Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients With Moderate or Severe Hidradenitis Suppurativa (HS) After 6 Months on Adalimumab Treatment (HOPE Study)
Conditions: Hidradenitis Suppurativa
Sponsor: AbbVie

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

$EE9LH,QF
30263URWRFRO3
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\RI/LIH&KDQJHVLQ6ZHGLVK
3DWLHQWVZLWK0RGHUDWHRU6HYHUH+LGUDGHQLWLV6XSSXUDWLYDDIWHU0RQWKVRQ
$GDOLPXPDE7UHDWPHQW+23(VWXG\
$PHQGPHQW
)HEUXDU\
7KHSXUSRVHRIWKLV$PHQGPHQWLVWR
x
([WHQG(QUROOPHQW3HULRG
x
$GGLQWHULPDQDO\VLV
x
,QFRUSRUDWH$GPLQLVWUDWLYH&KDQJH
&RQILGHQWLDO,QIRUPDWLRQ
1RXVHRUGLVFORVXUHRXWVLGH$EE9LHLVSHUPLWWHGZLWKRXWSULRUZULWWHQDXWKRUL]DWLRQIURP$EE9LH
1&7

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

6HFWLRQ$EVWUDFW
3UHYLRXVO\UHDG
0LOHVWRQHV
6WDUWRIGDWDFROOHFWLRQ3ODQQHG4
(QGRIGDWDFROOHFWLRQ3ODQQHG4
)LQDO5HSRUWRI6WXG\5HVXOWV3ODQQHG4
+DVEHHQFKDQJHGWRUHDG
0LOHVWRQHV
6WDUWRIGDWDFROOHFWLRQ3ODQQHG4
(QGRIGDWDFROOHFWLRQ3ODQQHG4
)LQDO5HSRUWRI6WXG\5HVXOWV3ODQQHG4

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

6HFWLRQ0LOHVWRQHV
3UHYLRXVO\UHDG
0DMRUVWXG\PLOHVWRQHVDQGWKHLUSODQQHGGDWHVDUHDVIROORZV

6WDUWRI'DWD&ROOHFWLRQ 



3ODQQHG4

(QGRI'DWD&ROOHFWLRQ




3ODQQHG4

)LQDO5HSRUWRI6WXG\5HVXOWV 


3ODQQHG4
+DVEHHQFKDQJHGWRUHDG
0DMRUVWXG\PLOHVWRQHVDQGWKHLUSODQQHGGDWHVDUHDVIROORZV
6WDUWRI'DWD&ROOHFWLRQ
3ODQQHG4
(QGRI'DWD&ROOHFWLRQ
3ODQQHG4
)LQDO5HSRUWRI6WXG\5HVXOWV
3ODQQHG4

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

6HFWLRQ'DWD$QDO\VLV
3UHYLRXVO\UHDG
$OOVWDWLVWLFDODQDO\VHVZLOOEHSHUIRUPHGDW6FDQGLQDYLDQ'HYHORSPHQW6HUYLFHV$%
6'6'DQGHU\G6ZHGHQXVLQJ6$69HUVLRQRUKLJKHU6$6,QVWLWXWH,QF&DU\
1&86$
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVQPHDQ6'PLQ
4PHGLDQ4PD[&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGLQIUHTXHQF\WDEOHV
IUHTXHQF\DQGSURSRUWLRQ*UDSKLFDOSUHVHQWDWLRQVHJGHVFULELQJWKHFKDQJHRYHUWLPH
ZLOOEHXVHGDVDSSURSULDWHDQGLQGLYLGXDOSDWLHQWGDWDZLOOEHOLVWHG
7KHSULPDU\DQGVHFRQGDU\HQGSRLQWVFKDQJHLQ'/4,3DWLHQW
V*OREDO$VVHVVPHQWRI
6NLQ3DLQ156+6,$+L6&5(4':3$,6+3DWDQGZHHNVZLOOEH
DQDO\]HGXVLQJWWHVWRUQRQSDUDPHWULFPHWKRGVVXFKDV:LOFR[RQVLJQHGUDQNWHVWDV
DSSURSULDWH7KHFKDQJHDWZHHNVZLOOEHRISULPDU\LQWHUHVW
1RDGMXVWPHQWIRUPXOWLSOHFRPSDULVRQVZLOOEHPDGH
$PRUHGHWDLOHG6WDWLVWLFDO$QDO\VLV3ODQ6$3ZLOOEHZULWWHQDQGILQDOL]HGEHIRUH
GDWDEDVHORFN
+DVEHHQFKDQJHGWRUHDG
$OOVWDWLVWLFDODQDO\VHVZLOOEHSHUIRUPHGDW6FDQGLQDYLDQ'HYHORSPHQW6HUYLFHV$%
6'6'DQGHU\G6ZHGHQXVLQJ6$69HUVLRQRUKLJKHU6$6,QVWLWXWH,QF&DU\
1&86$
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVQPHDQ6'PLQ
4PHGLDQ4PD[&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGLQIUHTXHQF\WDEOHV
IUHTXHQF\DQGSURSRUWLRQ*UDSKLFDOSUHVHQWDWLRQVHJGHVFULELQJWKHFKDQJHRYHUWLPH
ZLOOEHXVHGDVDSSURSULDWHDQGLQGLYLGXDOSDWLHQWGDWDZLOOEHOLVWHG

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

7KHSULPDU\DQGVHFRQGDU\HQGSRLQWVFKDQJHLQ'/4,3DWLHQW
V*OREDO$VVHVVPHQWRI
6NLQ3DLQ156+6,$+L6&5(4':3$,6+3DWDQGZHHNVZLOOEH
DQDO\]HGXVLQJWWHVWRUQRQSDUDPHWULFPHWKRGVVXFKDV:LOFR[RQVLJQHGUDQNWHVWDV
DSSURSULDWH7KHFKDQJHDWZHHNVZLOOEHRISULPDU\LQWHUHVW
1RDGMXVWPHQWIRUPXOWLSOHFRPSDULVRQVZLOOEHPDGH
$QLQWHULPDQDO\VLVLVSODQQHGWREHSHUIRUPHGGXULQJ41RIRUPDOVWDWLVWLFDOWHVWV
ZLOOEHSHUIRUPHGRQWKHLQWHULPGDWD
$PRUHGHWDLOHG6WDWLVWLFDO$QDO\VLV3ODQ6$3ZLOOEHZULWWHQDQGILQDOL]HGEHIRUH
LQWHULPGDWDEDVHORFNDQGILQDOGDWDEDVHORFN

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

6HFWLRQ$SSHQGL[$GPLQLVWUDWLYH&KDQJH±6XPPDU\RI&KDQJHV
3UHYLRXVO\UHDG
>QRQH@
+DVEHHQFKDQJHGWRUHDG
$SSHQGL[ $GPLQLVWUDWLYH&KDQJH6XPPDU\RI&KDQJHV
7KHSXUSRVHRIWKH$GPLQLVWUDWLYH&KDQJHGDWHG0D\ZDVWR
x
8SGDWHWKHSURWRFROWRUHIOHFWWKDWSDSHU&5)DQGQRWH&5)LVXVHGLQWKHVWXG\
x
8SGDWHWKHSURWRFROWRUHIOHFWWKDW3KDUPDFRYLJLODQFHZLOOQRORQJHUUHFHLYH6$(
UHSRUWVYLDID[LQJ
x
&RUUHFWW\SRV

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

6HFWLRQ6LJQDWXUH3DJH
3UHYLRXVO\UHDG
$EE9LH,QF$EE9LH
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\
3URWRFRO3
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\RI/LIH&KDQJHV
LQ6ZHGLVK3DWLHQWVZLWK0RGHUDWHRU6HYHUH+LGUDGHQLWLV6XSSXUDWLYD
DIWHUPRQWKVRQ$GDOLPXPDE7UHDWPHQW+23(VWXG\
$SSURYHGE\
3URWRFRO$XWKRU±


'DWH
3URWRFRO$XWKRU±


'DWH
6WXG\'HVLJQDWHG3K\VLFLDQ±


'DWH
6WDWLVWLFV5HSUHVHQWDWLYH±
6FDQGLQDYLDQ
'HYHORSPHQW6HUYLFHV

'DWH
3URMHFW'LUHFWRU±

'DWH

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

+DVEHHQFKDQJHGWRUHDG
$EE9LH,QF$EE9LH
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\
3URWRFRO3
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\RI/LIH&KDQJHV
LQ6ZHGLVK3DWLHQWVZLWK0RGHUDWHRU6HYHUH+LGUDGHQLWLV6XSSXUDWLYD
DIWHUPRQWKVRQ$GDOLPXPDE7UHDWPHQW+23(VWXG\
$SSURYHGE\
3URWRFRO$XWKRU±


'DWH
3URWRFRO$XWKRU7KHUDSHXWLF$UHD0HGLFDO'LUHFWRU±

'DWH
6WDWLVWLFV5HSUHVHQWDWLYH±
6FDQGLQDYLDQ
'HYHORSPHQW6HUYLFHV

'DWH
3URMHFW'LUHFWRU±

'DWH

$GDOLPXPDE
33URWRFRO
$PHQGPHQW±)HEUXDU\

$FNQRZOHGJPHQWRIWKH3ULQFLSDO,QYHVWLJDWRU

,KDYHUHDGWKLV$GPLQLVWUDWLYH&KDQJHWRWKHSURWRFRODQGDJUHHWKDWWKHVWXG\LV
HWKLFDO

,DJUHHWRFRQGXFWWKHVWXG\DVRXWOLQHGDQGLQDFFRUGDQFHZLWKDOODSSOLFDEOH
UHJXODWLRQVDQGJXLGHOLQHV

,DJUHHWRPDLQWDLQWKHFRQILGHQWLDOLW\RIDOOLQIRUPDWLRQUHFHLYHGRUGHYHORSHGLQ
FRQQHFWLRQZLWKWKLVSURWRFRO
3URWRFRO7LWOH
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\
RI/LIH&KDQJHVLQ6ZHGLVK3DWLHQWVZLWK0RGHUDWHRU
6HYHUH+LGUDGHQLWLV6XSSXUDWLYDDIWHU0RQWKVRQ
$GDOLPXPDE7UHDWPHQW+23(VWXG\
$PHQGPHQW'DWH
)HEUXDU\









6LJQDWXUHRI3ULQFLSDO,QYHVWLJDWRU

'DWH






1DPHRI3ULQFLSDO,QYHVWLJDWRUSULQWHGRUW\SHG






$GDOLPXPDE
33URWRFRO

7LWOH3DJH
7LWOH
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\RI
/LIH&KDQJHVLQ6ZHGLVK3DWLHQWVZLWK0RGHUDWHRU6HYHUH
+LGUDGHQLWLV6XSSXUDWLYDDIWHU0RQWKVRQ$GDOLPXPDE
7UHDWPHQW+23(VWXG\
3URWRFRO9HUVLRQ
,GHQWLILHU
9HUVLRQ
'DWHRI/DVW9HUVLRQRI
3URWRFRO
 2FWREHU
0DUNHWLQJ
$XWKRULVDWLRQ+ROGHUV
$EE9LH
5HVHDUFK4XHVWLRQDQG
2EMHFWLYHV
7KHREMHFWLYHRIWKLV3026LVWRSURYLGHQDWLRQDOGDWDRQ
4XDOLW\RI/LIHFKDQJHVLQ6ZHGLVKSDWLHQWVZLWKPRGHUDWH
DQGVHYHUH+6WUHDWHGZLWKDGDOLPXPDEDVSHUVWDQGDUG
FOLQLFDOFDUH
&RXQWU\LHVRI6WXG\
6ZHGHQ
$XWKRUV
$EE9LH
$%
$IILOLDWH5HVHDUFK
$EE9LH$%
7KLVVWXG\ZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKLVSURWRFRO
&RQILGHQWLDO,QIRUPDWLRQ
1RXVHRUGLVFORVXUHRXWVLGH$EE9LHLVSHUPLWWHGZLWKRXWSULRUZULWWHQDXWKRUL]DWLRQIURP$EE9LH
1&7

$GDOLPXPDE
33URWRFRO

0DUNHWLQJ$XWKRULVDWLRQ+ROGHUV
0DUNHWLQJ$XWKRULVDWLRQ+ROGHUV
$EE9LH $%
%R[
66ROQD
6ZHGHQ

$GDOLPXPDE
33URWRFRO


7DEOHRI&RQWHQWV
1.0 
Table of Contents ............................................................................................. 3 
2.0 
Abbreviations................................................................................................... 5 
3.0 
Responsible Parties .......................................................................................... 5 
4.0 
Abstract ........................................................................................................... 6 
5.0 
Amendments and Updates ............................................................................... 8 
6.0 
Milestones ....................................................................................................... 8 
7.0 
Background and Rationale ................................................................................ 9 
7.1 
+LGUDGHQLWLV6XSSXUDWLYD ...................................................................................... 9 
7.2 
Treatments .......................................................................................................... 10 
7.2.1 
Current treatments ................................................................................................... 10 
7.2.2 
$GDOLPXPDE .............................................................................................................. 10 
7.3 
Rationale ............................................................................................................. 13 
8.0 
Research Question and Objectives .................................................................. 14 
9.0 
Research Methods ......................................................................................... 14 
9.1 
Study Design ........................................................................................................ 14 
9.1.1 
Study Flow Chart ....................................................................................................... 15 
9.2 
Setting ................................................................................................................. 15 
9.2.1 
Inclusion criteria ........................................................................................................ 16 
9.2.2 
Exclusion criteria ....................................................................................................... 16 
9.3 
Variables .............................................................................................................. 16 
9.3.1 
Demographic/baseline data ...................................................................................... 16 
9.3.2 
Quality of Life Scales ................................................................................................. 17 
9.3.3 
Skin Pain .................................................................................................................... 17 
9.3.4 
Work Productivity ..................................................................................................... 18 
9.3.5 
Clinical Effectiveness ................................................................................................. 18 
9.3.6 
Safety Parameters ..................................................................................................... 18 
9.4 
Data Sources ........................................................................................................ 18 
9.5 
Study Size ............................................................................................................. 19 
9.6 
Data Management................................................................................................ 19 
9.7 
Data Analysis........................................................................................................ 20 
9.8 
Quality Control ..................................................................................................... 21 
9.9 
Limitations of the Research Methods .................................................................... 21 
9.10 
Other Aspects....................................................................................................... 21 
10.0
Protection of Human Subjects ........................................................................ 21
10.1 
Ethical Conduct of the Study ................................................................................. 21 

$GDOLPXPDE
33URWRFRO

10.2 
Independent Ethics Committee (IEC) ..................................................................... 22 
10.3 
Patient Information and Consent .......................................................................... 22 
11.0 
Management and Reporting of Complaints ..................................................... 22 
11.1 
Medical Complaints .............................................................................................. 23 
11.1.1 
Adverse Event Definition and Serious Adverse Event Categories ........................ 23 
11.1.2 
Severity ................................................................................................................. 24 
11.1.3 
Relationship to Pharmaceutical Product .............................................................. 25 
11.1.4 
Serious Adverse Event Collection Period .............................................................. 25 
11.1.5 
Serious Adverse Event Reporting .......................................................................... 25 
11.1.6 
Pregnancy Reporting ............................................................................................. 26 
11.2 
Product Complaint ............................................................................................... 26 
11.2.1 
Definition .............................................................................................................. 26 
11.2.2 
Reporting .............................................................................................................. 27 
12.0 
Plans for Disseminating and Communicating Study Results ............................. 28 
13.0 
References ..................................................................................................... 29 
Appendix 1. 
Dermatology Life Quality Index (DLQI) – Example ................................ 31 
Appendix 2. 
Patient’s Global Assessment of Skin Pain – NRS – Example .................. 33 
Appendix 3 
 EuroQol (EQ-5D) – Example ................................................................ 34 
Appendix 4  
Hidradenitis Suppurativa Impact Assessment  (HSIA) – Example .......... 36 
Appendix 5 
 Work Productivity and Activity Impairment     Questionnaire: Specific 
Health Problem (WPAI:SHP) - Example ...................................................................... 41 

$GDOLPXPDE
33URWRFRO


$EEUHYLDWLRQV
$(
$GYHUVH(YHQW
%0,
%RG\0DVV,QGH[
&5)
&DVH5HSRUW)RUP
'/4,
'HUPDWRORJ\/LIH4XDOLW\,QGH[
(4
(XUR4RO
*&3
*RRG&OLQLFDO3UDFWLFH
+L6&5
+LGUDGHQLWLV6XSSXUDWLYD &OLQLFDO5HVSRQVH
+6
+LGUDGHQWLV6XSSXUDWLYD
+6,$
+LGUDGHQLWLV6XSSXUDWLYD,PSDFW$VVHVVPHQW
,(&
,QGHSHQGHQW(WKLFV&RPPLWWHH
156
1XPHULFDO5DWLQJ6FDOH
3&*
3KDUPD&RQVXOWLQJ*URXS
4R/
4XDOLW\RI/LIH
6$(
6HULRXV$GYHUVH(YHQW
6'3
6WXG\'HVLJQDWHG3K\VLFLDQ
6P3&
6XPPDU\RI3URGXFW&KDUDFWHULVWLFV
71)
7XPRU1HFURVLV)DFWRU
:3$,6+3
:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW4XHVWLRQQDLUH6SHFLILF+HDOWK
3UREOHP

5HVSRQVLEOH3DUWLHV
&RQWDFWGHWDLOVDQGDOLVWRILQYHVWLJDWRUVZLOOEHNHSWDW$EE9LHDQGZLOOEHDYDLODEOH
XSRQUHTXHVW

$GDOLPXPDE
33URWRFRO


$EVWUDFW
7LWOH
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\WR$VVHVV4XDOLW\RI/LIH&KDQJHVLQ6ZHGLVK
3DWLHQWVZLWK0RGHUDWHRU6HYHUH+LGUDGHQLWLV6XSSXUDWLYDDIWHU0RQWKVRQ
$GDOLPXPDE7UHDWPHQW+23(VWXG\
5DWLRQDOHDQG%DFNJURXQG
+6KDVDKXJHLPSDFWRQWKHSDWLHQWV¶4XDOLW\RI/LIH&RPSDUHGWRRWKHU
GHUPDWRORJLFDOGLVHDVHVHJDFQHSVRULDVLVDWRSLFHF]HPDDQGVNLQWXPRUVWKH
LPSDFWPHDVXUHGE\WKH'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,LVVLJQLILFDQWO\
JUHDWHU$OWKRXJKWKLVLVVKRZQLQVWXGLHVIURPGLIIHUHQWSDUWVRIWKHZRUOGWKHUHLVRQO\
OLPLWHGLQIRUPDWLRQDYDLODEOH RQ WKH4XDOLW\RI/LIHLQ6ZHGLVK+6SDWLHQWV DQGWKHUH
DUHQRQDWLRQDOUHJLVWULHVFDSWXULQJWKLVLQIRUPDWLRQ
5HVHDUFK4XHVWLRQDQG2EMHFWLYHV
7KHREMHFWLYHRIWKLVREVHUYDWLRQDOVWXG\LVWR DVVHVV 4R/VNLQSDLQZRUN
SURGXFWLYLW\DFWLYLW\DQGKHDOWKUHODWHGSUREOHPVLQ6ZHGLVKSDWLHQWVZLWKPRGHUDWHWR
VHYHUH+6EHIRUHDQGDIWHUPRQWKVWUHDWPHQWZLWK$GDOLPXPDE7KHSDWLHQWVZLOOEH
WUHDWHGLQDFFRUGDQFHZLWKQRUPDOURXWLQHFOLQLFDOFDUH
6WXG\'HVLJQ
3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\3026
3RSXODWLRQ
$GXOWSDWLHQWVZLWKDGLDJQRVLVRI+LGUDGHQWLV 6XSSXUDWLYD
7KHSDWLHQWVZLOOEHWUHDWHGLQDFFRUGDQFHZLWKQRUPDOURXWLQHFDUHDQGWKHGUXJZLOOEH
SUHVFULEHGLQDFFRUGDQFHZLWKWKHDSSURYHGODEHOLQJ6XPPDU\RI3URGXFW
&KDUDFWHULVWLFV
9DULDEOHV
x
'HPRJUDSKLFEDVHOLQHGDWD
x
'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,
x
(XUR4RO(4'
x
3DWLHQW
V*OREDO$VVHVVPHQWRI6NLQ3DLQ156
x
+LGUDGHQLWLV6XSSXUDWLYD,PSDFW$VVHVVPHQW+6,$
x
:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW4XHVWLRQQDLUH6SHFLILF+HDOWK
3UREOHP:3$,6+3
x
+LGUDGHQLWLV6XSSXUDWLYD&OLQLFDO5HVSRQVH+L6&5

$GDOLPXPDE
33URWRFRO

x
6HULRXV$GYHUVH(YHQWV
'DWD6RXUFHV
'DWDZLOOEHFROOHFWHGIURPWKHSDWLHQW¶VPHGLFDOUHFRUGVE\LQYHVWLJDWRUDVVHVVPHQW
DQGE\SDWLHQWTXHVWLRQQDLUHV (OHFWURQLF&DVH5HSRUW)RUPVH&5)ZLOOEHXVHG IRU
HDFKSDWLHQWHQUROOHGLQWKLVVWXG\7KHVHIRUPVZLOOEHXVHGWRWUDQVPLWLQIRUPDWLRQ
FROOHFWHGGXULQJWKHVWXG\WR$EE9LH
6WXG\6L]H Q 
'DWD$QDO\VLV
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVQPHDQ6'
PLQ4PHGLDQ4PD[&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGLQIUHTXHQF\
WDEOHVIUHTXHQF\DQGSURSRUWLRQ*UDSKLFDOSUHVHQWDWLRQVHJGHVFULELQJWKHFKDQJH
RYHUWLPHZLOOEHXVHGDVDSSURSULDWHDQGLQGLYLGXDOSDWLHQWGDWDZLOOEHOLVWHG
7KHSULPDU\DQGVHFRQGDU\HQGSRLQWVFKDQJHLQ'/4,3DWLHQW
V*OREDO$VVHVVPHQWRI
6NLQ3DLQ156+6,$+L6&5(4':3$,6+3DWDQGZHHNVZLOOEH
DQDO\]HGXVLQJWWHVWRUQRQSDUDPHWULFPHWKRGVVXFKDV:LOFR[RQVLJQHGUDQNWHVWDV
DSSURSULDWH
0LOHVWRQHV
6WDUWRIGDWDFROOHFWLRQ3ODQQHG4
(QGRIGDWDFROOHFWLRQ3ODQQHG4
)LQDO5HSRUWRI6WXG\5HVXOWV3ODQQHG4

$GDOLPXPDE
33URWRFRO


$PHQGPHQWVDQG8SGDWHV
1RQH

0LOHVWRQHV
0DMRUVWXG\PLOHVWRQHVDQGWKHLUSODQQHGGDWHVDUHDVIROORZV
6WDUWRI'DWD&ROOHFWLRQ
3ODQQHG4
(QGRI'DWD&ROOHFWLRQ
3ODQQHG4
)LQDO 5HSRUWRI6WXG\5HVXOWV
3ODQQHG4

$GDOLPXPDE
33URWRFRO


%DFNJURXQGDQG5DWLRQDOH

+LGUDGHQLWLV6XSSXUDWLYD
+LGUDGHQLWLV6XSSXUDWLYD+6 DOVRNQRZQDVDFQHLQYHUVD LVDSDLQIXOFKURQLFVNLQ
GLVHDVHFKDUDFWHUL]HGE\UHFXUUHQWLQIODPHGQRGXOHVDQGDEVFHVVHVZKLFKPD\UXSWXUHWR
IRUPILVWXODVDQGVXEVHTXHQWVFDUULQJ7KHPRVWFRPPRQO\LQYROYHGDQDWRPLFORFDWLRQV
DUHWKH D[LOODU\DQGVXEPDPPDU\IROGVWKHLQJXLQRFUXUDOWKHJOXWHDODQGSHULQHDODUHDV
+6 KDVDVHYHUHO\QHJDWLYHHIIHFWRQSDWLHQWVTXDOLW\RIOLIH ,WW\SLFDOO\SUHVHQWVZLWK
SDLQIXOGHHSVHDWHGQRGXOHVZKLFKHLWKHUUHVROYHVSRQWDQHRXVO\SHUVLVWDVQRQWHQGHU
QRGXOHVRUSURJUHVVWRIRUPDEVFHVVHV$EVFHVVHVW\SLFDOO\UXSWXUHDQGUHOHDVHSXUXOHQW
GUDLQDJH$EVFHVVHVDQGQRGXOHVPD\KHDOZLWKVFDUULQJDQGWKHIRUPDWLRQRIILVWXODVRU
VLQXVWUDFWV7KXVPDQ\SDWLHQWVZLWK+6GHYHORSSHUPDQHQWVHTXHODHRISDVW
LQIODPPDWLRQWKDWDUHRQO\UHPHGLDEOHWKURXJKVXUJLFDOH[FLVLRQRIWKHLQYROYHGVNLQ
DUHDV7KHSK\VLFDODQGSV\FKRVRFLDOPRUELGLW\DVVRFLDWHGZLWKHQEORFH[FLVLRQRI
VFDUUHGD[LOODU\LQJXLQDORUJURLQVNLQLVVXEVWDQWLDO5DUHFRPSOLFDWLRQVRI+6LQFOXGH
ILVWXODIRUPDWLRQLQWRXUHWKUDEODGGHUUHFWXPRUSHULWRQHXPO\PSKHGHPDRIWKHOLPEV
RUVFURWDOHOHSKDQWLDVLVDQGVTXDPRXVFHOOFDUFLQRPDVRIWKHVNLQRULJLQDWLQJIURP+6
OHVLRQV
+6 DIIHFWVDSSUR[LPDWHO\ RIWKHJHQHUDOSRSXODWLRQ  'LVHDVHRQVHWLVW\SLFDOO\DIWHU
SXEHUW\'LVHDVHSUHYDOHQFHGHFUHDVHVIURPLQWKRVH \HDUVRIDJHWRLQ
WKRVHROGHUWKDQ\HDUVRIDJH,WDIIHFWVZRPHQIURP WRWLPHVPRUHFRPPRQO\WKDQ
PHQ6HYHUDOIDFWRUVPD\SUHGLVSRVHDSHUVRQWR+6LQFOXGLQJJHQHWLFVFLJDUHWWH
VPRNLQJDQGREHVLW\
+6LVDFOLQLFDOGLDJQRVLVWKHUHDUHQRVSHFLILFODERUDWRU\WHVWLQJRUKLVWRSDWKRORJLFDO
IHDWXUHV7KHVHYHULW\LVRIWHQFODVVLILHGDFFRUGLQJWR+XUOH\ 
x
6WDJH,$EVFHVVIRUPDWLRQVLQJOHRUPXOWLSOHZLWKRXWVLQXVWUDFWVDQG
FLFDWULVDWLRQ
x
6WDJH,,5HFXUUHQWDEVFHVVHVZLWKWUDFWIRUPDWLRQDQGFLFDWULVDWLRQVLQJOHRU
PXOWLSOHZLGHO\VHSDUDWHGOHVLRQV
x
6WDJH,,,'LIIXVHRUQHDUGLIIXVHLQYROYHPHQWRUPXOWLSOHLQWHUFRQQHFWHGWUDFWV
DQGDEVFHVVHVDFURVVWKHHQWLUHDUHD

$GDOLPXPDE
33URWRFRO

6WDJH,GLVHDVHRFFXUVLQRISDWLHQWVVWDJH,,LQRISDWLHQWVZKLOHRI+6
SDWLHQWVKDYHVWDJH,,,

7UHDWPHQWV

&XUUHQWWUHDWPHQWV
$GDOLPXPDE LVWKHILUVWSKDUPDFHXWLFDOSURGXFWDSSURYHGIRUWKHWUHDWPHQWRI+6DQGQR
WUHDWPHQWJXLGHOLQHVKDYHEHHQSXEOLVKHGDIWHUWKHDSSURYDO$VZLWKRWKHUGHUPDWRORJLFDO
GLVHDVHVZLWKRQO\DIHZRUQRDSSURYHGPHGLFDWLRQVWKHWUHDWPHQWRI+6KDVPDLQO\
EHHQEDVHGRQWULDODQGHUURUFOLQLFDOH[SHULHQFHFDVHUHSRUWVVHULHVDQGVPDOO5&7V
$FFRUGLQJWRWKH(XURSHDQ6+6*XLGHOLQHVSXEOLVKHGLQ$SULO+6WUHDWPHQW
VKRXOGEHEDVHGRQWKHLQGLYLGXDOVXEMHFWLYHLPSDFWDQGWKHREMHFWLYHVHYHULW\ +XUOH\
VWDJLQJLVUHFRPPHQGHGWREHXVHGDVEDVLVIRUWKHWUHDWPHQWDOJRULWKP
&ODVVLFVXUJHU\RU/$6(5VXUJHU\PD\EHXVHGRQPLOGHUIRUPVZLWKORFDO+6OHVLRQV
ZKLOHPHGLFDOWUHDWPHQWSRVVLEO\LQFRPELQDWLRQZLWKUDGLFDOVXUJHU\LVUHFRPPHQGHG
IRUPRGHUDWHWRVHYHUHFDVHVZLWKZLGHVSUHDGOHVLRQV0HGLFDOWUHDWPHQWPD\LQFOXGH
WRSLFDODQWLELRWLFVWRSLFDOFOLQGDP\FLQRUV\VWHPLFDQWLELRWLFVHLWKHUDVPRQRWKHUDS\
WHWUDF\FOLQRUFOLQGDP\FLQRUDVDFRPELQDWLRQRIWZRDQWLELRWLFVFOLQGDP\FLQDQG
ULIDPSLFLQ$FLWUHWLQDQGELRORJLFVDUHDOVRLQFOXGHGLQWKH*XLGHOLQHVDVSRVVLEOH
PHGLFDOWUHDWPHQWV$GMXYDQWWUHDWPHQW VXFKDVDSSURSULDWHGUHVVLQJVSDLQFRQWURO
ZHLJKWORVVDQGWREDFFRDEVWLQHQFHVKRXOGDOVREHFRQVLGHUHGDFFRUGLQJWRWKHFOLQLFDO
FRQGLWLRQDQGQHHG

$GDOLPXPDE
&DVHUHSRUWVDQGVHULHVKDYHVKRZQWKDWLQKLELWRUVRI7XPRU1HFURVLV)DFWRU71)Į DUH
HIIHFWLYHLQWUHDWLQJ+6 %DVHGRQWKHVHREVHUYDWLRQVWKHLQYHVWLJDWLRQRI$GDOLPXPDE
DIXOO\KXPDQDQWL71)PRQRFORQDODQWLERG\IRUWKHWUHDWPHQWRIPRGHUDWHWRVHYHUH+6
ZDVFRQVLGHUHGZDUUDQWHG
7KHVDIHW\DQGHIILFDF\RI$GDOLPXPDE ZHUHDVVHVVHGLQUDQGRPLVHGGRXEOHEOLQG
SODFHERFRQWUROOHGVWXGLHVDQGDQRSHQODEHOH[WHQVLRQVWXG\LQDGXOWSDWLHQWVZLWK

$GDOLPXPDE
33URWRFRO

PRGHUDWHWRVHYHUH+6 ZKRZHUH LQWROHUDQWKDGDFRQWUDLQGLFDWLRQRUDQLQDGHTXDWH
UHVSRQVHWRDWOHDVWDPRQWKWULDORIV\VWHPLFDQWLELRWLFWKHUDS\7KHSDWLHQWVLQ+6,DQG
+6,,KDG+XUOH\6WDJH,,RU,,,GLVHDVHZLWKDWOHDVWDEVFHVVHVRULQIODPPDWRU\QRGXOHV
6WXG\+6,3,21((5,  HYDOXDWHGSDWLHQWVZLWKWUHDWPHQWSHULRGV,Q3HULRG$
SDWLHQWVUHFHLYHGSODFHERRU$GDOLPXPDE DWDQLQLWLDOGRVHRIPJDW:HHNPJDW
:HHNDQGPJHYHU\ZHHNVWDUWLQJDW:HHNWR:HHN&RQFRPLWDQWDQWLELRWLF
XVHZDVQRWDOORZHGGXULQJWKHVWXG\$IWHUZHHNVRIWKHUDS\SDWLHQWVZKRKDG
UHFHLYHG$GDOLPXPDE LQ3HULRG$ZHUHUHUDQGRPLVHG LQ3HULRG%WRRIWUHDWPHQW
JURXSV$GDOLPXPDE PJHYHU\ZHHN$GDOLPXPDE PJHYHU\RWKHUZHHNRU
SODFHERIURP:HHNWR:HHN3DWLHQWVZKRKDGEHHQUDQGRPLVHGWRSODFHERLQ
3HULRG$ZHUHDVVLJQHGWRUHFHLYH$GDOLPXPDEPJHYHU\ZHHNLQ3HULRG%
6WXG\+6,,3,21((5,, HYDOXDWHGSDWLHQWVZLWKWUHDWPHQWSHULRGV,Q3HULRG$
SDWLHQWVUHFHLYHGSODFHERRU$GDOLPXPDE DWDQLQLWLDOGRVHRIPJDW:HHNDQG
PJDW:HHNDQGPJHYHU\ZHHNVWDUWLQJDW:HHNWR:HHNRISDWLHQWV
KDGFRQWLQXHGEDVHOLQHRUDODQWLELRWLFWKHUDS\GXULQJWKHVWXG\$IWHU ZHHNVRIWKHUDS\
SDWLHQWVZKRKDGUHFHLYHG$GDOLPXPDE LQ3HULRG$ZHUHUHUDQGRPLVHGLQ3HULRG%WR
RIWUHDWPHQWJURXSV$GDOLPXPDE PJHYHU\ZHHN$GDOLPXPDE PJHYHU\RWKHU
ZHHNRUSODFHERIURP:HHNWR:HHN3DWLHQWVZKRKDGEHHQUDQGRPLVHGWR
SODFHERLQ3HULRG$ZHUHDVVLJQHGWRUHFHLYHSODFHERLQ3HULRG%
3DWLHQWVSDUWLFLSDWLQJLQ6WXGLHV+6,DQG+6,,ZHUHHOLJLEOHWRHQURO LQWRDQRSHQODEHO
H[WHQVLRQVWXG\LQZKLFK$GDOLPXPDE PJZDVDGPLQLVWHUHGHYHU\ZHHN7KURXJKRXW
DOOVWXGLHVSDWLHQWVXVHGWRSLFDODQWLVHSWLFZDVKGDLO\
&OLQLFDO5HVSRQVH
5HGXFWLRQRILQIODPPDWRU\OHVLRQVDQGSUHYHQWLRQRIZRUVHQLQJRIDEVFHVVHVDQGGUDLQLQJ
ILVWXODVZDVDVVHVVHGXVLQJ+LGUDGHQLWLV6XSSXUDWLYD&OLQLFDO5HVSRQVH+L6&5
UHGXFWLRQLQWRWDODEVFHVVDQGLQIODPPDWRU\QRGXOHFRXQWZLWKQRLQFUHDVHLQDEVFHVV
FRXQWDQGQRLQFUHDVHLQGUDLQLQJILVWXODFRXQWUHODWLYHWR%DVHOLQH5HGXFWLRQLQ+6
UHODWHGVNLQSDLQZDVDVVHVVHGXVLQJD1XPHULF5DWLQJ6FDOHLQSDWLHQWVZKRHQWHUHGWKH
VWXG\ZLWKDQLQLWLDOEDVHOLQHVFRUHRIRUJUHDWHURQDSRLQWVFDOH
$W:HHNDVLJQLILFDQWO\KLJKHUSURSRUWLRQRISDWLHQWVWUHDWHGZLWK$GDOLPXPDE YHUVXV
SODFHERDFKLHYHG+L6&5$W:HHNDVLJQLILFDQWO\KLJKHUSURSRUWLRQRISDWLHQWVLQ
6WXG\+6,,H[SHULHQFHGDFOLQLFDOO\UHOHYDQWGHFUHDVHLQ+6UHODWHGVNLQSDLQVHH7DEOH

$GDOLPXPDE
33URWRFRO

3DWLHQWVWUHDWHGZLWK$GDOLPXPDEKDGVLJQLILFDQWO\UHGXFHGULVNRIGLVHDVHIODUH
GXULQJWKHLQLWLDOZHHNVRIWUHDWPHQW
7DEOH(IILFDF\ 5HVXOWVDW:HHNV+66WXGLHV,DQG,,
+66WXG\
3,21((5,
+66WXG\
3,21((5,,
3ODFHER
$GDOLPXPDE
PJ
:HHNO\
3ODFHER
$GDOLPXPDE
PJ
:HHNO\
+LGUDGHQLWLV6XSSXUDWLYD
&OLQLFDO5HVSRQVH+L6&5D
Q 

Q 

Q 

Q 


5HGXFWLRQLQ6NLQ3DLQE
Q 

Q 

Q 

Q 


33$GDOLPXPDEYHUVXVSODFHER
D $PRQJDOOUDQGRPLVHGSDWLHQWV
E $PRQJSDWLHQWVZLWKEDVHOLQH+6UHODWHGVNLQSDLQDVVHVVPHQWEDVHGRQ1XPHULF5DWLQJ
6FDOH±  QRVNLQSDLQ VNLQSDLQDVEDGDV\RXFDQLPDJLQH
$PRQJSDWLHQWVZKRZHUHUDQGRPLVHGWR$GDOLPXPDE FRQWLQXRXVZHHNO\GRVLQJWKH
RYHUDOO+L6&5UDWHDW:HHNZDVPDLQWDLQHGWKURXJK:HHN
*UHDWHULPSURYHPHQWVDW:HHNIURPEDVHOLQHFRPSDUHGWRSODFHERZHUHGHPRQVWUDWHG
LQVNLQVSHFLILFKHDOWKUHODWHGTXDOLW\RIOLIHDVPHDVXUHGE\WKH'HUPDWRORJ\/LIH
4XDOLW\,QGH['/4,6WXGLHV+6, DQG+6,,SDWLHQWJOREDOVDWLVIDFWLRQZLWKPHGLFDWLRQ
WUHDWPHQWDVPHDVXUHGE\WKH7UHDWPHQW6DWLVIDFWLRQ4XHVWLRQQDLUH PHGLFDWLRQ7640
6WXGLHV+6,DQG+6,,DQGSK\VLFDOKHDOWKDVPHDVXUHGE\WKHSK\VLFDOFRPSRQHQW
VXPPDU\VFRUHRIWKH6)6WXG\+6,

$GDOLPXPDE
33URWRFRO

0DUNHWLQJDXWKRUL]DWLRQ
$GDOLPXPDEKDVUHFHQWO\UHFHLYHGPDUNHWLQJDXWKRUL]DWLRQLQ(8DVWKHILUVW
SKDUPDFHXWLFDOSURGXFWDSSURYHGIRUWKHWUHDWPHQWRI+6DQGLVLQGLFDWHGIRUWKH
WUHDWPHQWRIDFWLYHPRGHUDWHWRVHYHUHKLGUDGHQLWLVVXSSXUDWLYDDFQHLQYHUVDLQDGXOW
SDWLHQWVZLWKDQLQDGHTXDWHUHVSRQVHWRFRQYHQWLRQDOV\VWHPLF+6WKHUDS\ 
 
,QDGGLWLRQWR+6$GDOLPXPDE LVDSSURYHG IRUVHYHUDORWKHULQGLFDWLRQVHJUKHXPDWRLG
DUWKULWLVSVRULDWLFDUWKULWLVD[LDOVSRQG\ORDUWKULWLV MXYHQLOHLGLRSDWKLFDUWKULWLVSVRULDVLV
SHGLDWULFSVRULDVLV&URKQ¶VGLVHDVHSHGLDWULF&KURQ¶VGLVHDVH DQGXOFHUDWLYHFROLWLV

5DWLRQDOH
+6KDVDKXJHLPSDFWRQWKHSDWLHQWV¶4XDOLW\RI/LIH&RPSDUHGWRRWKHUGHUPDWRORJLFDO
GLVHDVHVHJDFQHSVRULDVLVDWRSLFHF]HPDDQGVNLQWXPRUVWKHLPSDFWPHDVXUHGE\WKH
'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,LVVLJQLILFDQWO\JUHDWHU $OWKRXJKWKLVLV
VKRZQLQVWXGLHVIURPGLIIHUHQWSDUWVRIWKHZRUOGWKHUHLVRQO\OLPLWHGLQIRUPDWLRQ
DYDLODEOH RQWKH4XDOLW\RI/LIHLQ6ZHGLVK+6SDWLHQWV
5HVXOWVIURPWKHSKDVHVWXGLHVRI$GDOLPXPDEWUHDWPHQWLQSDWLHQWVZLWKPRGHUDWHWR
VHYHUH+6VKRZ VLJQLILFDQWFOLQLFDOUHVSRQVHLQFOXGLQJLPSURYHPHQWRI4R/UHGXFWLRQ
RISDLQDQGDFWLYLW\LPSDLUPHQWDIWHUZHHNVWUHDWPHQW
1DWLRQDOGDWDRQWKHLPSDFWRI+6RQ4R/SDLQZRUNSURGXFWLYLW\DQGDFWLYLW\EHIRUH
DQGDIWHU$GDOLPXPDEWUHDWPHQW PLJKWEHQHHGHGWRVXSSRUWUHLPEXUVHPHQWLQWKLV
LQGLFDWLRQ7RGDWHWKHUHDUHQRQDWLRQDOUHJLVWULHVFDSWXULQJWKLVLQIRUPDWLRQ 7KHUHLVDOVR
DQHHGWR HYDOXDWH$GDOLPXPDEWUHDWPHQWIRUDORQJHUSHULRGRIWLPHWKDQZHHNV LQ
6ZHGLVK+6SDWLHQWVLQZKRP FRQYHQWLRQDOWUHDWPHQWKDVIDLOHG %HVLGHV &2 ODVHULV
UDWKHUFRPPRQO\XVHGLQGHUPDWRORJLFDOFOLQLFDOSUDFWLVHLQ6ZHGLVK+6SDWLHQWVIRU
H[FLVLRQLQFLVLRQRIORFDO+6OHVLRQVDVZHOODVIRU PRUHZLGHVSUHDGOHVLRQV
+HQFHQDWLRQDOGDWDRQ$GDOLPXPDE WUHDWPHQWRI6ZHGLVK+6SDWLHQWVLQDFOLQLFDO
GHUPDWRORJLFDOVHWWLQJPLJKWEHQHHGHGLQRUGHUWRVXSSRUWUHLPEXUVHPHQWEXWDOVRWR
VXSSRUWWKHGHYHORSPHQWRIDQXSGDWHG +6WUHDWPHQWDOJRULWKP

$GDOLPXPDE
33URWRFRO


5HVHDUFK4XHVWLRQDQG2EMHFWLYHV
7KHREMHFWLYHV RIWKLVREVHUYDWLRQDOVWXG\LVWRDVVHVVWKHFKDQJHVLQ 4R/ VNLQSDLQZRUN
SURGXFWLYLW\DFWLYLW\DQGKHDOWKUHODWHGSUREOHPVEHIRUHDQGDIWHUPRQWKVWUHDWPHQWZLWK
$GDOLPXPDE RI6ZHGLVKSDWLHQWVZLWKPRGHUDWHWRVHYHUH+6LQUHDOOLIHDQGDVSHU
URXWLQHFOLQLFDOFDUH
3ULPDU\HQGSRLQWV
x
&KDQJHVLQ'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,DWZHHNV
6HFRQGDU\HQGSRLQWV
x
&KDQJHLQ'/4,DWDQGZHHNV
x
&KDQJHLQ3DWLHQW
V *OREDO $VVHVVPHQWRI 6NLQ 3DLQ 156DWDQGZHHNV
x
&KDQJHLQ(XUR4RO (4'DWDQGZHHNV
x
&KDQJHLQ+LGUDGHQLWLV6XSSXUDWLYD,PSDFW$VVHVVPHQW+6,$DWDQG
ZHHNV
x
&KDQJHLQ:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW4XHVWLRQQDLUH6SHFLILF
+HDOWK3UREOHP:3$,6+3DWDQGZHHNV
x
+LGUDGHQLWLV6XSSXUDWLYD&OLQLFDO5HVSRQVH+L6&5 DWDQGZHHNV

5HVHDUFK0HWKRGV

6WXG\'HVLJQ
7KLVLVD3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\3026DQRSHQQRQLQWHUYHQWLRQDOVWXG\
7KHSDWLHQWVZLOOEHWUHDWHGLQDFFRUGDQFHZLWKQRUPDOURXWLQHFDUHDQGWKHGUXJZLOOEH
SUHVFULEHGLQDFFRUGDQFHZLWKWKHDSSURYHGODEHOLQJ6XPPDU\RI3URGXFW
&KDUDFWHULVWLFVLH$EE9LHZLOOQRWEHLQYROYHGLQWKHVXSSO\RI$GDOLPXPDE

$GDOLPXPDE
33URWRFRO

3DWLHQWVZLOOEHLQFOXGHGLQWKHVWXG\DWWKHWLPHWKHSK\VLFLDQKDVGHFLGHGWRFKDQJHWKHLU
FXUUHQWWUHDWPHQWWR$GDOLPXPDE IRUDQ\UHDVRQ 7KHGHFLVLRQWRSUHVFULEHDGDOLPXPDE
VKRXOGEHFOHDUO\VHSDUDWHGIURPDQGSUHFHGLQJWKHGHFLVLRQWRLQFOXGHWKHSDWLHQWLQWKH
VWXG\7KHSDWLHQWVZLOOEHDVVHVVHGGXULQJURXWLQHYLVLWVDWWKHFOLQLFDWEDVHOLQH
LQFOXVLRQDQGDIWHUDSSUR[LPDWHO\ ZHHNVZHHNVDQGZHHNV'DWDZLOOEH
FROOHFWHGIURPWKHSDWLHQW¶VPHGLFDOUHFRUGVE\LQYHVWLJDWRUDVVHVVPHQWDQGE\SDWLHQW
TXHVWLRQQDLUHVDVGHVFULEHGLQVHFWLRQ 6WXG\)ORZ&KDUWDQGLQ6HFWLRQ
9DULDEOHV

6WXG\)ORZ&KDUW
3DWLHQWVWKDWKDYHEHHQSUHVFULEHG$GDOLPXPDEDVSHUURXWLQHFDUHZLOODVNHGWR
SDUWLFLSDWHLQWKLVVWXG\ ,QDFFRUGDQFHZLWKURXWLQHFDUHDSDWLHQW ZLOOEHVHHQE\WKH
SDWLHQW¶VSK\VLFLDQDWEDVHOLQHLQFOXVLRQDQGDSSUR[LPDWHO\DQGZHHNV DIWHUWKH
ILUVWGRVHRI$GDOLPXPDE
3DUDPHWHUV
%DVHOLQH
:HHN

:HHN

:HHN

,QIRUPHGFRQVHQW
;
'HPRJUDSKLFEDVHOLQHGDWD
;
'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,
;
;
;
;
(XUR4RO(4'
;
;
;
;
3DWLHQW
V*OREDO$VVHVVPHQWRI6NLQ3DLQ156
;
;
;
;
:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW
4XHVWLRQQDLUH6SHFLILF+HDOWK3UREOHP
:3$,6+3
;
;
;
;
+LGUDGHQLWLV6XSSXUDWLYD,PSDFW$VVHVVPHQW
+6,$
;
;
;
;
+LGUDGHQLWLV6XSSXUDWLYD&OLQLFDO5HVSRQVH
+L6&5
;
;
;
;
6HULRXV$GYHUVH(YHQW
;
;
;
3UHJQDQF\5HSRUWLQJ
;
;
;
&RQFRPLWDQW0HGLFDWLRQ
;
;
;
;
6XUJLFDO7UHDWPHQW
;
;
;
;
0LVVHG$GDOLPXPDEGRVHV
;
;
;

6HWWLQJ
3DWLHQWV WKDWKDYHEHHQSUHVFULEHG$GDOLPXPDEDVSHUURXWLQHFDUHZLOOEHDVNHGWR
SDUWLFLSDWHLQWKLVVWXG\WKDWZLOOIRFXVRQWKHLU4R/ VNLQSDLQ DQGZRUN
SURGXFWLYLW\DFWLYLW\ GXULQJDVL[PRQWKSHULRG

$GDOLPXPDE
33URWRFRO

7KHSDUWLFLSDWLQJLQYHVWLJDWRUVZLOOEHGHUPDWRORJLVWV WKDWURXWLQHO\VHH+6SDWLHQWV
$SSUR[LPDWHO\ FOLQLFVLQ6ZHGHQZLOOSDUWLFLSDWHLQWKHVWXG\
'DWDZLOOEHFROOHFWHGDWEDVHOLQHDQGDSSUR[LPDWHO\  DQGZHHNV DIWHUWKHILUVW
GRVHRI$GDOLPXPDE 3DWLHQWVZLOOEHWUHDWHGLQLQDFFRUGDQFHZLWKURXWLQHFDUH

,QFOXVLRQFULWHULD
x
$GXOW\HDUVDQGROGHU
x
'LDJQRVLVRI+LGUDGHQWLV 6XSSXUDWLYD
x
3UHVFULEHG$GDOLPXPDE DFFRUGLQJWRWKH6XPPDU\RI3URGXFW&KDUDFWHULVWLFV
6P3&
x
:LOOLQJQHVVWRVLJQDQGGDWHD3DWLHQW,QIRUPDWLRQ,QIRUPHG&RQVHQW)RUP

([FOXVLRQFULWHULD
x
3ULRUELRORJLFWUHDWPHQWGLVFRQWLQXHGPRQWKVEHIRUHWKHEDVHOLQHYLVLW
x
3DWLHQWQRWDEOHWRXQGHUVWDQGWKHODQJXDJHRIWKHSURYLGHG SDWLHQWTXHVWLRQQDLUHV
x
+LVWRU\RIQRQFRPSOLDQFHZLWKPHGLFDWLRQRUDPHGLFDOKLVWRU\WKDWFRXOG
HQKDQFHQRQFRPSOLDQFHZLWKPHGLFDWLRQDVGHWHUPLQHGE\WKHLQYHVWLJDWRU

9DULDEOHV

'HPRJUDSKLFEDVHOLQHGDWD
7KHIROORZLQJGDWDZLOOEHFROOHFWHGDWWKHEDVHOLQHYLVLW
x
'HPRJUDSKLF%DVHOLQHGDWD
R
$JHJHQGHUDQGHWKQLFLW\
R
6PRNLQJKDELWV
R
%RG\0DVV,QGH[%0,
R
$JHZKHQ+6V\PSWRPVVWDUWHG
R
'DWHRIGLDJQRVLV
R
+6DVVHVVPHQWOHVLRQFRXQWDQG+XUOH\VWDJH

$GDOLPXPDE
33URWRFRO

R
$GDOLPXPDE WUHDWPHQWVWDUWLQIRRQPLVVHGGRVHVZLOOEHFROOHFWHGDW
DQGZHHNV
R
3UHYLRXVWUHDWPHQWVIRU+6
R
3UHYLRXVVXUJHU\IRU+6LQIRRQQHZVXUJHULHVIRU+6ZLOOEHFROOHFWHGDW
DQGZHHNV
R
&RPRUELGLWLHV
x
&RQFRPLWDQWPHGLFDWLRQV FKDQJHVLQ&RQFRPLWDQW0HGLFDWLRQZLOOEHFROOHFWHGDW
DQGZHHNV

4XDOLW\RI/LIH6FDOHV
7KUHH4R/VFDOHVZLOOEHFRPSOHWHGDWEDVHOLQHDQGDWDQGZHHNV
x
7KH'HUPDWRORJ\/LIH4XDOLW\,QGH['/4,LVDVLPSOHTXHVWLRQYDOLGDWHG
GHUPDWRORJLFGLVHDVHTXHVWLRQQDLUH
x
7KH(XUR4RO(4'LVDILYHGLPHQVLRQVJHQHULFTXHVWLRQQDLUHXVHGWRPHDVXUH
KHDOWKUHODWHG4R/
x
7KH+LGUDGHQLWLV6XSSXUDWLYD,PSDFW$VVHVVPHQW+6,$LVDGLVHDVHVSHFLILF
TXHVWLRQQDLUHPHDVXULQJWKHLPSDFWWKHSDWLHQWH[SHULHQFHVDVVRFLDWHGZLWK+6

6NLQ3DLQ
7KH3DWLHQW
V*OREDO$VVHVVPHQWRI6NLQ3DLQ QXPHULFDOUDWLQJVFDOH156 ZLOOEH
FRPSOHWHGDWEDVHOLQHDQGDWDQGZHHNV3DLQZLOOEHUDWHGIURPQRVNLQSDLQ
WRVNLQSDLQDVEDGDV\RXFDQLPDJLQH

$GDOLPXPDE
33URWRFRO


:RUN3URGXFWLYLW\
7KH:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW4XHVWLRQQDLUH6SHFLILF+HDOWK3UREOHP
:3$,6+3 PHDVXUHVWKHZRUNSURGXFWLYLW\DQGDFWLYLW\LPSDLUPHQWZLOOEHFRPSOHWHG
E\WKHSDWLHQWVDWEDVHOLQHDQGDW DQGZHHNV

&OLQLFDO(IIHFWLYHQHVV
+L6&5LVDFOLQLFDOHQGSRLQWIRFXVLQJRQDVVHVVPHQWRI+6LQIODPPDWRU\VLJQVDQG
V\PSWRPVWKDWZLOOGHWHUPLQHWKHFOLQLFDOHIIHFWLYHQHVVRI$GDOLPXPDE
$VVHVVPHQWZLOOEHSHUIRUPHGE\WKHSK\VLFLDQDWEDVHOLQHDQGDWDQGZHHNV
+L6&5UHTXLUHV
x
$WOHDVWDUHGXFWLRQLQWKHWRWDODEVFHVVDQGLQIODPPDWRU\QRGXOHFRXQW$1
FRXQWUHODWLYHWREDVHOLQHDQG
x
1RLQFUHDVHLQDEVFHVVFRXQWDQG
x
1RLQFUHDVHLQGUDLQLQJILVWXODFRXQW

6DIHW\3DUDPHWHUV
3OHDVHVHHVHFWLRQ

'DWD6RXUFHV
'DWDZLOOEHFROOHFWHGIURPWKHSDWLHQW¶VPHGLFDOUHFRUGVE\LQYHVWLJDWRUDVVHVVPHQWDQG
E\SDWLHQWTXHVWLRQQDLUHVDVGHVFULEHGLQVHFWLRQ 6WXG\)ORZ&KDUWDQGLQ6HFWLRQ
9DULDEOHV
(OHFWURQLF&DVH5HSRUW)RUPVH&5)ZLOOEHXVHG IRUHDFKSDWLHQWHQUROOHGLQWKLVVWXG\
7KHVHIRUPVZLOOEHXVHGWRWUDQVPLWLQIRUPDWLRQFROOHFWHGGXULQJWKHVWXG\WR$EE9LH

$GDOLPXPDE
33URWRFRO


6WXG\6L]H
:LWKHYDOXDEOHSDWLHQWVWKHSRZHU LVEDVHGRQDFKDQJHLQ'/4, RIDQGDQ
DVVXPHGVWDQGDUGGHYLDWLRQRI DQG W\SH,HUURURI WZRVLGHG 7KHGURSRXWUDWH
LVFRQVLGHUHGWREHORZDSSUR[LPDWHO\DIWHUZHHNVZKLFKZLOOKDYHDPLQLPDO
LPSDFWRQWKHSRZHUGHFUHDVHGWR

'DWD0DQDJHPHQW
6RXUFHGRFXPHQWVDUHGHILQHGDVRULJLQDOGRFXPHQWVGDWDDQGUHFRUGV7KLVPD\LQFOXGH
KRVSLWDOUHFRUGVFOLQLFDODQGRIILFHFKDUWVODERUDWRU\GDWDLQIRUPDWLRQDQGSDWLHQWV
TXHVWLRQQDLUHV'DWDFROOHFWHGGXULQJWKLVVWXG\PXVWEHUHFRUGHGRQWKHDSSURSULDWH
VRXUFHGRFXPHQWV
7KHIROORZLQJDVVHVVPHQWVWKDWZLOOEHFRPSOHWHGE\WKHSDWLHQWVRUSK\VLFLDQZLOOEH
FRQVLGHUHGVRXUFHGRFXPHQWDWLRQ
x
'/4,
x
(4'
x
+6,$
x
3DWLHQW
V*OREDO$VVHVVPHQWRI6NLQ3DLQ156
x
:3$,6+3
x
+L6&5
(OHFWURQLF&DVH5HSRUW)RUPVH&5)PXVWEHFRPSOHWHGIRUHDFKSDWLHQW HQUROOHGLQWKLV
VWXG\ 7KHVHIRUPVZLOOEHXVHGWRWUDQVPLWLQIRUPDWLRQFROOHFWHGGXULQJWKHVWXG\WR
$EE9LH
7KHH&5)GDWDIRUWKLVVWXG\DUHEHLQJFROOHFWHGLQD V\VWHPFDOOHG9LH'RFSURYLGHGE\
WKHWHFKQRORJ\YHQGRU3KDUPD&RQVXOWLQJ*URXS3&*
7KHLQYHVWLJDWRUZLOOGRFXPHQWSDWLHQW GDWDLQKLVKHURZQSDWLHQW ILOHV7KHVHSDWLHQW ILOHV
ZLOOVHUYHDVVRXUFHGDWDIRUWKHVWXG\,QYHVWLJDWLYHVLWHSHUVRQQHOZLOOUHFRUGDOOH&5)
GDWDUHTXLUHGE\WKLVSURWRFRO LQWKHH&5) V\VWHP
7KHLQYHVWLJDWRURUDQDXWKRUL]HGPHPEHURIWKHLQYHVWLJDWRU
VVWDIIZLOOPDNHDQ\
QHFHVVDU\FRUUHFWLRQVWRWKHH&5)$OOFKDQJHLQIRUPDWLRQLQFOXGLQJWKHGDWHDQGSHUVRQ

$GDOLPXPDE
33URWRFRO

SHUIRUPLQJWKHFRUUHFWLRQVZLOOEHDYDLODEOHYLDWKHDXGLWWUDLOZKLFKLVSDUWRIWKH
V\VWHP
)RUDQ\FRUUHFWLRQDUHDVRQIRUWKHDOWHUDWLRQZLOOEHSURYLGHG7KHH&5)VZLOOEH
UHYLHZHGSHULRGLFDOO\IRUFRPSOHWHQHVVOHJLELOLW\DQGDFFHSWDELOLW\E\$EE9LHSHUVRQQHO
RUWKHLUUHSUHVHQWDWLYHV$VDSSOLFDEOH$EE9LHRUWKHLUUHSUHVHQWDWLYHVZLOODOVREH
DOORZHGDFFHVVWRDOOVRXUFHGRFXPHQWVSHUWLQHQWWRWKHVWXG\LQRUGHUWRYHULI\H&5)
HQWULHV7KH3ULQFLSDO,QYHVWLJDWRUZLOOUHYLHZWKH H&5)VIRUFRPSOHWHQHVVDQGDFFXUDF\
DQGSURYLGHKLVRUKHUHOHFWURQLFVLJQDWXUHDQGGDWHWRH&5)VDVHYLGHQFHWKHUHRI
3&* ZLOOSURYLGHDFFHVVWRWKHH&5) IRUWKHGXUDWLRQRIWKHWULDOWKURXJKDSDVVZRUG
SURWHFWHGPHWKRGRI,QWHUQHW DFFHVV6XFKDFFHVVZLOOEHUHPRYHGIURPLQYHVWLJDWRUVLWHV
DWWKHHQGRIWKHVLWH
VSDUWLFLSDWLRQLQWKHVWXG\'DWDIURPWKHH&5) V\VWHPZLOOEH
DUFKLYHGRQDSSURSULDWHGDWDPHGLD&'520HWFDQGSURYLGHGWRWKHLQYHVWLJDWRUDW
WKDWWLPHDVDGXUDEOHUHFRUGRIWKHVLWH
VH&5)GDWD,WZLOOEHSRVVLEOHIRUWKHLQYHVWLJDWRU
WRPDNHSDSHUSULQWRXWVIURPWKDWPHGLD

'DWD$QDO\VLV
$OOVWDWLVWLFDODQDO\VHVZLOOEHSHUIRUPHGDW6FDQGLQDYLDQ'HYHORSPHQW6HUYLFHV$%
6'6'DQGHU\G6ZHGHQXVLQJ6$69HUVLRQRUKLJKHU6$6,QVWLWXWH,QF&DU\
1&86$
&RQWLQXRXVYDULDEOHVZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYHVWDWLVWLFVQPHDQ 6'PLQ
4PHGLDQ4PD[&DWHJRULFDOYDULDEOHVZLOOEHVXPPDUL]HGLQIUHTXHQF\WDEOHV
IUHTXHQF\DQGSURSRUWLRQ*UDSKLFDOSUHVHQWDWLRQVHJGHVFULELQJWKHFKDQJHRYHUWLPH
ZLOOEHXVHG DVDSSURSULDWHDQGLQGLYLGXDOSDWLHQWGDWDZLOOEHOLVWHG
7KHSULPDU\DQGVHFRQGDU\HQGSRLQWVFKDQJHLQ'/4,3DWLHQW
V*OREDO$VVHVVPHQWRI
6NLQ3DLQ156+6,$+L6&5(4':3$,6+3DWDQGZHHNVZLOOEH
DQDO\]HG XVLQJWWHVWRUQRQSDUDPHWULFPHWKRGVVXFKDV:LOFR[RQVLJQHGUDQNWHVWDV
DSSURSULDWH 7KHFKDQJHDWZHHNVZLOOEHRISULPDU\LQWHUHVW
1RDGMXVWPHQWIRUPXOWLSOHFRPSDULVRQVZLOOEHPDGH
$PRUHGHWDLOHG6WDWLVWLFDO$QDO\VLV3ODQ6$3ZLOOEHZULWWHQDQGILQDOL]HGEHIRUH
GDWDEDVHORFN

$GDOLPXPDE
33URWRFRO


4XDOLW\&RQWURO
$QLQYHVWLJDWRU
VPHHWLQJDQGRUVWXG\LQLWLDWLRQYLVLW ZLOOEHRUJDQL]HGE\$EE9LH
SHUVRQQHOLQRUGHUWRWUDLQWKHLQYHVWLJDWRUVDQGVWXG\FRRUGLQDWRUVRQWKHSURWRFRO
H&5)SURFHGXUHVDQGRWKHUVWXG\SURFHGXUHV
7KHVWXG\ZLOOEHPRQLWRUHGLQDFFRUGDQFHZLWKWKHSUHGHILQHG0RQLWRULQJ3ODQ6RXUFH
GRFXPHQWUHYLHZZLOOEHSHUIRUPHGDJDLQVWHQWULHVLQWKHH&5)GDWDEDVH DVDSSOLFDEOH DQG
DTXDOLW\DVVXUDQFHFKHFNZLOOEHSHUIRUPHG
&RPSXWHUORJLFDQGPDQXDOFKHFNVZLOOEHUXQWRLGHQWLI\LWHPVVXFKDVLQFRQVLVWHQWVWXG\
GDWHV$Q\QHFHVVDU\FRUUHFWLRQVZLOOEHPDGHWRWKHH&5)
$ 6WXG\'HVLJQDWHG3K\VLFLDQ6'3 DW$EE9LHZLOOFRQGXFWDUHYLHZRIDOOFROOHFWHG
6HULRXV$GYHUVH(YHQWVDQGVSRQWDQHRXVO\UHSRUWHG$GYHUVH(YHQWV

/LPLWDWLRQVRIWKH5HVHDUFK0HWKRGV
7KLVLVD 3RVW0DUNHWLQJ2EVHUYDWLRQDO6WXG\ LQZKLFKWKHRXWFRPHRIWKHWUHDWPHQWZLOO
EHFRPSDUHGWRWKHEDVHOLQHGDWDIRUHDFKLQGLYLGXDOSDWLHQWLHQRFRQWUROJURXSVH[LVW LQ
WKHVWXG\

2WKHU$VSHFWV
1$

3URWHFWLRQRI+XPDQ6XEMHFWV

(WKLFDO&RQGXFWRIWKH6WXG\
7KHVWXG\ZLOOEHFRQGXFWHGLQDFFRUGDQFHZLWKWKHHWKLFDOSULQFLSOHVWKDWKDYHWKHLU
RULJLQLQWKH'HFODUDWLRQRI+HOVLQNLWKHSURWRFRO*RRG&OLQLFDO3UDFWLFH*&3 DV
DSSOLFDEOH DQGDSSOLFDEOH6ZHGLVKUHJXODWLRQV

$GDOLPXPDE
33URWRFRO


,QGHSHQGHQW(WKLFV&RPPLWWHH,(&
*RRG&OLQLFDO3UDFWLFH*&3UHTXLUHVWKDWWKHFOLQLFDOSURWRFRODQ\SURWRFRO
DPHQGPHQWV WKHLQIRUPHGFRQVHQWDQGDOORWKHUIRUPVRISDWLHQW LQIRUPDWLRQUHODWHGWR
WKHVWXG\HJDGYHUWLVHPHQWVXVHGWRUHFUXLWVXEMHFWVDQGDQ\RWKHUQHFHVVDU\
GRFXPHQWVEHUHYLHZHGE\DQ,(&7KH,(&ZLOOUHYLHZWKHHWKLFDOVFLHQWLILFDQGPHGLFDO
DSSURSULDWHQHVVRIWKHVWXG\EHIRUHLWLVFRQGXFWHG,(&,5%DSSURYDORIWKHSURWRFRO
LQIRUPHGFRQVHQWDQGSDWLHQW LQIRUPDWLRQDQGRUDGYHUWLVLQJDVUHOHYDQWZLOOEHREWDLQHG
SULRUWRWKHVWDUWRIDQ\VWXG\SURFHGXUH
$Q\DPHQGPHQWVWRWKHSURWRFROZLOOUHTXLUH,(&DSSURYDOSULRUWRLPSOHPHQWDWLRQRIDQ\
FKDQJHVPDGHWRWKHVWXG\GHVLJQ7KHLQYHVWLJDWRUZLOOEHUHTXLUHGWRVXEPLWPDLQWDLQ
DQGDUFKLYHVWXG\HVVHQWLDOGRFXPHQWVDFFRUGLQJWR*&3
$Q\6HULRXV$GYHUVH(YHQWVWKDWPHHWWKHUHSRUWLQJFULWHULDDVGLFWDWHGE\ORFDO
UHJXODWLRQVZLOOEHUHSRUWHGWRWKH 5HJXODWRU\$JHQFLHVDVUHTXLUHGE\ORFDOUHJXODWLRQV

3DWLHQW ,QIRUPDWLRQDQG&RQVHQW
7KHLQYHVWLJDWRURUKLVKHUUHSUHVHQWDWLYHZLOOH[SODLQWKHQDWXUHRIWKHVWXG\WRWKH
SDWLHQWDQGDQVZHUDOOTXHVWLRQVUHJDUGLQJWKLVVWXG\3ULRUWRDQ\VWXG\UHODWHG
SURFHGXUHVEHLQJSHUIRUPHGRQWKHSDWLHQWWKHLQIRUPHGFRQVHQWVWDWHPHQWZLOOEH
UHYLHZHGDQGVLJQHGDQGGDWHGE\WKHSDWLHQWWKHSHUVRQZKRDGPLQLVWHUHGWKHLQIRUPHG
FRQVHQWDQGDQ\RWKHUVLJQDWRULHVDFFRUGLQJWRORFDOUHTXLUHPHQWV
$FRS\RIWKHLQIRUPHGFRQVHQWIRUPZLOOEHJLYHQWRWKHSDWLHQW$QHQWU\PXVWDOVREH
PDGHLQWKHSDWLHQW
VVRXUFHGRFXPHQWVWRFRQILUPWKDWLQIRUPHGFRQVHQWZDVREWDLQHG
SULRUWRDQ\VWXG\UHODWHGSURFHGXUHVDQGWKDWWKHSDWLHPW UHFHLYHGDVLJQHGFRS\

0DQDJHPHQWDQG5HSRUWLQJRI&RPSODLQWV
$&RPSODLQWLVDQ\ZULWWHQHOHFWURQLFRURUDOFRPPXQLFDWLRQWKDWDOOHJHVGHILFLHQFLHV
UHODWHGWRWKHSK\VLFDOFKDUDFWHULVWLFVLGHQWLW\TXDOLW\SXULW\SRWHQF\GXUDELOLW\
UHOLDELOLW\VDIHW\HIIHFWLYHQHVVRUSHUIRUPDQFHRIDSURGXFWGHYLFHDIWHULWLVUHOHDVHGIRU
GLVWULEXWLRQ
7KHLQYHVWLJDWLRQDOSURGXFWLQWKLVWULDOFRQWDLQVERWK

$GDOLPXPDE
33URWRFRO

Ɣ
%LRORJLFFRPSRXQGVDQG
Ɣ
'HYLFHFRPSRQHQWVSUHILOOHGV\ULQJHSHQ
&RPSODLQWVDVVRFLDWHGZLWKDQ\FRPSRQHQWRIWKLVLQYHVWLJDWLRQDOSURGXFWPXVWEH
UHSRUWHGWRWKH6SRQVRU6HFWLRQ)RUDGYHUVHHYHQWVSOHDVHUHIHUWR
6HFWLRQV  WKURXJK)RUSURGXFWFRPSODLQWVSOHDVHUHIHUWR6HFWLRQ

0HGLFDO&RPSODLQWV

$GYHUVH(YHQW'HILQLWLRQDQG6HULRXV$GYHUVH(YHQW
&DWHJRULHV
$QDGYHUVHHYHQW$(LVGHILQHGDVDQ\XQWRZDUGPHGLFDORFFXUUHQFHLQDSDWLHQWZKLFK
GRHVQRWQHFHVVDULO\KDYHDFDXVDOUHODWLRQVKLSZLWKWKHLUWUHDWPHQW$QDGYHUVHHYHQWFDQ
WKHUHIRUHEHDQ\XQIDYRUDEOHDQGXQLQWHQGHGVLJQLQFOXGLQJDQDEQRUPDOODERUDWRU\
ILQGLQJV\PSWRPRUGLVHDVHWHPSRUDOO\DVVRFLDWHGZLWKWKHXVHRIDPHGLFLQDOSURGXFW
ZKHWKHURUQRWWKHHYHQWLVFRQVLGHUHGFDXVDOO\UHODWHGWRWKHXVHRIWKHSURGXFW
6XFKDQHYHQWFDQUHVXOWIURPXVHRIWKHGUXJDVVWLSXODWHGLQWKHODEHOLQJDVZHOODVIURP
DFFLGHQWDORULQWHQWLRQDORYHUGRVHGUXJDEXVHRUGUXJZLWKGUDZDO$Q\ZRUVHQLQJRID
SUHH[LVWLQJFRQGLWLRQRULOOQHVVLVFRQVLGHUHGDQDGYHUVHHYHQW
,IDQDGYHUVHHYHQWPHHWVDQ\RIWKHIROORZLQJFULWHULDLWLVFRQVLGHUHGDVHULRXVDGYHUVH
HYHQW6$(
'HDWKRI3DWLHQW
$QHYHQWWKDWUHVXOWVLQWKHGHDWKRIDSDWLHQW
/LIH7KUHDWHQLQJ
$QHYHQWWKDWLQWKHRSLQLRQRIWKHLQYHVWLJDWRU
ZRXOGKDYHUHVXOWHGLQLPPHGLDWHIDWDOLW\LIPHGLFDO
LQWHUYHQWLRQKDGQRWEHHQWDNHQ7KLVGRHVQRW
LQFOXGHDQHYHQWWKDWZRXOGKDYHEHHQIDWDOLILWKDG
RFFXUUHGLQDPRUHVHYHUHIRUP
+RVSLWDOL]DWLRQ
$QHYHQWWKDWUHVXOWVLQDQDGPLVVLRQWRWKHKRVSLWDO
IRUDQ\OHQJWKRIWLPH7KLVGRHVQRWLQFOXGHDQ
HPHUJHQF\URRPYLVLWRUDGPLVVLRQWRDQRXWSDWLHQW
IDFLOLW\

$GDOLPXPDE
33URWRFRO

3URORQJDWLRQRI
+RVSLWDOL]DWLRQ
$QHYHQWWKDWRFFXUVZKLOHWKHVWXG\SDWLHQWLV
KRVSLWDOL]HGDQGSURORQJVWKHSDWLHQW
VKRVSLWDOVWD\
&RQJHQLWDO$QRPDO\
$QDQRPDO\GHWHFWHGDWRUDIWHUELUWKRUDQ\DQRPDO\
WKDWUHVXOWVLQIHWDOORVV
3HUVLVWHQWRU6LJQLILFDQW
'LVDELOLW\,QFDSDFLW\
$QHYHQWWKDWUHVXOWVLQDFRQGLWLRQWKDWVXEVWDQWLDOO\
LQWHUIHUHVZLWKWKHDFWLYLWLHVRIGDLO\OLYLQJRIDVWXG\
SDWLHQW'LVDELOLW\LVQRWLQWHQGHGWRLQFOXGH
H[SHULHQFHVRIUHODWLYHO\PLQRUPHGLFDOVLJQLILFDQFH
VXFKDVKHDGDFKHQDXVHDYRPLWLQJGLDUUKHD
LQIOXHQ]DDQGDFFLGHQWDOWUDXPDHJVSUDLQHG
DQNOH
,PSRUWDQW0HGLFDO(YHQW
5HTXLULQJ0HGLFDORU
6XUJLFDO,QWHUYHQWLRQWR
3UHYHQW6HULRXV2XWFRPH
$QLPSRUWDQWPHGLFDOHYHQWWKDWPD\QRWEH
LPPHGLDWHO\OLIHWKUHDWHQLQJRUUHVXOWLQGHDWKRU
KRVSLWDOL]DWLRQEXWEDVHGRQPHGLFDOMXGJPHQWPD\
MHRSDUGL]HWKHSDWLHQWDQGPD\UHTXLUHPHGLFDORU
VXUJLFDOLQWHUYHQWLRQWRSUHYHQWDQ\RIWKHRXWFRPHV
OLVWHGDERYHLHGHDWKRISDWLHQWOLIHWKUHDWHQLQJ
KRVSLWDOL]DWLRQSURORQJDWLRQRIKRVSLWDOL]DWLRQ
FRQJHQLWDODQRPDO\RUSHUVLVWHQWRUVLJQLILFDQW
GLVDELOLW\LQFDSDFLW\$GGLWLRQDOO\DQ\HOHFWLYHRU
VSRQWDQHRXVDERUWLRQRUVWLOOELUWKLVFRQVLGHUHGDQ
LPSRUWDQWPHGLFDOHYHQW([DPSOHVRIVXFKHYHQWV
LQFOXGHDOOHUJLFEURQFKRVSDVPUHTXLULQJLQWHQVLYH
WUHDWPHQWLQDQHPHUJHQF\URRPRUDWKRPHEORRG
G\VFUDVLDVRUFRQYXOVLRQVWKDWGRQRWUHVXOWLQ
LQSDWLHQWKRVSLWDOL]DWLRQRUWKHGHYHORSPHQWRIGUXJ
GHSHQGHQF\RUGUXJDEXVH

6HYHULW\
7KHIROORZLQJGHILQLWLRQVZLOOEHXVHGWRUDWHWKHVHYHULW\IRUDQ\DGYHUVHHYHQWEHLQJ
FROOHFWHGDVDQHQGSRLQWGDWDSRLQWLQWKHVWXG\DQGIRUDOOVHULRXVDGYHUVHHYHQWV
0LOG
7KHDGYHUVHHYHQWLVWUDQVLHQWDQGHDVLO\WROHUDWHGE\WKHSDWLHQW

$GDOLPXPDE
33URWRFRO

0RGHUDWH
7KHDGYHUVHHYHQWFDXVHVWKHSDWLHQWGLVFRPIRUWDQGLQWHUUXSWVWKH
SDWLHQW
VXVXDODFWLYLWLHV
6HYHUH
7KHDGYHUVHHYHQWFDXVHVFRQVLGHUDEOHLQWHUIHUHQFHZLWKWKH
SDWLHQW
VXVXDODFWLYLWLHVDQGPD\EHLQFDSDFLWDWLQJRUOLIH
WKUHDWHQLQJ

5HODWLRQVKLSWR3KDUPDFHXWLFDO3URGXFW
7KHIROORZLQJGHILQLWLRQVZLOOEHXVHGWRDVVHVVWKHUHODWLRQVKLSRIWKHDGYHUVHHYHQWWR
WKHXVHRISURGXFW
5HDVRQDEOH3RVVLELOLW\
$QDGYHUVHHYHQWZKHUHWKHUHLVHYLGHQFHWRVXJJHVWD
FDXVDOUHODWLRQVKLSEHWZHHQWKHSURGXFWDQGWKHDGYHUVH
HYHQW
1R5HDVRQDEOH3RVVLELOLW\
$QDGYHUVHHYHQWZKHUHWKHUHLVQRHYLGHQFHWRVXJJHVWD
FDXVDOUHODWLRQVKLSEHWZHHQWKHSURGXFWDQGWKHDGYHUVH
HYHQW
,IQRUHDVRQDEOHSRVVLELOLW\RIEHLQJUHODWHGWRSURGXFWLVJLYHQDQDOWHUQDWHHWLRORJ\PXVW
EHSURYLGHGIRUWKHDGYHUVHHYHQW

6HULRXV$GYHUVH(YHQW&ROOHFWLRQ3HULRG
6HULRXVDGYHUVHHYHQWVZLOOEHUHSRUWHGWR$EE9LHIURPWKHWLPHWKHSK\VLFLDQREWDLQVWKH
SDWLHQW
VDXWKRUL]DWLRQWRXVHDQGGLVFORVHLQIRUPDWLRQRUWKHSDWLHQW
VLQIRUPHGFRQVHQW
XQWLOGD\VRUKDOIOLYHVIROORZLQJWKHLQWDNHRIWKHODVWGRVHRISK\VLFLDQSUHVFULEHG
WUHDWPHQW

6HULRXV$GYHUVH(YHQW5HSRUWLQJ
,QWKHHYHQWRIDVHULRXVDGYHUVHHYHQWDQGDGGLWLRQDOO\DQ\QRQVHULRXVHYHQWRI
PDOLJQDQF\LQSDWLHQWV\HDUVRIDJHDQG\RXQJHUZKHWKHUUHODWHGWRVWXG\GUXJRUQRW
WKH,QYHVWLJDWRU ZLOOQRWLI\WKH$EE9LHFRQWDFWLGHQWLILHGLQVHFWLRQZLWKLQKRXUV
RIWKHVLWHEHLQJPDGH DZDUHRIWKHHYHQWE\HQWHULQJWKHVHULRXVDGYHUVHHYHQWRUQRQ
VHULRXVHYHQWRIPDOLJQDQF\LQSDWLHQWV\HDUVRIDJHDQG\RXQJHUGDWDLQWRWKH
HOHFWURQLFGDWDFDSWXUH('&V\VWHP6HULRXVDGYHUVHHYHQWVDQGQRQVHULRXVHYHQWVRI
PDOLJQDQF\LQSDWLHQWV\HDUVRIDJHDQG\RXQJHUWKDWRFFXUSULRUWRWKHVLWHKDYLQJ

$GDOLPXPDE
33URWRFRO

)RUDSURGXFWWKLVPD\LQFOXGHEXWLVQRWOLPLWHGWRGDPDJHGEURNHQSURGXFWRU
SDFNDJLQJSURGXFWDSSHDUDQFHZKRVHFRORUPDUNLQJVGRQRWPDWFKWKHODEHOLQJODEHOLQJ
GLVFUHSDQFLHVLQDGHTXDFLHVLQWKHODEHOLQJLQVWUXFWLRQVH[DPSOHSULQWLQJLOOHJLEOH
PLVVLQJFRPSRQHQWVSURGXFWGHYLFHQRWZRUNLQJSURSHUO\ RUSDFNDJLQJLVVXHV
)RUPHGLFDOGHYLFHVDSURGXFWFRPSODLQWDOVRLQFOXGHVDOOGHDWKVRIDSDWLHQWXVLQJWKH
GHYLFHDQ\LOOQHVVLQMXU\RUDGYHUVHHYHQWLQWKHSUR[LPLW\RIWKHGHYLFHDQDGYHUVH
HYHQWWKDWFRXOGEHDUHVXOWRIXVLQJWKHGHYLFHDQ\HYHQWQHHGLQJPHGLFDORUVXUJLFDO
LQWHUYHQWLRQLQFOXGLQJKRVSLWDOL]DWLRQZKLOHXVLQJWKHGHYLFHDQGXVHHUURUV
$Q\LQIRUPDWLRQDYDLODEOHWRKHOSLQWKHGHWHUPLQDWLRQRIFDXVDOLW\ E\WKHGHYLFH WRWKH
HYHQWVRXWOLQHGGLUHFWO\DERYHVKRXOGEHFDSWXUHG

5HSRUWLQJ
3URGXFW&RPSODLQWVFRQFHUQLQJWKHLQYHVWLJDWLRQDOSURGXFWDQGRUGHYLFH PXVWEHUHSRUWHG
WRWKH6SRQVRUZLWKLQKRXUVRIWKHVWXG\VLWH
VNQRZOHGJHRIWKHHYHQWYLDORFDO3URGXFW
&RPSODLQWUHSRUWLQJSUDFWLFHV3URGXFW&RPSODLQWVRFFXUULQJGXULQJ WKHVWXG\ZLOOEH
IROORZHGXSWRDVDWLVIDFWRU\FRQFOXVLRQ$OOIROORZXSLQIRUPDWLRQLVWREHUHSRUWHGWR
WKH6SRQVRURUDQDXWKRUL]HGUHSUHVHQWDWLYHDQGGRFXPHQWHGLQVRXUFHDVUHTXLUHGE\WKH
6SRQVRU3URGXFW&RPSODLQWVDVVRFLDWHGZLWKDGYHUVHHYHQWVZLOOEHUHSRUWHGLQWKHVWXG\
VXPPDU\$OORWKHUFRPSODLQWVZLOOEHPRQLWRUHGRQDQRQJRLQJEDVLV
3URGXFWFRPSODLQWVLQYROYLQJDQRQ6SRQVRULQYHVWLJDWLRQDOSURGXFWVKRXOGEHUHSRUWHGWR
WKHLGHQWLILHGFRQWDFWRUPDQXIDFWXUHUDVQHFHVVDU\SHUORFDOUHJXODWLRQV
3URGXFW&RPSODLQWVPD\UHTXLUHUHWXUQRIWKHSURGXFWZLWKWKHDOOHJHGFRPSODLQW
FRQGLWLRQ V\ULQJHSHQHWF,QLQVWDQFHVZKHUHDUHWXUQLVUHTXHVWHGHYHU\HIIRUWVKRXOG
EHPDGHE\WKHLQYHVWLJDWRUWRUHWXUQWKHSURGXFWZLWKLQGD\V,IUHWXUQVFDQQRWEH
DFFRPPRGDWHGZLWKLQGD\VWKHVLWHZLOOQHHGWRSURYLGHMXVWLILFDWLRQDQGDQHVWLPDWHG
GDWHRIUHWXUQ
7KHGHVFULSWLRQRIWKHFRPSODLQWLVLPSRUWDQWIRU$EE9LHLQRUGHUWRHQDEOH$EE9LHWR
LQYHVWLJDWHDQGGHWHUPLQHLIDQ\FRUUHFWLYHDFWLRQVDUHUHTXLUHG

$GDOLPXPDE
33URWRFRO


3ODQVIRU'LVVHPLQDWLQJDQG&RPPXQLFDWLQJ6WXG\
5HVXOWV
&RUHSXEOLFDWLRQVZLOOEHDXWKRUHGE\3ULQFLSDO,QYHVWLJDWRUVVSHFLILHGE\$EE9LHZKR
FRQWULEXWHVLJQLILFDQWO\WRWKHLPSOHPHQWDWLRQDQGFRQGXFWRIWKHVWXG\DQGQRQVLWH
SHUVRQQHOZKRFRQWULEXWHVXEVWDQWLDOO\WRWKHGHVLJQLQWHUSUHWDWLRQRUDQDO\VLVRIWKH
VWXG\HJ$EE9LHSHUVRQQHORUFRQVXOWDQWV$EE9LHVFLHQWLVWVPDNLQJVLJQLILFDQW
FRQWULEXWLRQVWRWKHVWXG\ZLOOEHLQFOXGHGLQWKHOLVWRIDXWKRUV
'HYHORSPHQWRIWKHFRUHSXEOLFDWLRQZLOOEHFRRUGLQDWHGE\DSXEOLFDWLRQFRPPLWWHH
ZKRVHPHPEHUVKLSZLOOLQFOXGHLQYHVWLJDWRUVZKRSURYLGHGVLJQLILFDQWLQSXWLQWRVWXG\
GHVLJQLPSOHPHQWDWLRQFRQGXFWDQGLQWHUSUHWDWLRQLQDGGLWLRQWR$EE9LHVFLHQWLILF
SHUVRQQHOUHVSRQVLEOHIRUVWXG\FRQGXFW
$WWKHHQGRIWKHVWXG\$EE9LHZLOOZULWHDVWXG\UHSRUW7KLVUHSRUWZLOOFRQWDLQ D
GHVFULSWLRQRIWKHREMHFWLYHVRIWKH3026WKHPHWKRGRORJ\RIWKHVWXG\ LWVUHVXOWV DQG
FRQFOXVLRQV
7KHFRPSOHWHGFDVHUHSRUWIRUPVTXHVWLRQQDLUHVDQGWKHVWXG\UHSRUWDUH WKHFRQILGHQWLDO
SURSHUW\RI$EE9LHDQGPD\QRWEHUHOHDVHGWRXQDXWKRUL]HGSHRSOHLQ DQ\IRUP
SXEOLFDWLRQVRUSUHVHQWDWLRQV ZLWKRXWH[SUHVVZULWWHQDSSURYDOIURP$EE9LH
7KHUHVXOWVRIWKLV3026PD\EHSXEOLVKHGE\$EE9LHRUE\DQ\RQHRIWKHSDUWLFLSDWLQJ
,QYHVWLJDWRUVDIWHUDJUHHPHQWZLWK$EE9LH

$GDOLPXPDE
33URWRFRO


5HIHUHQFHV

YRQGHU:HUWK-0-HPHF*%(0RUELGLW\LQSDWLHQWVZLWKKLGUDGHQLWLV
VXSSXUDWLYD%U-'HUPDWRO

'XIRUHWDO+LGUDGHQLWLV6XSSXUDWLYDDFRPPRQDQGEXUGHQVRPH\HW
XQGHUGLDJQRVHGLQIODPPDWRU\VNLQGLVHDVH3RVWJUDG0HG-)HEU
GRL

5HYX]-(&DQRXL3RLWULQH):RONHQVWHLQ39LDOHWWH&*DELVRQ*
3RXJHW)3ROL)3UHYDOHQFHDQGIDFWRUVDVVRFLDWHGZLWKKLGUDGHQLWLV
VXSSXUDWLYDUHVXOWVIURPWZRFDVHFRQWUROVWXGLHV-$P$FDG'HUPDWRO


11DOGL/(SLGHPLRORJ\,Q+LGUDGHQLWLV6XSSXUDWLYD&KDSWHU
-HPHF*%5HYX]-/H\GHQ-HGLWRUV6SULQJHU9HUODJF

-HPHF*%7UHDWPHQW,Q+LGUDGHQLWLV6XSSXUDWLYD&KDSWHU-HPHF
*%5HYX]-/H\GHQ-HGLWRUV6SULQJHU9HUODJF

+XUOH\+$[LOODU\K\SHUKLGURVLVDSRFULQHEURPKLGURVLV+LGUDGHQLWLV
VXSSXUDWLYDDQGIDPLOLDOEHQLJQSHPSKLJXVVXUJLFDODSSURDFK,Q
5RHQLJK55+HG'HUPDWRORJLFVXUJHU\1HZ<RUN0DUFHO'HNNHU


&DQRXL3RLWULQH)5HYL]-:RONHQVWHLQ3HWDO&OLQLFDO&KDUDFWHULVWLFV
RIDVHULHVRI)UHQFK SDWLHQWVZLWK+LGUDGHQLWLVVXSSXUDWLYDZLWKDQ
DQDO\VLVRIIDFWRUVDVVRFLDWHGZLWKGLVHDVHVHYHULW\-$P$FDG'HUPDWRO


=RXERXOLV&&HWDO(XURSHDQ6*XLGHOLQHVIRUWKHWUHDWPHQWRI
+LGUDGHQLWLV6XSSXUDWLYDDFQHLQYHUVD-(XU$FDG'HUPDWRO9HQHUHRO
$SU

$GDPV'5*RUGRQ.%'HYHQ\L$*,RIIUHGD0'6HYHUHKLGUDGHQLWLV
VXSSXUDWLYDWUHDWHGZLWKLQIOL[LPDELQIXVLRQ$UFK'HUPDWRO


0RXO'..RUPDQ1-6HYHUH+LGUDGHQLWLV6XSSXUDWLYDWUHDWHGZLWK
$GDOLPXPDE$UFK'HUPDWRO

$GDOLPXPDE
33URWRFRO


*LDPDUHOORV%RXUERXOLV(-3HOHNDQRX($QWRQRSRXORX$3HWURSRXORX
+%D]LDND).DUDJLDQQL9HWDO$QRSHQODEHOSKDVH,,VWXG\RIWKH
VDIHW\DQGHIILFDF\RIHWDQHUFHSWIRUWKHWKHUDS\RIKLGUDGHQLWLV
VXSSXUDWLYD%U-'HUPDWRO

.LPEDOO$=RXERXOLV&$UPVWURQJ$.RUPDQ1&URZOH\-/\QGH&
%HONQDS.<LKXD*X:LOOLDPV'6DIHW\DQGHIILFDF\RIDGDOLPXPDELQ
PRGHUDWHWRVHYHUH+LGUDGHQLWLV6XSSXUDWLYD5HVXOWVIURPILUVWZHHNV
RI3,21((5,DSKDVHUDQGRPL]HGSODFHERFRQWUROOHGWULDOWK
$QQXDO(6'5PHHWLQJ&RSHQKDJHQ'HQPDUN6HSWHPEHU

-HPHF**RWWOLHE$)RUPDQ6*LDPDUHOORV%RXUERXOL (5HJXLDL
=<LKXD*X2NXQ0(IILFDF\DQGVDIHW\RIDGDOLPXPDE LQSDWLHQWZLWK
PRGHUDWHWRVHYHUH+LGUDGHQLWLV6XSSXUDWLYD5HVXOWVIURP3,21((5,,
DSKDVHUDQGRPL]HGSODFHERFRQWUROOHGWULDO

2QGHUGLMN$-YDQGHU=HH++(VPDQQ6HWO'HSUHVVLRQLQSDWLHQWV
ZLWKKLGUDGHQLWLVVXSSXUDWLYD-(XU$FDG'HUPDWRO9HQHURO


:RONHQVWHLQ3/RXQGRX$%DUUDX.HWDO4XDOLW\RIOLIHLPSDLUPHQWLQ
+LGUDGHQLWLVVXSSXUDWLYDDVWXG\RIFDVHV-$P$FDG'HUPDWRO


+RQJER<7KRPDV&/+DUULVRQ0$HWDO7UDQVODWLQJWKHVFLHQFHRI
TXDOLW\RIOLIHLQWRSUDFWLFH:KDWGRGHUPDWRORJ\OLIHTXDOLW\LQGH[
VFRUHVPHDQ"-,QYHVW'HUPDWRO

0DWXVLDN/%HQLHN$6]HSLHWRZVNL-&+LGUDGHQLWLVVXSSXUDWLYD
PDUNHGO\GHFUHDVHVTXDOLW\RIOLIHDQGSURIHVVLRQDODFWLYLW\-$P$FDG
'HUPDWRO

0DWXVLDN/%LHQLHN$6]HSLHWRZVNL-&3V\FKRSK\VLFDODVSHFWVRI
+LGUDGHQLWLVVXSSXUDWLYD$FWD'HUP9HQHURO

$GDOLPXPDE
33URWRFRO

$SSHQGL[  'HUPDWRORJ\/LIH4XDOLW\,QGH['/4, ± ([DPSOH

$GDOLPXPDE
33URWRFRO


$GDOLPXPDE
33URWRFRO

$SSHQGL[  3DWLHQW¶V*OREDO $VVHVVPHQWRI6NLQ3DLQ± 156±
([DPSOH

$GDOLPXPDE
33URWRFRO

$SSHQGL[ (XUR4RO(4'±([DPSOH

$GDOLPXPDE
33URWRFRO

$SSHQGL[ +LGUDGHQLWLV6XSSXUDWLYD ,PSDFW$VVHVVPHQW
+6,$±([DPSOH

$GDOLPXPDE
33URWRFRO


$GDOLPXPDE
33URWRFRO


$GDOLPXPDE
33URWRFRO


$GDOLPXPDE
33URWRFRO


$GDOLPXPDE
33URWRFRO

$SSHQGL[
:RUN3URGXFWLYLW\DQG$FWLYLW\,PSDLUPHQW
4XHVWLRQQDLUH6SHFLILF+HDOWK3UREOHP:3$,6+3 ([DPSOH

$GDOLPXPDE
33URWRFRO
