQWKHLQYHVWLJDWRU¶VMXGJPHQWFRQWUDLQGLFDWHVWKH
SDWLHQW
VSDUWLFLSDWLRQ
 3UHJQDQF\

6WXG\'XUDWLRQ
3HU3DWLHQWXSWRPRQWK
$WRWDORIPRQWKVWRUHFUXLWDQGWUHDWXSSDWLHQWV
6DPSOH6L]H
&DOFXODWLRQV
7KHSHUIRUPDQFH HQGSRLQW RI WKH VWXG\ ZLOO EH WR GHPRQVWUDWH WKDWWKH 3HUHJULQH
(QGRVFRSH ZLOO SHUIRUP FRPSDUDEOH WR RU EHWWHU WKDQ D 6WDQGDUG  PP
(QGRVFRSHZKHUHDGLIIHUHQFHRIRUPRUHEHWZHHQYLVXDOL]DWLRQVXFFHVVUDWHV
ZLOOEHFRQVLGHUHGWREHVWDWLVWLFDOO\VLJQLILFDQW3HUSURWRFRODVXEJURXSDQDO\VLV
RIHDFKRIWKHGLIIHUHQWVLQXVFDYLWLHVLH)URQWDO0D[LOODU\DQG6SKHQRLGZLOOEH
XVHGIRUSRZHUFDOFXODWLRQ
,QRUGHUWRPDLQWDLQPLQLPDO3RZHUDQG7\SH, ĮHUURURIWRGHWHFW
PLQLPDOGLIIHUHQFHVRIDVDPSOHVL]HRIVDPSOHVLVQHHGHGSHUVLQXV
FDYLW\7KLVQXPEHUGRHVQRWLQFOXGHDQHVWLPDWHGGURSRXWUDWHGXHWR
WHFKQLFDOUHDVRQVXQUHODWHGWRWKHGHYLFH7KHUHIRUHDVDPSOHVL]HRIVDPSOHV
SHUHDFKVLQXVFDYLW\DQGDWRWDORIVDPSOHVIRUDOOVLQXVHVWRWDORIXSWR
SDWLHQWVZLOOEHUHFUXLWHGWRWKHVWXG\
6WDWLVWLFDO
$QDO\VLV3ODQ
'HPRJUDSKLFDQGEDVHOLQHFKDUDFWHULVWLFVZLOOEHVXPPDUL]HGIRUDOOVXEMHFWV
LQFOXGHGLQWKHDQDO\VLV&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJVXPPDU\
VWDWLVWLFVPHDQVWDQGDUGGHYLDWLRQPHGLDQUDQJHFRPELQHGZLWKFRQILGHQFH
LQWHUYDOFDOFXODWLRQVDQGFDWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGXVLQJFRXQWVDQG
SHUFHQWDJHV
,QSDUWLFXODUWKHIROORZLQJWHVWVDFFRUGLQJWRWKHSDUDPHWHUVW\SHDUHJRLQJWREH
SHUIRUPHG
x
&RQWLQXRXVSDUDPHWHUVZLOOEHSUHVHQWHGE\WKHHVWLPDWHGYDOXHDQG
FDOFXODWLRQRIFRQILGHQFHLQWHUYDOV,QDGGLWLRQWKHFRPSDULVRQZLOOEH
E\XVLQJWKHUHOHYDQW6WXGHQW¶VWWHVW
x &DWHJRULFDOSDUDPHWHUVZLOOEHDQDO\]HGE\)LVKHUH[DFWWHVWFKLVTXDUHWHVWV
LQFDVHRIORZREVHUYHGIUHTXHQFLHV
7HVWVZLOOEHWZRVLGHGLQDFFRUGDQFHWRWKHK\SRWKHVLVUHJDUGLQJWKHWHVWHG
SDUDPHWHUVZLWKDVLJQLILFDQFHOHYHORI



170HGLFDO&RQILGHQWLDO

3DJHRI




%$&.*5281'

1DVDO(QGRVFRS\
1DVDO HQGRVFRS\LVDPLQLPDOO\LQYDVLYH GLDJQRVWLF PHGLFDO SURFHGXUHDQGFXUUHQWO\WKHPRVW
SUHIHUUHGLQLWLDOPHWKRGRIHYDOXDWLQJPHGLFDOSUREOHPVDIIHFWLQJQRVHDQGVLQXVHVVXFKDVQDVDO
VWXIILQHVV DQG REVWUXFWLRQ VLQXVLWLV QDVDO SRO\SRVLV QDVDO WXPRUV HSLVWD[LV UHFXUUHQW ERXWV RI
VQHH]LQJDQGUKLQRUUKHD
1DVDO HQGRVFRS\ DOORZV D GHWDLOHG H[DPLQDWLRQ RI WKH QDVDO DQG VLQXV FDYLWLHV QRW SRVVLEOH E\
VWDQGDUGH[DPLQDWLRQVXFKDVDQWHULRUUKLQRVFRS\XVLQJKHDGOLJKWRUKHDGPLUURU,WLVPRUH
VHQVLWLYH WKDQ FRPSXWHG WRPRJUDSK\ &7 IRU WKH HYDOXDWLRQ RI DFFHVVLEOH DQDWRP\  DQG
SURYLGHV YDOXDEOH LQIRUPDWLRQ UHJDUGLQJ SHUVLVWHQW DV\PSWRPDWLF GLVHDVH SRVWRSHUDWLYHO\ 0RVW
LPSRUWDQWO\&7VFDQLVDVVRFLDWHGZLWKUDGLDWLRQH[SRVXUHKDUPIXOWRWKHSDWLHQWDQGVKRXOGEH
DYRLGHGLISRVVLEOH
$UHDV YLVXDOL]HG GXULQJ HQGRVFRS\ LQFOXGH WKH QDVDO FDYLW\ LQIHULRU WXUELQDWH LQIHULRU PHDWXV
PLGGOH PHDWXV XQFLQDWH SURFHVV KLDWXV VHPLOXQDULV PD[LOODU\ RVWLD DQWHULRU HWKPRLGDO EXOOD
QDVRIURQWDO UHFHVV VSKHQRHWKPRLGDO UHFHVV VSKHQRLGDO RVWLXP ROIDFWRU\ FOHIW DQG WKH
QDVRSKDU\Q[
2YHUDOOWKHSURFHGXUHLVFRQVLGHUHGDYHU\VDIHDQGDORZULVNRQH2FFDVLRQDOO\JDJJLQJ
QRVHEOHHGVRUFRXJKLQJPD\RFFXUDVWKHHQGRVFRSHLVWKUHDGHGWKURXJKDQRVWULO0XFRVDO
WUDXPDDQGEOHHGLQJPD\UDUHO\RFFXUSDUWLFXODUO\LQVXVFHSWLEOHSDWLHQWVZLWKLQFUHDVHGULVNRI
EOHHGLQJ VXFK DV WKRVH UHFHLYLQJ DVSLULQ RU RWKHU DQWLFRDJXODQW PHGLFDWLRQV LH 3ODYL[
&RXPDGLQHWF,QDGGLWLRQDOWKRXJKQRWUHODWHGWRWKHHQGRVFRSLFGHYLFHVDGYHUVHUHDFWLRQVWR
WKH WRSLFDO GHFRQJHVWDQWV RU DQHVWKHWLF SURYLGHG SULRU WR WKH SURFHGXUH PD\ RFFXU SURPSWLQJ
YHULILFDWLRQRISDWLHQWV¶DOOHUJLHVSULRUWRDSSOLFDWLRQ
&XUUHQWO\QDVDOHQGRVFRS\FDQEHSHUIRUPHGZLWKDIOH[LEOHRUULJLGHQGRVFRSHW\SLFDOO\DIWHUD
WRSLFDOGHFRQJHVWDQWDQGDQHVWKHWLFDUHDSSOLHGWRWKHQDVDOPXFRVD1RWDEO\ORFDODQHVWKHWLFPD\
QRW QHFHVVDULO\ EH EHQHILFLDO ZKHQ SHUIRUPLQJ IOH[LEOH QDVDO HQGRVFRS\ QHLWKHU DORQH QRU LQ
FRPELQDWLRQZLWKDYDVRFRQVWULFWRU:DWHUZDVVXJJHVWHGWREHEHWWHUWKDQOXEULFDQWIRU)OH[LEOH
(QGRVFRSHSDVVDJH
5HSURFHVVLQJ LV DQ LVVXH RI FRQFHUQ HVSHFLDOO\ IRU )OH[LEOH (QGRVFRSH V ZKHUH PXOWLSOH VWHSV
ZHUH FRQILUPHGWREH FULWLFDOIRUUHSURFHVVLQJWREHHIIHFWLYH+LJKOHYHOGLVLQIHFWLRQKDV
EHHQGHWHUPLQHGWREHWKHPLQLPXPOHYHORIGLVLQIHFWLRQUHTXLUHGZLWKVHYHUDOVWHSVDUHLPSRUWDQW
LQDOOUHSURFHVVLQJWHFKQLTXHVLQFOXGLQJPDQXDOFOHDQLQJOHDNWHVWLQJFOHDQLQJZLWKDQHQ]\PDWLF
DJHQWKLJKOHYHOGLVLQIHFWLRQDQGGU\LQJZLWKYHUWLFDOVWRUDJH


170HGLFDO&RQILGHQWLDO

3DJHRI


17 0HGLFDO /WG KDV GHYHORSHG WKH 3HUHJULQH70 'ULYDEOH (17 6FRSH ZKLFK RIIHUV WKH
FRQYHQLHQFH RI D VLQJOHXVH HQGRVFRSH FRPSRQHQW FRXSOHG ZLWK SHUIRUPDQFH FKDUDFWHULVWLFV RI
FRPPHUFLDOO\ DYDLODEOH VWDWHRIWKHDUW UHXVDEOH HQGRVFRS\ V\VWHPV 7KH VLQJOHXVH HQGRVFRSH
HVVHQWLDOO\ UHPRYHV FRQFHUQV UHODWHG WR EXUGHQVRPH UHSURFHVVLQJ WHFKQLTXHV RI D GHOLFDWH WRRO
UHTXLUHGWRDFKLHYHKLJKOHYHORILWVGLVLQIHFWLRQ
7KH3HUHJULQH'ULYDEOH(176FRSHLVDPLQRUPRGLILFDWLRQWRWKH6LQXVZD\HQGRVFRS\V\VWHP
WKDWZDVFOHDUHGE\WKH)'$XQGHU.DQGZDVWHVWHGDQGIRXQGWREHVDIHDQGHIIHFWLYHLQ
YDULRXVFOLQLFDOVWXGLHV
 2%-(&7,9(6
7KHREMHFWLYHRIWKLVVWXG\LVWRDVVHVVWKHVDIHW\DQGSHUIRUPDQFHRI3HUHJULQHHQGRVFRSHLQSDWLHQWVLQ
WKHRIILFHVHWWLQJLQWHUPVRIDFFHVVDQGYLVXDOL]DWLRQRIWKHSDUDQDVDOVLQXVDQDWRP\LPDJHTXDOLW\
SDWLHQWWROHUDELOLW\DQGSDLQ
)RUWKLVVWXG\XSWRSDWLHQWVZKRKDYHKDGSULRU(66DQGDUHVFKHGXOHGIRUQDVDOHQGRVFRS\LQWKH
RIILFHDVSDUWRIDURXWLQHSRVWRSHUDWLYHRIILFHYLVLWRUGXHWRUHFXUUHQFHRIV\PSWRPVZLOOEHHYDOXDWHG
ZLWK3HUHJULQH(QGRVFRSH$FFHVVDQGYLVXDOL]DWLRQE\DQDGGLWLRQDOVWDQGDUGHQGRVFRSHZLOOEH
FRQGXFWHGDQGFRPSDUHGWR3HUHJULQHHQGRVFRSH,PDJHTXDOLW\RIWKH3HUHJULQHHQGRVFRSH3DWLHQW
WROHUDELOLW\DQGSDLQDQGWKHLPSDFWRI3HUHJULQHRQFOLQLFDOGHFLVLRQPDNLQJZLOOEHHYDOXDWHG

6DIHW\DVVHVVPHQW
6DIHW\DVVHVVPHQWZLOOEHEDVHGXSRQPRQLWRULQJWKHDGYHUVHGHYLFHHIIHFWVZKLFKZLOOEHFROOHFWHG
WKURXJKRXWWKHSURFHGXUH
$OO DGYHUVH HYHQWV DQG VHULRXV DGYHUVH HYHQWV ZLOO EH UHSRUWHG LQ DFFRUGDQFH ZLWK UHYLHZLQJ (WKLFV
&RPPLWWHH,QVWLWXWLRQDO5HYLHZ%RDUG,5%)'$DQG&RPSHWHQWDXWKRULW\UHTXLUHPHQWV

3HUIRUPDQFHDVVHVVPHQW
x 7RFRPSDUHYLVXDOL]DWLRQVXFFHVVUDWHVRIWKHSDUDQDVDOVLQXVDQDWRP\E\3HUHJULQHDQGE\VWDQGDUG
HQGRVFRSHVXVHGLQWKHRIILFHVHWWLQJ
x 7RDVVHVVZKHWKHUWKHLPDJHTXDOLW\RI3HUHJULQHLVDGHTXDWHIRUHQGRVFRS\SURFHGXUHVLQWKHRIILFH
x
7RHYDOXDWHSDWLHQWWROHUDELOLW\DQGSDLQ
x 7RHYDOXDWH3HUHJULQHXWLOLW\LQFOLQLFDOGHFLVLRQPDNLQJ


170HGLFDO&RQILGHQWLDO

3DJHRI



6WXG\(QG3RLQWV

3ULPDU\6DIHW\
$OODGYHUVHGHYLFHHIIHFWVZLOOEHFDSWXUHGDQGVXPPDUL]HGDVGHILQHGLQ6HFWLRQ$GYHUVHGHYLFH
HIIHFWVW\SHIUHTXHQF\VHYHULW\DUHH[SHFWHGWREHVLPLODUWRWKRVHUHSRUWHGLQWKHOLWHUDWXUHIRU1DVDO
(QGRVFRS\VHFWLRQ
)RUWKLVVWXG\WKH6DIHW\FRPSDULVRQZLWKWKHGDWDRI1DVDO(QGRVFRS\UHSRUWHGLQWKHOLWHUDWXUHZLOOEH
GHVFULSWLYHZLWKQRVWDWLVWLFDOHQGSRLQWV

3ULPDU\±3HUIRUPDQFH
(YDOXDWLRQRIDELOLW\RI3HUHJULQHDQGWKHFRPSDULVRQHQGRVFRSHWRDFFHVVDQGYLVXDOL]HVLQXV
DQDWRP\DWWKHIROORZLQJODQGPDUNV
x 0D[LOODU\RVWLXPDQWHULRUZDOOODWHUDODVSHFWIORRU
x )URQWDORVWLXPSRVWHULRUZDOODQWHULRUZDOOODWHUDOUHFHVV
x 6SKHQRLGRVWLXPVHOODIORRUODWHUDOUHFHVV
6XEMHFWVZLOOEHHYDOXDWHGZLWK
D 0DQGDWRU\±3HUHJULQH(QGRVFRSHWKHVWXG\GHYLFH
E 0DQGDWRU\±$6WDQGDUGPPHQGRVFRSH
F 2SWLRQDO±$6WDQGDUGPPHQGRVFRSH
G 2SWLRQDO±$VWDQGDUG)OH[LEOH(QGRVFRSH


9LVXDOL]DWLRQVXFFHVVUDWHVFDOFXODWHGDVWKH1RRIVXFFHVVHVGLYLGHGE\WKH1RRIDWWHPSWVZLOO
EHFRQILUPHGE\GLUHFWYLVXDOL]DWLRQ

5HSUHVHQWDWLYHLPDJHVRIWKHDFFHVVHGDQDWRPLFODQGPDUNVZLOOEHUHFRUGHG

/HYHORISULRUUHVHFWLRQZLOOEHUHFRUGHG±DQWHULRURUSRVWHULRUHWKPRLGHFWRP\GUDI,,DGUDI,,E
XQFLQHFWRP\DQWURVWRP\PD[LOOHFWRP\VSKHQRLGRWRP\GLODWLRQ

6HFRQGDU\3HUIRUPDQFH
x ,PDJHTXDOLW\±ZLOOEHDVVHVVHGWKURXJKD\HVQRVWDWHPHQWUHJDUGLQJDGHTXDF\RI3HUHJULQH
LPDJHTXDOLW\IRURIILFHHQGRVFRS\SURFHGXUHVLQFRPSDULVRQWRWKHFRPSDULVRQGHYLFH
x 3DWLHQWSDLQDQGWROHUDELOLW\ZLOOEHDVVHVVHGWKURXJKYDOLGDWHG9$6IRUERWK3HUHJULQHDQGWKH
FRPSDULVRQHQGRVFRSH
x ,PSDFWRI3HUHJULQH
VH[WHQGHGYLVXDOL]DWLRQFDSDELOLW\RQFOLQLFDOZRUNIORZZLOOEHHYDOXDWHG
WKURXJKDVHULHVRITXHVWLRQVUHJDUGLQJLGHQWLILFDWLRQRISDWKRORJ\HYDOXDWLRQRIPXFRVDFKDQJH
LQPHGLFDOPDQDJHPHQWQHHGIRUDGGLWLRQDO&7VFDQLQGLFDWLRQIRUUHYLVLRQVXUJHU\HWF
x 3HUHJULQHHDVHRIXVHZLOOEHHYDOXDWHGWKURXJKDXVHUTXHVWLRQQDLUH
2WKHU0HDVXUHPHQW±3HUIRUPDQFHDQGHIIHFWLYHQHVV
x ,UULJDWLRQWKURXJK3HUHJULQHZRUNLQJFKDQQHOZLOOEHGRFXPHQWHGSHUIRUPHGQRWSHUIRUPHG
ZKHQSHUIRUPHG
x 7RHYDOXDWHQDVDOFDYLW\LQIODPPDWLRQDQGVLQXVHVLQIODPPDWLRQXVLQJ/XQG0DFND\&7VFRUH
DQG/XQG.HQQHG\(QGRVFRSLFVFRULQJLIDSSOLFDEOH


170HGLFDO&RQILGHQWLDO

3DJHRI


$VOHDUQLQJFXUYHHDFKLQYHVWLJDWRUSDUWLFLSDWLQJLQWKHVWXG\ZLOOXVH3HUHJULQHLQDFDGDYHUVSHFLPHQ
DQGRUDQDWRPLFPRGHODQGRUGXULQJDWOHDVWSURFHGXUHSHUIRUPHGLQWKHRSHUDWLQJURRP25XQGHU
JHQHUDODQHVWKHVLD7KHVXEMHFWWUHDWHGLQWKH25ZLOOEHLQFOXGHGLQWKHVDIHW\DQDO\VLVEXWQRWLQFOXGHG
LQWKHHIILFDF\DQDO\VLV
 '(6&5,37,212)3$7,(173238/$7,21

3DWLHQW6HOHFWLRQ
3DWLHQWVZKRKDYHKDGSULRU(66DQGDUHLQGLFDWHGIRUQDVDOHQGRVFRS\LQWKHRIILFHDVSDUWRIDURXWLQH
SRVWRSHUDWLYHRIILFHYLVLWRUGXHWRUHFXUUHQFHRIV\PSWRPV

6XEMHFW(QUROOPHQW
D
3DWLHQWVZKRDSSHDUWREHHOLJLEOHZLOOEHDVNHGLIWKH\ZRXOGOLNHWRSDUWLFLSDWHLQWKLVVWXG\
E
:ULWWHQLQIRUPHGFRQVHQWZLOOEHREWDLQHGIURPHDFKSDUWLFLSDWLQJSDWLHQWSULRUWRFROOHFWLQJD
SDWLHQWKLVWRU\RURWKHUWHVWLQJ7KHSDWLHQWZLOOEHFRXQVHOHGFRQFHUQLQJWKHUHVHDUFKQDWXUHRIWKLV
VWXG\DQGWKHULVNVDQGSRVVLEOHEHQHILWVWRSDUWLFLSDWLRQ3DUWLFLSDWLRQLVIXOO\YROXQWDU\

,QFOXVLRQ&ULWHULD
 $PDOHRUIHPDOHSDWLHQWZKRKDVKDGSULRU(66DQGZKRLVLQGLFDWHGIRURIILFHHQGRVFRS\E\
WKH(17VSHFLDOLVW
 3DWLHQWDJHDGXOW!\HDUVROG
 $SDWLHQWZKRLVDEOHWRXQGHUVWDQGWKHUHTXLUHPHQWVRIWKHVWXG\LVZLOOLQJWRFRPSO\ZLWKLWV
LQVWUXFWLRQVDQGVFKHGXOHVDQGDJUHHVWRVLJQWKHLQIRUPHGFRQVHQW

([FOXVLRQ&ULWHULD
 $Q\PHGLFDOGLVRUGHUZKLFKLQWKHLQYHVWLJDWRU¶VMXGJPHQWFRQWUDLQGLFDWHVWKHSDWLHQW
V
SDUWLFLSDWLRQ
 3UHJQDQF\
 ,19(67,*$7,213/$1

6WXG\'HVLJQ

7\SHRI6WXG\
7KLV LV DQ RSHQ VLQJOHFHQWHU SURVSHFWLYH VWXG\ LQ ZKLFK WKH LQYHVWLJDWLRQDO GHYLFH WKH 3HUHJULQH
'ULYDEOH(176FRSHZLOOEHWHVWHGLQDVLQJOHJURXSRIDGXOWSDWLHQWVPDOHRUIHPDOHV


170HGLFDO&RQILGHQWLDO

3DJHRI


7KHUDWLRQDOHEHKLQGWKLVVWXG\LVWRVKRZWKDWWKHDELOLW\WRYLVXDOL]HLQWUDVLQXVDQDWRPLFODQGPDUNVRI
WKH0D[LOODU\)URQWDODQG6SKHQRLGVLQXVHVLVFRPSDUDEOHWRRUEHWWHUWKDQWKHDELOLW\WRYLVXDOL]HWKHP
ZLWK D 6WDQGDUG  PP (QGRVFRSH LQ WKH RIILFH VHWWLQJ 7KLV VWXG\ ZLOO HYDOXDWH WKH VDIHW\ DQG
SHUIRUPDQFHRIWKH3HUHJULQHHQGRVFRSHZKLFKHQDEOHVLQWUDVLQXVYLVXDOL]DWLRQDVDILUVWVWHSWRDVVHVV
SRWHQWLDO EHQHILWV VXFK DV PLQLPL]LQJ &7 VFDQV DQG DVVRFLDWHG UDGLDWLRQ H[SRVXUH FKDQJH LQ
PHGLFDWLRQUHJLPHQUHIHUUDOWRUHYLVLRQVXUJHU\VDYLQJPXOWLSOHRIILFHYLVLWVDQGFRVW
7KLVVWXG\LVSURSRVHGDIWHUFRPSOHWLQJDVHULHVRIFOLQLFDOFDVHVZLWKWKH6LQXVZD\HQGRVFRS\V\VWHP
ZKLFKLVVLPLODUWRWKH3HUHJULQH(QGRVFRS\V\VWHPZKLFKGHPRQVWUDWHGWKDWWKHV\VWHPLVVDIHDQG
SHUIRUPHG ZHOO WR SK\VLFLDQ
V VDWLVIDFWLRQ GHWDLOHG LQIRUPDWLRQ RQ WKH VWXGLHV LV SURYLGHG LQ WKH
,QYHVWLJDWRU¶V%URFKXUH

0HDVXUHVWR0LQLPL]H%LDV
6XEMHFWV VKDOO FRQVWLWXWH WKHLU RZQ FRQWURO JURXS E\ FRPSDULQJ WKH DELOLW\ WR YLVXDOL]H LQWUDVLQXV
DQDWRPLFODQGPDUNVDQGSDLQDQGWROHUDELOLW\EHWZHHQ3HUHJULQHDQGDVWDQGDUGHQGRVFRSHLQWKHVDPH
VXEMHFW)RUWKLVUHDVRQQRUDQGRPL]DWLRQLVQHFHVVDU\LQWKLVVWXG\

6WXG\3URFHGXUHV

9LVLWV6FUHHQLQJDQG(QUROOPHQW
x 6FUHHQLQJZLOOWDNHSODFHDWWKHGD\RISURFHGXUHRUZLWKLQGD\GD\VEHIRUHWKHSURFHGXUHDV
SDUWRIDUHJXODURIILFHYLVLW
x 3DWLHQWVZKRSRWHQWLDOO\TXDOLI\IRUWKHVWXG\ZLOOEHRIIHUHGDQ,QIRUPHG&RQVHQWWRVLJQSULRU
WRIXUWKHUHYDOXDWLRQ$Q\SDWLHQWVZKRGRQRWTXDOLI\ZLOOEHH[LWHGIURPWKHVWXG\DVVFUHHQLQJ
IDLOXUHVDQGZLOOQRWEHLQFOXGHGLQWKHVDIHW\HIIHFWLYHQHVVDQDO\VHV
x 7KHIROORZLQJDVVHVVPHQWVZLOOEHSHUIRUPHGEHIRUHWKHSURFHGXUHIRUHDFKSDWLHQW
0HGLFDOKLVWRU\LQFOXGLQJFRQFRPLWDQWPHGLFDWLRQVGHHPHGUHOHYDQWE\WKHLQYHVWLJDWRU
6LQR1DVDORXWFRPHWHVW6127
9LWDOVLJQV±RSWLRQDO
&7VFDQ±RSWLRQDODVDYDLODEOHLQWKHSDWLHQWILOH
1DVDO&DYLW\DQGVLQXVHVLQIODPPDWLRQVFRUHZLOOEHFDSWXUHGXVLQJWKH/XQG0DFND\&7
&RPSOLDQFHZLWKLQFOXVLRQH[FOXVLRQFULWHULD
3DWLHQWV IRXQG HOLJLEOHWRSDUWLFLSDWH LQ WKH VWXG\GXULQJ YLVLWZLOOEHVFKHGXOHGWRXQGHUJR
QDVDOHQGRVFRS\HYDOXDWLRQZLWK3HUHJULQH



9LVLW3URFHGXUH
7KH SURFHGXUH ZLOO EH RIILFH HQGRVFRS\ DV SDUW RI D URXWLQH SRVWRSHUDWLYH RIILFH YLVLW RU GXH WR
UHFXUUHQFHRIV\PSWRPV9LVLWVDQGFDQEHFRPELQHGLQWRDVLQJOHYLVLW
x
%HIRUHWKHSURFHGXUH
(OLJLEOHVXEMHFWVZLOODWWHQGWKH0HGLFDO&HQWHUDWWKHGD\RISURFHGXUHDQGZLOOEHLQTXLUHG
E\WKH3,UHJDUGLQJFKDQJHVWRWKHLUKHDOWKVWDWXVVLQFHWKHVFUHHQLQJYLVLW,IDWWKLVSRLQWLWLV


170HGLFDO&RQILGHQWLDO

3DJHRI


GHWHUPLQHGWKDWWKHSDWLHQWGRHVQRWPHHWDOO,QFOXVLRQDQG([FOXVLRQFULWHULDDQGFDQQRWEH
WUHDWHGWKHSDWLHQWZLOOEHH[LWHGIURPWKHVWXG\7KHVHSDWLHQWVZLOOEHFRQVLGHUHGVFUHHQLQJ
IDLOXUHVDQGZLOOQRWEHLQFOXGHGLQDQ\RIWKHVDIHW\RUHIILFDF\HQGSRLQWDQDO\VHV
x
(QGRVFRS\
 3DWLHQWVZLOOXQGHUJRWKHSURFHGXUHXQGHUORFDORUWRSLFDODQHVWKHVLDDWSK\VLFLDQGLVFUHWLRQ
 7KH3HUHJULQHHQGRVFRS\V\VWHPZLOOEHSUHSDUHGIRUXVHSHULWVLQVWUXFWLRQVIRUXVH
 2EOLJDWRU\±WKHVXUJHRQZLOODWWHPSWWRYLVXDOL]HWKHSUHGHILQHGVLQXVDQDWRP\ODQGPDUNV
ZLWKDVWDQGDUG°PPHQGRVFRSHZKLFKZLOOEHUHFRUGHGDVVXFFHVVIDLOXUHDQGDQLPDJHRI
WKHDQDWRPLFODQGPDUNVYLVXDOL]HGZLOOEHWDNHQ3DWLHQWZLOOEHDVNHGWRVFRUHWKHHQGRVFRSH
IRUSDLQDQGWROHUDELOLW\
 2EOLJDWRU\ ± WKH VXUJHRQ ZLOO WKHQ DWWHPSW WR YLVXDOL]H WKH SUHGHILQHG VLQXV DQDWRP\
ODQGPDUNVZLWK3HUHJULQHHQGRVFRSHZKLFKZLOOEHUHFRUGHGDVVXFFHVVIDLOXUHDQGDQLPDJH
RIWKHDQDWRPLFODQGPDUNVYLVXDOL]HGZLOOEHWDNHQ3DWLHQWZLOOEHDVNHGWRVFRUH3HUHJULQHIRU
SDLQDQGWROHUDELOLW\
 2SWLRQDO ± WKH VXUJHRQ ZLOO KDYH WKH RSWLRQ WR DWWHPSW WR YLVXDOL]H WKH SUHGHILQHG VLQXV
DQDWRP\ODQGPDUNVZLWKDVWDQGDUG°PPHQGRVFRSHDQGRUDIOH[LEOHHQGRVFRSHZKLFK
ZLOOEHUHFRUGHGDVVXFFHVVIDLOXUHDQGDQLPDJHRIWKHDQDWRPLFODQGPDUNVYLVXDOL]HGZLOOEH
WDNHQ3DWLHQWZLOOEHDVNHGWRVFRUHWKHHQGRVFRSHIRUSDLQDQGWROHUDELOLW\
 2SWLRQDOLUULJDWLRQRIWKHQDVDODQDWRP\ZLOOEHSHUIRUPHGDQGUHFRUGHGDV'RQH1RW'RQH
DQGZKLFKVLQXVZDVLUULJDWHG
 7KH SK\VLFLDQ ZLOO DQVZHU D VHW RI TXHVWLRQV UHODWHG WR HQGRVFRSH XVDELOLW\ DQG XWLOLW\ LQ
FOLQLFDOGHFLVLRQPDNLQJLQFRPSDULVRQWRWKHVWDQGDUGHQGRVFRSH
 7KH SURFHGXUH ZLOO EH UHFRUGHG E\ VLWH
V $,'$ V\VWHP WR HQDEOH WKH SK\VLFLDQ WR SHUIRUP
DVVHVVPHQWVSRVWSURFHGXUH
x
$IWHUWKHSURFHGXUH
7KHSDWLHQWZLOOUHFRYHUIURPWKHSURFHGXUHDFFRUGLQJWRFHQWHU
VFRPPRQSUDFWLFH%HIRUHWKH
SDWLHQWLVGLVPLVVHGUHFRUGLQJRI$(LIDQ\ZLOOEHSHUIRUPHG3DWLHQWZLOOH[LWWKHVWXG\

9LVLW7HOHSKRQH)ROORZXSYLVLW
 7HOHSKRQH)ROORZXSIRUVDIHW\DVVHVVPHQWZLOOEHFRQGXFWHGE\VWXG\SHUVRQQHOWZRZHHNV
GD\VIROORZLQJSDWLHQWODVWVWXG\YLVLW
 ,QWKHDEVHQFHRIDQ\RQJRLQJ$'(¶VWKHSDWLHQWZLOOH[LWWKHVWXG\DQG([LW)RUPZLOOEH
FRPSOHWHG

0HWKRGVDQG7LPLQJIRUDVVHVVPHQWV
6FKHGXOHVRIDVVHVVPHQWVDUHOLVWHGLQ7DEOH1REHORZ


170HGLFDO&RQILGHQWLDO

3DJHRI


7DEOH6WXG\YLVLWVFKHGXOH
6WXG\$FWLYLWLHV
9LVLW,
6FUHHQLQJDQG
,QFOXVLRQ

9LVLW,,
3URFHGXUH
$WGD\RIVFUHHQLQJ
RUZLWKLQGD\V
SRVWVFUHHQLQJ
9LVLW,,,
7HOHSKRQH
)ROORZXS
8SWRZHHNV
GD\VIURPYLVLW
,,
,QIRUPHG&RQVHQW
;


'HPRJUDSKLF'DWD
;


0HGLFDO+LVWRU\
;


6127
;


&RQFRPLWDQWPHGLFDWLRQ
UHODWHGWRVLQXVGLVHDVH
;


3K\VLFDO([DPLQDWLRQ
;
9LWDO6LJQVRSWLRQDO
;


,QFOXVLRQH[FOXVLRQ
FULWHULD
;


&7VFDQDVDYDLODEOH
;RSWLRQDO


/XQG0DFND\.HQQHG\
LQIODPPDWLRQVFRUH
;


(QGRVFRS\ZLWK
3HUHJULQHDQGDVWDQGDUG
(QGRVFRSH
;
8VHUTXHVWLRQQDLUH

;

3DWLHQW WROHUDELOLW\ DQG
SDLQVFRUH

;

$(V6$(V

;
;
3DWLHQW([LW 
 
 
;


170HGLFDO&RQILGHQWLDO

3DJHRI



67$7,67,&$/&216,'(5$7,216$1'6$03/(6,=(
6WDWLVWLFDO&RQVLGHUDWLRQV
'HPRJUDSKLFDQGEDVHOLQHFKDUDFWHULVWLFVZLOOEHVXPPDUL]HGIRUDOOVXEMHFWVLQFOXGHGLQWKHDQDO\VLV
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJVXPPDU\VWDWLVWLFVPHDQVWDQGDUGGHYLDWLRQPHGLDQ
UDQJHFRPELQHGZLWKFRQILGHQFHLQWHUYDOFDOFXODWLRQVDQGFDWHJRULFDOYDULDEOHVZLOOEH
VXPPDUL]HGXVLQJFRXQWVDQGSHUFHQWDJHV
,QSDUWLFXODUWKHIROORZLQJWHVWVDFFRUGLQJWRWKHSDUDPHWHUVW\SHDUHJRLQJWREHSHUIRUPHG
x &RQWLQXRXVSDUDPHWHUVZLOOEHSUHVHQWHGE\WKHHVWLPDWHGYDOXHDQGFDOFXODWLRQRI
FRQILGHQFHLQWHUYDOV,QDGGLWLRQWKHFRPSDULVRQZLOOEHE\XVLQJWKHUHOHYDQW6WXGHQW¶VWWHVW
x &DWHJRULFDOSDUDPHWHUVZLOOEHDQDO\]HGE\)LVKHUH[DFWWHVWFKLVTXDUHWHVWVLQFDVHRIORZ
REVHUYHGIUHTXHQFLHV
7HVWVZLOOEHWZRVLGHGLQDFFRUGDQFHWRWKHK\SRWKHVLVUHJDUGLQJWKHWHVWHGSDUDPHWHUVZLWKD
VLJQLILFDQFHOHYHORI
6DPSOH6L]H
8SWRWKLUW\SDWLHQWVDUHH[SHFWHGWRFRPSOHWHWKHVWXG\
7KHSULPDU\HQGSRLQWRIWKHVWXG\ZLOOEHWRGHPRQVWUDWHWKDWWKH3HUHJULQH(QGRVFRSHZLOOSHUIRUP
FRPSDUDEOHWRRUEHWWHUWKDQD6WDQGDUGPP(QGRVFRSHZKHUHDGLIIHUHQFHRIRUPRUH
EHWZHHQYLVXDOL]DWLRQVXFFHVVUDWHVZLOOEHFRQVLGHUHGWREHVWDWLVWLFDOO\VLJQLILFDQW3HUSURWRFRODVXE
JURXSDQDO\VLVRIHDFKRIWKHGLIIHUHQWVLQXVFDYLWLHVLH)URQWDO0D[LOODU\DQG6SKHQRLGZLOOEHXVHG
IRUSRZHUFDOFXODWLRQ
,QRUGHUWRPDLQWDLQPLQLPDO3RZHUDQG7\SH, ĮHUURURIWRGHWHFWPLQLPDOGLIIHUHQFHVRI
DVDPSOHVL]HRIVDPSOHVLVQHHGHGSHUVLQXVFDYLW\7KLVQXPEHUGRHVQRWLQFOXGHDQHVWLPDWHG
GURSRXWUDWHGXHWRWHFKQLFDOUHDVRQVXQUHODWHGWRWKHGHYLFH7KHUHIRUHDVDPSOHVL]HRI
VDPSOHVSHUHDFKVLQXVFDYLW\DQGDWRWDORIVDPSOHVIRUDOOVLQXVHVWRWDORIXSWRSDWLHQWVZLOO
EHUHFUXLWHGWRWKHVWXG\
 5,6.$1$/<6,6
5LVNDQDO\VLVIRUWKH6LQXVZD\GHYLFHKDVEHHQFRQGXFWHGDVSDUWRI)'$NVXEPLVVLRQ.
7KH5LVNDQDO\VLVZDVUHYLVHGIROORZLQJWKHPRGLILFDWLRQDSSOLHGWRWKH3HUHJULQHHQGRVFRSH7KLVULVN
DQDO\VLVLVDSSOLFDEOHWRWKHSURSRVHGFOLQLFDOLQYHVWLJDWLRQ7KHSRWHQWLDOULVNVGHVFULEHGEHORZZLOOEH
H[SODLQHGWRWKHVXEMHFWLQWKHLQIRUPHGFRQVHQWSURFHVV5LVNDQG%HQHILWVVXPPDU\RIWKH
LQYHVWLJDWLRQDOGHYLFHZLOOEHSUHVHQWHGLQWKH,QYHVWLJDWRU¶VEURFKXUH


170HGLFDO&RQILGHQWLDO

3DJHRI



3RWHQWLDOULVNV±3HUHJULQH
(QGRVFRS\LVDPLQLPDOO\LQYDVLYHGLDJQRVWLFPHGLFDOSURFHGXUH2YHUDOOQDVDOHQGRVFRS\LVD
VDIHDQGORZULVNSURFHGXUH2FFDVLRQDOO\JDJJLQJQRVHEOHHGVRUFRXJKLQJPD\RFFXUDVWKHHQGRVFRSH
LVWKUHDGHGWKURXJKDQRVWULO0XFRVDOWUDXPDDQGEOHHGLQJPD\UDUHO\RFFXUSDUWLFXODUO\LQ
VXVFHSWLEOHSDWLHQWVZLWKLQFUHDVHGULVNRIEOHHGLQJVXFKDVWKRVHUHFHLYLQJDVSLULQRURWKHU
DQWLFRDJXODQWPHGLFDWLRQVLH3ODYL[&RXPDGLQHWF,QDGGLWLRQDOWKRXJKQRWUHODWHGWRWKH
HQGRVFRSLFGHYLFHVDGYHUVHUHDFWLRQVWRWKHWRSLFDOGHFRQJHVWDQWVRUDQHVWKHWLFSURYLGHGSULRUWRWKH
SURFHGXUHPD\RFFXUSURPSWLQJYHULILFDWLRQRISDWLHQWV¶DOOHUJLHVSULRUWRDSSOLFDWLRQ

'HILQLWLRQVRI$GYHUVH'HYLFH(YHQWVDQG$GYHUVH(YHQWV

$GYHUVH'HYLFH(IIHFW$'(
x
$Q$GYHUVH'HYLFH(IIHFWLVDQDGYHUVHHYHQWUHODWHGWRWKHXVHRIDQLQYHVWLJDWLRQDOPHGLFDO
GHYLFH
x
7KLVLQFOXGHVDQ\DGYHUVHHYHQWUHVXOWLQJIURPLQVXIILFLHQFLHVRULQDGHTXDFLHVLQWKHLQVWUXFWLRQV
IRUXVHWKHGHSOR\PHQWWKHLQVWDOODWLRQWKHRSHUDWLRQRUDQ\PDOIXQFWLRQRIWKHLQYHVWLJDWLRQDO
PHGLFDOGHYLFH
x
7KLVLQFOXGHVDQ\HYHQWWKDWLVDUHVXOWRIDXVHHUURURULQWHQWLRQDOPLVXVH
x
$GYHUVH(YHQWVDUHGHILQHGDVDQ\XQWRZDUGPHGLFDORFFXUUHQFHXQLQWHQGHGGLVHDVHRULQMXU\
RUDQ\XQWRZDUGFOLQLFDOVLJQVLQFOXGLQJDQDEQRUPDOODERUDWRU\ILQGLQJLQVXEMHFWVXVHUVRU
RWKHUSHUVRQVZKHWKHURUQRWUHODWHGWRWKHLQYHVWLJDWLRQDOPHGLFDOGHYLFH
x
7KLVLQFOXGHVHYHQWVUHODWHGWRWKHLQYHVWLJDWLRQDOGHYLFH
x
7KLV LQFOXGHV HYHQWV UHODWHG WR WKH SURFHGXUHV LQYROYHG DQ\ SURFHGXUH LQ WKH FOLQLFDO
LQYHVWLJDWLRQSODQ
x
)RUXVHUVRURWKHUSHUVRQVWKLVLVUHVWULFWHGWRHYHQWVUHODWHGWRWKHLQYHVWLJDWLRQDOPHGLFDOGHYLFH
x
$OO$GYHUVHGHYLFHHIIHFWVPXVWEHUHFRUGHGLQWKH&5)$GHVFULSWLRQRIWKHHYHQWLQFOXGLQJ
WKHVWDUWGDWHUHVROXWLRQGDWHDFWLRQWDNHQDQGWKHRXWFRPHVKRXOGEHSURYLGHG

$OODGYHUVHHYHQWVZLOOEHJUDGHGIRUVHYHULW\DVIROORZV


170HGLFDO&RQILGHQWLDO

3DJHRI


*UDGH
'HJUHH
'HVFULSWLRQ

0LOG
6\PSWRPVEDUHO\QRWLFHDEOHWRSDWLHQWRUGRHVQRWPDNHSDWLHQWXQFRPIRUWDEOH
GRHV QRW LQIOXHQFH SHUIRUPDQFH RU IXQFWLRQLQJ SUHVFULSWLRQ GUXJ QRW RUGLQDULO\
QHHGHGIRUUHOLHIRIV\PSWRPVEXWPD\EHJLYHQEHFDXVHRISHUVRQDOLW\RISDWLHQW

0RGHUDWH
6\PSWRPVRIDVXIILFLHQWVHYHULW\WRPDNHSDWLHQWXQFRPIRUWDEOHSHUIRUPDQFHRI
GDLO\ DFWLYLW\ LV LQIOXHQFHG SDWLHQW LV DEOH WR FRQWLQXH LQ VWXG\ WUHDWPHQW IRU
V\PSWRPVPD\EHQHHGHG

6HYHUH
&DXVHVHYHUHGLVFRPIRUWV\PSWRPVFDXVHLQFDSDFLWDWLRQRUVLJQLILFDQWLPSDFWRQ
SDWLHQW¶VGDLO\OLIHVHYHULW\PD\FDXVHFHVVDWLRQRIWUHDWPHQWZLWKVWXG\GHYLFH
WUHDWPHQWIRUV\PSWRPVPD\EHJLYHQDQGRUSDWLHQWKRVSLWDOL]HG

/LIHWKUHDWHQLQJ
0D\UHVXOWLQGHDWKLIQRWSURPSWO\WUHDWHGDQGUHYHUVHG

)DWDO
5HVXOWVLQGHDWK
5HODWLRQVKLSZKHWKHURUQRWWKHWHVWSURFHGXUHGHYLFHFDXVHGWKHDGYHUVHHYHQW
'HJUHH
'HVFULSWLRQ
'HILQLWHO\
7KHUHLVHYLGHQFHRIH[SRVXUHWRWKHWHVWSURFHGXUHGHYLFHWKH$(LVPRVWOLNHO\WREH
H[SODLQHG E\ WKH WHVW SURFHGXUH  GHYLFH WKDQ E\ DQRWKHU FDXVH WKH FKDOOHQJH LV
SRVLWLYHUHFKDOOHQJHLIIHDVLEOHLVSRVLWLYHWKH$(VKRZVDSDWWHUQFRQVLVWHQWZLWK
SUHYLRXVNQRZOHGJHRIWKHWHVWSURFHGXUHGHYLFH
3UREDEO\
7KHUHLVHYLGHQFHRIH[SRVXUHWRWKHWHVWSURFHGXUHGHYLFHWKHWHPSRUDOVHTXHQFHRI
WKH$(RQVHWUHODWLYHWRWKHWHVWSURFHGXUHGHYLFHLVUHDVRQDEOHWKH$(LVPRUHOLNHO\
H[SODLQHGE\WKHWHVWSURFHGXUHGHYLFHWKDQE\DQRWKHUFDXVH
3RVVLEO\
7KHUHLVHYLGHQFHRIH[SRVXUHWRWKHWHVWSURFHGXUHGHYLFHWKHWHPSRUDOVHTXHQFHRI
WKH$(UHODWLYHWRWKHWHVWSURFHGXUHGHYLFHLVUHDVRQDEOHWKH$(FRXOGKDYHEHHQGXH
WRDQRWKHUHTXDOO\OLNHO\FDXVH
3UREDEO\QRW
7KHUH LV HYLGHQFH RI H[SRVXUH WR WKH WHVW SURFHGXUH  GHYLFH WKHUH LV DQRWKHU PRUH
OLNHO\FDXVHRIWKH$(
'HILQLWHO\QRW
7KHSDWLHQWGLGQRWUHFHLYHWKHWHVWSURFHGXUHGHYLFHRUWHPSRUDOVHTXHQFHRIWKH$(
RQVHWUHODWLYHWRWHVWSURFHGXUHGHYLFHLVQRWUHDVRQDEOHRUWKHUHLVDQRWKHUREYLRXV
FDXVHRIWKH$(
$FWLRQWDNHQZKHWKHURUQRWWKHDGYHUVHHYHQWFDXVHGWKHVXEMHFWWREHGLVFRQWLQXHGIURPWKH
VWXG\
&OLQLFDO2XWFRPH±ZKHWKHUWKHDGYHUVHHYHQWZDVUHVROYHGRURQJRLQJ
$OODGYHUVHHYHQWVLQFOXGLQJDZRUVHQLQJRISK\VLFDOH[DPLQDWLRQILQGLQJVLQFRPSDULVRQZLWK
EDVHOLQHYDOXHVPXVWEHIROORZHGXQWLOWKHHYHQWUHVROYHVWKHFRQGLWLRQVWDELOL]HVWKHHYHQWLV
RWKHUZLVHH[SODLQHGRUWKHSDWLHQWLVORVWWRIROORZXS
 




170HGLFDO&RQILGHQWLDO

3DJHRI



'HILQLWLRQVRI6HULRXV$GYHUVH'HYLFH(IIHFWVDQGGHYLFHGHILFLHQFLHV

6HULRXV$GYHUVH'HYLFH(IIHFW6$'(
$ 6HULRXV $GYHUVH 'HYLFH (IIHFW LV DQ DGYHUVH GHYLFH HIIHFW WKDW KDV UHVXOWHG LQ DQ\ RI WKH
FRQVHTXHQFHVFKDUDFWHULVWLFRIDVHULRXVDGYHUVHHYHQW

6HULRXV$GYHUVH(YHQW6$(
$6HULRXV$GYHUVH(YHQW´LVDQDGYHUVHHYHQWWKDW
D
OHGWRDGHDWK1RWH,QWKHHYHQWRIVXEMHFWGHDWKGXULQJWKHFRQGXFWRIWKHVWXG\HIIRUWV
VKRXOGEHPDGHWRSHUIRUPDQDXWRSV\
E OHGWRDVHULRXVGHWHULRUDWLRQLQKHDOWKWKDWHLWKHU
 UHVXOWHGLQDOLIHWKUHDWHQLQJLOOQHVVRULQMXU\RU
 UHVXOWHGLQDSHUPDQHQWLPSDLUPHQWRIDERG\VWUXFWXUHRUDERG\IXQFWLRQRU

UHTXLUHGLQSDWLHQWKRVSLWDOL]DWLRQRUSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQRU

UHVXOWHGLQPHGLFDORUVXUJLFDOLQWHUYHQWLRQWRSUHYHQWOLIHWKUHDWHQLQJLOOQHVVRULQMXU\
RUSHUPDQHQWLPSDLUPHQWWRDERG\VWUXFWXUHRUDERG\IXQFWLRQ
F
OHGWRIHWDOGLVWUHVVIHWDOGHDWKRUDFRQJHQLWDODEQRUPDOLW\RUELUWKGHIHFW
¾ 7KLV LQFOXGHV GHYLFH GHILFLHQFLHV WKDW PLJKW KDYH OHG WR D VHULRXV DGYHUVH HYHQW LI D
VXLWDEOH DFWLRQ KDG QRW EHHQ WDNHQ RU E LQWHUYHQWLRQ KDG QRW EHHQ PDGH RU F LI
FLUFXPVWDQFHV KDG EHHQ OHVV IRUWXQDWH 7KHVH DUH KDQGOHG XQGHU WKH 6$( UHSRUWLQJ
V\VWHP
¾ $ SODQQHG KRVSLWDOL]DWLRQ IRU SUHH[LVWLQJ FRQGLWLRQ RU D SURFHGXUH UHTXLUHG E\ WKH
&OLQLFDO,QYHVWLJDWLRQ3ODQZLWKRXWDVHULRXVGHWHULRUDWLRQLQKHDOWKLVQRWFRQVLGHUHG
WREHDVHULRXVDGYHUVHHYHQW


8QDQWLFLSDWHG6HULRXV$GYHUVH'HYLFH(IIHFW86$'(
6HULRXV DGYHUVH GHYLFH HIIHFW ZKLFK E\ LWV QDWXUH LQFLGHQFH VHYHULW\ RU RXWFRPH KDV QRW EHHQ
LGHQWLILHGLQWKHFXUUHQWYHUVLRQRIWKHULVNDQDO\VLVUHSRUW
$QWLFLSDWHGDQHIIHFW ZKLFKE\LWVQDWXUHLQFLGHQFHVHYHULW\RURXWFRPHKDVEHHQSUHYLRXVO\
LGHQWLILHGLQWKHOLWHUDWXUH)RUH[DPSOHPLQRUEOHHGLQJ
3OHDVHQRWH$OOSURFHGXUHVFDUU\VRPHULVNEXW(17HQGRVFRS\LVYHU\VDIH0LQRUFRPSOLFDWLRQV
DUHXQFRPPRQDQGPDMRUFRPSOLFDWLRQVDUHYHU\UDUH


170HGLFDO&RQILGHQWLDO

3DJHRI



$GYHUVH(IIHFWVDQG3UHFDXWLRQV
7KHVXEMHFWVZLOOEHFRXQVHOHGFRQFHUQLQJZKDWWRH[SHFWGXULQJWKHSURFHGXUHDQGWKHLPSRUWDQFH
RIFRPPXQLFDWLQJDQ\SUREOHPVWRWKHLQYHVWLJDWRU

$GYHUVH(YHQW5HSRUWLQJ
,W LV WKH UHVSRQVLELOLW\ RI WKH LQYHVWLJDWRU WR GRFXPHQW DOO WUHDWPHQW UHODWHG DQG GHYLFH UHODWHG
$GYHUVH(YHQWV$'(¶VZKLFKRFFXUGXULQJWKHFRXUVHRIWKHVWXG\$OO$'(VZLOOEHUHFRUGHG
RQWKHDGYHUVHHYHQWVSDJHRIWKH&5)6HYHULW\DQGUHODWLRQVKLSWRVWXG\GHYLFHZLOOEHDVVLJQHG
E\WKHLQYHVWLJDWRUDVGHVFULEHGLQWKHVHFWLRQDERYH$'(VZLOOEHUHFRUGHGDIWHUWKHVXEMHFWKDV
EHHQDGPLWWHGWRWKHFOLQLF9LVLW
$Q\6$(ZKHWKHUGHHPHGGHYLFHUHODWHGRUQRWPXVWEHUHSRUWHGWRWKHVLWH(WKLFV&RPPLWWHH
DQGWRWKHVSRQVRUDVVRRQDVSRVVLEOHDIWHUWKHLQYHVWLJDWRUKDVEHFRPHDZDUHRILWVRFFXUUHQFH
HYHQLIQRWDOOWKHLQIRUPDWLRQLVDYDLODEOHDWWKHWLPHRILQLWLDOFRQWDFW
7KH LQYHVWLJDWRU PXVW FRPSOHWH D 6$( )RUP DQG VHQG LW WR WKH 6SRQVRU ZLWKLQ  KRXUV RI
EHFRPLQJ DZDUH RI WKH HYHQW $FFRPSDQ\LQJ GRFXPHQWDWLRQ VXFK DV FRSLHV RI KRVSLWDO FDVH
UHSRUWVDXWRSV\UHSRUWDQGRWKHUGRFXPHQWVZKHQDSSOLFDEOHVKRXOGEHVHQWDVVRRQDVWKH\DUH
DYDLODEOH
7KHVLWH¶V(WKLFV&RPPLWWHHPXVWDOVREHGXO\QRWLILHGDQGGHDOWZLWKDFFRUGLQJWRWKH+RVSLWDO
DQG )'$0LQLVWU\ RI +HDOWK UHJXODWLRQV 6XEMHFWV ZKR KDYH KDG D 6$( PXVW EH IROORZHG
FOLQLFDOO\ XQWLO DOO SDUDPHWHUV LQFOXGLQJ ODERUDWRU\ KDYH HLWKHU UHWXUQHG WR QRUPDO RU DUH
VWDELOL]HG
 '$7$0$1$*(0(17
'DWD IURP HDFK VXEMHFW ZLOO EH UHFRUGHG LQ VRXUFH GDWD DQG WUDQVPLWWHG WR FDVH UHSRUW IRUPV&5)V
VXSSOLHGE\WKH6SRQVRU7KHGDWDZLOOEHLQVHUWHGPDQXDOO\DQGTXDOLW\FKHFNIRUHUURUVDQGRPLVVLRQV
ZLOOEHSHUIRUPHGWRHQVXUHWKHDFFXUDF\RIWKHHQWHUHGGDWD
7KHVRXUFHGDWDVKRXOGEHFRPSOHWHGGXULQJWKHVWXG\E\TXDOLILHGSHUVRQQHO$OOGDWDPXVWEHILOOHGRXW
XVLQJEDOOSHQVQRWSHQFLOVDFFXUDWHO\DQGSURPSWO\IROORZLQJHDFKUHOHYDQWVWHSRIWKHVWXG\7KH
&5)VKRXOGEHFRPSOHWHGLQIXOOLHQRILHOGVVKRXOGEHOHIWEODQNRQFHWKHVXEMHFWKDVFRPSOHWHGWKH
VWXG\&5)VHQWULHVFRUUHFWLRQVPXVWEHPDGHRQO\E\OLQLQJRXWVLQJOHOLQHLQFRUUHFWGDWDDQGZULWLQJ
LQWKHUHYLVLRQV$OOFRUUHFWLRQVPXVWEHLQLWLDOHGDQGGDWHGE\WKHLQGLYLGXDOSHUIRUPLQJUHFRUGLQJWKH
FRUUHFWLRQ,IWKHUHDVRQIRUWKHFKDQJHLVQRWREYLRXVDQH[SODQDWLRQIRUWKHFKDQJHVKRXOGEHUHFRUGHG
DQGDWWDFKHGWRWKH&5)%ODFNLQJRXWRUXVLQJFRUUHFWLRQIOXLGRUDQHUDVHULVQRWDOORZHGWRFRUUHFWRU
HOLPLQDWH GDWD 7KH LQYHVWLJDWRU PXVW UHYLHZ WKH &5)V IRU FRPSOHWHQHVV DQG DFFXUDF\ DQG PXVW
VLJQGDWHWKHIRUPVZKHUHLQGLFDWHG
7KH LQYHVWLJDWRU ZLOO UHWDLQ RULJLQDOV RI &5)V VXEMHFW FRQVHQW IRUPV DQG VWXG\ GDWD DV SHUPDQHQW
UHFRUGVIRUDSHULRGRI\HDUVRUXQWLOWKHGDWDLVQRORQJHUUHTXLUHGIRUUHJXODWRU\SXUSRVHVWKHORQJHVW
EHWZHHQWKHVHWZR


170HGLFDO&RQILGHQWLDO

3DJHRI


(OHFWURQLF&5)VPD\EHXVHGLQWKLVVWXG\7KHHOHFWURQLFGDWDFDSWXUH('&SURJUDPFRPSOLHVZLWK
&)5SDUW
 021,725,1*3/$1
&OLQLFDO0RQLWRULQJIRUWKLVVWXG\ZLOOEHPDQDJHGE\170HGLFDO7KH&OLQLFDO0RQLWRULVTXDOLILHG
E\WUDLQLQJDQGH[SHULHQFHWRRYHUVHHWKHFRQGXFWRIWKLVVWXG\7KH&OLQLFDO0RQLWRU¶VUHVSRQVLELOLWLHV
LQFOXGHPDLQWDLQLQJUHJXODUFRQWDFWZLWKHDFKLQYHVWLJDWLRQDOVLWHWKURXJKWHOHSKRQHHPDLOFRQWDFWDQG
RQVLWHYLVLWVWRHQVXUHWKDW
x 7KHWULDOLVFRQGXFWHGDFFRUGLQJWR)'$,&+*&3DQG(1,62UHTXLUHPHQWV
x 7KH,QYHVWLJDWLRQDO3ODQLVIROORZHG
x &RPSOHWHWLPHO\DQGDFFXUDWHGDWDDUHVXEPLWWHG
x 3UREOHPVZLWKLQFRQVLVWHQWRULQFRPSOHWHGDWDDUHDGGUHVVHG
x &RPSOLFDWLRQVDQGXQDQWLFLSDWHGDGYHUVHHIIHFWVDUHUHSRUWHGWRWKH6SRQVRUDQGWKH,5%
x 7KHVLWHIDFLOLWLHVZLOOEHPRQLWRUHGWRVWD\DGHTXDWHWRPHHWWKHUHTXLUHPHQWVRIWKHVWXG\
7KH&OLQLFDO0RQLWRUZLOOLQLWLDWHWKH6WXG\GXULQJDQRQVLWHYLVLWDQGZLOOFRQWLQXHWRSHUIRUPRQVLWH
PRQLWRULQJYLVLWVDVIUHTXHQWO\DVGHHPHGQHFHVVDU\7KHILUVWPRQLWRULQJYLVLWZLOOXVXDOO\EHPDGHDV
VRRQDVSRVVLEOHDIWHUHQUROOPHQWKDVEHHQLQLWLDWHG$WWKLVYLVLWDQGDOOPRQLWRULQJYLVLWVWKH&OLQLFDO
0RQLWRUZLOOFRPSDUHWKHGDWDHQWHUHGRQWRWKH&5)VZLWKWKHKRVSLWDORUFOLQLFDOUHFRUGVVRXUFH
GRFXPHQWV6RXUFHGRFXPHQWDWLRQPXVWEHDYDLODEOHWRVXEVWDQWLDWHSURSHULQIRUPHGFRQVHQW
SURFHGXUHVDGKHUHQFHWRSURWRFROSURFHGXUHVDGHTXDWHUHSRUWLQJDQGIROORZXSRI$(VDQGGHYLFH
SURFHGXUHLQIRUPDWLRQ)LQGLQJVIURPWKHUHYLHZRI&5)VDQGVRXUFHGRFXPHQWVGXULQJDPRQLWRULQJ
YLVLWZLOOEHGLVFXVVHGZLWKWKH3,&RPSOHWHGSDSHU&5)VZLOOEHUHYLHZHGSULRUWRGDWDFORVXUHDWHDFK
YLVLW7KHGDWHVRIWKHPRQLWRULQJYLVLWVZLOOEHUHFRUGHGLQD/RJWREHNHSWDWWKHFOLQLFDOVLWH'XULQJ
PRQLWRULQJYLVLWVWKH6SRQVRUH[SHFWVWKDWWKHVWXG\FRRUGLQDWRUDQGWKH3,ZLOOEHDYDLODEOHWKHVRXUFH
GRFXPHQWDWLRQZLOOEHDYDLODEOHDQGDVXLWDEOHHQYLURQPHQWZLOOEHSURYLGHGIRUUHYLHZRI6WXG\UHODWHG
GRFXPHQWV
0RQLWRULQJSURFHGXUHVZLOOIROORZWKH6SRQVRU623V
 ,19(67,*$7255(63216,%,/,7,(6
$OOSULQFLSDOLQYHVWLJDWRUVZLOOEHUHTXLUHGWRVLJQDQ,QYHVWLJDWRU$JUHHPHQW
 $0(1'0(176727+(35272&2/
1R DOWHUDWLRQV RU FKDQJHV WR WKLV SURWRFRO ZLOO EH SHUPLWWHG +RZHYHU VKRXOG WKHUH EH TXHVWLRQ RU
FRQVLGHUDWLRQ RI GHYLDWLRQ IURP WKH SURWRFRO FODULILFDWLRQ DQG DSSURYDO PXVW EH VRXJKW IURP WKH
VSRQVRU
3URWRFROPRGLILFDWLRQVPXVWEHFRQILUPHGLQZULWLQJSULRUWRLPSOHPHQWDWLRQ


170HGLFDO&RQILGHQWLDO

3DJHRI


 '(9,$7,21)5207+(678'<3/$1
$OOPDMRUSURWRFRODPHQGPHQWVPXVWEHDSSURYHGE\WKH(&,5%SULRUWRLPSOHPHQWDWLRQ
1RSURWRFRODPHQGPHQWVVKRXOGEHDGRSWHGZLWKRXWSULRUZULWWHQDSSURYDOIURPWKH,5%H[FHSWLQWKH
IROORZLQJFDVHV
x
,QRUGHUWRHOLPLQDWHLPPHGLDWHKD]DUGWRWKHVXEMHFWV
x
&KDQJHVLQYROYLQJRQO\ORJLVWLFDORUDGPLQLVWUDWLYHDVSHFWVRIWKHWULDO
7KH LQYHVWLJDWRU VKRXOG GRFXPHQW DQG H[SODLQ DQ\ GHYLDWLRQ IURP WKH DSSURYHG SURWRFRO DQG WR ILOH
ZDLYHUVUHFHLYHGIURPWKHVSRQVRULIDSSOLFDEOH7KHUHDVRQVIRULWDQGLIDSSURSULDWHWKHSURSRVHG
SURWRFRODPHQGPHQWVVKRXOGEHVXEPLWWHGWR
7KH6SRQVRUIRUDJUHHPHQW
7KH(&,5%
$Q\VXEMHFWWUHDWHGLQDPDQQHUWKDWGHYLDWHVIURPWKHSURWRFRORUZKRLVDGPLWWHGLQWRWKHVWXG\EXWLV
QRWHOLJLEOHDFFRUGLQJWRWKHSURWRFROPD\EHLQHOLJLEOHIRUDQDO\VLVDQGWKHUHE\FRPSURPLVHVWKHVWXG\
 '(9,&($&&2817$%,/,7<
170HGLFDOZLOOSURYLGHWKHVWXG\VLWHZLWK3HUHJULQHGHYLFHVDQGLPDJLQJUHFRUGLQJV\VWHPIRUWKH
GXUDWLRQ RI WKH VWXG\ 7KH V\VWHPV ZLOO EH PDUNHG ³IRU LQYHVWLJDWLRQDO XVH´ DQG WKH LQYHVWLJDWRU LV
UHVSRQVLEOHIRUVWRULQJWKHV\VWHPVLQDVHFXUHSODFHWRDYRLGXQDXWKRUL]HGXVH
,PPHGLDWHO\ XSRQ FRPSOHWLRQ RI WKH VWXG\ DOO V\VWHPV DQG XQXVHG LWHPV ZLOO EH UHWXUQHG WR 17
0HGLFDO
 98/1(5$%/(3238/$7,21
1RYXOQHUDEOHSRSXODWLRQZLOOEHLQFOXGHGLQWKLVVWXG\
 68%-(&7&21),'(17,$/,7<
6XEMHFW FRQILGHQWLDOLW\ ZLOO EH PDLQWDLQHG WKURXJKRXW WKLV VWXG\ LQFOXGLQJ DOO SXEOLFDWLRQV  'DWD
FROOHFWHGDQGHQWHUHGLQWRWKH&5)VDUHWKHSURSHUW\RIWKHVWXG\VSRQVRU5HSUHVHQWDWLYHVIURPWKH
VWXG\ VSRQVRU RU DXWKRUL]HG VSRQVRU UHSUHVHQWDWLYHV WKH ,QVWLWXWLRQDO 5HYLHZ %RDUG ,5% (WKLFV
&RPPLWWHH)'$PD\UHFHLYHFRSLHVRIWKHVWXG\UHFRUGVDQGPD\UHYLHZPHGLFDOUHFRUGVUHODWHGWRWKH
VWXG\
 68%-(&7:,7+'5$:$/25',6&217,18$7,21
$Q\SDWLHQWZLOOEHLQIRUPHGRIKLVULJKWWRZLWKGUDZIURPWKHVWXG\DWDQ\WLPHDQGIRUDQ\UHDVRQ


170HGLFDO&RQILGHQWLDO

3DJHRI


7KH ,QYHVWLJDWRU RU 6SRQVRU PD\ ZLWKGUDZDSDWLHQWIURPWKHVWXG\DWDQ\WLPHLIKHFRQVLGHUVWKDW
UHPDLQLQJLQWKHVWXG\FRPSURPLVHVWKHSDWLHQW¶VKHDOWKRUWKHSDWLHQWLVQRWVXIILFLHQWO\FRRSHUDWLYH
7KHUHDVRQVIRUDQ\SDWLHQWZLWKGUDZDOZLOOEHUHFRUGHGRQWKHVWXG\FRPSOHWLRQIRUPRIWKH&5)
7KHLQYHVWLJDWRUZLOOLQIRUPWKH6SRQVRULQZULWLQJRIWKHVXEMHFW
VHDUO\ZLWKGUDZDOIRUDQ\UHDVRQ
,IZLWKGUDZDOLVFDXVHGE\DQDGYHUVHHYHQWWKDWWKHLQYHVWLJDWRUFRQVLGHUVPD\EHUHODWHGWRWKHGHYLFH
LWZLOOEHUHSRUWHGWRWKH(&,5%DQGWRWKH6SRQVRU
 6863(16,212535(0$785(7(50,1$7,212)7+(678'<
7KH6SRQVRUUHVHUYHVWKHULJKWWRGLVFRQWLQXHWKHVWXG\DWDQ\WLPHIRUDQ\UHDVRQEDVHGRQEXWQRW
H[FOXVLYHO\WKHIROORZLQJFULWHULD
x 7HFKQLFDOSUREOHPVLQWKHGHYLFH
x 8QDQWLFLSDWHG6HULRXVDGYHUVHGHYLFHHIIHFW86$'(
x 7KH3ULQFLSDO,QYHVWLJDWRU
VRUWKH(WKLFV&RPPLWWHHUHFRPPHQGDWLRQ
x 3RRUSHUIRUPDQFHRUFRPSOLDQFHRIWKHFOLQLFDOVLWH
x &RPSDQ\FRQVLGHUDWLRQV
,QFDVHRISUHPDWXUHWHUPLQDWLRQRIWKHVWXG\WKH(WKLFV&RPPLWWHHZLOOEHGXO\LQIRUPHGDFFRUGLQJWR
WKHORFDOUHJXODWLRQV
 38%/,&$7,2132/,&<
$Q\SUHVHQWDWLRQSXEOLFDWLRQRIFRPSOHWHRUSDUWLDOVWXG\GDWDE\WKH,QYHVWLJDWRUVRUDQ\RWKHUSDUW\LV
VWLSXODWHGE\ZULWWHQDXWKRUL]DWLRQIURPWKHVSRQVRU
 5()5(1&(6
<.0*XSWD<1DVDO(QGRVFRS\9HUVXV2WKHU'LDJQRVWLF7RROVLQ6LQRQDVDO'LVHDVHV,QGLDQ-
2WRODU\QJRO+HDG1HFN6XUJ
0DUX<.*XSWD<1DVDO(QGRVFRS\9HUVXV2WKHU'LDJQRVWLF7RROVLQ6LQRQDVDO'LVHDVHV,QGLDQ-
2WRODU\QJRO+HDG1HFN6XUJ
5RVHQIHOG503LFFLULOOR-)&KDQGUDVHNKDU66%URRN,$VKRN.XPDU..UDPSHU0HWDO&OLQLFDO
SUDFWLFHJXLGHOLQHXSGDWHDGXOWVLQXVLWLV2WRODU\QJRORJ\KHDGDQGQHFNVXUJHU\RIILFLDOMRXUQDO
RI$PHULFDQ$FDGHP\RI2WRODU\QJRORJ\+HDGDQG1HFN6XUJHU\6XSSO66
 6RXGU\ ( 1D\DN -9 1DVDO (QGRVFRS\ $PHULFDQ 5KLQRORJLF 6RFLHW\  >$YDLODEOH IURP
KWWSFDUHDPHULFDQUKLQRORJLFRUJQDVDOBHQGRVFRS\


170HGLFDO&RQILGHQWLDO

3DJHRI


%XUWRQ0+DOO	&ROPDQ
V'LVHDVHVRIWKH(DU1RVHDQG7KURDW,QWHUQDWLRQDO(GLWLRQ&KXUFKLOO
/LYLQJVWRQ
 +HJD]\ + 0 &DUUDX 5 / 6Q\GHUPDQ & + .DVVDP $ 	 =ZHLJ -  7UDQVQDVDO
(QGRVFRSLF5HSDLURI&HUHEURVSLQDO)OXLG5KLQRUUKHD$0HWDဨ$QDO\VLV7KH/DU\QJRVFRSH

&ROOLQV:2$UHYLHZRIUHSURFHVVLQJWHFKQLTXHVRIIOH[LEOHQDVRSKDU\QJRVFRSHV2WRODU\QJRORJ\
KHDGDQGQHFNVXUJHU\RIILFLDOMRXUQDORI$PHULFDQ$FDGHP\RI2WRODU\QJRORJ\+HDGDQG1HFN
6XUJHU\
 &DYDOLHUH 0 ,HPPD 0 *XLGHOLQHV IRU UHSURFHVVLQJ QRQOXPHQHG KHDWVHQVLWLYH HDUQRVHWKURDW
HQGRVFRSHV7KH/DU\QJRVFRSH
-DYHG)6RRG6%DQILHOG*'HFRQWDPLQDWLRQPHWKRGVIRUIOH[LEOHQDVDOHQGRVFRSHV%U-1XUV

-RVHI 6KDUJRURGVN\ 0' 03+ HW DO :KDW LV WKH 5ROH RI 1DVDO
(QGRVFRS\LQWKH'LDJQRVLVRI&KURQLF5KLQRVLQXVLWLV"7KH/DU\QJRVFRSH7KH$PHULFDQ
/DU\QJRORJLFDO5KLQRORJLFDODQG2WRORJLFDO6RFLHW\,QF
 : +RVHPDQQ & 'UDI   'DQJHU SRLQWV FRPSOLFDWLRQV DQG PHGLFROHJDO DVSHFWV LQ
HQGRVFRSLFVLQXVVXUJHU\+HDGDQG1HFN6XUJHU\9RO
.DVVDP$%3UHYHGHOOR'0&DUUDX5/6Q\GHUPDQ&+7KRPDV$*DUGQHU3	
+RURZLW]0%(QGRVFRSLFHQGRQDVDOVNXOOEDVHVXUJHU\DQDO\VLVRIFRPSOLFDWLRQVLQWKH
DXWKRUV
LQLWLDOSDWLHQWVDUHYLHZ-RXUQDORIQHXURVXUJHU\
 .UDPHU $ .RKQHQ : ,VUDHO 6 5\OO 6 +EQHU 1 2 /XFNKDXSW + 	 +RVHPDQQ :
3ULQFLSOHVRILQIHFWLRQSUHYHQWLRQDQGUHSURFHVVLQJLQ(17HQGRVFRS\*06FXUUHQWWRSLFV
LQRWRUKLQRODU\QJRORJ\KHDGDQGQHFNVXUJHU\
'DO]LHO.6WHLQ.5RXQG$*DUVLGH5	5R\OH3(QGRVFRSLFVLQXVVXUJHU\IRUWKH
H[FLVLRQ RI QDVDO SRO\SV $ V\VWHPDWLF UHYLHZ RI VDIHW\ DQG HIIHFWLYHQHVV $PHULFDQ MRXUQDO RI
UKLQRORJ\
 9OHPLQJ 0 0LGGHOZHHUG 5 - 	 GH 9ULHV 1  &RPSOLFDWLRQV RI HQGRVFRSLF VLQXV
VXUJHU\$UFKLYHVRI2WRODU\QJRORJ\±+HDG	1HFN6XUJHU\
0RUL$2KDVKL10DUX\DPD7,WR00L\DZDNL7	2NXQR0$SURSRVDOIRU
JUDGLQJQDVRPXFRVDOLQMXU\DVDFRPSOLFDWLRQRIWUDQVQDVDOHQGRVFRS\(QGRVFRS\6(
(
 5RPERXW - 	 GH 9ULHV 1  &RPSOLFDWLRQV LQ VLQXV VXUJHU\ DQG QHZ FODVVLILFDWLRQ
SURSRVDO$PHULFDQMRXUQDORIUKLQRORJ\
 3ODWW 03 6KD\H ' 	 3DUQHV 6 0  0DQDJHPHQW RI XQH[SHFWHG FHUHEURVSLQDO IOXLG
ILVWXODHGXULQJHQGRVFRSLFVLQXVVXUJHU\$PHULFDQMRXUQDORIUKLQRORJ\
%DFKPDQQ*'MHQDEL8-XQJHKOVLQJ03HWHUHLW+	0LFKHO2,QFLGHQFHRIRFFXOW
FHUHEURVSLQDO IOXLG ILVWXOD GXULQJ SDUDQDVDO VLQXV VXUJHU\ $UFKLYHV RI 2WRODU\QJRORJ\±+HDG 	
1HFN6XUJHU\
&DVLDQR55	-DVVLU'(QGRVFRSLFFHUHEURVSLQDOIOXLGUKLQRUUKHDUHSDLULVDOXPEDU
GUDLQQHFHVVDU\"2WRODU\QJRORJ\+HDGDQG1HFN6XUJHU\


170HGLFDO&RQILGHQWLDO

3DJHRI


'HO*DXGLR-0	,QJOH\$37UHDWPHQWRISQHXPRFHSKDOXVDIWHUHQGRVFRSLFVLQXVDQG
PLFURVFRSLFVNXOOEDVHVXUJHU\$PHULFDQMRXUQDORIRWRODU\QJRORJ\
 :DUQHFNH $ $YHUEHFN 7 :XUVWHU 8 +DUPHQLQJ 0 /HQDU] 7 	 6W|YHU 7 
'LDJQRVWLFUHOHYDQFHRIȕ7UDQVIHUULQIRUWKHGHWHFWLRQRIFHUHEURVSLQDOIOXLGILVWXODV$UFKLYHVRI
2WRODU\QJRORJ\±+HDG	1HFN6XUJHU\
%KDWWL07	6WDQNLHZLF]-$2SKWKDOPLFFRPSOLFDWLRQVRIHQGRVFRSLFVLQXVVXUJHU\
6XUYH\RIRSKWKDOPRORJ\
 5DPDNULVKQDQ 9 5 	 3DOPHU - 1  3UHYHQWLRQ DQG PDQDJHPHQW RI RUELWDO
KHPDWRPD2WRODU\QJRORJLF&OLQLFVRI1RUWK$PHULFD


