Clinical trial NCT01854918
Conditions: Hyperlipidemia and Mixed Dyslipidemia
Keywords: High cholesterol Raised cholesterol Cholesterol Elevated Cholesterol
Sponsor: Amgen
Start date: 2013-04-23; Completion date: 2018-05-31
Enrollment: 3681 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Detailed description:

Arms: arm 1: Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period. arm 2: Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
Interventions: intervention 1: Evolocumab intervention 2: Standard of Care
Intervention descriptions: intervention 1: Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen intervention 2: Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Protocol documents:
Prot_000.pdf: 
3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7LWOH$0XOWLFHQWHU&RQWUROOHG 2SHQODEHO([WHQVLRQ 2/(6WXG\WR$VVHVVWKH
/RQJWHUP6DIHW\DQG(IILFDF\RI$0*
$PJHQ3URWRFRO1XPEHU
(XGUD&71XPEHU
26/(5
2SHQ/DEHO6WXG\RI/RQJ7HUP(YDOXDWLRQ$JDLQVW/'/&7ULDO
&OLQLFDO6WXG\6SRQVRU
$PJHQ,QF
2QH$PJHQ&HQWHU'ULYH
7KRXVDQG2DNV&$
3KRQH
.H\6SRQVRU&RQWDFWV

2QH$PJHQ&HQWHU'ULYH06&
7KRXVDQG2DNV&$86$
'DWH
2ULJLQDO3URWRFRO 'DWH6HSWHPEHU
$PHQGPHQW'DWH)HEUXDU\
$PHQGPHQW'DWH$SULO
6XSHUVHGLQJ$PHQGPHQW'DWH0D\
$PHQGPHQW'DWH1RYHPEHU
6XSHUVHGLQJ$PHQGPHQW'DWH)HEUXDU\
6XSHUVHGLQJ$PHQGPHQW'DWH)HEUXDU\
$PHQGPHQW'DWH$SULO
$PHQGPHQW'DWH'HFHPEHU
$PHQGPHQW'DWH$SULO
&RQILGHQWLDOLW\1RWLFH
7KLVGRFXPHQWFRQWDLQVFRQILGHQWLDOLQIRUPDWLRQRI$PJHQ,QF
7KLVGRFXPHQWPXVWQRWEHGLVFORVHGWRDQ\RQHRWKHUWKDQWKHVWXG\VWDIIDQGPHPEHUV
RIWKHLQGHSHQGHQWHWKLFVFRPPLWWHHLQVWLWXWLRQDOUHYLHZERDUG
7KHLQIRUPDWLRQLQWKLVGRFXPHQWFDQQRWEHXVHGIRUDQ\SXUSRVHRWKHUWKDQWKH
HYDOXDWLRQRUFRQGXFWRIWKHFOLQLFDOLQYHVWLJDWLRQZLWKRXWWKHSULRUZULWWHQFRQVHQWRI
$PJHQ,QF
,I\RXKDYHTXHVWLRQVUHJDUGLQJKRZWKLVGRFXPHQWPD\EHXVHGRUVKDUHGFDOOWKH
$PJHQ0HGLFDO,QIRUPDWLRQQXPEHU86VLWHVFDOO$0*(1&DQDGLDQVLWHV
FDOO$0*(1DOORWKHUFRXQWULHVFDOO)RUDOORWKHU
VWXG\UHODWHGTXHVWLRQVFRQWLQXHWRFRQWDFWWKH.H\6SRQVRU&RQWDFW
1&71XPEHU
7KLV1&7QXPEHUKDVEHHQDSSOLHGWRWKHGRFXPHQW
IRUSXUSRVHVRISRVWLQJRQFOLQLFDOWULDOVJRY
PPD
PPD


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
,QYHVWLJDWRU¶V$JUHHPHQW
,KDYHUHDGWKHDWWDFKHGSURWRFROHQWLWOHG³$0XOWLFHQWHU&RQWUROOHG2SHQODEHO
([WHQVLRQ2/(6WXG\WR$VVHVVWKH/RQJWHUP6DIHW\DQG(IILFDF\RI$0*´GDWHG
$SULODQGDJUHHWRDELGHE\DOOSURYLVLRQVVHWIRUWKWKHUHLQ
,DJUHHWRFRPSO\ZLWKWKH,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQLVDWLRQ7ULSDUWLWH
*XLGHOLQHRQ*RRG&OLQLFDO3UDFWLFHDQGDSSOLFDEOHQDWLRQDORUUHJLRQDO
UHJXODWLRQVJXLGHOLQHV
,DJUHHWRHQVXUHWKDW)LQDQFLDO'LVFORVXUH6WDWHPHQWVZLOOEHFRPSOHWHGE\
x
PHLQFOXGLQJLIDSSOLFDEOHP\VSRXVH>RUOHJDOSDUWQHU@DQGGHSHQGHQWFKLOGUHQ
x
P\VXELQYHVWLJDWRUVLQFOXGLQJLIDSSOLFDEOHWKHLUVSRXVHV>RUOHJDOSDUWQHUV@DQG
GHSHQGHQWFKLOGUHQ
DWWKHVWDUWRIWKHVWXG\DQGIRUXSWR\HDUDIWHUWKHVWXG\LVFRPSOHWHGLIWKHUHDUH
FKDQJHVWKDWDIIHFWP\ILQDQFLDOGLVFORVXUHVWDWXV
,DJUHHWRHQVXUHWKDWWKHFRQILGHQWLDOLQIRUPDWLRQFRQWDLQHGLQWKLVGRFXPHQWZLOOQRWEH
XVHGIRUDQ\SXUSRVHRWKHUWKDQWKHHYDOXDWLRQRUFRQGXFWRIWKHFOLQLFDOLQYHVWLJDWLRQ
ZLWKRXWWKHSULRUZULWWHQFRQVHQWRI$PJHQ,QF



6LJQDWXUH
1DPHRI3ULQFLSDO,QYHVWLJDWRU
'DWH''0RQWK<<<<


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 3 of 65 
CONFIDENTIAL 
 
Protocol Synopsis 
Title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term 
Safety and Efficacy of AMG 145 
Study Phase: 3 
Indication:  Primary hyperlipidemia and mixed dyslipidemia 
Primary Objective:  To characterize the safety and tolerability of long-term administration of 
AMG 145. 
Secondary Objectives:  
To characterize efficacy of long-term administration of AMG 145 as assessed by low density 
lipoprotein cholesterol (LDL-C) in subjects with primary hyperlipidemia and subjects with mixed 
dyslipidemia. 
Hypotheses:  The primary clinical hypothesis is that long-term exposure of AMG 145 will be safe 
and well-tolerated in subjects with primary hyperlipidemia and subjects with mixed dyslipidemia. 
Primary Endpoint:  Subject incidence of adverse events.  
Secondary Endpoints: 
 
Percent change from baseline in LDL-C at Week 48 and Week 104 
 
Change from baseline in LDL-C at Week 48 and Week 104 
Study Design:  This is a multicenter, randomized, controlled, open-label extension study 
designed to assess the long-term safety and efficacy of AMG 145.  Subjects that successfully 
complete a qualifying protocol and sign informed consent will be randomized 2:1 to one of two 
groups: AMG 145 + standard of care (SOC) or SOC-alone. Subjects randomized to the treatment 
group will also be expected to take background lipid lowering therapy and will be able to choose 
from one of two dose regimens:  AMG 145 (140mg) administered every 2 weeks (Q2W) + SOC, 
or AMG 145 (420mg) administered monthly (QM) + SOC.  Subjects randomized to the control 
group will receive SOC alone for the first 48 weeks of the study. During the first 12 weeks of the 
study participation, LDL-C will remain blinded and subjects must remain on stable background 
lipid lowering therapy.  Using clinical judgment, the primary investigator or qualified delegate 
should recommend background lipid lowering therapy the subject can be expected to tolerate: 
therapy either prescribed to them PRIOR to participation in parent study, or statin or ezetimibe 
therapy given during parent study.  Investigators will be informed if triglycerides are > 1000 mg/dL 
(11.3 mmol/L) so that appropriate subject follow-up can be initiated if necessary (see Protocol 
Section 6.1.3.4).  Randomization should occur within 30 days after the parent study’s EOS visit. 
Subjects will be stratified by their parent study and frequency of SC dose (Q2W or QM) within the 
parent study. After Week 48 all subjects will receive open-label AMG 145 for up to 2 years (or 
until the investigator’s recommendation for discontinuation, Amgen’s recommendation for 
discontinuation, the subject’s decision to discontinue for any reason, or until an administrative 
decision is made to close the study). 
Sample Size:  The number of subjects entering this study will depend on the number of subjects 
completing their respective AMG 145 parent studies and willingness to enroll.  Approximately 
4428 subjects are expected to participate in this study.   
Summary of Subject Eligibility Criteria:  Subjects who complete a qualifying AMG 145 protocol 
and do not discontinue IP in the parent study for any reason including an adverse event will be 
eligible for this study.  For a full list of eligibility criteria, please refer to Section 4.1 and 
Section 4.2. 
Amgen Investigational Product Dosage and Administration: AMG 145 will be administered 
via subcutaneous injection using a spring-based prefilled 1.0 mL auto-injector/pen (AI/Pen) or 
when available, a 3.5 mL Personal Injector. 
AMG 145 will be administered via 1 of 2 regimens: 
 
AMG 145 140 mg SC Q2W (1 prefilled AI/Pen injection) or 
 
AMG 145 420 mg SC QM (3 prefilled AI/Pen injections or 1 Personal Injector, once 
made available) 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7KHP/3HUVRQDO,QMHFWRUZLOORQO\EHPDGHDYDLODEOHIRUXVHLQWKLVVWXG\RQFHLWKDVEHHQ
GHWHUPLQHGWKDWWKHLQWHQGHGXVHUSRSXODWLRQIRU$0*FDQVDIHO\DQGHIIHFWLYHO\XVHWKH
GHYLFHLQFOLQLFDOWULDOVXQGHUJXLGDQFHRIVWXG\LQYHVWLJDWRUV
8SRQFRPSOHWLRQRIWKH:HHN9LVLWVXEMHFWVZLOOKDYHWKHRSSRUWXQLW\WRVZLWFKEHWZHHQ4:
DQG40HYHU\PRQWKVSURYLGHGWKHDSSURSULDWHVXSSO\RI,3LVDYDLODEOH
1RQ$PJHQ,QYHVWLJDWLRQDO3URGXFW'RVDJHDQG$GPLQLVWUDWLRQ1RQH
&RQWURO*URXS7KHFRQWUROJURXSFRPSULVHVRIVXEMHFWVUDQGRPL]HGWR62&DORQHGXULQJWKH
ILUVWZHHNVRIVWXG\SDUWLFLSDWLRQ8QWLOODERUDWRU\UHVXOWVDUHXQEOLQGHGDW:HHNWKH
FRQWUROJURXSVKRXOGUHPDLQRQVWDEOHOLSLGORZHULQJWKHUDS\HJWKHUDS\SUHVFULEHGLQSDUHQW
VWXG\RUWKHVDPHWKHUDS\SUHVFULEHGEHIRUHSDUHQWVWXG\SDUWLFLSDWLRQZKLFKHYHUWKHVXEMHFWLV
OLNHO\WRWROHUDWH$IWHUXQEOLQGLQJDW:HHNLQYHVWLJDWRUVPD\SUHVFULEHDQ\FRQFRPLWDQW
PHGLFDWLRQVRUWUHDWPHQWVGHHPHGQHFHVVDU\WRSURYLGHDGHTXDWHVXSSRUWLYHFDUH
6HFWLRQ$IWHUZHHNVRISDUWLFLSDWLRQWKHVHVXEMHFWVZLOOUHFHLYHRSHQODEHO$0*LQ
WKHUHJLPHQRIWKHLUFKRLFH4:RU40DQGZLOOQRORQJHUEHFRQVLGHUHGSDUWRIDFRQWUROJURXS
7KHVHVXEMHFWVPD\DOVRVZLWFKEHWZHHQUHJLPHQVHYHU\ZHHNV
3URFHGXUHV3ULRUWRHQUROOLQJLQWKLVVWXG\VXEMHFWVZLOOQHHGWRXQGHUJRHQGRIVWXG\(26
SURFHGXUHVIRUWKHLUTXDOLI\LQJSDUHQWVWXG\,QDGGLWLRQVXEMHFWVZLOOQHHGWRVLJQDQHZVWXG\
,QIRUPHG&RQVHQW)RUPDQGPHHWLQFOXVLRQH[FOXVLRQFULWHULDUHTXLUHPHQWV6XEMHFWLGHQWLILFDWLRQ
QXPEHUVZLOOEHWKHVDPHDVWKRVHLQWKHLUSDUHQWSURWRFROV
6XEMHFWVWKDWIDOOZLWKLQDGD\ZLQGRZRIFRPSOHWLQJWKHILQDOODERUDWRU\DVVHVVPHQWVIRUD
TXDOLI\LQJSDUHQWVWXG\GRQRWUHTXLUHODERUDWRU\SURFHGXUHVWREHUHSHDWHG
6XEMHFWYLVLWVFKHGXOHZLOOGLIIHUEDVHGXSRQIDFWRUVUDQGRPL]DWLRQVHOHFWLRQRI4:RU40
UHJLPHQDQGSULRUH[SHULHQFHZLWKVHOILQMHFWLRQRI$0*6XEMHFWVUDQGRPL]HGWR
$0*62&ZLWKRXWSUHYLRXVH[SHULHQFHZLWKVHOILQMHFWLRQRI$0*ZLOOKDYHDGGLWLRQDO
,3WUDLQLQJYLVLWVDWWLPHRIVWXG\VWDUW$W:HHNDVLPLODUWUDLQLQJVFKHGXOHZLOOEHXWLOL]HGIRU
VXEMHFWVUDQGRPL]HGWR62&DORQHDW'D\ZLWKQRSUHYLRXVH[SHULHQFHZLWKVHOILQMHFWLRQRI
$0*
$GGLWLRQDOYLVLWVZLOORFFXUTXDUWHUO\'XULQJVLWHYLVLWVYLWDOVLJQVDGYHUVHHYHQWV$(V6HULRXV
$GYHUVH(YHQWV6$(VDQGFRQFRPLWDQWWKHUDS\ZLOOEHHYDOXDWHG2WKHUDVVHVVPHQWVDQG
SURFHGXUHVLQFOXGHIDVWLQJOLSLGVSK\VLFDOH[DPPHDVXULQJERG\ZHLJKWODERUDWRU\
DVVHVVPHQWVLQFOXGLQJDQWL$0*DQWLERGLHVXULQHSUHJQDQF\WHVWLQJIHPDOHVRI
FKLOGEHDULQJSRWHQWLDODQGXULQDO\VLV,3DGPLQLVWUDWLRQE\6&LQMHFWLRQZLOOEHGRQHDIWHUDOO
RWKHUSURFHGXUHVKDYHEHHQFRPSOHWHG
6WDWLVWLFDO&RQVLGHUDWLRQV
*HQHUDO&RQVLGHUDWLRQV
6WDWLVWLFDODQDO\VHVLQWKLVPXOWLFHQWHURSHQODEHOVWXG\ZLOOEHGHVFULSWLYH
7KHUHZLOOEHLQWHULPDQDO\VHVWRVXSSRUWVDIHW\GDWDUHSRUWLQJDQGDVVHVVPHQWVRIHIILFDF\
HQGSRLQWV,QSDUWLFXODULQWHULPDQDO\VHVRIWKHUDQGRPL]HGVWXG\SHULRGXSWR:HHNZLOOEH
FRQGXFWHGDIWHUDOOVXEMHFWVIURPVHWVRISDUHQWVWXGLHVKDYHFRPSOHWHGWKH:HHNYLVLWRU
HQGHGWKHVWXG\
)RUDOOHQGSRLQWVUHVXOWVZLOOEHVXPPDUL]HGE\WKHWUHDWPHQWJURXSWRZKLFKVXEMHFWVDUH
UDQGRPL]HGLQWKLVVWXG\XQOHVVRWKHUZLVHVSHFLILHG
6XEMHFWGLVSRVLWLRQGHPRJUDSKLFVDQGEDVHOLQHFKDUDFWHULVWLFVZLOOEHVXPPDUL]HG
6XPPDU\VWDWLVWLFVIRUFRQWLQXRXVYDULDEOHVZLOOLQFOXGHWKHQXPEHURIVXEMHFWVPHDQPHGLDQ
VWDQGDUGGHYLDWLRQRUVWDQGDUGHUURUILUVWDQGWKLUGTXDUWLOHVPLQLPXPDQGPD[LPXP)RU
FDWHJRULFDOYDULDEOHVWKHIUHTXHQF\DQGSHUFHQWDJHZLOOEHJLYHQFRQILGHQFHLQWHUYDOVZLOO
EHFDOFXODWHGIRUVHOHFWFRQWLQXRXVDQGFDWHJRULFDOHQGSRLQWV
8QOHVVRWKHUZLVHVSHFLILHGWKHEDVHOLQHYDOXHLVGHILQHGDVWKHVXEMHFW¶VEDVHOLQHYDOXHIURPWKH
SDUHQWVWXG\
7KHIXOODQDO\VLVVHW)$6ZLOOLQFOXGHDOOVXEMHFWVUDQGRPL]HGLQWKLVVWXG\$OODQDO\VHVRI
UDQGRPL]HGFRQWUROOHGSHULRGRIWKHVWXG\ZLOOEHSHUIRUPHGXVLQJWKH)$6$QDO\VHVRIWKH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
SHULRGDIWHUWKHUDQGRPL]HGFRQWUROOHGSHULRGPD\EHOLPLWHGWRWKRVHUHFHLYLQJLQYHVWLJDWLRQDO
SURGXFW7KHUHZLOOEHQRLPSXWDWLRQIRUPLVVLQJGDWD
'HDWKVDQGPDMRUFDUGLRYDVFXODUHYHQWVIURPWKLVDQGRWKHUSKDVHVWXGLHVZLOOEHDGMXGLFDWHG
E\DQLQGHSHQGHQW&OLQLFDO(YHQWV&RPPLWWHH&(&WRIDFLOLWDWHDJJUHJDWHGDQDO\VHVDFURVVWKH
SURJUDP
$QDO\VHVRIWKH3ULPDU\(QGSRLQW
$GYHUVHHYHQWVZLOOEHFRGHGXVLQJWKHODWHVWYHUVLRQRI0HGLFDO'LFWLRQDU\IRU5HJXODWRU\
$FWLYLWLHV0HG'5$6XEMHFWLQFLGHQFHVRIDGYHUVHHYHQWVVHULRXVDGYHUVHHYHQWVDQGDGYHUVH
HYHQWVOHDGLQJWRZLWKGUDZDOZLOOEHWDEXODWHGE\V\VWHPRUJDQFODVVDQGSUHIHUUHGWHUP
$QDO\VLVRI6HFRQGDU\(QGSRLQWV
3RLQWHVWLPDWHVRIWUHDWPHQWJURXSPHDQVDQGWKHLUFRQILGHQFHLQWHUYDOVZLOOEHFDOFXODWHG
'LIIHUHQFHVLQJURXSPHDQVIRUWKHVHFRQGDU\HQGSRLQWVZLOOEHHVWLPDWHGEHWZHHQWKH
$0*62&JURXSDQGWKH62&DORQHJURXS
2WKHU6DIHW\$QDO\VHV
0HDVXUHPHQWVRIODERUDWRU\SDUDPHWHUVDQGYLWDOVLJQVZLOOEHVXPPDUL]HGDWHDFKVFKHGXOHG
YLVLW/DEVKLIWWDEOHVZLOOEHSURYLGHG7KHLQFLGHQFHDQGSHUFHQWDJHVRIVXEMHFWVZKRGHYHORS
DQWL$0*DQWLERGLHVELQGLQJDQGQHXWUDOL]LQJDWDQ\WLPHZLOOEHWDEXODWHG6XPPDULHVRI
YLWDOVLJQVZLOODOVREHSURYLGHG
)RUDIXOOGHVFULSWLRQRIVWDWLVWLFDODQDO\VLVPHWKRGVUHIHUWR6HFWLRQ
6SRQVRU$PJHQ,QF


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
6WXG\'HVLJQDQG7UHDWPHQW6FKHPD




3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 8 of 65 
CONFIDENTIAL 
 
Study Glossary 
Abbreviation or Term 
Definition/Explanation 
AE 
Adverse event 
AHA 
American Heart Association 
AI/pen 
Prefilled Autoinjector/pen 
ALP 
Alkaline phosphatase 
ALT (SGPT) 
Alanine aminotransferase (serum glutamic-pyruvic transaminase) 
ApoA1 
Apolipoprotein A-1 
ApoB 
Apolipoprotein B 
AST (SGOT) 
Aspartate aminotransferase (serum glutamic-oxaloacetic 
transaminase) 
BP 
Blood pressure 
CAD 
Coronary artery disease 
CBC 
Complete blood count 
CEC 
Clinical Events Committee 
CK 
Creatine kinase 
CHD 
Coronary heart disease 
CRP 
C-reactive protein 
CVD 
Cardiovascular disease 
CTCAE 
NCI Common Terminology Criteria for AEs 
Day 1 
Defined as the first day that protocol-specified investigational 
product is administered to the subject.   
DILI 
Drug-induced liver injury 
eCRF 
 
EDC  
Electronic case report form 
 
Electronic Data Capture  
End of treatment 
Defined as the last assessment for the protocol-specified treatment 
phase of the study for an individual subject 
EOS 
End-of-study for individual subject 
EU 
European Union 
FAS 
Full analysis set 
FSH 
Follicle-stimulating hormone 
GCP 
HCV 
Good Clinical Practice 
Hepatitis C Virus 
HDL-C 
High density lipoprotein cholesterol 
HepG2 cells 
Human hepatocellular carcinoma cell line 
HR 
Heart Rate 
hsCRP 
High sensitivity CRP 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$EEUHYLDWLRQRU7HUP
'HILQLWLRQ([SODQDWLRQ
,%*
,QGHSHQGHQW%LRVWDWLVWLFDO*URXS
,&)
,QIRUPHGFRQVHQWIRUP
,&+
,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ
,(&,5%
,QGHSHQGHQW(WKLFV&RPPLWWHH,QVWLWXWLRQDO5HYLHZ%RDUG
,3
,03
,QYHVWLJDWLRQDOSURGXFW
,QYHVWLJDWLRQDO0HGLFLQDO3URGXFW
,3,0
,QYHVWLJDWLRQDO3URGXFW,QVWUXFWLRQ0DQXDO
/'/&
/RZGHQVLW\OLSRSURWHLQFKROHVWHURO
/'/5
/'/UHFHSWRU
/2)
/RVVRIIXQFWLRQ
/SD
/LSRSURWHLQD
0RQWK
'D\V
0HG'5$
0HGLFDOGLFWLRQDU\IRUUHJXODWRU\DFWLYLWLHV
1$6+
1RQDOFRKROLFVWHDWRKHSDWLWLV
2/(
2SHQ/DEHO([WHQVLRQ
3&6.
3URSURWHLQFRQYHUWDVHVXEWLOLVLQNH[LQW\SH
4:
(YHU\ZHHNV
40
(YHU\PRQWK
6$(
6HULRXVDGYHUVHHYHQW
6&
6XEFXWDQHRXV
6RXUFH'DWD
,QIRUPDWLRQIURPDQRULJLQDOUHFRUGRUDFHUWLILHGFRS\RIWKHRULJLQDO
UHFRUGFRQWDLQLQJVXEMHFWLQIRUPDWLRQIRUXVHLQFOLQLFDOUHVHDUFK
7KHLQIRUPDWLRQPD\LQFOXGHEXWLVQRWOLPLWHGWRFOLQLFDOILQGLQJV
REVHUYDWLRQVRURWKHUDFWLYLWLHVLQDFOLQLFDOWULDOQHFHVVDU\IRUWKH
UHFRQVWUXFWLRQDQGHYDOXDWLRQRIWKHWULDO6RXUFHGDWDDUHFRQWDLQHG
LQVRXUFHGRFXPHQWVRULJLQDOUHFRUGVRUFHUWLILHGFRSLHV
,&+*XLGHOLQH(([DPSOHVRIVRXUFHGDWDLQFOXGH6XEMHFW,'
5DQGRPL]DWLRQ,'DQG6WUDWLILFDWLRQ9DOXH
7%/
7RWDOELOLUXELQ
8/1
8SSHUOLPLWRIQRUPDO
9/'/&
9HU\ORZGHQVLW\OLSRSURWHLQFKROHVWHURO


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7DEOHRI&RQWHQWV
3DJH
3URWRFRO6\QRSVLV 
6WXG\'HVLJQDQG7UHDWPHQW6FKHPD 
6WXG\*ORVVDU\ 

2%-(&7,9(6
 
3ULPDU\ 
 
6HFRQGDU\ 

%$&.*5281'$1'5$7,21$/(
 
&DUGLRYDVFXODU'LVHDVH 
 
$0*%DFNJURXQG 
 
)LUVWLQ+XPDQ),+3KDVH6WXGLHV 
 
&RPSOHWHG3KDVH:HHN/'/&/RZHULQJ
6WXGLHV 
 
5DWLRQDOH 
 
&OLQLFDO+\SRWKHVHV 
 
(;3(5,0(17$/3/$1 
 
6WXG\'HVLJQ 
 
1XPEHURI&HQWHUV 
 
1XPEHURI6XEMHFWV 
 
6WXG\'XUDWLRQIRU3DUWLFLSDQWV 
 
(QGRI6WXG\ 
 
68%-(&7(/,*,%,/,7< 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 
 
68%-(&7(152//0(17 
 
75($70(17352&('85(6 
 
$0* 
 
'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH 
 
'RVDJH$GMXVWPHQWV 
 
&ULWHULDIRU:LWKKROGLQJRI,QYHVWLJDWLRQDO3URGXFW 
 
(OHYDWLRQRI&UHDWLQH.LQDVH&. 
 
(OHYDWLRQRI/LYHU)XQFWLRQ7HVWV 
 
&ULWHULDIRU5HFKDOOHQJHRI$0*$IWHU
3RWHQWLDO+HSDWRWR[LFLW\ 
 
(OHYDWLRQRI7ULJO\FHULGHV 
 
3URGXFW&RPSODLQWV,QFOXGLQJ'HYLFH&RPSODLQWV 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
 
&RQFRPLWDQW7KHUDS\3K\VLFDO([HUFLVHDQG'LHW 
 
([FOXGHG7UHDWPHQWV'XULQJ6WXG\3HULRG 
 
678'<352&('85(6 
 
*HQHUDO6WXG\3URFHGXUHV 
 
(QUROOPHQW(263DUHQW6WXG\'D\2/( 
 
:HHN'D\V±,I6XEMHFWZLWKQR
3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQLV
5DQGRPL]HGWR$0*62&DQG
6HOHFWV4:5HJLPHQ 
 
:HHN'D\V±3KRQH9LVLWIRU
62&DORQH6XEMHFWV 
 
:HHN'D\V±,I6XEMHFWZLWKQR
3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQLV
5DQGRPL]HGWR$0*62& 
 
:HHN'D\V±3KRQH9LVLWIRU
62&DORQH6XEMHFWV 
 
:HHN'D\V±,I6XEMHFWZLWKQR
3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQLV
5DQGRPL]HGWR$0*62&DQG
6HOHFWV405HJLPHQ 
 
:HHN'D\V±3KRQH9LVLWIRU
62&DORQH6XEMHFWV 
 
:HHN'D\V 
 
:HHN9LVLW'D\V 
 
:HHN9LVLW'D\V 
 
:HHNGD\V±IRU6XEMHFWVRQ40
5HJLPHQ2QO\ 
 
:HHN'D\V±3KRQH9LVLWIRU
62&DORQH6XEMHFWV 
 
:HHNGD\V±IRU6XEMHFWVRQ4:
5HJLPHQ2QO\ 
 
:HHN'D\V±3KRQH9LVLWIRU
62&DORQH6XEMHFWV 
 
:HHN9LVLW'D\V 
 
:HHN'D\V±$GGLWLRQDO
3URFHGXUHVIRU6XEMHFWV5DQGRPL]HGWR
62&±DORQHLQ<HDUZLWKQR3UHYLRXV
([SHULHQFHRI6HOILQMHFWLRQDQG6HOHFWV
4:5HJLPHQ 
 
:HHN'D\V±$GGLWLRQDO3URFHGXUHV
IRU6XEMHFWV5DQGRPL]HGWR62&±DORQHLQ
<HDUZLWKQR3UHYLRXV([SHULHQFHRI
6HOILQMHFWLRQ 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
 
:HHN'D\V±$GGLWLRQDO
3URFHGXUHVIRU6XEMHFWV5DQGRPL]HGWR
62&±DORQHLQ<HDUZLWKQR3UHYLRXV
([SHULHQFHRI6HOILQMHFWLRQDQG6HOHFWV
405HJLPHQ 
 
:HHN'D\V 
 
:HHN'D\V±$GGLWLRQDO
3URFHGXUHVIRU6XEMHFWV5DQGRPL]HGWR
3ODFHERRU62&LQ3DUHQW6WXG\DQG
5DQGRPL]HGWR62&DORQHLQ<HDU 
 
:HHN'D\V 
 
:HHN'D\V 
 
:HHN'D\V 
 
:HHN'D\V±IRU6XEMHFWVRQ40
5HJLPHQ2QO\ 
 
:HHN'D\V±IRU6XEMHFWVRQ4:
5HJLPHQ2QO\ 
 
:HHN'D\V 
 
:HHNVRU'D\V 
 
:HHN'D\V 
 
(QGRI6WXG\±:N'D\V±3KRQH
YLVLW 
 
6WDQGDUGL]DWLRQRI6WXG\3URFHGXUHV 
 
0HDVXUHPHQWRI9LWDO6LJQV 
 
%ORRG6DPSOH8VH 
 
/LSLG0HDVXUHPHQWV 
 
/DERUDWRU\$VVHVVPHQWV 
 
'HYLFH4XHVWLRQQDLUH 
 
$QWLERG\7HVWLQJ3URFHGXUHV 
 
6DPSOH6WRUDJHDQG'HVWUXFWLRQ 
 
5(029$/$1'5(3/$&(0(172)68%-(&76 
 
5HPRYDORI6XEMHFWV 
 
5HSODFHPHQWRI6XEMHFWV 
 
6$)(7<'$7$&2//(&7,215(&25',1*$1'5(3257,1* 
 
$GYHUVH(YHQWV 
 
'HILQLWLRQRI$GYHUVH(YHQWV 
 
5HSRUWLQJ3URFHGXUHVIRU$GYHUVH(YHQWV 
 
6HULRXV$GYHUVH(YHQWV 
 
'HILQLWLRQRI6HULRXV$GYHUVH(YHQWV 
 
5HSRUWLQJ3URFHGXUHVIRU6HULRXV$GYHUVH(YHQWV 
 
3UHJQDQF\DQG/DFWDWLRQ5HSRUWLQJ 
 
67$7,67,&$/&216,'(5$7,216 
 
6WXG\(QGSRLQWV6XEVHWVDQG&RYDULDWHV 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
 
3ULPDU\(QGSRLQW 
 
6HFRQGDU\(QGSRLQWV 
 
([SORUDWRU\(QGSRLQWV 

2WKHU6DIHW\(QGSRLQWV 
 
$QDO\VLV6HWV 
 
%DVHOLQH&RYDULDWHV 
 
6DPSOH6L]H&RQVLGHUDWLRQV 
 
,QWHULP$QDO\VLVDQG(DUO\6WRSSLQJ*XLGHOLQHV 
 
3ODQQHG0HWKRGVRI$QDO\VLV 
 
*HQHUDO$SSURDFK&RQVLGHUDWLRQV 
 
$QDO\VLVRI.H\6WXG\(QGSRLQWV 
 
3ULPDU\(QGSRLQW$QDO\VHV 
 
6HFRQGDU\(QGSRLQW$QDO\VHV 
 
([SORUDWRU\(QGSRLQW$QDO\VHV 
 
6DIHW\(QGSRLQW$QDO\VHV 
 
5(*8/$725<2%/,*$7,216 
 
,QIRUPHG&RQVHQW 
 
,QGHSHQGHQW(WKLFV&RPPLWWHH,QVWLWXWLRQDO5HYLHZ%RDUG
,(&,5% 
 
6XEMHFW&RQILGHQWLDOLW\ 
 
,QYHVWLJDWRU6LJQDWRU\2EOLJDWLRQV 
 
$'0,1,675$7,9($1'/(*$/2%/,*$7,216 
 
3URWRFRO$PHQGPHQWVDQG6WXG\7HUPLQDWLRQ 
 
6WXG\'RFXPHQWDWLRQDQG$UFKLYH 
 
6WXG\0RQLWRULQJDQG'DWD&ROOHFWLRQ 
 
,QYHVWLJDWRU5HVSRQVLELOLWLHVIRU'DWD&ROOHFWLRQ 
 
/DQJXDJH 
 
3XEOLFDWLRQ3ROLF\ 
 
&RPSHQVDWLRQ 
 
5()(5(1&(6 
 
$33(1',&(6 
/LVWRI7DEOHV
7DEOH$QDO\WH/LVWLQJ
 

/LVWRI$SSHQGLFHV
$SSHQGL[$6FKHGXOHRI$VVHVVPHQWV
 

$SSHQGL[%$GGLWLRQDO6DIHW\$VVHVVPHQW,QIRUPDWLRQ
 

$SSHQGL[&6DPSOH6HULRXV$GYHUVH(YHQW)RUP'212786(
$SSHQGL[ '3UHJQDQF\DQG/DFWDWLRQ1RWLILFDWLRQ:RUNVKHHWV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

2%-(&7,9(6

3ULPDU\
7RFKDUDFWHUL]HWKHVDIHW\DQGWROHUDELOLW\RIORQJWHUPDGPLQLVWUDWLRQRI$0*

6HFRQGDU\
7RFKDUDFWHUL]HWKHHIILFDF\RIORQJWHUPDGPLQLVWUDWLRQRI$0*DVDVVHVVHGE\ORZ
GHQVLW\OLSRSURWHLQFKROHVWHURO/'/&LQVXEMHFWVZLWKSULPDU\K\SHUOLSLGHPLDDQG
VXEMHFWVZLWKPL[HGG\VOLSLGHPLD

%$&.*5281'$1'5$7,21$/(

&DUGLRYDVFXODU'LVHDVH
&DUGLRYDVFXODUGLVHDVH&9'UHPDLQVWKHPRVWLPSRUWDQWKHDOWKFDUHLVVXHLQWKH
GHYHORSHGZRUOGDQGLVUDSLGO\EHFRPLQJVRLQODUJHSDUWVRIWKHGHYHORSLQJZRUOG7KH
IROORZLQJIDFWVIURPWKH$PHULFDQ+HDUW$VVRFLDWLRQ$+$+HDUWDQG6WURNH)DFWV
8SGDWHIURPLOOXVWUDWHWKHPDJQLWXGHRIWKHSUREOHPLQWKH865RJHUHWDO
 7KHRYHUDOOGHDWKUDWHIURP&9'LQWKH86ZDVSHU1HDUO\
$PHULFDQVGLHRI&9'HDFKGD\DQDYHUDJHRIGHDWKHYHU\VHFRQGV
0RUHWKDQ$PHULFDQVNLOOHGE\&9'LQZHUHOHVVWKDQ\HDUVRI
DJH,QRIGHDWKVIURP&9'RFFXUUHGEHIRUHWKHDJHRI\HDUV
ZKLFKLVZHOOEHIRUHWKHDYHUDJHOLIHH[SHFWDQF\RI\HDUV3UHOLPLQDU\
PRUWDOLW\GDWDIURPVKRZWKDW&9'DFFRXQWHGIRURIDOO
GHDWKVLQRURIHYHU\GHDWKVLQWKH8QLWHG6WDWHV
 &RURQDU\KHDUWGLVHDVH&+'FDXVHGRIHYHU\GHDWKVLQWKH8QLWHG6WDWHVLQ
&RURQDU\KHDUWGLVHDVHPRUWDOLW\ZDV,QDQHVWLPDWHG
$PHULFDQVZLOOKDYHDQHZFRURQDU\DWWDFNDQGDERXWZLOOKDYH
DUHFXUUHQWDWWDFN,WLVHVWLPDWHGWKDWDQDGGLWLRQDOVLOHQWILUVW
P\RFDUGLDOLQIDUFWLRQVRFFXUHDFK\HDU$ERXWHYHU\VHFRQGVDQ$PHULFDQ
ZLOOKDYHDFRURQDU\HYHQWDQGDERXWHYHU\PLQXWHVRPHRQHZLOOGLHIURPRQH
 (DFK\HDUDERXWSHRSOHH[SHULHQFHDQHZRUUHFXUUHQWVWURNH$ERXW
RIWKHVHDUHILUVWDWWDFNVDQGDUHUHFXUUHQWDWWDFNV3UHOLPLQDU\
GDWDIURPLQGLFDWHWKDWVWURNHDFFRXQWHGIRUDERXWRIHYHU\GHDWKVLQ
WKH8QLWHG6WDWHV2QDYHUDJHHYHU\VHFRQGVVRPHRQHLQWKH8QLWHG6WDWHV
KDVDVWURNH)URPWRWKHVWURNHGHDWKUDWHIHOODQGWKHDFWXDO
QXPEHURIVWURNHGHDWKVGHFOLQHG
&RURQDU\DUWHU\GLVHDVH&$'DIIHFWVDOPRVWPLOOLRQ$PHULFDQV2IWKRVH
VXIIHUIURPP\RFDUGLDOLQIDUFWLRQIURPDQJLQDSHFWRULV
IURPFRQJHVWLYHKHDUWIDLOXUHDQGPLOOLRQIURPVWURNH2QHLQWKUHH
LQGLYLGXDOVLQWKH86KDVVRPHIRUPRIFDUGLRYDVFXODUGLVHDVH7KHDJLQJRIWKH
SRSXODWLRQZLOOXQGRXEWHGO\UHVXOWLQDQLQFUHDVHGLQFLGHQFHRIFRURQDU\DUWHU\
GLVHDVHKHDUWIDLOXUHDQGVWURNH7KHUHKDVEHHQDQH[SORVLYHLQFUHDVHLQWKH
SUHYDOHQFHRIREHVLW\DQGW\SHGLDEHWHVDQGWKHLUUHODWHGFRPSOLFDWLRQV
K\SHUWHQVLRQK\SHUOLSLGHPLDDQGDWKHURVFOHURWLFYDVFXODUGLVHDVHZLOODOVR


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
LQFUHDVH$QDODUPLQJLQFUHDVHLQXQDWWHQGHGULVNIDFWRUVLQWKH\RXQJHU
JHQHUDWLRQVZLOOFRQWLQXHWRIXHOWKHFDUGLRYDVFXODUHSLGHPLFIRU\HDUVWRFRPH
 &DUGLRYDVFXODUGLVHDVHFODLPVPRUHOLYHVHDFK\HDUWKDQWKHQH[WOHDGLQJ
FDXVHVRIGHDWKFRPELQHG&DUGLRYDVFXODUGLVHDVHFODLPHGRIDOOGHDWKV
LQWKH8QLWHG6WDWHVLQ6LQFHFDUGLRYDVFXODUGLVHDVHKDVEHHQWKH
1RNLOOHULQWKH8QLWHG6WDWHVHYHU\\HDUEXW
,Q(XURSHWKHVLWXDWLRQLVVLPLODUWRWKHGDWDUHSRUWHGIRUWKH8QLWHG6WDWHV&RURQDU\
KHDUWGLVHDVHE\LWVHOIUHPDLQVWKHVLQJOHPRVWFRPPRQFDXVHRIGHDWKVLQWKH
(XURSHDQ8QLRQ(8DOWKRXJKWKH(XURSHDQFDUGLRYDVFXODUGLVHDVHVWDWLVWLFV
VKRZVDUHGXFWLRQLQWKHFUXGHQXPEHURI&+'GHDWKVZKHQFRPSDUHGZLWKWKH
HGLWLRQ$OOHQGHUHWDO7KLVUHIOHFWVDJHQHUDOWUHQGLQ:HVWHUQ1RUWKHUQ
DQG6RXWKHUQ(XURSHDQFRXQWULHVZKHUH&+'PRUWDOLW\UDWHVDUHIDOOLQJVWHDGLO\7KH
VLWXDWLRQLQVRPH&HQWUDODQG(DVWHUQ(XURSHDQFRXQWULHVLVYHU\GLIIHUHQWZLWK&+'
UDWHVULVLQJGUDPDWLFDOO\7KLVJUDGLHQWLVPRUHPDUNHGIRUVWURNHPRUWDOLW\ZKHUHWKH
FUXGHQXPEHURIGHDWKVLQFUHDVHGVLQFH2YHUPHQDQGQHDUO\
ZRPHQGLHRIVWURNHLQWKH(8HYHU\\HDU
(DFK\HDU&9'FDXVHVRYHUPLOOLRQGHDWKVLQ(XURSHDQGRYHUPLOOLRQGHDWKVLQ
WKH(XURSHDQ8QLRQ(8&9'FDXVHVQHDUO\KDOIRIDOOGHDWKVLQ(XURSHDQGLQ
WKH(8&9'LVWKHPDLQFDXVHRIGHDWKLQZRPHQLQDOOFRXQWULHVRI(XURSHDQG
LVWKHPDLQFDXVHRIGHDWKLQPHQLQDOOFRXQWULHVH[FHSW)UDQFHWKH1HWKHUODQGVDQG
6SDLQ&9'LVWKHPDLQFDXVHRIWKHGLVHDVHEXUGHQLOOQHVVDQGGHDWKLQ(XURSH
RIWKHHQWLUHGLVHDVHEXUGHQDQGWKHVHFRQGPDLQFDXVHRIWKHGLVHDVHEXUGHQLQ
WKRVH(8FRXQWULHVZLWKYHU\ORZFKLOGDQGDGXOWPRUWDOLW\&9'PRUWDOLW\
LQFLGHQFHDQGFDVHIDWDOLW\DUHIDOOLQJLQPRVW1RUWKHUQ6RXWKHUQDQG:HVWHUQ(XURSHDQ
&RXQWULHVEXWHLWKHUQRWIDOOLQJDVIDVWRUULVLQJLQ&HQWUDODQG(DVWHUQ(XURSHDQ
FRXQWULHV
&OHDUO\PRUHHIIHFWLYHSULPDU\DQGVHFRQGDU\&+'SUHYHQWLRQPHDVXUHVDUHUHTXLUHG
&+'SUHYHQWLRQLQWKHIXWXUHZLOOEHWKHUHVXOWRIWKHJURXQGEUHDNLQJUHVHDUFKWKDWKDV
EHHQFRQGXFWHGRYHUWKHSDVW\HDUV)RUH[DPSOHLQWKHVGDWDIURPWKH
)UDPLQJKDP(SLGHPLRORJLFDO6WXG\GHPRQVWUDWHGWKDWLQFUHDVHVLQVHUXPFKROHVWHURO
OHYHOVLQWKHJHQHUDOSRSXODWLRQZHUHDVVRFLDWHGZLWKDQLQFUHDVHGULVNRIGHDWKIURP
&+'.DQQHOHWDO.DQQHOHWDO.DQQHO,QWKH1DWLRQDO
&KROHVWHURO(GXFDWLRQ3URJUDP1&(3LGHQWLILHGHOHYDWHGORZGHQVLW\OLSRSURWHLQ
FKROHVWHURO/'/&DVDSULPDU\ULVNIDFWRUIRU&+'1&(3,QWKH1&(3
$GXOW7UHDWPHQW3DQHO,,5HSRUWWKLVFRQFOXVLRQZDVIXUWKHUVWUHQJWKHQHGE\WKH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
DGGLWLRQRIDJJUHVVLYHGLHWDU\DQGGUXJWKHUDS\UHFRPPHQGDWLRQVIRUVXEMHFWVZLWK
NQRZQ&+'1&(3,Q*RXOGDQGDVVRFLDWHVUHSRUWHGPHWDDQDO\VLVGDWD
RQUDQGRPL]HGFOLQLFDOWULDOVWKDWODVWHGPRUHWKDQWZR\HDUVDQGZHUHGHVLJQHGWR
UHGXFHVHUXPFKROHVWHUROOHYHOV*RXOGHWDO7KH\FRQFOXGHGWKDWIRUHYHU\
SHUFHQWDJHSRLQWVRIFKROHVWHUROORZHULQJ&+'PRUWDOLW\ZDVUHGXFHGE\
SDQGWRWDOPRUWDOLW\E\S$FFRUGLQJWRWKHPRVWUHFHQWO\
UHSRUWHG8QLWHG6WDWHV1DWLRQDO+HDOWKDQG1XWULWLRQ([DPLQDWLRQ6XUYH\1+$1(6,,,
DQHVWLPDWHGPLOOLRQ$PHULFDQVZLWK&+'VKRXOGEHWUHDWHGZLWKOLSLGORZHULQJ
PHGLFDWLRQVXQGHUWKH1&(3JXLGHOLQHV6HPSRVHWDO3UHVHQWO\OHVVWKDQ
RQHWKLUGRIWKRVH&+'VXEMHFWVZKRUHTXLUHOLSLGORZHULQJPHGLFDWLRQVDFWXDOO\UHFHLYH
WUHDWPHQWDQGRQO\DVPDOOSURSRUWLRQRIWKRVHZKRGRUHFHLYHWUHDWPHQWDFKLHYH1&(3
WDUJHWOHYHOV(LVHQEHUJ
'HVSLWHWKHDYDLODELOLW\RIVHYHUDOFODVVHVRIYHU\HIIHFWLYHGUXJVG\VOLSLGHPLDDQGULVN
IDFWRUFRQWURODUHSRRUO\VHUYHGDQGWKHUHUHPDLQVDODUJHXQPHWPHGLFDOQHHGIRUQHZ
HIIHFWLYHDQGZHOOWROHUDWHGWKHUDSLHV

$0*%DFNJURXQG
5HF\FOLQJRIWKHKHSDWLFFHOOVXUIDFH/'/UHFHSWRU/'/5SOD\VDFULWLFDOUROHLQWKH
PDLQWHQDQFHRIFHOOXODUDQGZKROHERG\FKROHVWHUROEDODQFHE\UHJXODWLQJSODVPD/'/&
OHYHOV5HFHQWO\LWKDVEHHQVKRZQWKDW3URSURWHLQFRQYHUWDVHVXEWLOLVLQNH[LQW\SH
3&6.SOD\VDQLPSRUWDQWUROHLQWKHUHF\FOLQJDQGUHJXODWLRQRI/'/5
+RUWRQHWDO%URZQDQG*ROGVWHLQ3&6.LVDPHPEHURIWKHVXEWLOLVLQ
IDPLO\RIVHULQHSURWHDVHVDQGLVH[SUHVVHGSUHGRPLQDQWO\LQWKHOLYHUNLGQH\DQG
LQWHVWLQH=DLGHWDO)ROORZLQJVHFUHWLRQLWFDXVHVSRVWWUDQVODWLRQDOGRZQ
UHJXODWLRQRIKHSDWLFFHOOVXUIDFH/'/5E\DPHFKDQLVPWKDWLQYROYHVGLUHFWELQGLQJWR
WKH/'/5'RZQUHJXODWLRQRIKHSDWLF/'/5LQWXUQOHDGVWRLQFUHDVHGOHYHOVRI
FLUFXODWLQJ/'/&7KXV3&6.PD\UHSUHVHQWDWDUJHWIRULQKLELWLRQE\QRYHO
WKHUDSHXWLFVLQWKHVHWWLQJRIG\VOLSLGHPLD7KHUDWLRQDOHIRUVXFKDQDSSURDFKLV
DYDLODEOHIURPVWXGLHVLQSUHFOLQLFDOPRGHOVDQGIURPKXPDQJHQHWLFGDWDWKDWSURYLGH
VWURQJYDOLGDWLRQIRUWKHUROHRI3&6.LQPRGXODWLQJ/'/&OHYHOVDQGWKHLQFLGHQFHRI
&+'LQPDQ7KHVHKXPDQVWXGLHVKDYHLGHQWLILHGJDLQRIIXQFWLRQPXWDWLRQVLQWKH
3&6.JHQHWKDWDUHDVVRFLDWHGZLWKHOHYDWHGVHUXP/'/&OHYHOV!PJG/
>DSSUR[LPDWHO\PPRO/@DQGSUHPDWXUH&+'$ELIDGHOHWDODQG
ORVVRIIXQFWLRQ/2)PXWDWLRQVWKDWDUHDVVRFLDWHGZLWKORZVHUXP/'/&OHYHOV
dPJG/>DSSUR[LPDWHO\PPRO/@&RKHQHWDO6WULNLQJO\VXEMHFWVZLWK


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
KHWHUR]\JRXV/2)PXWDWLRQVH[KLELWORZHUVHUXP3&6.OHYHOVDQGDVPXFKDV
UHGXFWLRQLQWKHLQFLGHQFHRI&+'RYHUD\HDUSHULRGFRPSDUHGZLWKQRQFDUULHUV
RIWKHPXWDWLRQV&RKHQHWDO0RUHRYHUGHVSLWHFRPSOHWHORVVRI3&6.DQG
DVVRFLDWHGYHU\ORZVHUXP/'/&OHYHOVPJG/>DSSUR[LPDWHO\PPRO/@WKH
VXEMHFWVZKRKDYHEHHQLGHQWLILHGZLWKFRPSRXQGKHWHUR]\JRWH/2)PXWDWLRQVDSSHDU
KHDOWK\+RRSHUHWDO=KDRHWDO
$0*LVDIXOO\KXPDQPRQRFORQDOLPPXQRJOREXOLQ,J*WKDWELQGVVSHFLILFDOO\WR
KXPDQ3&6.DQGSUHYHQWVWKHLQWHUDFWLRQRI3&6.ZLWK/'/5'HWDLOVRIWKH
ELRFKHPLVWU\QRQFOLQLFDOSKDUPDFRORJ\QRQFOLQLFDOSKDUPDFRNLQHWLFV3.DQG
QRQFOLQLFDOWR[LFRORJ\ZLWK$0*DUHFRQWDLQHGLQWKH,QYHVWLJDWRU¶V%URFKXUH
$0*ELQGVWRKXPDQPRQNH\DQGKDPVWHU3&6.ZLWKKLJKDIILQLW\.GS0
$0*FDXVHGDGRVHGHSHQGHQWLQKLELWLRQRI3&6.ELQGLQJWRWKH/'/5DQGRI
3&6.PHGLDWHGUHGXFWLRQLQORZGHQVLW\OLSRSURWHLQ/'/XSWDNHLQ+HS*FHOOV
KXPDQKHSDWRFHOOXODUFDUFLQRPDFHOOOLQHLQFXOWXUH,QF\QRPRORJXVPRQNH\VDQGLQ
KDPVWHUVLQYLYRDGPLQLVWUDWLRQRI$0*UHVXOWHGLQUHGXFHGVHUXPOLSRSURWHLQ
FKROHVWHUROOHYHOVLQDGRVHGHSHQGHQWPDQQHU%DVHGRQDFRPSUHKHQVLYHSDFNDJHRI
3.SKDUPDFRG\QDPLFV3'DQGWR[LFRORJ\VWXGLHV,QYHVWLJDWRU¶V%URFKXUHD
SURJUDPWRGHYHORS$0*DVDWUHDWPHQWIRUG\VOLSLGHPLDZDVLQLWLDWHG

)LUVWLQ+XPDQ),+3KDVH6WXGLHV
3OHDVHFRQVXOWWKH,QYHVWLJDWRU¶V%URFKXUHIRUVWXG\GHWDLOV

&RPSOHWHG3KDVH:HHN/'/&/RZHULQJ6WXGLHV
3OHDVHFRQVXOWWKH,QYHVWLJDWRU¶V%URFKXUHIRUVWXG\UHVXOWV

5DWLRQDOH
7KLVVWXG\LVEHLQJFRQGXFWHGWRJDWKHULQIRUPDWLRQRQWKHORQJWHUPVDIHW\DQGHIILFDF\
RI$0*DQGWRSURYLGHVXEMHFWVZKRSDUWLFLSDWHGLQ3KDVHVWXGLHVZLWKDQ
RSSRUWXQLW\WRUHFHLYH$0*IRUDSSUR[LPDWHO\\HDUVRUXQWLOWKHLQYHVWLJDWRU¶V
UHFRPPHQGDWLRQRIGLVFRQWLQXDWLRQ$PJHQ¶VUHFRPPHQGDWLRQRIGLVFRQWLQXDWLRQWKH
VXEMHFW¶VGHFLVLRQWRGLVFRQWLQXHIRUDQ\UHDVRQRUXQWLODQDGPLQLVWUDWLYHGHFLVLRQLV
PDGHWRFORVHWKHVWXG\0DQ\RIWKHVXEMHFWVLQWKHSDUHQW3KDVHVWXGLHVDUHLQD
KLJKXQPHWPHGLFDOQHHGJURXSVXFKDVKHWHUR]\JRXVIDPLOLDOK\SHUFKROHVWHUROHPLDRU
VWDWLQLQWROHUDQFHRUKDYHIDLOHGWRUHDFKJRDOZLWKDYDLODEOHWKHUDSLHV)RUWKHVH
SRSXODWLRQVSDUWLFLSDWLRQLQWKLVRSHQODEHOH[WHQVLRQZLOOSURYLGHFORVHPHGLFDO
VXSHUYLVLRQYLDKHDOWKFDUHSURIHVVLRQDOVZKLOHRQFXUUHQWVWDQGDUGRIFDUHWKHUDSLHVDQG
DQRSSRUWXQLW\WRUHFHLYHDQDGGLWLRQDOWKHUDSHXWLFRSWLRQIRU/'/&ORZHULQJ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

&OLQLFDO+\SRWKHVHV
7KHSULPDU\FOLQLFDOK\SRWKHVLVLVWKDWORQJWHUPH[SRVXUHRI$0* ZLOOEHVDIHDQG
ZHOOWROHUDWHGLQVXEMHFWVZLWKSULPDU\K\SHUOLSLGHPLDDQGVXEMHFWVZLWKPL[HG
G\VOLSLGHPLD

(;3(5,0(17$/3/$1

6WXG\'HVLJQ
7KLVLVDPXOWLFHQWHUUDQGRPL]HGFRQWUROOHGRSHQODEHOH[WHQVLRQVWXG\GHVLJQHGWR
DVVHVVWKHORQJWHUPVDIHW\DQGHIILFDF\RI$0*
7KHRYHUDOOVWXG\GHVLJQLVGHVFULEHGE\DVWXG\VFKHPDDWWKHHQGRIWKHSURWRFRO
V\QRSVLVVHFWLRQ
7KHVWXG\HQGSRLQWVDUHGHILQHGLQ6HFWLRQ

1XPEHURI&HQWHUV
,WLVDQWLFLSDWHGWKDWDSSUR[LPDWHO\FHQWHUVZLOOSDUWLFLSDWHLQWKHVWXG\7KHQXPEHU
RIVLWHVPD\YDU\GHSHQGLQJRQWKHQXPEHURIVXEMHFWVIURPWKHSDUHQWVWXG\

1XPEHURI6XEMHFWV
7KHQXPEHURIVXEMHFWVHQWHULQJWKLVVWXG\ZLOOGHSHQGRQWKHQXPEHURIVXEMHFWV
FRPSOHWLQJWKHLUUHVSHFWLYH$0*SDUHQWVWXGLHVDQGZLOOLQJQHVVWRHQUROO7KH
QXPEHURIVXEMHFWVH[SHFWHGWRSDUWLFLSDWHLQWKLVVWXG\LVDSSUR[LPDWHO\

6WXG\'XUDWLRQIRU3DUWLFLSDQWV
6XEMHFWVZLOOEHHQUROOHGLQWRWKHVWXG\DIWHUFRPSOHWLRQRIDTXDOLI\LQJ$0*VWXG\
DQGVLJQLQJWKHLQIRUPHGFRQVHQWIRUP,&)RIWKLVVWXG\7KHVWXG\GXUDWLRQLV
DQWLFLSDWHGWRFRQWLQXHIRUZHHNVDSSUR[LPDWHO\\HDUV'XULQJWKDWWLPHVXEMHFWV
ZLOOYLVLWWKHVLWHPXOWLSOHWLPHV

(QGRI6WXG\
7KHVWXG\ZLOOFRQWLQXHIRUZHHNVDSSUR[LPDWHO\\HDUVRUXQWLOWKHLQYHVWLJDWRU¶V
UHFRPPHQGDWLRQRIGLVFRQWLQXDWLRQ$PJHQ¶VUHFRPPHQGDWLRQRIGLVFRQWLQXDWLRQWKH
VXEMHFW¶VGHFLVLRQWRGLVFRQWLQXHIRUDQ\UHDVRQRUXQWLODQDGPLQLVWUDWLYHGHFLVLRQLV
PDGHWRFORVHWKHVWXG\

68%-(&7(/,*,%,/,7<
7KHVWXG\SRSXODWLRQZLOOFRQVLVWRIPDOHDQGIHPDOHVXEMHFWVZKRKDYHFRPSOHWHGD
TXDOLI\LQJ$0*SURWRFRO6XEMHFWVZKRFRPSOHWHDQ\IXWXUHTXDOLI\LQJ$0*
VWXGLHVPD\EHDOORZHGWRHQUROOLIWKH\PHHWWKHLQFOXVLRQH[FOXVLRQFULWHULDDQGWKH
VSRQVRUDJUHHVWRRSHQWKHVWXG\WRDGGLWLRQDOVXEMHFWV7KHSRSXODWLRQZLOOLQFOXGH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
VXEMHFWVZKRVHSULPDU\K\SHUOLSLGHPLDRUPL[HGG\VOLSLGHPLDLVWUHDWHGZLWKDYDULHW\RI
PHWKRGV

,QFOXVLRQ&ULWHULD
6XEMHFWVZLOOEHHOLJLEOHIRUWKHVWXG\LIWKH\
&RPSOHWHDTXDOLI\LQJ$0*SDUHQWVWXG\SURWRFROZKLOHVWLOORQDVVLJQHGVWXG\
PHGLFDWLRQ

([FOXVLRQ&ULWHULD
6XEMHFWVZLOOEHLQHOLJLEOHIRUWKHVWXG\LIWKH\IXOILOODQ\RIWKHIROORZLQJFULWHULD
 'LVFRQWLQXHGDVVLJQHGVWXG\GUXJGXULQJWKHTXDOLI\LQJVWXG\IRUDQ\UHDVRQ
LQFOXGLQJDQDGYHUVHHYHQWRUVHULRXVDGYHUVHHYHQW
 )HPDOHVXEMHFWLVQRWZLOOLQJWRXVHDQDFFHSWDEOHPHWKRGVRIHIIHFWLYHELUWK
FRQWUROGXULQJWUHDWPHQWZLWKLQYHVWLJDWLRQDOSURGXFW,3DQGIRUDQDGGLWLRQDO
ZHHNVDIWHUWKHHQGRIWUHDWPHQWZLWK,3)HPDOHVXEMHFWVZKRKDYHKDGD
K\VWHUHFWRP\ELODWHUDOVDOSLQJHFWRP\ELODWHUDORRSKRUHFWRP\RUZKRDUH
SRVWPHQRSDXVDODUHQRWUHTXLUHGWRXVHFRQWUDFHSWLRQ
R 0HQRSDXVHLVGHILQHGDVPRQWKVRIVSRQWDQHRXVDQGFRQWLQXRXV
DPHQRUUKHDLQDIHPDOH\HDUVROGRUDJH\HDUVEXWQR
VSRQWDQHRXVPHQVHVIRUDWOHDVW\HDUVRUDJH\HDUVDQG
VSRQWDQHRXVPHQVHVZLWKLQWKHSDVW\HDUEXWFXUUHQWO\DPHQRUUKHLF
HJVSRQWDQHRXVRUVHFRQGDU\WRK\VWHUHFWRP\DQGZLWK
SRVWPHQRSDXVDOJRQDGRWURSLQOHYHOVOXWHLQL]LQJKRUPRQHDQGIROOLFOH
VWLPXODWLQJKRUPRQHOHYHOV!,8/RUSRVWPHQRSDXVDOHVWUDGLROOHYHOV
QJG/RUDFFRUGLQJWRWKHGHILQLWLRQRISRVWPHQRSDXVDOUDQJHIRU
WKHODERUDWRU\LQYROYHG
R $FFHSWDEOHPHWKRGVRIHIIHFWLYHELUWKFRQWUROLQFOXGHVH[XDO
DEVWLQHQFHZKHQWKLVLVLQOLQHZLWKWKHSUHIHUUHGDQGXVXDOOLIHVW\OH
RIWKHVXEMHFW>SHULRGLFDEVWLQHQFHHJFDOHQGDURYXODWLRQ
V\PSWRWKHUPDOSRVWRYXODWLRQPHWKRGVGHFODUDWLRQRIDEVWLQHQFH
IRUWKHGXUDWLRQRIDWULDODQGZLWKGUDZDODUHQRWDFFHSWDEOH
PHWKRGVRIFRQWUDFHSWLRQ@VXUJLFDOFRQWUDFHSWLYHPHWKRGV
YDVHFWRP\RUELODWHUDOWXEDOOLJDWLRQXVHRIKRUPRQDOELUWKFRQWURO
PHWKRGVSLOOVVKRWVLPSODQWVRUSDWFKHVLQWUDXWHULQHGHYLFHV
,8'VRUWZREDUULHUPHWKRGVHDFKSDUWQHUPXVWXVHRQHEDUULHU
PHWKRGZLWKVSHUPLFLGH±PDOHVPXVWXVHDFRQGRPZLWK
VSHUPLFLGHIHPDOHVPXVWFKRRVHHLWKHUDGLDSKUDJPZLWK
VSHUPLFLGH25FHUYLFDOFDSZLWKVSHUPLFLGH25FRQWUDFHSWLYH
VSRQJHZLWKVSHUPLFLGH1RWH$GGLWLRQDOPHGLFDWLRQVJLYHQGXULQJ
WUHDWPHQWZLWKHYRORFXPDEPD\DOWHUWKHFRQWUDFHSWLYH
UHTXLUHPHQWV7KHVHDGGLWLRQDOPHGLFDWLRQVPD\UHTXLUHDQLQFUHDVH
LQWKHQXPEHURIFRQWUDFHSWLYHPHWKRGVDQGRUOHQJWKRIWLPHWKDW
FRQWUDFHSWLRQLVWREHXWLOL]HGDIWHUWKHODVWGRVHRI
SURWRFROUHTXLUHGWKHUDSLHV7KHLQYHVWLJDWRULVWRGLVFXVVWKHVH
FRQWUDFHSWLYHFKDQJHVZLWKWKHVWXG\VXEMHFW


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
 )HPDOHVXEMHFWLVSUHJQDQWRUEUHDVWIHHGLQJSODQQLQJWREHFRPHSUHJQDQWRU
SODQQLQJWREUHDVWIHHGGXULQJWUHDWPHQWZLWK,3DQGRUZLWKLQZHHNVDIWHUWKH
HQGRIWUHDWPHQWZLWK,3
 8QUHOLDELOLW\DVDVWXG\SDUWLFLSDQWEDVHGRQWKHLQYHVWLJDWRU
VRUGHVLJQHH¶V
NQRZOHGJHRIWKHVXEMHFWHJLQDELOLW\RUXQZLOOLQJQHVVWRDGKHUHWRWKHSURWRFRO
 'LVRUGHUWKDWZRXOGLQWHUIHUHZLWKXQGHUVWDQGLQJDQGJLYLQJLQIRUPHGFRQVHQWRU
FRPSOLDQFHZLWKSURWRFROUHTXLUHPHQWV
 +DYHDQXQVWDEOHPHGLFDOFRQGLWLRQLQWKHMXGJPHQWRIWKHLQYHVWLJDWRU
 6XEMHFW¶VPHGLFDOFRQGLWLRQUHTXLUHVOLSLGPHDVXUHPHQWDQGRUDGMXVWPHQWRI
EDFNJURXQGOLSLGUHJXODWLQJWKHUDS\GXULQJWKHILUVWZHHNVRIVWXG\
SDUWLFLSDWLRQ
 .QRZQVHQVLWLYLW\WRDQ\RIWKHSURGXFWVWREHDGPLQLVWHUHGGXULQJGRVLQJ
 &XUUHQWO\HQUROOHGLQDQRWKHULQYHVWLJDWLRQDOGHYLFHRUGUXJVWXG\H[FOXGLQJ
$0*SDUHQWVWXG\RUOHVVWKDQGD\VVLQFHHQGLQJDQRWKHU
LQYHVWLJDWLRQDOGHYLFHRUGUXJVWXG\VRUUHFHLYLQJRWKHULQYHVWLJDWLRQDODJHQWV

68%-(&7(152//0(17
%HIRUHVXEMHFWVPD\EHHQWHUHGLQWRWKHVWXG\$PJHQUHTXLUHVDFRS\RIWKHVLWH¶V
ZULWWHQLQGHSHQGHQWHWKLFVFRPPLWWHHDQGRULQVWLWXWLRQDOUHYLHZERDUG,(&,5%
DSSURYDORIWKHSURWRFRO,&)DQGDOORWKHUVXEMHFWLQIRUPDWLRQDQGRUUHFUXLWPHQW
PDWHULDOLIDSSOLFDEOHVHH6HFWLRQ$OOVXEMHFWVPXVWSHUVRQDOO\VLJQDQGGDWHWKH
,&)EHIRUHFRPPHQFHPHQWRIVWXG\VSHFLILFSURFHGXUHV$VXEMHFWLVFRQVLGHUHG
HQUROOHGRQFHWKH\KDYHFRPSOHWHGWKHLUHQGRIVWXG\YLVLWLQWKHSDUHQWSURWRFRODQG
KDYHVLJQHGWKH,&)
$OOVXEMHFWVZKRHQWHUWKHVWXG\ZLOONHHSWKHVDPHVXEMHFWLGHQWLILFDWLRQQXPEHUIURP
WKHSDUHQWVWXG\(DFKVLWHSDUWLFLSDWLQJLQWKLVVWXG\ZLOOEHDVVLJQHGDGLIIHUHQWVLWH
QXPEHUIURPWKHSDUHQWVWXG\

75($70(17352&('85(6
$0*ZLOOEHWKHLQYHVWLJDWLRQDOPHGLFLQDOSURGXFW,03LQWKLVVWXG\
7KHPHGLFDOGHYLFHVXVHGLQWKLVVWXG\DUHWKHSUHILOOHGDXWRLQMHFWRUSHQ$,3HQDQG
WKHP/3HUVRQDO,QMHFWRUZKHQDYDLODEOH
$Q,QYHVWLJDWLRQDO3URGXFW,QVWUXFWLRQ0DQXDO,3,0FRQWDLQLQJGHWDLOHGLQIRUPDWLRQ
UHJDUGLQJWKHVWRUDJHSUHSDUDWLRQDQGDGPLQLVWUDWLRQRIWKHLQYHVWLJDWLRQDOPHGLFLQDO
SURGXFWZLOOEHSURYLGHGVHSDUDWHO\


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

$0* 
$0*ZLOOEHPDQXIDFWXUHGDQGSDFNDJHGE\$PJHQ,QFDQGGLVWULEXWHGXVLQJ
$PJHQFOLQLFDO,3GLVWULEXWLRQSURFHGXUHV
$0*ZLOOEHSUHVHQWHGDVDVWHULOHSUHVHUYDWLYHIUHHVROXWLRQLQDVLQJOHXVH
GLVSRVDEOHKDQGKHOGPHFKDQLFDOVSULQJEDVHGP/SUHILOOHGDXWRLQMHFWRUSHQ
$,3HQRUP/3HUVRQDO,QMHFWRU3HUVRQDO,QMHFWRUIRUIL[HGGRVHVXEFXWDQHRXV
LQMHFWLRQ7KHSUHILOOHG$,3HQFRQWDLQVDP/GHOLYHUDEOHYROXPHRIPJP/
$0*LQ
P0SUROLQH
P0DFHWDWH
ZYSRO\VRUEDWHS+
7KH
3HUVRQDO,QMHFWRUZLWKSUHILOOHGFDUWULGJHDVVHPEO\LVDVLQJOHXVHGLVSRVDEOHRQERG\
HOHFWURPHFKDQLFDOLQMHFWLRQGHYLFHWKDWLVFRSDFNDJHGZLWKDSUHILOOHG&U\VWDO=HQLWK
&=FDUWULGJHDVVHPEO\FRQWDLQLQJP/GHOLYHUDEOHYROXPHRIPJP/$0*
LQ
P0SUROLQH
P0DFHWDWH
ZYSRO\VRUEDWHS+

7KHP/3HUVRQDO,QMHFWRUZLOORQO\EHPDGHDYDLODEOHIRUXVHLQWKLVVWXG\RQFHLWKDV
EHHQGHWHUPLQHGWKDWWKHLQWHQGHGXVHUSRSXODWLRQIRU$0*FDQVDIHO\DQG
HIIHFWLYHO\XVHWKHGHYLFHLQFOLQLFDOWULDOVXQGHUWKHJXLGDQFHRIWKHVWXG\LQYHVWLJDWRUV
$0*VKRXOGEHVWRUHGSURWHFWHGIURPOLJKWDQGDFFRUGLQJWRWKHVWRUDJHDQG
H[SLUDWLRQLQIRUPDWLRQSURYLGHGRQWKHODEHO$0*VKRXOGEHKDQGOHGSHUWKH
LQVWUXFWLRQVSURYLGHGLQWKH,3,0DQGWKH,QVWUXFWLRQVIRU8VH,)8IRUWKHSUHILOOHG
$,SHQRU3HUVRQDO,QMHFWRU7KHSUHILOOHG$,SHQRU3HUVRQDO,QMHFWRUVKRXOGEHFKHFNHG
IRUGDPDJHWKDWPD\RFFXUGXULQJVKLSPHQWRULIQRWKDQGOHGSURSHUO\'DPDJHG
SURGXFWVKRXOGQRWEHXVHG)XUWKHUGHWDLOVDUHSURYLGHGLQWKH,3,0DQG,)8
7KHORWQXPEHURILQYHVWLJDWLRQDOSURGXFWVKRXOGEHUHFRUGHGRQHDFKVXEMHFW¶V'UXJ
$GPLQLVWUDWLRQ&DVH5HSRUW)RUP

'RVDJH$GPLQLVWUDWLRQDQG6FKHGXOH
,3ZLOOEHDGPLQLVWHUHG6&LQDFFRUGDQFHZLWKLQVWUXFWLRQVLQWKH,3,0
,3DGPLQLVWUDWLRQDWHDFKRQVLWHYLVLWPXVWEHGRQHDIWHUYLWDOVLJQVDQGEORRGGUDZ
SURFHGXUHVDVDSSOLFDEOH7KHGDWHWLPHDQGDPRXQWDVGHVLJQDWHGE\SDUWLDORUIXOO
LQMHFWLRQRI$0*ZLOOEHUHFRUGHGRQWKHLQGLYLGXDOVXEMHFW¶VZRUNVKHHWDQGRU
HOHFWURQLF&DVH5HSRUW)RUPH&5)$IWHU,3DGPLQLVWUDWLRQRQ'D\RU:HHNIRU
VXEMHFWVLQLWLDOO\UDQGRPL]HGWRVWDQGDUGRIFDUH62&DORQHVXEMHFWVVKRXOGEHNHSW
IRUREVHUYDWLRQIRUDWOHDVWPLQXWHVEHIRUHEHLQJGLVFKDUJHG
2Q'D\RIWKHVWXG\VXEMHFWVUDQGRPL]HGWR$0*SOXV62&ZLOOEHWUDLQHGRQ
VHOIDGPLQLVWUDWLRQRIVWXG\GUXJDQGZLOOVHOIDGPLQLVWHU,3DWWKHLQYHVWLJDWLRQDOVLWH
CCI
C
CI
CCI
CC
I
CCI
C
CI
CCI
CC
I


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
XQGHUWKHVXSHUYLVLRQRIDKHDOWKFDUHSURYLGHU6XEMHFWVZLWKRXWSULRUH[SHULHQFHRI
VHOILQMHFWLRQRI$0*ZLOOVXEVHTXHQWO\YLVLWWKHVLWHWRVHOIDGPLQLVWHU$0*DW
:HHN4:UHJLPHQRQO\:HHN4:DQG40UHJLPHQVDQG:HHN
40UHJLPHQRQO\$IWHUWKH:HHNYLVLWIRUVXEMHFWVRQ4:UHJLPHQRU:HHNYLVLW
IRUVXEMHFWVRQ40UHJLPHQ,3FDQEHDGPLQLVWHUHGDWDORFDWLRQH[WHUQDOWRWKHVWXG\
VLWHXVLQJWKHSUHILOOHG$,3HQRU3HUVRQDO,QMHFWRUSURYLGHG7KHUHDIWHU$0*ZLOO
EHVHOIDGPLQLVWHUHGRUDGPLQLVWHUHGE\DFDUHJLYHUDWKRPH
7KHVXEMHFWRUGHVLJQHHPXVWKDYHGHPRQVWUDWHGFRPSHWHQF\LQDGPLQLVWUDWLRQRI6&
LQMHFWLRQVEHIRUHVHOILQMHFWLRQZLOOEHSHUPLWWHG)RUVXEMHFWVWKDWSUHIHUQRWWR
VHOIDGPLQLVWHU,3,3PD\EHDGPLQLVWHUHGDWWKHVLWH
6XEMHFWVZLOOUHFHLYHWUDLQLQJRQ,3XVHSULRUWRKRPHDGPLQLVWUDWLRQKRZHYHU,3PD\EH
DGPLQLVWHUHGDWWKHVLWHLIVXEMHFWVSUHIHUQRWWRVHOILQMHFW$0*
6XEMHFWVUDQGRPL]HGWR$0*62&DQGVHOHFWLQJ4:,3DGPLQLVWUDWLRQZLOO
UHFHLYHDWRWDOYROXPHRIP/YLDSUHILOOHG$,SHQLQMHFWLRQHYHU\ZHHNV
6XEMHFWVUDQGRPL]HGWR$0*62&DQGVHOHFWLQJ40,3DGPLQLVWUDWLRQZLOOUHFHLYH
DWRWDOYROXPHRIP/PRQWKO\YLDVHSDUDWHSUHILOOHG$,SHQLQMHFWLRQVRUDWRWDO
YROXPHRIP/YLDDVLQJOH3HUVRQDO,QMHFWRU,QMHFWLRQVLWHVVKRXOGEHURWDWHG
WKURXJKRXWWKHVWXG\)RUWKH$,SHQWKH6&LQMHFWLRQVVKRXOGEHDGPLQLVWHUHGLQD
FRQVHFXWLYHIDVKLRQZLWKDOOLQMHFWLRQVFRPSOHWHGZLWKLQPLQXWHV
7KHGRVLQJVFKHGXOHLVDOVRGHVFULEHGE\DVFKHPDLQWKHSURWRFROV\QRSVLV
)RUIXUWKHUGHWDLOVUHJDUGLQJ,3DGPLQLVWUDWLRQSURFHGXUHVWKH,3,0VKRXOGEHFRQVXOWHG

'RVDJH$GMXVWPHQWV
'RVHDGMXVWPHQWVRIEDFNJURXQGOLSLGORZHULQJWKHUDS\GXULQJWKHVWXG\DUH
GLVFRXUDJHGEXWZLOOEHSHUPLWWHGIRUVXEMHFWVWKDWH[SHULHQFHLQWROHUDEOHDGYHUVH
HYHQWV,IDQLQYHVWLJDWRUZDQWVWRPDNHDGRVHDGMXVWPHQWWKH\PXVWFRQWDFWWKH
PHGLFDOPRQLWRUSULRUWRGRLQJVR$OOEDFNJURXQGWKHUDS\DGMXVWPHQWVPXVWEHFOHDUO\
GRFXPHQWHGDQGUHFRUGHGRQWKHDSSURSULDWHH&5)SDJHDQGLQWKHVRXUFHGRFXPHQWV
,IDVXEMHFWLVODWHIRUDGPLQLVWUDWLRQRI,3DGPLQLVWUDWLRQVKRXOGRFFXUDVVRRQDV
SRVVLEOH$40GRVHRI,3VKRXOGQRWEHDGPLQLVWHUHGZLWKLQOHVVWKDQGD\VRID
SUHYLRXVGRVH,ID40VXEMHFWDUULYHVIRUDVFKHGXOHGYLVLWDQG,3ZDVDGPLQLVWHUHG
ZLWKLQWKHSULRUGD\VWKHGRVHVKRXOGQRWEHDGPLQLVWHUHGEXWDOORWKHUVWXG\
6XEMHFWVZKRDUH/DWHIRUD6FKHGXOHG'RVHRI,QYHVWLJDWLRQDO3URGXFW


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
SURFHGXUHVVKRXOGEHFRQGXFWHGDQGDGPLQLVWUDWLRQRI,3VKRXOGRFFXUDVVRRQDV
SRVVLEOHDWOHDVWGD\VDIWHUWKHSUHYLRXVDGPLQLVWUDWLRQ,I4:GRVHVKDYHEHHQ
DGPLQLVWHUHGZLWKLQGD\VRIHDFKRWKHUDQ\VXEVHTXHQWGRVHVKRXOGRFFXUDWOHDVW
GD\VDIWHUWKHPRVWUHFHQWGRVH

&ULWHULDIRU:LWKKROGLQJRI,QYHVWLJDWLRQDO3URGXFW
5HSRUWVIURPWKHFHQWUDOODERUDWRU\DIWHUHDFKYLVLWPXVWEHUHYLHZHGRQUHFHLSW,I
DEQRUPDOLWLHVWKDWZRXOGSUHFOXGHIXUWKHUGRVLQJDUHQRWHGVXEMHFWVVKRXOGEHFDOOHGDW
KRPHDQGLQVWUXFWHGWRZLWKKROGIXUWKHUGRVLQJDQGVFKHGXOHGWRUHWXUQIRUDQDGKRF
YLVLW

(OHYDWLRQRI&UHDWLQH.LQDVH&.
,I&.LV![XSSHUOLPLWRIQRUPDO8/1&.PXVWEHUHWHVWHGEHIRUH,3LVDGPLQLVWHUHG
7KHIROORZLQJUXOHVDSSO\
&.DWSULRUYLVLW
&.RQUHWHVW
,QYHVWLJDWLRQDO3URGXFW$GPLQLVWUDWLRQ
![8/1
![8/1
'LVFRQWLQXH,3D &RQWDFW$PJHQ0HGLFDO0RQLWRU
![WR[8/1
&RQVLGHUFRQWLQXLQJ,3LIDOWHUQDWLYHH[SODQDWLRQ
[8/1
&RQVLGHUFRQWLQXLQJ,3
D &.HOHYDWLRQV![8/1WKDWKDYHEHHQFRQILUPHGWREHVHFRQGDU\WRP\RFDUGLDOLQIDUFWLRQGRQRWUHTXLUH
GLVFRQWLQXDWLRQRI,3

(OHYDWLRQRI/LYHU)XQFWLRQ7HVWV
6XEMHFWVZLWKDEQRUPDOKHSDWLFODERUDWRU\YDOXHVHJDONDOLQHSKRVSKDWDVH>$/3@$67
$/7WRWDOELOLUXELQ>7%/@RULQWHUQDWLRQDOQRUPDOL]HGUDWLR>,15@RUVLJQVV\PSWRPVRI
KHSDWLWLVPD\PHHWWKHFULWHULDIRUZLWKKROGLQJRI,3
,3PXVWEHGLVFRQWLQXHGDQGWKHVXEMHFWVKRXOGEHIROORZHGDFFRUGLQJWRWKH
UHFRPPHQGDWLRQVLQ$SSHQGL[%$GGLWLRQDO6DIHW\$VVHVVPHQW,QIRUPDWLRQIRUSRVVLEOH
GUXJLQGXFHGOLYHULQMXU\',/,LI$//RIWKHFULWHULDEHORZDUHPHW
x
7%/![XSSHUOLPLWRIQRUPDO8/1RU,15!
$1'
x
$67RU$/7![8/1
$1'


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
QRRWKHUFDXVHIRUWKHFRPELQDWLRQRIODERUDWRU\DEQRUPDOLWLHVLVLPPHGLDWHO\
DSSDUHQWLPSRUWDQWSRWHQWLDOFDXVHVIRUDEQRUPDO$67$/7RU7%/YDOXHVLQFOXGH
EXWDUHQRWOLPLWHGWR

2EVWUXFWLYHJDOOEODGGHURUELOHGXFWGLVHDVH

9LUDORUDOFRKROLFKHSDWLWLVHJ+HSDWLWLV$%&'((SVWHLQ%DUU9LUXV
F\WRPHJDORYLUXV+HUSHV6LPSOH[9LUXV9DULFHOOD

3URJUHVVLRQRIPDOLJQDQF\LQYROYLQJWKHOLYHUQRWHWKDWPHWDVWDWLFGLVHDVHWRWKH
OLYHUE\LWVHOIVKRXOGQRWEHXVHGDVDQH[SODQDWLRQIRUVLJQLILFDQW$67$/7
HOHYDWLRQV

+\SR[LFRULVFKHPLFKHSDWRSDWK\RUFRQJHVWLYHKHSDWRSDWK\LQDVVRFLDWLRQZLWK
VLJQLILFDQWULJKWVLGHGKHDUWIDLOXUH

&RQFRPLWDQWDGPLQLVWUDWLRQRIRWKHUKHSDWRWR[LQVLQFOXGLQJGUXJVWKDWLQKLELW
ELOLUXELQJOXFXURQLGDWLRQHJLQGLQDYLUDWD]DQDYLULULQRWHFDQRUKHUEDORUGLHWDU\
VXSSOHPHQWV

+HULWDEOHGLVRUGHUVFDXVLQJLPSDLUHGJOXFXURQLGDWLRQHJ*LOEHUW¶V6\QGURPH
DOSKDRQHDQWLWU\SVLQGHILFLHQF\

$XWRLPPXQHKHSDWLWLV

1RQDOFRKROLFVWHDWRKHSDWLWLV1$6+RURWKHU³IDWW\OLYHUGLVHDVH´
,3VKRXOGDOVREHZLWKKHOGDQGWKHVXEMHFWVKRXOGEHHYDOXDWHGIRU',/,LI$1<RIWKH
IROORZLQJFULWHULDDUHPHW
x
$67RU$/7![8/1DWDQ\WLPH
x
$67RU$/7![8/1EXW[8/1IRUZHHNV
x
7%/![8/1DWDQ\WLPH
x
$/3![8/1DWDQ\WLPH
x
&OLQLFDOVLJQVRUV\PSWRPVWKDWDUHLQWKHRSLQLRQRIWKHLQYHVWLJDWRUFRQVLVWHQWZLWK
KHSDWLWLVVXFKDVULJKWXSSHUTXDGUDQWSDLQWHQGHUQHVVIHYHUQDXVHDYRPLWLQJ
MDXQGLFHUDVKRUHRVLQRSKLOLD!,IVXFKVLJQVRUV\PSWRPVDUHFRXSOHGZLWK
$/7RU$67HOHYDWLRQV![8/1,3VKRXOGEHZLWKKHOG
,I,3LVZLWKKHOGGXHWRDQ\RIWKHFRQGLWLRQVDERYHWKHVXEMHFWVKRXOGEHIROORZHG
DFFRUGLQJWRUHFRPPHQGDWLRQVLQ$SSHQGL[%IRUSRVVLEOH',/,

&ULWHULDIRU5HFKDOOHQJHRI$0*$IWHU3RWHQWLDO+HSDWRWR[LFLW\
7KHGHFLVLRQWRUHFKDOOHQJHWKHVXEMHFWVKRXOGEHGLVFXVVHGDQGDJUHHGXSRQ
XQDQLPRXVO\E\WKHVXEMHFW3ULQFLSDO,QYHVWLJDWRUDQG$PJHQ
,IVLJQVRUV\PSWRPVUHFXUZLWKUHFKDOOHQJHWKHQ$0*VKRXOGEHSHUPDQHQWO\
GLVFRQWLQXHG6XEMHFWVZKRFOHDUO\PHHWWKHFULWHULDIRUSHUPDQHQWGLVFRQWLQXDWLRQ
VKRXOGQHYHUEHUHFKDOOHQJHG


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

(OHYDWLRQRI7ULJO\FHULGHV
,IWULJO\FHULGHVDUH!PJG/PPRO/WKHLQYHVWLJDWRUZLOOEHLQIRUPHGDQGD
UHSHDWIDVWLQJWULJO\FHULGHUHSHDWWHVWZLOOEHUHTXHVWHG,IWKHUHWHVWFRQILUPV
WULJO\FHULGHV!PJG/PPRO/WKH$PJHQPHGLFDOPRQLWRUDQGWKH
LQYHVWLJDWRUZLOOEHLQIRUPHGVRWKDWDSSURSULDWHPHGLFDOIROORZXSIRUWKHVXEMHFWFDQEH
LQLWLDWHG

3URGXFW&RPSODLQWV,QFOXGLQJ'HYLFH&RPSODLQWV
$SURGXFWFRPSODLQWLVGHILQHGDVDQ\ZULWWHQHOHFWURQLFRURUDOFRPPXQLFDWLRQWKDW
DOOHJHVGHILFLHQFLHVUHODWHGWRWKHLGHQWLW\TXDOLW\GXUDELOLW\UHOLDELOLW\VDIHW\
HIIHFWLYHQHVVRUSHUIRUPDQFHRIDGUXJRUGHYLFHDIWHULWLVUHOHDVHGIRUGLVWULEXWLRQWR
PDUNHWRUFOLQLFE\HLWKHU$PJHQRUE\GLVWULEXWRUVDQGSDUWQHUVIRUZKRP$PJHQ
PDQXIDFWXUHVWKHPDWHULDO
$Q\FRPSODLQWVDVVRFLDWHGZLWKDQLQYHVWLJDWLRQDOSURGXFWVRUQRQLQYHVWLJDWLRQDO
SURGXFWVRUGHYLFHVVXSSOLHGE\$PJHQDUHWREHUHSRUWHGDFFRUGLQJWRWKH
LQVWUXFWLRQVSURYLGHGLQWKH,3,0
&RQFHUQVRULUUHJXODULWLHVDERXWWKHSDFNDJLQJDSSHDUDQFHRUXVDJHRIWKHSUHILOOHG
$,SHQRU3HUVRQDO,QMHFWRUDUHWREHUHSRUWHGWR$PJHQZLWKLQKRXUVRIGLVFRYHU\RU
QRWLILFDWLRQRIWKHFRQFHUQRULUUHJXODULW\6KRXOGDQ\VXFKFRQFHUQVRULUUHJXODULWLHV
RFFXUSOHDVHGRQRWXVHWKHSUHILOOHG$,SHQRU3HUVRQDO,QMHFWRUXQWLO$PJHQFRQILUPV
WKDWLWLVSHUPLVVLEOHWRXVH
([DPSOHVRISRWHQWLDOSURGXFWFRPSODLQWVWKDWQHHGWREHUHSRUWHGWR$PJHQLQFOXGHEXW
DUHQRWOLPLWHGWR
x
EURNHQFRQWDLQHURUFUDFNHGFRQWDLQHU
x
VXEMHFWRUKHDOWKFDUHSURYLGHUFDQQRWDSSURSULDWHO\XVHWKHSURGXFWGHVSLWHWUDLQLQJ
HJGXHWRPDOIXQFWLRQRIWKHSUHILOOHG$,SHQRU3HUVRQDO,QMHFWRU
x
PLVVLQJODEHOVLOOHJLEOHODEHOVLQFRUUHFWODEHOVDQGRUVXVSHFWODEHOV
x
FKDQJHLQ,03DSSHDUDQFHIRUH[DPSOHFRORUFKDQJHRUYLVLEOHSUHVHQFHRIIRUHLJQ
PDWHULDO
x
XQH[SHFWHGTXDQWLW\RUYROXPHIRUH[DPSOHDPRXQWRIIOXLGLQWKHSUHILOOHG$,SHQRU
3HUVRQDO,QMHFWRURU
x
HYLGHQFHRIWDPSHULQJRUVWROHQPDWHULDO
,ISRVVLEOHSOHDVHKDYHWKHSUHILOOHG$,SHQRU3HUVRQDO,QMHFWRUDYDLODEOHIRU
H[DPLQDWLRQZKHQPDNLQJDSURGXFWFRPSODLQW0DLQWDLQWKHSUHILOOHG$,SHQRU3HUVRQDO


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 26 of 65 
CONFIDENTIAL 
 
Injector at appropriate storage conditions until further instructions are received from 
Amgen.   
The investigator is responsible for ensuring that all product complaints observed by the 
investigator or reported by the subject that occur after signing of the ICF through 30 days 
after the last dose of IP or EOS, whichever is later, are reported to Amgen within 
24 hours of discovery or notification of the product complaint.   
For more details regarding the identification and reporting of product and device 
complaints, refer to the IPIM and the IFU. 
6.3 
Concomitant Therapy, Physical Exercise, and Diet 
Throughout the study, investigators may prescribe any concomitant medications or 
treatments deemed necessary to provide adequate supportive care except for those 
listed in Section 6.4.  Background lipid lowering concomitant medications should be 
stable throughout study participation. 
Subjects should maintain baseline level of exercise during the first year of study 
participation.  Subjects will be required to refrain from unaccustomed intensive exercise 
(eg, heavy lifting or long runs) 48 hours prior to each visit. 
6.4 
Excluded Treatments During Study Period 
The use of magnesium or aluminum hydroxide-containing antacids is not recommended 
within the period of two hours before and two hours after dosing with statins given the 
potential for interference with absorption.   
7. 
STUDY PROCEDURES 
Written informed consent must be obtained and will be implemented before protocol 
specific procedures are carried out.  The risks and benefits of participating in the study 
will be verbally explained to each potential subject prior to entering into the study.  The 
procedures to be performed at each clinic visit are described below and are summarized 
in Appendix A IP administered in clinic should not be administered until all study 
procedures are completed at each visit. 
Subject visit schedule will differ based upon 3 factors:  randomization, selection of Q2W 
or QM regimen, and prior experience with self-injection of AMG 145.  Subjects 
randomized to AMG 145 + SOC without previous experience with self-injection of 
AMG 145 will have additional IP training visits at time of study start. At Week 48, a 
similar training schedule will be utilized for subjects randomized to SOC-alone at Day 1 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
ZLWKQRSUHYLRXVH[SHULHQFHZLWKVHOILQMHFWLRQRI$0*$OOYLVLWVDOVRDSSO\WR
VXEMHFWVUDQGRPL]HGWR62&DORQHXQOHVVRWKHUZLVHVSHFLILHG

*HQHUDO6WXG\3URFHGXUHV

(QUROOPHQW(263DUHQW6WXG\'D\2/(
$OOHIIRUWVVKRXOGEHPDGHWRPLQLPL]HDQ\WLPHJDSVEHWZHHQFRPSOHWLRQRIWKHSDUHQW
VWXG\HQGRIVWXG\(26ODERUDWRU\YLVLWDQG'D\RIWKH2/(YLVLW,WLVUHFRPPHQGHG
WKDWWKH'D\2/(YLVLWRFFXUVZLWKLQGD\VRIFRPSOHWLRQRIWKHSDUHQW(26
ODERUDWRU\YLVLW,IWKH'D\2/(YLVLWGRHVQRWRFFXUZLWKLQGD\VRIFRPSOHWLRQRIWKH
SDUHQW(26ODERUDWRU\YLVLWWKHQDOORIWKHSURFHGXUHVGHWDLOHGEHORZZLOOQHHGWREH
UHSHDWHGDWWKH'D\2/(YLVLW
x
3DUHQW6WXG\(26ODEYLVLWSURFHGXUHV
 0HGLFDO+LVWRU\
 9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
 5HYLHZDGYHUVHHYHQWVVHULRXVDGYHUVHHYHQWV$(V6$(V
 5HYLHZFRQFRPLWDQWPHGLFDWLRQV
 %RG\ZHLJKW
 3K\VLFDOH[DP
 8ULQHSUHJQDQF\IHPDOHVRIFKLOGEHDULQJSRWHQWLDORQO\
 6HUXP)ROOLFOHVWLPXODWLQJKRUPRQH)6+IHPDOHVGHHPHGVWHULOHRU
SRVWPHQRSDXVDODVGHILQHGDERYH
 8ULQDO\VLV
 8ULQHPLFURDOEXPLQ
 +HSDWLWLV&YLUXV+&9DQWLERGLHV2QO\LQKLJKULVNVXEMHFWVRULI$/7RU
$67!;8/1
 +&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
 %ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%FKHPLVWU\
KHPDWRORJ\KLJKVHQVLWLYH&UHDFWLYHSURWHLQKV&53/SD+E$FDQG
DQWL$0*DQWLERGLHV76+
2Q'D\2/(SRWHQWLDOVXEMHFWVZLOOKDYHWKHULVNVDQGEHQHILWVRISDUWLFLSDWLQJLQWKLV
VWXG\H[SODLQHGWRWKHP6XEMHFWVZLOOQHHGWRVLJQDQHZ2/(,&)DQGZLOOEH
HYDOXDWHGDJDLQVWLQFOXVLRQH[FOXVLRQFULWHULD
7KHIROORZLQJSURFHGXUHVZLOOEHSHUIRUPHGGXULQJWKH'D\2/(YLVLW
x
0HGLFDO+LVWRU\
x
&DUGLDF+LVWRU\,I!GD\VIURPHQGRISDUHQWVWXG\
x
9LWDO6LJQV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
:HLJKW
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
5HSHDWSDUHQW(26ODERUDWRU\YLVLWSURFHGXUHVLI'D\2/(!GD\VIURPSDUHQW
VWXG\(26ODERUDWRU\YLVLWSURFHGXUHVVHHDERYH
x
&RDJXODWLRQ37,15
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*LIUDQGRPL]HGWR$0*62&
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWHLIUDQGRPL]HGWR$0*62&
$0*DGPLQLVWUDWLRQPXVWRFFXUDIWHUFRPSOHWLRQRIYLWDOVLJQVLIDSSOLFDEOH
DQGEORRGGUDZSURFHGXUHV
x
'LVSHQVH,3IRUDWKRPHLQMHFWLRQVRQO\IRUVXEMHFWVZKRKDYHSUHYLRXVH[SHULHQFH
RIVHOILQMHFWLQJ$0*

:HHN'D\V±,I6XEMHFWZLWKQR3UHYLRXV([SHULHQFHRI
6HOILQMHFWLRQLV5DQGRPL]HGWR$0*62&DQG6HOHFWV4:
5HJLPHQ
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV

:HHN'D\V±3KRQH9LVLWIRU62&DORQH6XEMHFWV
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV

:HHN'D\V±,I6XEMHFWZLWKQR3UHYLRXV([SHULHQFHRI
6HOILQMHFWLRQLV5DQGRPL]HGWR$0*62&
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVIRU
VXEMHFWVRQ4:GRVLQJRQO\

:HHN'D\V±3KRQH9LVLWIRU62&DORQH6XEMHFWV
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

:HHN'D\V±,I6XEMHFWZLWKQR3UHYLRXV([SHULHQFHRI
6HOILQMHFWLRQLV5DQGRPL]HGWR$0*62&DQG6HOHFWV40
5HJLPHQ
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV

:HHN'D\V±3KRQH9LVLWIRU62&DORQH6XEMHFWV
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD
9LWDPLQ(VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/DQG
FKHPLVWU\KHPDWRORJ\+E$F$QWL$0*DQWLERGLHV
x
+&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQHSUHJQDQF\
x
8ULQDO\VLV
x
8ULQHPLFURDOEXPLQ
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVIRUVXEMHFWVRQ$0*62&
x
,3UHFRQFLOLDWLRQ

:HHN9LVLW'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD
9LWDPLQ(VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/FKHPLVWU\
KHPDWRORJ\+E$F$QWL$0*DQWLERGLHV
x
+&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQHSUHJQDQF\
x
8ULQDO\VLV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVIRUVXEMHFWVRQ$0*62&
x
,3UHFRQFLOLDWLRQ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

:HHN9LVLW'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVIRUVXEMHFWVRQ$0*62&
x
,3UHFRQFLOLDWLRQ

:HHNGD\V±IRU6XEMHFWVRQ405HJLPHQ2QO\
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
,QRIILFH,3DGPLQLVWUDWLRQHLWKHUVHOILQMHFWLRQRU+&3DGPLQLVWHUHG
x
,3UHFRQFLOLDWLRQ

:HHN'D\V±3KRQH9LVLWIRU62&DORQH6XEMHFWV
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV

:HHNGD\V±IRU6XEMHFWVRQ4:5HJLPHQ2QO\
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
,QRIILFH,3DGPLQLVWUDWLRQHLWKHUVHOILQMHFWLRQRU+&3DGPLQLVWHUHG
x
,3UHFRQFLOLDWLRQ

:HHN'D\V±3KRQH9LVLWIRU62&DORQH6XEMHFWV
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV

:HHN9LVLW'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
%RG\ZHLJKW
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD9LWDPLQ(
VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/KV&53FKHPLVWU\
KHPDWRORJ\+E$F$QWL$0*DQWLERGLHVFRDJXODWLRQ
x
+&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQHSUHJQDQF\
x
8ULQDO\VLV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
8ULQHPLFURDOEXPLQ
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*IRUVXEMHFWVUDQGRPL]HGWR62&DORQHLQ
<HDU
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWHIRUVXEMHFWVUDQGRPL]HGWR62&
DORQHLQ<HDU$0*DGPLQLVWUDWLRQPXVWRFFXUDIWHURWKHUSURFHGXUHV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVWRVXEMHFWVZLWKSUHYLRXVH[SHULHQFHRI
VHOILQMHFWLRQZLWK$0*

:HHN'D\V±$GGLWLRQDO3URFHGXUHVIRU6XEMHFWV5DQGRPL]HG
WR62&±DORQHLQ<HDUZLWKQR3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQ
DQG6HOHFWV4:5HJLPHQ
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV

:HHN'D\V±$GGLWLRQDO3URFHGXUHVIRU6XEMHFWV5DQGRPL]HG
WR62&±DORQHLQ<HDUZLWKQR3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQ
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQVIRUVXEMHFWVRQ4:GRVLQJRQO\

:HHN'D\V±$GGLWLRQDO3URFHGXUHVIRU6XEMHFWV5DQGRPL]HG
WR62&±DORQHLQ<HDUZLWKQR3UHYLRXV([SHULHQFHRI6HOILQMHFWLRQ
DQG6HOHFWV405HJLPHQ
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
7UDLQVXEMHFWRQVHOILQMHFWLRQRI$0*
x
2EVHUYHVXEMHFWVHOILQMHFW$0*DWVWXG\VLWH$0*DGPLQLVWUDWLRQPXVW
RFFXUDIWHURWKHUSURFHGXUHV

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV
x
,3UHFRQFLOLDWLRQ

:HHN'D\V±$GGLWLRQDO3URFHGXUHVIRU6XEMHFWV5DQGRPL]HG
WR3ODFHERRU62&LQ3DUHQW6WXG\DQG5DQGRPL]HGWR62&DORQHLQ
<HDU
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD9LWDPLQ
(VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/FKHPLVWU\DQG
KHPDWRORJ\
x
+&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQHSUHJQDQF\WHVW
x
8ULQDO\VLV
x
8ULQHPLFURDOEXPLQ

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV
x
,3UHFRQFLOLDWLRQ

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
8ULQHSUHJQDQF\WHVW
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD
9LWDPLQ(VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/FKHPLVWU\
KHPDWRORJ\DQGDQWL$0*DQWLERGLHV
x
+&9YLUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQDO\VLV
x
8ULQH0LFURDOEXPLQ
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV
x
,3UHFRQFLOLDWLRQ

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
,3UHFRQFLOLDWLRQ

:HHN'D\V±IRU6XEMHFWVRQ405HJLPHQ2QO\
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
,QRIILFH,3DGPLQLVWUDWLRQHLWKHUVHOILQMHFWLRQRU+&3DGPLQLVWHUHG
x
,3UHFRQFLOLDWLRQ

:HHN'D\V±IRU6XEMHFWVRQ4:5HJLPHQ2QO\
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
,QRIILFH,3DGPLQLVWUDWLRQHLWKHUVHOILQMHFWLRQRU+&3DGPLQLVWHUHG
x
,3UHFRQFLOLDWLRQ

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
8ULQHSUHJQDQF\WHVW
x
%RG\ZHLJKW
x
3K\VLFDOH[DP
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOH$SR$$SR%/SD
9LWDPLQ(VDPSOHGUDZQWHVWLQJE\UHIOH[ZKHQ/'/&LVPJG/FKHPLVWU\
KHPDWRORJ\KV&53DQWL$0*DQWLERGLHV+E$FFRDJXODWLRQ
x
+&99LUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
8ULQDO\VLV
x
8ULQHPLFURDOEXPLQ
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV

:HHNVRU'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
'LVSHQVH,3TXDQWLW\IRUDWKRPHLQMHFWLRQV
x
,3UHFRQFLOLDWLRQ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

:HHN'D\V
x
9LWDOVLJQVVLWWLQJEORRGSUHVVXUH%3KHDUWUDWH+5
x
3K\VLFDOH[DP
x
%RG\ZHLJKW
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
x
%ORRGGUDZIRUIDVWLQJOLSLGVKRXUIDVWLQJVDPSOHFKHPLVWU\KHPDWRORJ\DQWL
$0*DQWLERGLHV+E$FFRDJXODWLRQ
x
8ULQHSUHJQDQF\WHVW
x
+&99LUDOORDGLQVXEMHFWVSRVLWLYHIRU+&9
x
,3UHFRQFLOLDWLRQ

(QGRI6WXG\±:N'D\V±3KRQHYLVLW
x
5HYLHZ$(V6$(V
x
5HYLHZFRQFRPLWDQWPHGLFDWLRQV
&RPSOHWLRQRIWKHVWXG\LVGHILQHGDVWKHODVWGD\WKDWSURWRFROVSHFLILHGSURFHGXUHVDUH
FRQGXFWHGIRUDQLQGLYLGXDOVXEMHFW,IDVXEMHFWZLWKGUDZVIURPWKHVWXG\HDUO\DOO
HIIRUWVVKRXOGEHPDGHWRFRPSOHWHDQGUHSRUWWKHREVHUYDWLRQVDVWKRURXJKO\DV
SRVVLEOHXSWRWKHGDWHRIZLWKGUDZDO,ISRVVLEOHWKHSURFHGXUHVRI:HHNVKRXOGEH
FRPSOHWHGDWWKHWLPHRIZLWKGUDZDOLIZLWKGUDZDORFFXUVSULRUWR:

6WDQGDUGL]DWLRQRI6WXG\3URFHGXUHV

0HDVXUHPHQWRI9LWDO6LJQV
%ORRGSUHVVXUH%3DQGKHDUWUDWH+5VKRXOGEHPHDVXUHGDWHDFKYLVLW%3VKRXOG
FRQWLQXHWREHPHDVXUHGLQWKHVDPHDUPDVLQWKHSDUHQWVWXG\XQOHVVDFRQFRPLWDQW
FRQGLWLRQIDYRUVWKHXVHRIDGLIIHUHQWDUP7KHDSSURSULDWHVL]HFXIIVKRXOGEHXVHG
7KHGLDVWROLFEORRGSUHVVXUH'%3ZLOOEHUHFRUGHGDVWKHSUHVVXUHQRWHGZKHQVRXQG
GLVDSSHDUV.RURWNRII3KDVH9%ORRGSUHVVXUHDQGKHDUWUDWHPHDVXUHPHQWVVKRXOG
EHGHWHUPLQHGDIWHUWKHVXEMHFWKDVEHHQVHDWHGIRUDWOHDVWPLQXWHV7KHVXEMHFW¶V
SXOVHVKRXOGEHPHDVXUHGIRUVHFRQGVDQGWKHQXPEHUVKRXOGEHPXOWLSOLHGE\WR
REWDLQKHDUWUDWH

%ORRG6DPSOH8VH
$Q\EORRGVDPSOHFROOHFWHGDFFRUGLQJWRWKH6FKHGXOHRI$VVHVVPHQWV$SSHQGL[$
PD\EHDQDO\]HGIRUDQ\RIWKHWHVWVRXWOLQHGLQWKHSURWRFRODQGIRUDQ\WHVWVQHFHVVDU\
WRHQVXUHVXEMHFWVDIHW\7KLVLQFOXGHVWHVWLQJWRHQVXUHDQDO\WLFDOPHWKRGVSURGXFH
UHOLDEOHDQGYDOLGGDWDWKURXJKRXWWKHFRXUVHRIWKHVWXG\7KLVPD\DOVRLQFOXGHEXWLV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
QRWOLPLWHGWRLQYHVWLJDWLRQRIXQH[SHFWHGUHVXOWVLQFXUUHGVDPSOHUHDQDO\VLVDQG
DQDO\VHVIRUPHWKRGWUDQVIHUDQGFRPSDUDELOLW\
$PJHQPD\GRDGGLWLRQDOWHVWLQJRQWKHUHPDLQLQJVDPSOHVLHUHVLGXDODQGEDFNXSWR
LQYHVWLJDWHDQGEHWWHUXQGHUVWDQGSULPDU\K\SHUOLSLGHPLDDQGPL[HGG\VOLSLGHPLD
PHWDEROLFGLVRUGHUVWKHGRVHUHVSRQVHDQGRUSUHGLFWLRQRIUHVSRQVHWR$0*
FKDUDFWHUL]HDQWLERG\UHVSRQVHDQGFKDUDFWHUL]HDVSHFWVRIWKHPROHFXOH
HJPHWDEROLWHV5HVXOWVIURPWKLVDQDO\VLVZLOOEHGRFXPHQWHGDQGPDLQWDLQHGEXW
PD\QRWEHUHSRUWHGDVSDUWRIWKLVVWXG\

/LSLG0HDVXUHPHQWV
,QRUGHUWRSURWHFWWKHEOLQGLQJRIWKHSDUHQWVWXG\WKHIROORZLQJUXOHVUHODWHGWROLSLG
UHVXOWVREWDLQHGDWDQ\WLPHGXULQJWKHILUVWZHHNVZLOOEHIROORZHG)DVWLQJOLSLGV
$SR$$SR%/SDRUKV&53PHDVXUHPHQWVSULRUWRWKHZHHNYLVLWIRUH[DPSOHDW
EDVHOLQHGXHWRDGHOD\EHWZHHQWKHSDUHQW(26YLVLWDQG'D\ZLOOEHEOLQGHGWR
LQYHVWLJDWRUVVLWHVWDIIDQGVXEMHFWV7KHVWXG\WHDPZLOOUHPDLQEOLQGWRWKHVH
PHDVXUHPHQWVXQWLOWKHVXEMHFW¶VSDUHQWVWXG\LVXQEOLQGHG,QYHVWLJDWRUVDQGVWDII
LQYROYHGZLWKWKLVWULDODQGDOOPHGLFDOVWDIILQYROYHGLQWKHVXEMHFW¶VPHGLFDOFDUHVKRXOG
UHIUDLQIURPREWDLQLQJOLSLGSDQHOVEHWZHHQSDUHQW(26DQG:HHN,IDOLSLGSDQHOLV
GUDZQSULRUWR:HHNDOOUHDVRQDEOHVWHSVPXVWEHXQGHUWDNHQWRDYRLGLQIRUPLQJWKH
VXEMHFWDQGVWXG\SHUVRQQHORIWKHUHVXOWV%DFNJURXQGOLSLGORZHULQJFRQFRPLWDQW
PHGLFDWLRQVVKRXOGEHVWDELOL]HGDVVRRQDVSRVVLEOHDIWHUREWDLQLQJ:HHNGDWD
9LWDPLQ(VDPSOHVZLOOEHGUDZQIRUDOODSSOLFDEOHYLVLWVWHVWLQJZLOOEHFRQGXFWHGE\
UHIOH[ZKHQ/'/&LVPJG/

/DERUDWRU\$VVHVVPHQWV
$OORQVWXG\ODERUDWRU\VDPSOHVZLOOEHSURFHVVHGDQGVHQWWRWKHFHQWUDOODERUDWRU\
$PJHQRUGHVLJQHHZLOOEHUHVSRQVLEOHIRUDQWL$0*DQWLERG\DVVHVVPHQWVDQGWKH
FHQWUDOODERUDWRU\ZLOOVKLSWKHVDPSOHVWR$PJHQRUDVSHFLDOW\ODERUDWRU\IRUDVVD\
GHSHQGLQJRQWKHDVVHVVPHQW
7KHFHQWUDOODERUDWRU\ZLOOSURYLGHDVWXG\PDQXDOWKDWRXWOLQHVKDQGOLQJODEHOLQJDQG
VKLSSLQJSURFHGXUHVIRUDOOEORRGVDPSOHV7KHGDWHDQGWLPHRIVDPSOHFROOHFWLRQZLOO
EHUHFRUGHGLQWKHVRXUFHGRFXPHQWVDWWKHVLWH
7DEOHEHORZRXWOLQHVWKHVSHFLILFDQDO\WHVIRUVHUXPFKHPLVWU\KHPDWRORJ\XULQDO\VLV
DQGRWKHUWHVWLQJWREHFRQGXFWHG


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7DEOH $QDO\WH/LVWLQJ
&KHPLVWU\
&RDJXODWLRQ
8ULQDO\VLV
+HPDWRORJ\
6RGLXP
2WKHU/DEV
3RWDVVLXP
&KORULGH
%LFDUERQDWH
7RWDOSURWHLQ
$OEXPLQ
&DOFLXP
0DJQHVLXP
3KRVSKRUXV
*OXFRVH
%81RU8UHD
&UHDWLQLQH
8ULFDFLG
7RWDOELOLUXELQ
'LUHFWELOLUXELQ
&.
$/3
/'+
$676*27
$/76*37
37,15SHU
$SSHQGL[%
6SHFLILFJUDYLW\
S+
%ORRG
3URWHLQ
*OXFRVH
%LOLUXELQ
:%&
5%&
(SLWKHOLDOFHOOV
%DFWHULD
&DVWV
&U\VWDOV
0LFURDOEXPLQ
+HPRJORELQ
+HPDWRFULW
0&9
0&+
0&+&
5':
3ODWHOHWV
5%&
:%&

)DVWLQJOLSLGV
 7RWDOFKROHVWHURO
 +'/&
 /'/&
 7ULJO\FHULGHV
 9/'/&
 1RQ+'/&
$SR$
$SR%
$SR%$SR$UDWLR
7RWDO&KROHVWHURO+'/&
UDWLR
KV&53
/SD
9LWDPLQ(
$QWL$0*DQWLERGLHV
+E$F
8ULQH3UHJQDQF\WHVW
+&9DQWLERGLHV
+&9YLUDOORDG
)6+LIDSSOLFDEOH

+LJKULVNVXEMHFWVIRU+&9IRUWKLVSURWRFRODUHWKRVHZKRPHHWDQ\RIWKHIROORZLQJ
FRQGLWLRQV
x
(YHULQMHFWHGLOOHJDOGUXJV
x
5HFHLYHGFORWWLQJIDFWRUVPDGHEHIRUH
x
5HFHLYHGEORRGRUJDQVEHIRUH-XO\RUZHUHH[SRVHGWREORRGNQRZQWREH
LQIHFWHGZLWK+&9
x
:HUHHYHURQFKURQLFKHPRGLDO\VLV
x
$UHNQRZQWKHEHLQIHFWHGZLWK+,9
x
+DYHDNQRZQ+&9LQIHFWHGVH[XDOSDUWQHU

'HYLFH4XHVWLRQQDLUH
,QRUGHUIRUWKH6SRQVRUWREHWWHUXQGHUVWDQGWKHVXEMHFWSHUVSHFWLYHRQGHYLFHXVHDQG
UDWLRQDOHIRUVZLWFKLQJGHYLFHVVXEMHFWVH[SHULHQFLQJDFKDQJHLQWKHGHYLFHXVHGWR
GHOLYHU$0*PD\EHDVNHGWRFRPSOHWHDVKRUWTXHVWLRQQDLUHDWWKHQH[WTXDUWHUO\
YLVLWIROORZLQJWKHLUVZLWFK7KLVTXHVWLRQQDLUHZLOORQO\EHJLYHQWRDVXEMHFWRQFH7KH
6SRQVRUPD\FKRRVHWRGLVFRQWLQXHWKHXVHRIWKHTXHVWLRQQDLUHIROORZLQJD


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
QRQVSHFLILHGQXPEHURIVXEMHFWUHVSRQVHV&OLQLFDOVLWHVZLOOEHFKRVHQE\WKH6SRQVRU
WRDGPLQLVWHUWKHTXHVWLRQQDLUH
,IDQ$GYHUVH(YHQWRU3URGXFW&RPSODLQWLVLGHQWLILHGIURPWKHTXHVWLRQQDLUHLWVKRXOG
EHLQYHVWLJDWHGDQGUHSRUWHGZLWKLQWKHDSSURSULDWHWLPHIUDPHHJZLWKLQKRXUVLI
VHULRXV
1RWDOOVLWHVRUFRXQWULHVLQYROYHGLQWKHFRQGXFWRIWKLVVWXG\ZLOOEHSURYLGHGWKH
TXHVWLRQQDLUH

$QWLERG\7HVWLQJ3URFHGXUHV
%ORRGVDPSOHVZLOOEHFROOHFWHGIURPDOOVXEMHFWVDW'D\:HHN:HHN:HHN
:HHN:HHNDQG:HHNIRUWKHPHDVXUHPHQWRIDQWL$0* ELQGLQJ
DQWLERGLHV6DPSOHVWHVWLQJSRVLWLYHIRUELQGLQJDQWLERGLHVZLOODOVREHWHVWHGIRU
QHXWUDOL]LQJDQWLERGLHVDQGPD\EHIXUWKHUFKDUDFWHUL]HGIRUTXDQWLW\WLWHULVRW\SHDIILQLW\
DQGSUHVHQFHRILPPXQHFRPSOH[HV$GGLWLRQDOEORRGVDPSOHVPD\EHREWDLQHGWRUXOH
RXWDQWL$0*DQWLERGLHVGXULQJWKHVWXG\
6XEMHFWVZKRWHVWSRVLWLYHIRUQHXWUDOL]LQJDQWLERGLHVWR$0*DWWKHILQDOVFKHGXOHG
VWXG\YLVLWZLOOEHDVNHGWRUHWXUQIRUDGGLWLRQDOIROORZXSWHVWLQJ7KLVWHVWLQJVKRXOG
RFFXUDSSUR[LPDWHO\HYHU\ZHHNVVWDUWLQJIURPZKHQWKHVLWHKDVEHHQQRWLILHGRIWKH
SRVLWLYHUHVXOWXQWLOQHXWUDOL]LQJDQWLERGLHVDUHQRORQJHUGHWHFWDEOHRUWKH
VXEMHFWKDVEHHQIROORZHGIRUDSHULRGRIDWOHDVW\HDUZHHNV0RUHIUHTXHQW
WHVWLQJHJHYHU\ZHHNVRUWHVWLQJIRUDORQJHUSHULRGRIWLPHPD\EHUHTXHVWHGLQ
WKHHYHQWRIVDIHW\UHODWHGFRQFHUQV)ROORZXSWHVWLQJZLOOQRWEHUHTXLUHGZKHUHLWLV
HVWDEOLVKHGWKDWWKHVXEMHFWGLGQRWUHFHLYH$0*
6XEMHFWVZKRWHVWSRVLWLYHIRUELQGLQJQRQQHXWUDOL]LQJDQWLERGLHVDQGKDYHFOLQLFDO
VHTXHODHWKDWDUHFRQVLGHUHGSRWHQWLDOO\UHODWHGWRDQDQWL$0*DQWLERG\UHVSRQVH
PD\DOVREHDVNHGWRUHWXUQIRUDGGLWLRQDOIROORZXSWHVWLQJ

6DPSOH6WRUDJHDQG'HVWUXFWLRQ
6DPSOHVDQGDQ\RWKHUFRPSRQHQWVIURPWKHFHOOVPD\EHVWRUHGIRUXSWR\HDUVIURP
WKHHQGRIWKHVWXG\WRUHVHDUFKVFLHQWLILFTXHVWLRQVUHODWHGWRK\SHUOLSLGHPLDDQGPL[HG
G\VOLSLGHPLDPHWDEROLFGLVRUGHUVDQGRU$0*7KHVXEMHFWUHWDLQVWKHULJKWWR
UHTXHVWWKDWWKHVDPSOHPDWHULDOEHGHVWUR\HGDWDQ\WLPHE\FRQWDFWLQJWKHSULQFLSDO
LQYHVWLJDWRU7KHVSRQVRUZLOOEHWKHH[FOXVLYHRZQHURIDQ\GDWDGLVFRYHULHVRU
GHULYDWLYHPDWHULDOVIURPWKHVDPSOHPDWHULDOVDQGLVUHVSRQVLEOHIRUWKHGHVWUXFWLRQRI
WKHVDPSOHVDWWKHUHTXHVWRIWKHVXEMHFWWKURXJKWKHSULQFLSDOLQYHVWLJDWRURUDWWKH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
HQGRIWKHVWRUDJHSHULRGRUDVDSSURSULDWHHJWKHVFLHQWLILFUDWLRQDOHIRU
H[SHULPHQWDWLRQZLWKDFHUWDLQVDPSOHW\SHQRORQJHUMXVWLILHVNHHSLQJWKHVDPSOH
)ROORZLQJWKHUHTXHVWIURPWKHVXEMHFWWKHSULQFLSDOLQYHVWLJDWRUZLOOSURYLGHWKHVSRQVRU
ZLWKWKHUHTXLUHGVWXG\DQGVXEMHFWQXPEHUVVRWKDWDQ\UHPDLQLQJSODVPDDQGEORRG
VDPSOHVDQGDQ\RWKHUFRPSRQHQWVIURPWKHFHOOVFDQEHORFDWHGDQGGHVWUR\HG,ID
FRPPHUFLDOSURGXFWLVGHYHORSHGIURPWKLVUHVHDUFKSURMHFWWKHVSRQVRUZLOORZQWKH
FRPPHUFLDOSURGXFW7KHVXEMHFWZLOOKDYHQRFRPPHUFLDOULJKWVWRVXFKSURGXFWDQGZLOO
KDYHQRFRPPHUFLDOULJKWVWRWKHGDWDLQIRUPDWLRQGLVFRYHULHVRUGHULYDWLYHPDWHULDOV
JDLQHGRUSURGXFHGIURPWKHVDPSOH6HH6HFWLRQIRUVXEMHFWFRQILGHQWLDOLW\

5(029$/$1'5(3/$&(0(172)68%-(&76

5HPRYDORI6XEMHFWV
6XEMHFWVKDYHWKHULJKWWRZLWKGUDZIURPWKHVWXG\DWDQ\WLPHDQGIRUDQ\UHDVRQ
ZLWKRXWSUHMXGLFHWRKLVRUKHUIXWXUHPHGLFDOFDUHE\WKHSK\VLFLDQRUDWWKHLQVWLWXWLRQ
:LWKGUDZDORIIXOOFRQVHQWIRUDVWXG\PHDQVWKDWWKHVXEMHFWGRHVQRWZLVKWRUHFHLYH
IXUWKHULQYHVWLJDWLRQDOWUHDWPHQWDQGGRHVQRWZLVKWRRULVXQDEOHWRFRQWLQXHIXUWKHU
VWXG\SDUWLFLSDWLRQLQFOXGLQJDQ\IROORZXSLQSHUVRQE\SKRQHWKURXJKUGSDUWLHV
LQFOXGLQJUHODWLYHVRUIULHQGVYLDGLVFXVVLRQZLWKRWKHUWUHDWLQJSK\VLFLDQVDQGE\XVHRI
PHGLFDOUHFRUGVVXEMHFWGDWDXSWRZLWKGUDZDORIIXOOFRQVHQWZLOOEHLQFOXGHGLQWKH
DQDO\VLVRIWKHVWXG\$Q\VXEMHFWPD\ZLWKGUDZIXOOFRQVHQWWRSDUWLFLSDWHLQWKHVWXG\
DWDQ\WLPHGXULQJWKHVWXG\7KHLQYHVWLJDWRUZLOOGLVFXVVZLWKWKHVXEMHFWDSSURSULDWH
SURFHGXUHVIRUZLWKGUDZDOIURPWKHVWXG\7KHLQYHVWLJDWRUVKRXOGDVNWKHVXEMHFW¶V
FRQVHQWWRSHUIRUPWKHSURFHGXUHVOLVWHGXQGHUWKHILQDOVWXG\YLVLW
6XEMHFWVPD\GHFOLQHWRFRQWLQXHUHFHLYLQJ,3RURWKHUSURWRFROUHTXLUHGSURFHGXUHVDW
DQ\WLPHGXULQJWKHVWXG\,IWKLVRFFXUVWKHLQYHVWLJDWRUZLOOGLVFXVVZLWKWKHVXEMHFW
DSSURSULDWHSURFHGXUHVIRUGLVFRQWLQXDWLRQIURP,3RURWKHUSURWRFROUHTXLUHGSURFHGXUHV
DQGVKRXOGHQFRXUDJHWKHVXEMHFWWRFRQWLQXHZLWKFROOHFWLRQRIGDWDLQFOXGLQJHQGSRLQWV
DQGDGYHUVHHYHQWV7KHVHVXEMHFWVDVZHOODVWKRVHZKRKDYHVWRSSHGUHFHLYLQJ,3RU
RWKHUSURWRFROUHTXLUHGSURFHGXUHVIRURWKHUUHDVRQVHJLQYHVWLJDWRURUVSRQVRU
FRQFHUQVKRXOGFRQWLQXHWKHVFKHGXOHRIVWXG\REVHUYDWLRQV,IWKHVXEMHFWLVXQDEOHRU
XQZLOOLQJWRFRQWLQXHWKHVFKHGXOHRIREVHUYDWLRQWKHLQYHVWLJDWRUVVKRXOGFODULI\ZKDW
W\SHRIIROORZXSWKHVXEMHFWLVDJUHHDEOHWRLQSHUVRQE\SKRQHPDLOWKURXJK
IDPLO\IULHQGVLQFRUUHVSRQGHQFHFRPPXQLFDWLRQZLWKRWKHUSK\VLFLDQVDQGRUIURP
UHYLHZRIWKHPHGLFDOUHFRUGV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
6KRXOGDVXEMHFWRUDOHJDOO\DFFHSWDEOHUHSUHVHQWDWLYHUHTXHVWRUGHFLGHWRZLWKGUDZ
IURPWKHVWXG\DOOHIIRUWVZLOOEHPDGHWRFRPSOHWHDQGUHSRUWWKHREVHUYDWLRQVDV
WKRURXJKO\DVSRVVLEOHXSWRWKHGDWHRIZLWKGUDZDO$OOLQIRUPDWLRQVKRXOGEHUHSRUWHG
RQWKHDSSOLFDEOHH&5)V
5HDVRQVIRUUHPRYDOIURPSURWRFROUHTXLUHGLQYHVWLJDWLRQDOSURGXFWZLOOLQFOXGH
x
ZLWKGUDZDORIIXOOFRQVHQW
x
VXEMHFWUHTXHVWWRHQGLQYHVWLJDWLRQDOSURGXFWDGPLQLVWUDWLRQ
x
DGPLQLVWUDWLYHGHFLVLRQE\$PJHQ
x
GHFLVLRQE\WKHSULPDU\LQYHVWLJDWRUSK\VLFLDQ
x
SUHJQDQF\LQDIHPDOHVXEMHFWUHSRUWRQ3UHJQDQF\1RWLILFDWLRQ:RUNVKHHW
VHH$SSHQGL['
x
DGYHUVHHYHQWHJVHULRXVDGYHUVHHYHQWUHODWHGWRVWXG\GUXJRUSURFHGXUHV
5HDVRQVIRUUHPRYDORIDVXEMHFWIURPWKHVWXG\DUH
x
GHFLVLRQE\$PJHQVSRQVRU
x
ZLWKGUDZDORIIXOOFRQVHQWIURPVWXG\
x
GHDWK
x
ORVWWRIROORZXS

5HSODFHPHQWRI6XEMHFWV
7KHUHZLOOEHQRUHSODFHPHQWRIVXEMHFWV

6$)(7<'$7$&2//(&7,215(&25',1*$1'5(3257,1*

$GYHUVH(YHQWV

'HILQLWLRQRI$GYHUVH(YHQWV
$QDGYHUVHHYHQWLVGHILQHGDVDQ\XQWRZDUGPHGLFDORFFXUUHQFHLQDFOLQLFDOWULDO
VXEMHFW7KHHYHQWGRHVQRWQHFHVVDULO\KDYHDFDXVDOUHODWLRQVKLSZLWKVWXG\WUHDWPHQW
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWDQ\DGYHUVHHYHQWVREVHUYHGE\WKH
LQYHVWLJDWRURUUHSRUWHGE\WKHVXEMHFWDUHUHFRUGHGLQWKHVXEMHFW¶VPHGLFDOUHFRUG
7KHGHILQLWLRQRIDGYHUVHHYHQWVLQFOXGHVZRUVHQLQJRIDSUHH[LVWLQJPHGLFDOFRQGLWLRQ
:RUVHQLQJLQGLFDWHVWKHSUHH[LVWLQJPHGLFDOFRQGLWLRQHJGLDEHWHVPLJUDLQH
KHDGDFKHVJRXWKDVLQFUHDVHGLQVHYHULW\IUHTXHQF\DQGRUGXUDWLRQDQGRUKDVDQ
DVVRFLDWLRQZLWKDVLJQLILFDQWO\ZRUVHRXWFRPH$SUHH[LVWLQJFRQGLWLRQWKDWKDVQRW
ZRUVHQHGGXULQJWKHVWXG\RULQYROYHVDQLQWHUYHQWLRQVXFKDVHOHFWLYHFRVPHWLFVXUJHU\
RUDPHGLFDOSURFHGXUHZKLOHRQVWXG\LVQRWFRQVLGHUHGDQDGYHUVHHYHQW


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 40 of 65 
CONFIDENTIAL 
 
An adverse device effect (ADE) is any adverse event related to the use of a medical 
device.  Adverse device effects include adverse events resulting from insufficient or 
inadequate instructions for use, adverse events resulting from any malfunction of the 
device, or adverse events resulting from use error or from intentional misuse of the 
device. 
9.1.2 
Reporting Procedures for Adverse Events 
The investigator is responsible for ensuring that all adverse events observed by the 
investigator or reported by the subject that occur after enrollment through the EOS are 
reported using the applicable eCRF (eg, Adverse Event Summary eCRF).   
The investigator must assign the following adverse event attributes: 
 
Adverse event diagnosis or syndrome(s), if known (if not known, signs or symptoms) 
 
Dates of onset and resolution (if resolved), 
 
Severity 
 
Assessment of relatedness to IMP: AMG 145 
 
Assessment of relatedness to the device (prefilled Autoinjector/Pen (AI/Pen) or 
3.5 mL Personal Injector), or other protocol-required therapies  
 
Action taken 
The adverse event grading scale used will be the NCI Common Terminology Criteria for 
AEs (CTCAE) grading scale.  The toxicity grading scale used in this study is described in 
Appendix B. 
The investigator must assess whether the adverse event is possibly related to AMG 145 
and/or other protocol-required therapies.  This relationship is indicated by a “yes” or “no” 
response to the question:  Is there a reasonable possibility that the event may have been 
caused by AMG 145 and/or other protocol required therapies?  
The investigator must assess whether the adverse event is possibly related to the 
prefilled AI/pen or 3.5 mL Personal Injector device used to administer IMP: AMG 145.  
The relationship is indicated by a “yes” or “no” response to the question: Is there a 
reasonable possibility that the event may have been caused by the device? 
The investigator must assess whether the adverse event is possibly related to any other 
study-mandated activity or procedure.  This relationship is indicated by a “yes” or “no” 
response to the question: “Is there a reasonable possibility that the event may have 
been caused by a study activity/procedure”? 


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUUHYLHZLQJODERUDWRU\WHVWUHVXOWVDQGGHWHUPLQLQJ
ZKHWKHUDQDEQRUPDOYDOXHLQDQLQGLYLGXDOVWXG\VXEMHFWUHSUHVHQWVDFOLQLFDOO\
VLJQLILFDQWFKDQJHIURPWKHVXEMHFW¶VEDVHOLQHYDOXHV,QJHQHUDODEQRUPDOODERUDWRU\
ILQGLQJVZLWKRXWFOLQLFDOVLJQLILFDQFHEDVHGRQWKHLQYHVWLJDWRU
VMXGJPHQWVKRXOGQRWEH
UHFRUGHGDVDGYHUVHHYHQWV+RZHYHUODERUDWRU\YDOXHFKDQJHVWKDWUHTXLUHWUHDWPHQW
RUDGMXVWPHQWLQFXUUHQWWKHUDS\DUHFRQVLGHUHGDGYHUVHHYHQWV:KHUHDSSOLFDEOH
FOLQLFDOVHTXHODHQRWWKHODERUDWRU\DEQRUPDOLW\VKRXOGEHUHFRUGHGDVWKHDGYHUVH
HYHQW
7KHLQYHVWLJDWRU¶VFOLQLFDOMXGJPHQWLVXVHGWRGHWHUPLQHZKHWKHUDVXEMHFWLVWREH
UHPRYHGIURPWUHDWPHQWRUIURPWKHVWXG\GXHWRDQDGYHUVHHYHQW$VXEMHFWRU
VXEMHFW¶VSDUHQWOHJDOJXDUGLDQFDQDOVRYROXQWDULO\ZLWKGUDZIURPWUHDWPHQWGXHWRDQ
DGYHUVHHYHQW,IWKHVXEMHFWZLWKGUDZVIXOOFRQVHQWWKHVXEMHFWLVHQFRXUDJHGWR
XQGHUJRDWDPLQLPXPDQHQGRIVWXG\DVVHVVPHQW
7KH,QYHVWLJDWRULVH[SHFWHGWRIROORZUHSRUWHGDGYHUVHHYHQWVXQWLOVWDELOL]DWLRQRU
UHYHUVLELOLW\

6HULRXV$GYHUVH(YHQWV

'HILQLWLRQRI6HULRXV$GYHUVH(YHQWV
$VHULRXVDGYHUVHHYHQW6$(LVGHILQHGDVDQDGYHUVHHYHQWWKDWPHHWVDWOHDVWRI
WKHIROORZLQJVHULRXVFULWHULD
x
IDWDO
x
OLIHWKUHDWHQLQJSODFHVWKHVXEMHFWDWLPPHGLDWHULVNRIGHDWK
x
UHTXLUHVLQSDWLHQWKRVSLWDOL]DWLRQRUSURORQJDWLRQRIH[LVWLQJKRVSLWDOL]DWLRQ
x
UHVXOWVLQSHUVLVWHQWRUVLJQLILFDQWGLVDELOLW\LQFDSDFLW\
x
FRQJHQLWDODQRPDO\ELUWKGHIHFW
x
RWKHUPHGLFDOO\LPSRUWDQWVHULRXVHYHQW
$QDGYHUVHHYHQWZRXOGPHHWWKHFULWHULRQRI³UHTXLUHVKRVSLWDOL]DWLRQ´LIWKHHYHQW
QHFHVVLWDWHGDQDGPLVVLRQWRDKHDOWKFDUHIDFLOLW\HJRYHUQLJKWVWD\
,IDQLQYHVWLJDWRUFRQVLGHUVDQHYHQWWREHFOLQLFDOO\LPSRUWDQWEXWLWGRHVQRWPHHWDQ\
RIWKHVHULRXVFULWHULDWKHHYHQWFRXOGEHFODVVLILHGDVDVHULRXVDGYHUVHHYHQWXQGHUWKH
FULWHULRQRI³RWKHUPHGLFDOO\LPSRUWDQWVHULRXVHYHQW´([DPSOHVRIVXFKHYHQWVFRXOG
LQFOXGHDOOHUJLFEURQFKRVSDVPFRQYXOVLRQVEORRGG\VFUDVLDVGUXJLQGXFHGOLYHULQMXU\
VHH$SSHQGL[%IRUGUXJLQGXFHGOLYHULQMXU\UHSRUWLQJFULWHULDRUHYHQWVWKDW
QHFHVVLWDWHDQHPHUJHQF\URRPYLVLWRXWSDWLHQWVXUJHU\RUXUJHQWLQWHUYHQWLRQ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
,IDGYHUVHHYHQWVFRUUHVSRQGWRJUDGH³OLIHWKUHDWHQLQJ´&7&$(HJODERUDWRU\
DEQRUPDOLW\UHSRUWHGDVJUDGHZLWKRXWPDQLIHVWDWLRQRIOLIHWKUHDWHQLQJVWDWXVLWZLOOEH
OHIWWRWKHLQYHVWLJDWRU¶VMXGJPHQWWRDOVRUHSRUWWKHVHDEQRUPDOLWLHVDVVHULRXVDGYHUVH
HYHQWV)RUDQ\DGYHUVHHYHQWWKDWDSSOLHVWRWKLVVLWXDWLRQFRPSUHKHQVLYH
GRFXPHQWDWLRQRIWKHHYHQW¶VVHYHULW\VWDWXVPXVWEHUHFRUGHGLQWKHVXEMHFW¶VPHGLFDO
UHFRUG

5HSRUWLQJ3URFHGXUHVIRU6HULRXV$GYHUVH(YHQWV
7KHLQYHVWLJDWRULVUHVSRQVLEOHIRUHQVXULQJWKDWDOOVHULRXVDGYHUVHHYHQWVREVHUYHGE\
WKHLQYHVWLJDWRURUUHSRUWHGE\WKHVXEMHFWWKDWRFFXUDIWHUVLJQLQJRIWKHLQIRUPHG
FRQVHQWWKURXJKGD\VDIWHUWKHODVWGRVHRILQYHVWLJDWLRQDOSURGXFWRU(26ZKLFKHYHU
LVODWHUDUHUHFRUGHGLQWKHVXEMHFW¶VPHGLFDOUHFRUGVDQGDUHVXEPLWWHGWR$PJHQ
+RZHYHUWKH,QYHVWLJDWRUPD\UHSRUWDQ6$(LUUHVSHFWLYHRIUHODWHGQHVVWR$PJHQ
DIWHUWKHSURWRFROUHSRUWLQJWLPHIUDPHKDVHQGHG
6HULRXVDGYHUVHHYHQWVPXVWEHVXEPLWWHGWR$PJHQZLWKLQKRXUVIROORZLQJWKH
,QYHVWLJDWRU¶VNQRZOHGJHRIWKHHYHQWYLDWKHDSSOLFDEOH&5)6HH$SSHQGL[&IRUD
VDPSOHRIWKH6HULRXV$GYHUVH(YHQW5HSRUW)RUP
$IWHUWKHSURWRFROUHTXLUHGUHSRUWLQJSHULRGGHILQHGDERYHWKHLQYHVWLJDWRUGRHVQRW
QHHGWRDFWLYHO\PRQLWRUVXEMHFWVIRUVHULRXVDGYHUVHHYHQWV+RZHYHULIWKH
LQYHVWLJDWRUEHFRPHVDZDUHRIDVHULRXVDGYHUVHHYHQWDIWHUWKLVSURWRFROUHTXLUHG
UHSRUWLQJSHULRGWKHLQYHVWLJDWRUZLOOUHSRUWWKHHYHQWWR$PJHQZLWKLQKRXUVIROORZLQJ
WKHLQYHVWLJDWRU¶VNQRZOHGJHRIWKHHYHQW6HULRXVDGYHUVHHYHQWVUHSRUWHGRXWVLGHRI
WKHSURWRFROUHTXLUHGUHSRUWLQJSHULRGZLOOEHFDSWXUHGZLWKLQWKHVDIHW\GDWDEDVHDV
FOLQLFDOWULDOFDVHVIRUWKHSXUSRVHVRIH[SHGLWHGUHSRUWLQJ
7KHLQYHVWLJDWRUPXVWDVVHVVZKHWKHUWKHVHULRXVDGYHUVHHYHQWLVSRVVLEO\UHODWHGWR
WKHLQYHVWLJDWLRQDOPHGLFLQDOSURGXFW$0*DQGRURWKHUSURWRFROUHTXLUHGWKHUDSLHV
7KLVUHODWLRQVKLSLVLQGLFDWHGE\D³\HV´RU³QR´UHVSRQVHWRWKHTXHVWLRQ,VWKHUHD
UHDVRQDEOHSRVVLELOLW\WKDWWKHHYHQWPD\KDYHEHHQFDXVHGE\LQYHVWLJDWLRQDOPHGLFLQDO
SURGXFW$0*DQGRURWKHUSURWRFROUHTXLUHGWKHUDSLHV"
7KHLQYHVWLJDWRUPXVWDVVHVVZKHWKHUWKHVHULRXVDGYHUVHHYHQWLVSRVVLEO\UHODWHGWR
WKHSUHILOOHG$,SHQRUP/3HUVRQDO,QMHFWRUGHYLFHXVHGWRDGPLQLVWHU,03
$0*7KHUHODWLRQVKLSLVLQGLFDWHGE\D³\HV´RU³QR´UHVSRQVHWRWKHTXHVWLRQ,V
WKHUHDUHDVRQDEOHSRVVLELOLW\WKDWWKHHYHQWPD\KDYHEHHQFDXVHGE\WKHGHYLFH"


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
7KHLQYHVWLJDWRUPXVWDVVHVVZKHWKHUWKHVHULRXVDGYHUVHHYHQWLVSRVVLEO\UHODWHGWR
DQ\VWXG\PDQGDWHGDFWLYLW\RUSURFHGXUH7KLVUHODWLRQVKLSLVLQGLFDWHGE\D³\HV´RU
³QR´UHVSRQVHWRWKHTXHVWLRQ³,VWKHUHDUHDVRQDEOHSRVVLELOLW\WKDWWKHHYHQWPD\KDYH
EHHQFDXVHGE\DVWXG\DFWLYLW\SURFHGXUH´"
7KHLQYHVWLJDWRULVH[SHFWHGWRIROORZUHSRUWHGVHULRXVDGYHUVHHYHQWVXQWLOVWDELOL]DWLRQ
RUUHYHUVLELOLW\
1HZLQIRUPDWLRQUHODWLQJWRDSUHYLRXVO\UHSRUWHGVHULRXVDGYHUVHHYHQWPXVWEH
VXEPLWWHGWR$PJHQ$OOQHZLQIRUPDWLRQIRUVHULRXVDGYHUVHHYHQWVPXVWEHVHQWWR
$PJHQZLWKLQKRXUVRIUHFHLSWIROORZLQJNQRZOHGJHRIWKHQHZLQIRUPDWLRQ7KH
LQYHVWLJDWRUPD\EHDVNHGWRSURYLGHDGGLWLRQDOIROORZXSLQIRUPDWLRQZKLFKPD\LQFOXGH
DGLVFKDUJHVXPPDU\RUH[WUDFWVIURPWKHPHGLFDOUHFRUG,QIRUPDWLRQSURYLGHGDERXW
WKHVHULRXVDGYHUVHHYHQWPXVWEHFRQVLVWHQWZLWKWKDWUHFRUGHGRQWKHDSSOLFDEOH&5)
HJ$GYHUVH(YHQW6XPPDU\&5)
,IDVXEMHFWLVSHUPDQHQWO\ZLWKGUDZQIURPSURWRFROUHTXLUHGWKHUDSLHVEHFDXVHRID
VHULRXVDGYHUVHHYHQWWKLVLQIRUPDWLRQPXVWEHVXEPLWWHGWR$PJHQZLWKLQKRXUV
7RFRPSO\ZLWKZRUOGZLGHUHSRUWLQJUHJXODWLRQVIRUVHULRXVDGYHUVHHYHQWVWKHWUHDWPHQW
DVVLJQPHQWRIVXEMHFWVZKRGHYHORSVHULRXVXQH[SHFWHGDQGUHODWHGDGYHUVHHYHQWV
PD\EHXQEOLQGHGE\$PJHQEHIRUHVXEPLVVLRQWRUHJXODWRU\DXWKRULWLHV,QYHVWLJDWRUV
ZLOOUHFHLYHQRWLILFDWLRQRIUHODWHGVHULRXVDGYHUVHHYHQWVUHSRUWVVHQWWRUHJXODWRU\
DXWKRULWLHVLQDFFRUGDQFHZLWKORFDOUHTXLUHPHQWV
$PJHQZLOOUHSRUWVHULRXVDGYHUVHHYHQWVDQGRUVXVSHFWHGXQH[SHFWHGVHULRXVDGYHUVH
UHDFWLRQVDVUHTXLUHGWRUHJXODWRU\DXWKRULWLHVLQYHVWLJDWRUVLQVWLWXWLRQVDQG,5%V(&VLQ
FRPSOLDQFHZLWKDOOUHSRUWLQJUHTXLUHPHQWVDFFRUGLQJWRORFDOUHJXODWLRQVDQGJRRG
FOLQLFDOSUDFWLFH*&3
7KHLQYHVWLJDWRUVKRXOGQRWLI\WKHDSSURSULDWH,5%(&RIVHULRXVDGYHUVHHYHQWV
RFFXUULQJDWWKHVLWHDQGRWKHUDGYHUVHHYHQWUHSRUWVUHFHLYHGIURP$PJHQLQ
DFFRUGDQFHZLWKORFDOSURFHGXUHVDQGVWDWXWHV

3UHJQDQF\DQG/DFWDWLRQ5HSRUWLQJ
,IDSUHJQDQF\RFFXUVLQDIHPDOHVXEMHFWRUIHPDOHSDUWQHURIDPDOHVXEMHFWZKLOHWKH
VXEMHFWLVWDNLQJHYRORFXPDEUHSRUWWKHSUHJQDQF\WR$PJHQDVVSHFLILHGEHORZ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
,QDGGLWLRQWRUHSRUWLQJDQ\SUHJQDQFLHVRFFXUULQJGXULQJWKHVWXG\LQYHVWLJDWRUVVKRXOG
PRQLWRUIRUSUHJQDQFLHVWKDWRFFXUWKURXJKZHHNVDIWHUWKHHQGRIWUHDWPHQWZLWK
HYRORFXPDE
7KHSUHJQDQF\VKRXOGEHUHSRUWHGWR$PJHQ*OREDO3DWLHQW6DIHW\ZLWKLQKRXUVRI
WKHLQYHVWLJDWRU¶VNQRZOHGJHRIWKHSUHJQDQF\5HSRUWDSUHJQDQF\RQWKH3UHJQDQF\
1RWLILFDWLRQ:RUNVKHHW$SSHQGL['
,IDODFWDWLRQFDVHRFFXUVZKLOHDIHPDOHVXEMHFWLVWDNLQJHYRORFXPDEUHSRUWWKH
ODFWDWLRQFDVHWR$PJHQDVVSHFLILHGEHORZ,QDGGLWLRQWRUHSRUWLQJDODFWDWLRQFDVH
GXULQJWKHVWXG\LQYHVWLJDWRUVVKRXOGPRQLWRUIRUODFWDWLRQFDVHVWKDWRFFXUWKURXJK
ZHHNVDIWHUWKHHQGRIWUHDWPHQWZLWKHYRORFXPDE$Q\ODFWDWLRQFDVHVKRXOGEH
UHSRUWHGWR$PJHQ*OREDO3DWLHQW6DIHW\ZLWKLQKRXUVRIWKH,QYHVWLJDWRU¶VNQRZOHGJH
RIWKHHYHQW5HSRUWDODFWDWLRQFDVHRQWKH/DFWDWLRQ1RWLILFDWLRQ:RUNVKHHW
$SSHQGL['

67$7,67,&$/&216,'(5$7,216

6WXG\(QGSRLQWV6XEVHWVDQG&RYDULDWHV

3ULPDU\(QGSRLQW
6XEMHFWLQFLGHQFHRIDGYHUVHHYHQWV

6HFRQGDU\(QGSRLQWV
x
3HUFHQWFKDQJHIURPEDVHOLQHLQ/'/&DW:HHNDQG:HHN
x
&KDQJHIURPEDVHOLQHLQ/'/&DW:HHNDQG:HHN

([SORUDWRU\(QGSRLQWV
x
$FKLHYLQJDQ/'/&PJG/PPRO/DW:HHNDQG:HHN
x
&KDQJHDQGSHUFHQWFKDQJHIURPEDVHOLQHDWHDFKVFKHGXOHGYLVLWLQHDFKRIWKH
IROORZLQJOLSLGSDUDPHWHUV
x
/'/&
x
1RQ+'/&
x
$SR%
x
7RWDOFKROHVWHURO+'/&UDWLR
x
7RWDOFKROHVWHURO
x
$SR%$SR$
x
/SD
x
7ULJO\FHULGHV
x
+'/&
x
9/'/&


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
$SR$
x
+LJKVHQVLWLYLW\&UHDFWLYHSURWHLQKV&53

2WKHU6DIHW\(QGSRLQWV
x
&KDQJHVIURPEDVHOLQHLQVDIHW\ODERUDWRU\YDOXHVLQFOXGLQJFOLQLFDOFKHPLVWU\DQG
KHPDWRORJ\DQGYLWDOVLJQVDWHDFKVFKHGXOHGVLWHYLVLW
x
6XEMHFWLQFLGHQFHRIDQWL$0*DQWLERGLHV

$QDO\VLV6HWV
7KHIXOODQDO\VLVVHW)$6ZLOOLQFOXGHDOOVXEMHFWVUDQGRPL]HGLQWKLVVWXG\$OODQDO\VHV
RIWKHUDQGRPL]HGFRQWUROOHGSHULRGRIWKHVWXG\ZLOOEHSHUIRUPHGXVLQJWKH)$6
$QDO\VHVRIWKHSHULRGDIWHUWKHUDQGRPL]HGFRQWUROOHGSHULRGPD\EHOLPLWHGWRWKRVH
UHFHLYLQJLQYHVWLJDWLRQDOSURGXFW

%DVHOLQH&RYDULDWHV
7KHVWUDWLILFDWLRQIDFWRUVDUHWKHSDUHQWVWXG\DQGWKHUDQGRPL]HGWUHDWPHQWGRVH
IUHTXHQF\LQWKHSDUHQWVWXG\4:RU40
%DVHOLQHFRYDULDWHVIRUVXEJURXSDQDO\VHVLQFOXGHEXWDUHQRWOLPLWHGWR
x
$JH
x
6H[
x
5DFH
x
/'/&
x
)DPLO\KLVWRU\RISUHPDWXUHFRURQDU\KHDUWGLVHDVH

6DPSOH6L]H&RQVLGHUDWLRQV
7KHQXPEHURIVXEMHFWVHQWHULQJWKLVVWXG\ZLOOGHSHQGRQWKHQXPEHURIVXEMHFWV
FRPSOHWLQJWKHLUUHVSHFWLYH$0*SDUHQWVWXGLHVDQGZLOOLQJQHVVWRHQUROO$WWKHWLPH
RIWKLVSURWRFRODPHQGPHQWVXEMHFWVKDYHHQUROOHGIURPFORVHGSDUHQWVWXGLHV
%DVHGRQWKHREVHUYHGUROORYHUUDWHDQGWKHSODQQHGVDPSOHVL]HVIRUDGGLWLRQDOSDUHQW
VWXGLHVWKDWDUHQRWFORVHGDSSUR[LPDWHO\DGGLWLRQDOVXEMHFWVDUHH[SHFWHGWRHQUROO
7KLVJLYHVDWRWDOH[SHFWHGVDPSOHVL]HRIVXEMHFWV
$GGLWLRQDOSDUHQWVWXGLHVPD\EHLGHQWLILHGLQWKHIXWXUHIXUWKHULQFUHDVLQJWKHVDPSOH
VL]H
7KHDQWLFLSDWHGH[DFWFRQILGHQFHLQWHUYDOIRUDLQFLGHQFHUDWHIRUDSDUWLFXODU
DGYHUVHHYHQWIRUWKH62&DORQHWUHDWPHQWJURXSLVDQGIRUWKH
$0*62&WUHDWPHQWJURXSLV7KHHVWLPDWHVDUHGHULYHGXVLQJ
5YHUVLRQLJQRULQJVWUDWLILFDWLRQ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

,QWHULP$QDO\VLVDQG(DUO\6WRSSLQJ*XLGHOLQHV
7KHUHZLOOEHLQWHULPDQDO\VHVWRVXSSRUWVDIHW\GDWDUHSRUWLQJDQGDVVHVVPHQWVRI
HIILFDF\HQGSRLQWV,QSDUWLFXODULQWHULPDQDO\VHVRIWKHUDQGRPL]HGVWXG\SHULRGXSWR
:HHNZLOOEHFRQGXFWHGDIWHUDOOVXEMHFWVIURPVHWVRISDUHQWVWXGLHVKDYHFRPSOHWHG
WKH:HHNYLVLWRUHQGHGWKHVWXG\
7KHVWXG\LVQRWDQWLFLSDWHGWRVWRSHDUO\XQOHVVDPDMRUXQH[SHFWHGVDIHW\VLJQDOLV
GHWHFWHG

3ODQQHG0HWKRGVRI$QDO\VLV

*HQHUDO$SSURDFK&RQVLGHUDWLRQV
6WDWLVWLFDODQDO\VHVLQWKLVRSHQODEHOH[WHQVLRQVWXG\ZLOOEHGHVFULSWLYH6XEMHFW
GLVSRVLWLRQGHPRJUDSKLFVDQGEDVHOLQHFKDUDFWHULVWLFVZLOOEHVXPPDUL]HG
6XPPDU\VWDWLVWLFVIRUFRQWLQXRXVYDULDEOHVZLOOLQFOXGHWKHQXPEHURIVXEMHFWVPHDQ
PHGLDQVWDQGDUGGHYLDWLRQRUVWDQGDUGHUURUILUVWDQGWKLUGTXDUWLOHVPLQLPXPDQG
PD[LPXP)RUFDWHJRULFDOYDULDEOHVWKHIUHTXHQF\DQGSHUFHQWDJHZLOOEHJLYHQ
FRQILGHQFHLQWHUYDOVZLOOEHFDOFXODWHGIRUVHOHFWFRQWLQXRXVDQGFDWHJRULFDOHQGSRLQWV
8QOHVVVSHFLILHGRWKHUZLVHWKHEDVHOLQHYDOXHLVGHILQHGDVWKHVXEMHFW¶VEDVHOLQHYDOXH
IURPWKHSDUHQWVWXG\7KHUHZLOOEHQRLPSXWDWLRQIRUPLVVLQJGDWD
'HDWKVDQGPDMRUFDUGLRYDVFXODUHYHQWVIURPWKLVDQGRWKHUSKDVHVWXGLHVZLOOEH
DGMXGLFDWHGE\DQLQGHSHQGHQW&OLQLFDO(YHQWV&RPPLWWHH&(&WRIDFLOLWDWHDJJUHJDWHG
DQDO\VHVDFURVVWKHSURJUDP7KHVHHYHQWVDGMXGLFDWHGE\WKH&(&LQFOXGH
íGHDWKE\DQ\FDXVH
íFDUGLRYDVFXODUGHDWK
íP\RFDUGLDOLQIDUFWLRQ
íKRVSLWDOL]DWLRQIRUXQVWDEOHDQJLQD
íFRURQDU\UHYDVFXODUL]DWLRQ
íVWURNH
íKRVSLWDOL]DWLRQIRUKHDUWIDLOXUH
íWUDQVLHQWLVFKHPLFDWWDFN7,$
7KH&(&ZLOODGKHUHWRDFKDUWHUZKLFKGHWDLOVWKHDGMXGLFDWLRQSURFHVV

$QDO\VLVRI.H\6WXG\(QGSRLQWV

3ULPDU\(QGSRLQW$QDO\VHV
$GYHUVHHYHQWVZLOOEHFRGHGXVLQJWKHODWHVWYHUVLRQRI0HGLFDO'LFWLRQDU\IRU
5HJXODWRU\$FWLYLWLHV0HG'5$6XEMHFWLQFLGHQFHVRIDGYHUVHHYHQWVVHULRXVDGYHUVH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
HYHQWVDQGDGYHUVHHYHQWVOHDGLQJWRZLWKGUDZDOZLOOEHWDEXODWHGE\V\VWHPRUJDQ
FODVVDQGSUHIHUUHGWHUPIRUHDFKWUHDWPHQWJURXS
6XEJURXSDQDO\VHVRQWKHSULPDU\HQGSRLQWZLOOEHFRQGXFWHGE\SDUHQWVWXG\

6HFRQGDU\(QGSRLQW$QDO\VHV
3RLQWHVWLPDWHVRIWUHDWPHQWJURXSPHDQVDQGWKHLUFRQILGHQFHLQWHUYDOVZLOOEH
FDOFXODWHGXVLQJDPL[HGHIIHFWVPRGHOFRQWDLQLQJWKHVWUDWLILFDWLRQIDFWRUVWUHDWPHQW
JURXSYLVLWDQGWUHDWPHQWJURXSE\YLVLW'LIIHUHQFHVLQJURXSPHDQVIRUWKHVHFRQGDU\
DQGH[SORUDWRU\HQGSRLQWVZLOOEHHVWLPDWHGEHWZHHQWKH$0*62&JURXSDQGWKH
62&DORQHJURXS
6XEJURXSDQDO\VHVIRUVHFRQGDU\HQGSRLQWVPD\EHFRQGXFWHGRQEDVHOLQHFRYDULDWHV
VSHFLILHGLQ6HFWLRQ

([SORUDWRU\(QGSRLQW$QDO\VHV
7KHSHUFHQWFKDQJHDQGFKDQJHIURPEDVHOLQHLQODERUDWRU\EDVHGH[SORUDWRU\
HQGSRLQWVDWHDFKVFKHGXOHGYLVLWZLOOEHVXPPDUL]HG)RUDFKLHYLQJ/'/&PJG/
VXEMHFWVPLVVLQJ/'/&IRUDSDUWLFXODUSODQQHGYLVLWZLOOEHFRQVLGHUHGDVQRWDFKLHYLQJ
/'/&PJG/)RUFRQWLQXRXVH[SORUDWRU\HQGSRLQWVWKHVDPHPRGHODVIRUWKH
VHFRQGDU\HQGSRLQWDQDO\VHVPD\EHXVHGIRUHVWLPDWLQJWUHDWPHQWJURXSPHDQVDQG
GLIIHUHQFHVDWZHHNVDQG
6XEJURXSDQDO\VHVIRUH[SORUDWRU\HQGSRLQWVPD\EHFRQGXFWHGRQEDVHOLQHFRYDULDWHV
VSHFLILHGLQ6HFWLRQ

6DIHW\(QGSRLQW$QDO\VHV
/DERUDWRU\SDUDPHWHUVZLOOEHVXPPDUL]HGIRUHDFKWUHDWPHQWJURXSXVLQJGHVFULSWLYH
VWDWLVWLFVDWHDFKVFKHGXOHGYLVLW/DERUDWRU\VKLIWWDEOHVIRUFHUWDLQDQDO\WHVZLOOEH
SURYLGHGXVLQJWKH&7&$(YWR[LFLW\FULWHULD7KHUHVXOWVZLOOEHEDVHGRQWKH
PD[LPXPLHZRUVWVKLIWIURPEDVHOLQHWRWKHHQGRIVWXG\
6DIHW\/DERUDWRU\3DUDPHWHUV
9LWDOVLJQVZLOOEHVXPPDUL]HGIRUHDFKWUHDWPHQWJURXSXVLQJGHVFULSWLYHVWDWLVWLFVDW
HDFKVFKHGXOHGYLVLW
9LWDO6LJQV
7KHLQFLGHQFHDQGSHUFHQWDJHVRIVXEMHFWVZKRGHYHORSDQWL$0*DQWLERGLHV
ELQGLQJDQGQHXWUDOL]LQJDWDQ\WLPHZLOOEHWDEXODWHG
$QWL$0*  DQWLERGLHV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
&RQFRPLWDQWPHGLFDWLRQVRILQWHUHVWZLOOEHVXPPDUL]HGIRUHDFKWUHDWPHQWJURXS
&RQFRPLWDQW0HGLFDWLRQV

5(*8/$725<2%/,*$7,216

,QIRUPHG&RQVHQW
$QLQLWLDOJHQHULFLQIRUPHGFRQVHQWWHPSODWHIRUPLVSURYLGHGIRUWKHLQYHVWLJDWRUWRXVH
WRFXVWRPL]HDFFRUGLQJO\WRKLVRUKHUVLWH¶VUHTXLUHPHQWV8SGDWHVWRWKHWHPSODWHZLOO
EHFRPPXQLFDWHGE\OHWWHUIURPWKH$PJHQVWXG\PDQDJHUWRWKHLQYHVWLJDWRU7KH
ZULWWHQLQIRUPHGFRQVHQWGRFXPHQWVKRXOGEHSUHSDUHGLQWKHODQJXDJHVRIWKH
SRWHQWLDOVXEMHFWSRSXODWLRQ
%HIRUHDVXEMHFW¶VSDUWLFLSDWLRQLQWKHFOLQLFDOVWXG\WKHLQYHVWLJDWRULVUHVSRQVLEOHIRU
REWDLQLQJZULWWHQLQIRUPHGFRQVHQWIURPWKHVXEMHFWDIWHUDGHTXDWHH[SODQDWLRQRIWKH
DLPVPHWKRGVDQWLFLSDWHGEHQHILWVDQGSRWHQWLDOKD]DUGVRIWKHVWXG\DQGEHIRUHDQ\
SURWRFROVSHFLILFVFUHHQLQJSURFHGXUHVRUDQ\LQYHVWLJDWLRQDOSURGXFWVDUHDGPLQLVWHUHG
7KHDFTXLVLWLRQRILQIRUPHGFRQVHQWVKRXOGEHGRFXPHQWHGLQWKHVXEMHFW¶VPHGLFDO
UHFRUGVDQGWKHLQIRUPHGFRQVHQWIRUPVKRXOGEHVLJQHGDQGSHUVRQDOO\GDWHGE\WKH
VXEMHFWDQGE\WKHSHUVRQZKRFRQGXFWHGWKHLQIRUPHGFRQVHQWGLVFXVVLRQ7KHRULJLQDO
VLJQHGLQIRUPHGFRQVHQWIRUPVKRXOGEHUHWDLQHGLQDFFRUGDQFHZLWKLQVWLWXWLRQDOSROLF\
DQGDFRS\RIWKHVLJQHGFRQVHQWIRUPVKRXOGEHSURYLGHGWRWKHVXEMHFW
,IDSRWHQWLDOVXEMHFWLVLOOLWHUDWHRUYLVXDOO\LPSDLUHGDQGGRHVQRWKDYHDOHJDOO\
DFFHSWDEOHUHSUHVHQWDWLYHWKHLQYHVWLJDWRUPXVWSURYLGHDQLPSDUWLDOZLWQHVVWRUHDGWKH
LQIRUPHGFRQVHQWIRUPWRWKHVXEMHFWDQGPXVWDOORZIRUTXHVWLRQV7KHUHDIWHUERWKWKH
VXEMHFWDQGWKHZLWQHVVPXVWVLJQWKHLQIRUPHGFRQVHQWIRUPWRDWWHVWWKDWLQIRUPHG
FRQVHQWZDVIUHHO\JLYHQDQGXQGHUVWRRG

,QGHSHQGHQW(WKLFV&RPPLWWHH,QVWLWXWLRQDO5HYLHZ%RDUG,(&,5%
$FRS\RIWKHSURWRFROSURSRVHGLQIRUPHGFRQVHQWIRUPRWKHUZULWWHQVXEMHFW
LQIRUPDWLRQDQGDQ\SURSRVHGDGYHUWLVLQJPDWHULDOPXVWEHVXEPLWWHGWRWKH,(&,5%IRU
ZULWWHQDSSURYDO$FRS\RIWKHZULWWHQDSSURYDORIWKHSURWRFRODQGLQIRUPHGFRQVHQW
IRUPPXVWEHUHFHLYHGE\$PJHQEHIRUHUHFUXLWPHQWRIVXEMHFWVLQWRWKHVWXG\DQG
VKLSPHQWRI$PJHQLQYHVWLJDWLRQDOSURGXFW
7KHLQYHVWLJDWRUPXVWVXEPLWDQGZKHUHQHFHVVDU\REWDLQDSSURYDOIURPWKH,(&,5%
IRUDOOVXEVHTXHQWSURWRFRODPHQGPHQWVDQGFKDQJHVWRWKHLQIRUPHGFRQVHQW
GRFXPHQW7KHLQYHVWLJDWRUVKRXOGQRWLI\WKH,(&,5%RIGHYLDWLRQVIURPWKHSURWRFRORU


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
VHULRXVDGYHUVHHYHQWVRFFXUULQJDWWKHVLWHDQGRWKHUDGYHUVHHYHQWUHSRUWVUHFHLYHG
IURP$PJHQLQDFFRUGDQFHZLWKORFDOSURFHGXUHV
7KHLQYHVWLJDWRUZLOOEHUHVSRQVLEOHIRUREWDLQLQJDQQXDO,(&,5%DSSURYDOUHQHZDO
WKURXJKRXWWKHGXUDWLRQRIWKHVWXG\&RSLHVRIWKHLQYHVWLJDWRU¶VUHSRUWVDQGWKH
,(&,5%FRQWLQXDQFHRIDSSURYDOPXVWEHVHQWWR$PJHQ

6XEMHFW&RQILGHQWLDOLW\
7KHLQYHVWLJDWRUPXVWHQVXUHWKDWWKHVXEMHFW¶VFRQILGHQWLDOLW\LVPDLQWDLQHG
x
2QWKH&5)VRURWKHUGRFXPHQWVVXEPLWWHGWR$PJHQVXEMHFWVVKRXOGEHLGHQWLILHG
E\DVXEMHFWLGHQWLILFDWLRQQXPEHURQWKHGHPRJUDSKLFV&5)
x
)RU6HULRXV$GYHUVH(YHQWVUHSRUWHGWR$PJHQVXEMHFWVVKRXOGEHLGHQWLILHGE\D
VXEMHFWLGHQWLILFDWLRQQXPEHU
x
'RFXPHQWVWKDWDUHQRWIRUVXEPLVVLRQWR$PJHQHJVLJQHGLQIRUPHGFRQVHQW
IRUPVVKRXOGEHNHSWLQVWULFWFRQILGHQFHE\WKHLQYHVWLJDWRU
,QFRPSOLDQFHZLWK)HGHUDOUHJXODWLRQV,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ
,&+*&3*XLGHOLQHVLWLVUHTXLUHGWKDWWKHLQYHVWLJDWRUDQGLQVWLWXWLRQSHUPLW
DXWKRUL]HGUHSUHVHQWDWLYHVRIWKHFRPSDQ\RIWKHUHJXODWRU\DJHQF\VDQGWKH,(&,5%
GLUHFWDFFHVVWRUHYLHZWKHVXEMHFW¶VRULJLQDOPHGLFDOUHFRUGVIRUYHULILFDWLRQRI
VWXG\UHODWHGSURFHGXUHVDQGGDWD'LUHFWDFFHVVLQFOXGHVH[DPLQLQJDQDO\]LQJ
YHULI\LQJDQGUHSURGXFLQJDQ\UHFRUGVDQGUHSRUWVWKDWDUHLPSRUWDQWWRWKHHYDOXDWLRQRI
WKHVWXG\7KHLQYHVWLJDWRULVREOLJDWHGWRLQIRUPDQGREWDLQWKHFRQVHQWRIWKHVXEMHFWWR
SHUPLWQDPHGUHSUHVHQWDWLYHVWRKDYHDFFHVVWRKLVKHUVWXG\UHODWHGUHFRUGVLQFOXGLQJ
SHUVRQDOLQIRUPDWLRQZLWKRXWYLRODWLQJWKHFRQILGHQWLDOLW\RIWKHVXEMHFW

,QYHVWLJDWRU6LJQDWRU\2EOLJDWLRQV
(DFKFOLQLFDOVWXG\UHSRUWVKRXOGEHVLJQHGE\WKHLQYHVWLJDWRURULQWKHFDVHRI
PXOWLFHQWHUVWXGLHVWKHFRRUGLQDWLQJLQYHVWLJDWRU
7KHFRRUGLQDWLQJLQYHVWLJDWRULGHQWLILHGE\$PJHQZLOOHLWKHUEH
x
DUHFRJQL]HGH[SHUWLQWKHWKHUDSHXWLFDUHD
x
DQLQYHVWLJDWRUZKRSURYLGHGVLJQLILFDQWFRQWULEXWLRQVWRHLWKHUWKHGHVLJQRU
LQWHUSUHWDWLRQRIWKHVWXG\
x
DQLQYHVWLJDWRUFRQWULEXWLQJDKLJKQXPEHURIHOLJLEOHVXEMHFWV

$'0,1,675$7,9($1'/(*$/2%/,*$7,216

3URWRFRO$PHQGPHQWVDQG6WXG\7HUPLQDWLRQ
,I$PJHQDPHQGVWKHSURWRFRODJUHHPHQWIURPWKHLQYHVWLJDWRUPXVWEHREWDLQHG7KH
,(&,5%PXVWEHLQIRUPHGRIDOODPHQGPHQWVDQGJLYHDSSURYDO7KHLQYHVWLJDWRUPXVW
VHQGDFRS\RIWKHDSSURYDOOHWWHUIURPWKH,(&,5%WR$PJHQ


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$PJHQUHVHUYHVWKHULJKWWRWHUPLQDWHWKHVWXG\DWDQ\WLPH%RWK$PJHQDQGWKH
LQYHVWLJDWRUUHVHUYHWKHULJKWWRWHUPLQDWHWKHLQYHVWLJDWRU¶VSDUWLFLSDWLRQLQWKHVWXG\
DFFRUGLQJWRWKHVWXG\FRQWUDFW7KHLQYHVWLJDWRUVKRXOGQRWLI\WKH,(&,5%LQZULWLQJRI
WKHVWXG\¶VFRPSOHWLRQRUHDUO\WHUPLQDWLRQDQGVHQGDFRS\RIWKHQRWLILFDWLRQWR$PJHQ
6XEMHFWVPD\EHHOLJLEOHIRUFRQWLQXHGWUHDWPHQWZLWK$PJHQLQYHVWLJDWLRQDOSURGXFW,3
E\DQH[WHQVLRQSURWRFRORUDVSURYLGHGIRUE\WKHORFDOFRXQWU\¶VUHJXODWRU\PHFKDQLVP
+RZHYHU$PJHQUHVHUYHVWKHXQLODWHUDOULJKWDWLWVVROHGLVFUHWLRQWRGHWHUPLQH
ZKHWKHUWRVXSSO\$PJHQ,3DQGE\ZKDWPHFKDQLVPDIWHUWHUPLQDWLRQRIWKHWULDODQG
EHIRUHLWLVDYDLODEOHFRPPHUFLDOO\

6WXG\'RFXPHQWDWLRQDQG$UFKLYH
7KHLQYHVWLJDWRUVKRXOGPDLQWDLQDOLVWRIDSSURSULDWHO\TXDOLILHGSHUVRQVWRZKRPKHVKH
KDVGHOHJDWHGVWXG\UHVSRQVLELOLWLHV$OOSHUVRQVDXWKRUL]HGWRPDNHHQWULHVDQGRU
FRUUHFWLRQVRQ&5)VZLOOEHLQFOXGHGRQWKH$PJHQ'HOHJDWLRQRI$XWKRULW\)RUP
6RXUFHGRFXPHQWVDUHRULJLQDOGRFXPHQWVGDWDDQGUHFRUGVIURPZKLFKWKHVXEMHFW¶V
&5)GDWDDUHREWDLQHG7KHVHLQFOXGHEXWDUHQRWOLPLWHGWRKRVSLWDOUHFRUGVFOLQLFDO
DQGRIILFHFKDUWVODERUDWRU\DQGSKDUPDF\UHFRUGVGLDULHVPLFURILFKHVUDGLRJUDSKV
DQGFRUUHVSRQGHQFH
7KHLQYHVWLJDWRUDQGVWXG\VWDIIDUHUHVSRQVLEOHIRUPDLQWDLQLQJDFRPSUHKHQVLYHDQG
FHQWUDOL]HGILOLQJV\VWHPRIDOOVWXG\UHODWHGHVVHQWLDOGRFXPHQWDWLRQVXLWDEOHIRU
LQVSHFWLRQDWDQ\WLPHE\UHSUHVHQWDWLYHVIURP$PJHQDQGRUDSSOLFDEOHUHJXODWRU\
DXWKRULWLHV
(OHPHQWVVKRXOGLQFOXGH
x
6XEMHFWILOHVFRQWDLQLQJFRPSOHWHGVWXG\UHODWHGZRUNVKHHWVLQIRUPHGFRQVHQW
IRUPVDQGVXEMHFWLGHQWLILFDWLRQOLVW
x
6WXG\ILOHVFRQWDLQLQJWKHSURWRFROZLWKDOODPHQGPHQWVLQYHVWLJDWRU¶VEURFKXUH
FRSLHVRISUHVWXG\GRFXPHQWDWLRQDQGDOOFRUUHVSRQGHQFHWRDQGIURPWKH,(&,5%
DQG$PJHQ
x
,INHSWSURRIRIUHFHLSWGHOLYHU\VKHHW,QYHVWLJDWLRQDO3URGXFW$FFRXQWDELOLW\5HFRUG
5HWXUQRI,QYHVWLJDWLRQDO3URGXFWIRU'HVWUXFWLRQ)LQDO,QYHVWLJDWLRQDO3URGXFW
5HFRQFLOLDWLRQ6WDWHPHQWLIDSSOLFDEOHDQGDOOGUXJUHODWHGFRUUHVSRQGHQFH
,QDGGLWLRQDOORULJLQDOVRXUFHGRFXPHQWVVXSSRUWLQJHQWULHVLQWKH&5)VPXVWEH
PDLQWDLQHGDQGEHUHDGLO\DYDLODEOH
5HWHQWLRQRIVWXG\GRFXPHQWVZLOOEHJRYHUQHGE\WKH&OLQLFDO7ULDO$JUHHPHQW


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

6WXG\0RQLWRULQJDQG'DWD&ROOHFWLRQ
7KH$PJHQUHSUHVHQWDWLYHDQGUHJXODWRU\DXWKRULW\LQVSHFWRUVDUHUHVSRQVLEOHIRU
FRQWDFWLQJDQGYLVLWLQJWKHLQYHVWLJDWRUIRUWKHSXUSRVHRILQVSHFWLQJWKHIDFLOLWLHVDQG
XSRQUHTXHVWLQVSHFWLQJWKHYDULRXVUHFRUGVRIWKHFOLQLFDOVWXG\HJ&5)VDQGRWKHU
SHUWLQHQWGDWDSURYLGHGWKDWVXEMHFWFRQILGHQWLDOLW\LVUHVSHFWHG
7KH$PJHQPRQLWRULVUHVSRQVLEOHIRUYHULI\LQJWKH&5)VDWUHJXODULQWHUYDOVWKURXJKRXW
WKHVWXG\WRYHULI\DGKHUHQFHWRWKHSURWRFROFRPSOHWHQHVVDFFXUDF\DQGFRQVLVWHQF\
RIWKHGDWDDQGDGKHUHQFHWRORFDOUHJXODWLRQVRQWKHFRQGXFWRIFOLQLFDOUHVHDUFK7KH
PRQLWRUVKRXOGKDYHDFFHVVWRVXEMHFWPHGLFDOUHFRUGVDQGRWKHUVWXG\UHODWHGUHFRUGV
QHHGHGWRYHULI\WKHHQWULHVRQWKH&5)V
7KHLQYHVWLJDWRUDJUHHVWRFRRSHUDWHZLWKWKHPRQLWRUWRHQVXUHWKDWDQ\SUREOHPV
GHWHFWHGLQWKHFRXUVHRIWKHVHPRQLWRULQJYLVLWVLQFOXGLQJGHOD\VLQFRPSOHWLQJ&5)V
DUHUHVROYHG
,QDFFRUGDQFHZLWK,&+*&3DQGWKHVSRQVRU¶VDXGLWSODQVWKLVVWXG\PD\EHVHOHFWHG
IRUDXGLWE\UHSUHVHQWDWLYHVIURP$PJHQ¶V*OREDO&RPSOLDQFH$XGLWLQJIXQFWLRQ
RUGHVLJQHHV,QVSHFWLRQRIVLWHIDFLOLWLHVHJSKDUPDF\GUXJVWRUDJHDUHDV
ODERUDWRULHVDQGUHYLHZRIVWXG\UHODWHGUHFRUGVZLOORFFXUWRHYDOXDWHWKHVWXG\FRQGXFW
DQGFRPSOLDQFHZLWKWKHSURWRFRO,&+*&3DQGDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV
'DWDFDSWXUHIRUWKLVVWXG\LVSODQQHGWREHHOHFWURQLF
x
$OOVRXUFHGRFXPHQWDWLRQVXSSRUWLQJHQWULHVLQWRWKHHOHFWURQLF&5)VPXVWEH
PDLQWDLQHGDQGUHDGLO\DYDLODEOH
x
8SGDWHVWRHOHFWURQLF&5)VH&5)ZLOOEHDXWRPDWLFDOO\GRFXPHQWHGWKURXJKWKH
VRIWZDUH¶V³DXGLWWUDLO´
x
7RHQVXUHWKHTXDOLW\RIFOLQLFDOGDWDDFURVVDOOVXEMHFWVDQGVLWHVDFOLQLFDOGDWD
PDQDJHPHQWUHYLHZZLOOEHSHUIRUPHGRQVXEMHFWGDWDUHFHLYHGDW$PJHQ'XULQJ
WKLVUHYLHZVXEMHFWGDWDZLOOEHFKHFNHGIRUFRQVLVWHQF\RPLVVLRQVDQGDQ\
DSSDUHQWGLVFUHSDQFLHV,QDGGLWLRQWKHGDWDZLOOEHUHYLHZHGIRUDGKHUHQFHWRWKH
SURWRFRODQG*&37RUHVROYHDQ\TXHVWLRQVDULVLQJIURPWKHFOLQLFDOGDWD
PDQDJHPHQWUHYLHZSURFHVVGDWDTXHULHVDQGRUVLWHQRWLILFDWLRQVZLOOEHFUHDWHGLQ
WKH('&V\VWHPGDWDEDVHIRUVLWHUHVROXWLRQDQGFORVHGE\$PJHQUHYLHZHU
x
7KHSULQFLSDOLQYHVWLJDWRUVLJQVRQO\WKH,QYHVWLJDWRU9HULILFDWLRQ)RUPIRUWKLV
HOHFWURQLFGDWDFDSWXUHVWXG\7KLVVLJQDWXUHZLOOLQGLFDWHWKDWWKHSULQFLSDO
LQYHVWLJDWRULQVSHFWHGRUUHYLHZHGWKHGDWDRQWKH&5)WKHGDWDTXHULHVDQGWKH
VLWHQRWLILFDWLRQVDQGDJUHHVZLWKWKHFRQWHQW
$PJHQRUGHVLJQHHZLOOSHUIRUPVHOIHYLGHQWFRUUHFWLRQVWRREYLRXVGDWDHUURUVLQWKH
FOLQLFDOWULDOGDWDEDVHDVGRFXPHQWHGLQWKH6WXG\6SHFLILF6HOI(YLGHQW&RUUHFWLRQV
3ODQ([DPSOHVRIREYLRXVGDWDHUURUVWKDWPD\EHFRUUHFWHGE\$PJHQRUGHVLJQHH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
LQFOXGHGHOHWLRQRIREYLRXVGXSOLFDWHGDWDHJVDPHUHVXOWVVHQWWZLFHZLWKWKHVDPH
GDWHZLWKGLIIHUHQWYLVLW²:HHNDQGHDUO\WHUPLQDWLRQDQGFODULI\LQJ³RWKHUVSHFLI\´LI
GDWDDUHSURYLGHGHJUDFHSK\VLFDOH[DPLQDWLRQ(DFKLQYHVWLJDWLYHVLWHZLOOEH
SURYLGHGDOLVWRIWKHW\SHVRIFRUUHFWLRQVDSSOLHGWRVWXG\GDWDDWWKHLQLWLDWLRQRIWKHWULDO
DQGDWVWXG\FORVHRXW

,QYHVWLJDWRU5HVSRQVLELOLWLHVIRU'DWD&ROOHFWLRQ
7KH,QYHVWLJDWRULVUHVSRQVLEOHWRFRPSO\ZLWKWKHUHTXLUHPHQWVIRUDOODVVHVVPHQWVDQG
GDWDFROOHFWLRQLQFOXGLQJVXEMHFWVQRWUHFHLYLQJSURWRFROUHTXLUHGWKHUDSLHVDV
VWLSXODWHGLQWKHSURWRFROIRUHDFKVXEMHFWLQWKHVWXG\)RUVXEMHFWVZKRZLWKGUDZSULRU
WRFRPSOHWLRQRIDOOSURWRFROUHTXLUHGYLVLWVDQGDUHXQDEOHRUXQZLOOLQJWRFRQWLQXHWKH
6FKHGXOHRI$VVHVVPHQWV$SSHQGL[$WKH,QYHVWLJDWRUFDQVHDUFKSXEOLFDOO\DYDLODEOH
UHFRUGV>ZKHUHSHUPLWWHG@WRDVFHUWDLQVXUYLYDOVWDWXV7KLVHQVXUHVWKDWWKHGDWDVHWV
SURGXFHGDVDQRXWFRPHRIWKHVWXG\LVDUHDVFRPSUHKHQVLYHDVSRVVLEOH

/DQJXDJH
H&5)VPXVWEHFRPSOHWHGLQ(QJOLVK75$'(1$0(6£LIXVHGIRUFRQFRPLWDQW
PHGLFDWLRQVPD\EHHQWHUHGLQWKHORFDOODQJXDJH
$OOZULWWHQLQIRUPDWLRQDQGRWKHUPDWHULDOWREHXVHGE\VXEMHFWVDQGLQYHVWLJDWLYHVWDII
PXVWXVHYRFDEXODU\DQGODQJXDJHWKDWDUHFOHDUO\XQGHUVWRRG&RQVXOWWKH
FRXQWU\VSHFLILFUHTXLUHPHQWVIRUODQJXDJHUHTXLUHPHQWV

3XEOLFDWLRQ3ROLF\
7RFRRUGLQDWHGLVVHPLQDWLRQRIGDWDIURPWKLVVWXG\$PJHQHQFRXUDJHVWKHIRUPDWLRQRI
DSXEOLFDWLRQFRPPLWWHHFRQVLVWLQJRIVHYHUDOSULQFLSDOLQYHVWLJDWRUVDQGDSSURSULDWH
$PJHQVWDIIWKHJRYHUQDQFHDQGUHVSRQVLELOLWLHVRIZKLFKDUHVHWIRUWKLQD3XEOLFDWLRQ
&KDUWHU7KHFRPPLWWHHLVH[SHFWHGWRVROLFLWLQSXWDQGDVVLVWDQFHIURPRWKHU
LQYHVWLJDWRUVDQGWRFROODERUDWHZLWKDXWKRUVDQG$PJHQVWDIIDVDSSURSULDWHDVGHILQHG
LQWKH3XEOLFDWLRQ&KDUWHU0HPEHUVKLSRQWKHFRPPLWWHHERWKIRULQYHVWLJDWRUVDQG
$PJHQVWDIIGRHVQRWJXDUDQWHHDXWKRUVKLS²WKHFULWHULDGHVFULEHGEHORZVKRXOGEHPHW
IRUHYHU\SXEOLFDWLRQ
$XWKRUVKLSRIDQ\SXEOLFDWLRQVUHVXOWLQJIURPWKLVVWXG\ZLOOEHGHWHUPLQHGRQWKHEDVLV
RIWKH8QLIRUP5HTXLUHPHQWIRU0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDO-RXUQDOV
,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUVZKLFKVWDWHV
x
$XWKRUVKLSFUHGLWVKRXOGEHEDVHGRQVXEVWDQWLDOFRQWULEXWLRQVWRFRQFHSWLRQDQG
GHVLJQDFTXLVLWLRQRIGDWDRUDQDO\VLVDQGLQWHUSUHWDWLRQRIGDWDGUDIWLQJWKH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
DUWLFOHRUUHYLVLQJLWFULWLFDOO\IRULPSRUWDQWLQWHOOHFWXDOFRQWHQWILQDODSSURYDORIWKH
YHUVLRQWREHSXEOLVKHG$XWKRUVVKRXOGPHHWFRQGLWLRQVDQG
x
:KHQDODUJHPXOWLFHQWHUJURXSKDVFRQGXFWHGWKHZRUNWKHJURXSVKRXOGLGHQWLI\
WKHLQGLYLGXDOVZKRDFFHSWGLUHFWUHVSRQVLELOLW\IRUWKHPDQXVFULSW7KHVHLQGLYLGXDOV
VKRXOGIXOO\PHHWWKHFULWHULDIRUDXWKRUVKLSGHILQHGDERYH
x
$FTXLVLWLRQRIIXQGLQJFROOHFWLRQRIGDWDRUJHQHUDOVXSHUYLVLRQRIWKHUHVHDUFK
JURXSDORQHGRHVQRWMXVWLI\DXWKRUVKLS
x
$OOSHUVRQVGHVLJQDWHGDVDXWKRUVVKRXOGTXDOLI\IRUDXWKRUVKLSDQGDOOWKRVHZKR
TXDOLI\VKRXOGEHOLVWHG
x
(DFKDXWKRUVKRXOGKDYHSDUWLFLSDWHGVXIILFLHQWO\LQWKHZRUNWRWDNHSXEOLF
UHVSRQVLELOLW\IRUDSSURSULDWHSRUWLRQVRIWKHFRQWHQW
$OOSXEOLFDWLRQVHJPDQXVFULSWVDEVWUDFWVRUDOVOLGHSUHVHQWDWLRQVERRNFKDSWHUV
EDVHGRQWKLVVWXG\PXVWEHVXEPLWWHGWR$PJHQIRUFRUSRUDWHUHYLHZ7KH&OLQLFDO
6WXG\$JUHHPHQWDPRQJWKHLQVWLWXWLRQSULQFLSDOLQYHVWLJDWRUDQG$PJHQZLOOGHWDLOWKH
SURFHGXUHVIRUDQGWLPLQJRI$PJHQ¶VUHYLHZRISXEOLFDWLRQV

&RPSHQVDWLRQ
$Q\DUUDQJHPHQWVIRUFRPSHQVDWLRQWRVXEMHFWVIRULQMXU\RULOOQHVVWKDWDULVHVLQWKH
VWXG\DUHGHVFULEHGLQWKH&RPSHQVDWLRQIRU,QMXU\VHFWLRQRIWKH,QIRUPHG&RQVHQW
'HSHQGLQJRQWKHW\SHRIVWXG\DQGLISHUPLWWHGXQGHUDSSOLFDEOHUHJLRQDOODZVRU
UHJXODWRU\JXLGHOLQHVVXEMHFWVPD\EHFRPSHQVDWHGIRURWKHULQFRQYHQLHQFHVQRW
DVVRFLDWHGZLWKVWXG\UHODWHGLQMXULHVHJWUDYHOFRVWV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

5()(5(1&(6
$ELIDGHO09DUUHW05DEHV-3HWDO0XWDWLRQVLQ3&6.FDXVHDXWRVRPDOGRPLQDQW
K\SHUFKROHVWHUROHPLD1DWXUH*HQHWLFV
$OOHQGHU66FDUERURXJK33HWR9HWDO(XURSHDQ&DUGLRYDVFXODU'LVHDVH6WDWLVWLFV
(GLWLRQ
$PJHQ$0*,QYHVWLJDWRU¶V%URFKXUHHGLWLRQ0D\
%URZQ06*ROGVWHLQ-/%LRPHGLFLQH/RZHULQJ/'/QRWRQO\KRZORZEXWKRZ
ORQJ"6FLHQFH
&RKHQ-3HUWVHPOLGLV$.RWRZVNL,.HWDO/RZ/'/FKROHVWHUROLQLQGLYLGXDOVRI
$IULFDQGHVFHQWUHVXOWLQJIURPIUHTXHQWQRQVHQVHPXWDWLRQVLQ3&6.1DWXUH
*HQHWLFV
&RKHQ-&%RHUZLQNOH(0RVOH\7+-U+REEV++6HTXHQFHYDULDWLRQVLQ3&6.ORZ
/'/DQGSURWHFWLRQDJDLQVWFRURQDU\KHDUWGLVHDVH1(QJO-0HG
(LVHQEHUJ'$&KROHVWHUROORZHULQJLQWKHPDQDJHPHQWRIFRURQDU\DUWHU\GLVHDVHWKH
FOLQLFDOLPSOLFDWLRQVRIUHFHQWWULDOV$P-0HG$66
([SHUW3DQHORQ'HWHFWLRQ(YDOXDWLRQDQG7UHDWPHQWRI+LJK%ORRG&KROHVWHUROLQ
$GXOWV6XPPDU\RIWKHVHFRQGUHSRUWRIWKH1DWLRQDO&KROHVWHURO(GXFDWLRQ3URJUDP
1&(3H[SHUWSDQHORQGHWHFWLRQHYDOXDWLRQDQGWUHDWPHQWRIKLJKEORRGFKROHVWHUROLQ
DGXOWV$GXOW7UHDWPHQW3DQHO,,-$0$
*RXOG$/5RVVRXZ-(6DQWDQHOOR1&+H\VH-))XUEHUJ&'&KROHVWHUROUHGXFWLRQ
\LHOGVFOLQLFDOEHQHILW$QHZORRNDWROGGDWD&LUFXODWLRQ
+RRSHU$-0DUDLV$'7DQ\DQ\LZD'0%XUQHWW-57KH&;PXWDWLRQLQ3&6.LV
SUHVHQWDQGORZHUVEORRGFKROHVWHUROLQD6RXWKHUQ$IULFDQSRSXODWLRQ
$WKHURVFOHURVLV
+RUWRQ-'&RKHQ-&+REEV++0ROHFXODUELRORJ\RI3&6.LWVUROHLQ/'/
PHWDEROLVP7UHQGV%LRFKHP6FL
.DQQHO:%HWDO7KH)UDPLQJKDP6WXG\$QHSLGHPLRORJLFDOLQYHVWLJDWLRQRI
FDUGLRYDVFXODUGLVHDVH6HFWLRQ6RPHFKDUDFWHULVWLFVUHODWHGWRWKHLQFLGHQFHRI
FDUGLRYDVFXODUGLVHDVHDQGGHDWK7KH)UDPLQJKDP6WXG\\HDUIROORZ
XS:DVKLQJWRQ'&'HSWRI+HDOWK(GXFDWLRQDQG:HOIDUH3XEOLFDWLRQ1R1,+

.DQQHO:%&DVWHOOL:3*RUGRQ7/LSRSURWHLQFKROHVWHUROLQWKHSUHGLFWLRQRI
DWKHURVFOHURWLFGLVHDVH1HZSHUVSHFWLYHVEDVHGRQWKH)UDPLQJKDP6WXG\$QQ,QW
0HG
.DQQHO:%5DQJHRIVHUXPFKROHVWHUROYDOXHVLQWKHSRSXODWLRQGHYHORSLQJFRURQDU\
DUWHU\GLVHDVH$P-&DUGLRO&&
5RJHU9/*R$6/OR\G-RQHV'0HWDO+HDUW'LVHDVHDQG6WURNH6WDWLVWLFV±
8SGDWH&LUFXODWLRQHH
6HPSRV&7&OHHPDQ&7&DUUROO0'HWDO3UHYDOHQFHRIKLJKEORRGFKROHVWHURODPRQJ
86DGXOWV$QXSGDWHEDVHGRQJXLGHOLQHVIURPWKHVHFRQGUHSRUWRIWKH1DWLRQDO
&KROHVWHURO(GXFDWLRQ3URJUDP$GXOW7UHDWPHQW3DQHO-$0$
=DLG$5RXEWVRYD$(VVDOPDQL5HWDO3URSURWHLQFRQYHUWDVHVXEWLOLVLQNH[LQW\SH
3&6.KHSDWRF\WHVSHFLILFORZGHQVLW\OLSRSURWHLQUHFHSWRUGHJUDGDWLRQDQGFULWLFDO
UROHLQPRXVHOLYHUUHJHQHUDWLRQ+HSDWRORJ\


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
=KDR=7XDNOL:RVRUQX</DJDFH7$HWDO0ROHFXODUFKDUDFWHUL]DWLRQRI
ORVVRIIXQFWLRQPXWDWLRQVLQ3&6.DQGLGHQWLILFDWLRQRIDFRPSRXQG
KHWHUR]\JRWH$P-+XP*HQHW


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/

$33(1',&(6


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL[$6FKHGXOHRI$VVHVVPHQWV
$SSOLHVWRERWK$0*DQG62&DORQHJURXSVXQOHVVVSHFLILHGRWKHUZLVH
7LPHSRLQW)UHTXHQF\
'D :E
:EF
:F :
:
:
:I
:J
:
:L
:LM
:M
:
:

:

:
:I
:J
:
*HQHUDO3URFHGXUHV













,QIRUPHGFRQVHQW
;














0HGLFDOKLVWRU\
;
9LWDO6LJQVVLWWLQJ%3+5
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
;
5HYLHZ IRU$(V6$(V
;
;H
;H
;H
;
;
;
;H
;H
;
;
;
;
;
;
;
;
;
;
;
&RQFRPLWDQWWKHUDS\
;
;H
;H
;H
;
;
;
;H
;H
;
;
;
;
;
;
;
;
;
;
;
3K\VLFDOH[DP
;G













;
%RG\ZHLJKW
;
;
;
5DQGRPL]DWLRQ
;














&HQWUDO/DERUDWRU\













)DVWLQJOLSLGV
;G


;
;

;



;N
;



;
$SR$$SR%/SD
;G


;
;

;



;N

;



;
9LWDPLQ(K
;
;
;
;N
;
;
KV&53
;G




;









;
3DJHRI
)RRWQRWHVGHILQHGRQODVWSDJHRIWKLVWDEOH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL[$6FKHGXOHRI$VVHVVPHQWV
$SSOLHVWRERWK$0*DQG62&DORQHJURXSVXQOHVVVSHFLILHGRWKHUZLVH
7LPHSRLQW)UHTXHQF\
'D
:E
:EF
:F
:
:
:
:I
:J
:
:L
:LM
:M
:
:
: :
:I
:J
:
&HQWUDO/DERUDWRU\














&KHPLVWU\IDVWLQJJOXFRVH
;G


;
;



;

;N

;



;
&RDJXODWLRQ37,15
;






;






;
+HPDWRORJ\
;G



;
;



;



;N

;



;
76+
;G


















+E$F
;G
;
;
;
;
$QWL$0* DQWLERGLHV
;G
;
;
;
;
;
+&9DQWLERGLHVO
;G
+&9YLUDOORDGO
;G
;
;
;
;N
;
;
8ULQHSUHJQDQF\)6+P
;G


;
;



;

;N

;



;
8ULQDO\VLV
;G


;
;



;

;N

;



;
8ULQHPLFURDOEXPLQ
;G


;
;



;

;N

;



;
,QYHVWLJDWLRQDO3URGXFW














6XEMHFWZLWKRXWSUHYLRXV
LQKRPHXVHH[SHULHQFH,3
LQRIILFHDGPLQLVWUDWLRQ
;IJ
;E
; EF
;F



;
;
;LM
;L
;LM
;M




;
;

6XEMHFWZLWKSUHYLRXVLQKRPH
XVHH[SHULHQFH,3LQRIILFH
DGPLQLVWUDWLRQ
;IJ






;
;
;LM






;
;

,3GLVSHQVH
;

;E

;
;
;


;

;L
;
;
;
;


;
,3UHFRQFLOLDWLRQ
;
;
;
;
;
;
;
;
;
;
;
3DJHRI
)RRWQRWHVGHILQHGRQODVWSDJHRIWKLVWDEOH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL[$6FKHGXOHRI$VVHVVPHQWV
$SSOLHVWRERWK$0*DQG62&DORQHJURXSVXQOHVVVSHFLILHGRWKHUZLVH
7LPHSRLQW)UHTXHQF\
:
:
:
:
(263KRQHYLVLW
:
*HQHUDO3URFHGXUHV
9LWDO6LJQVVLWWLQJ%3+5
;
;
;
;
5HYLHZ IRU$(V6$(V
;
;
;
;
;
&RQFRPLWDQWWKHUDS\
;
;
;
;
;
3K\VLFDO([DP



;

%RG\:HLJKW


;

/DERUDWRU\




)DVWLQJOLSLGV
;
&KHPLVWU\IDVWLQJJOXFRVH
;
+HPDWRORJ\
;
&RDJXODWLRQ37,15


;

+E$F


;

$QWL$0*DQWLERGLHV


;

+&9YLUDOORDGO


;

8ULQHSUHJQDQF\



;

,QYHVWLJDWLRQDO3URGXFW




,3'LVSHQVH
;
;
;


,35HFRQFLOH
;
;
;
;

3DJHRI
D ' GD\RIILUVWDGPLQLVWUDWLRQRI,37KLVYLVLWVKRXOGDOVRFRLQFLGHZLWK(26YLVLWIRUSDUHQWVWXG\IRUYLVLWZ LQGRZVVHH6HFWLRQRIWKHSURWRFRO3URFHGXUHV127FRQGXFWHGDVSDUWRI
(26YLVLWIRUSDUHQWVWXG\VKRXOGEHFRPSOHWHGDWWKLVYLVLW
EE7UDLQLQJYLVLWDSSOLHVWRVXEMHFWVZKRDUHUDQGRPL]HGWR$0*DQGVHOHFWWKH4:UHJLPHQ
F 7UDLQLQJYLVLWDSSOLHVWRVXEMHFWVZKRDUHUDQGRPL]HGWR$0*DQGVHOHFW40UHJLPHQ
G 2QO\LIHQUROOPHQWLQWRH[FHHGVODVWODERUDWRU\YLVLWIURPSDUHQWVWXG\E\GD\V&DUGLDF+LVWRU\)RUPZ LOODOVRQHHGWREHFRPSOHWHG
H 7HOHSKRQHYLVLWIRUVXEMHFWVUDQGRPL]HGWR62&DORQH
I2QO\ IRUVXEMHFWVUHFHLYLQJ$0*Z KRKDYHVHOHFWHGWKH40UHJLPHQ
J 2QO\IRUVXEMHFWVUHFHLYLQJ$0*ZKRKDYHVHOHFWHGWKH4:UHJLPHQ
K9LWDPLQ(VDPSOHVZ LOOEHGUDZQIRUDOODSSOLFDEOHYLVLWVWHVWLQJZ LOOEHFRQGXFWHGE\UHIOH[ZKHQ/'/&LVPJG/
LL7UDLQLQJYLVLWDSSOLHVWRVXEMHFWVZKRDUHUDQGRPL]HG62&DORQHLQ\HDUDQGVHOHFWWKH4:UHJLPHQLQ\HDU
M7UDLQLQJYLVLWDSSOLHVWRVXEMHFWVZKRDUHUDQGRPL]HG62&DORQHLQ\HDUDQGVHOHFWWKH40UHJLPHQLQ\HDU
N2QO\IRUVXEMHFWVUDQGRPL]HGWRSODFHERRU62&LQSDUHQWVWXG\$1'UDQGRPL]HGWR62&DORQHLQ<HDU
O+&9DQWLERGLHVRQO\LQKLJKULVNVXEMHFWVVHH6HFWLRQRULI$/7RU$67![8/1YLUDOORDGRQO\LQVXEMHFWVSRVLWLYHIRU+&9
P)6+LQDSSOLFDEOHVXEMHFWVIRUVWXG\HQWU\RQO\±VHHH[FOXVLRQFULWHULDXULQHSUHJQDQF\LQIHPDOHVRIFKLOGEHDULQJSRWHQWLDO
Q 'LVSHQVH,3IRUDWKRPHLQMHFWLRQVRQO\IRUVXEMHFWVZKRKDYHSUHYLRXVH[SHULHQFHRIVHOILQMHFWLQJ$0*



3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL[%$GGLWLRQDO6DIHW\$VVHVVPHQW,QIRUPDWLRQ
5HIHUWRWKH1&,&RPPRQ7HUPLQRORJ\&ULWHULDIRU$(V&7&$(9HUVLRQIRU
$(JUDGLQJDQGLQIRUPDWLRQ7KH&7&$(LVDYDLODEOHDWWKHIROORZLQJOLQN
$GYHUVH(YHQW7R[LFLW\*UDGLQJ6FDOH
KWWSFWHSFDQFHUJRYSURWRFRO'HYHORSPHQWHOHFWURQLFBDSSOLFDWLRQVFWFKWP
'UXJLQGXFHG/LYHU,QMXU\5HSRUWLQJ	$GGLWLRQDO$VVHVVPHQWV
7RIDFLOLWDWHDSSURSULDWHPRQLWRULQJIRUVLJQDOVRI',/,FDVHVRIFRQFXUUHQW$67$/7DQG
7%/HOHYDWLRQDFFRUGLQJWRWKHFULWHULDVSHFLILHGLQ6HFWLRQ
5HSRUWLQJ
 [8/1 IRU$67$/7
DQG[8/1IRU7%/RU,15!8/1UHTXLUHWKHIROORZLQJ
x
7KHHYHQWVKRXOGEHUHSRUWHGWR$PJHQDVDVHULRXVDGYHUVHHYHQWZLWKLQKRXUV
RIGLVFRYHU\RUQRWLILFDWLRQRIWKHHYHQWLHEHIRUHDGGLWLRQDOHWLRORJLFLQYHVWLJDWLRQV
KDYHEHHQFRQFOXGHG
x
7KHDSSURSULDWHH&5)HJDGYHUVHHYHQWH&5)WKDWFDSWXUHVLQIRUPDWLRQ
QHFHVVDU\WRIDFLOLWDWHWKHHYDOXDWLRQRIWUHDWPHQWHPHUJHQWOLYHUDEQRUPDOLWLHV
VKRXOGEHFRPSOHWHG
2WKHUHYHQWVRIKHSDWRWR[LFLW\DQGSRWHQWLDO',/,VKRXOGEHUHSRUWHGDVVHULRXVDGYHUVH
HYHQWVLIWKH\PHHWWKHFULWHULDIRUDVHULRXVDGYHUVHHYHQWGHILQHGLQ6HFWLRQ
$OOVXEMHFWVLQZKRP,3LVZLWKKHOGGXHWRSRWHQWLDO',/,RUZKRH[SHULHQFH$67$/7
HOHYDWLRQV![8/1VKRXOGXQGHUJRDSHULRGRI³FORVHREVHUYDWLRQ´XQWLODEQRUPDOLWLHV
UHWXUQWRQRUPDORUWRWKHVXEMHFW¶VEDVHOLQHOHYHOV$VVHVVPHQWVWKDWVKRXOGEH
SHUIRUPHGGXULQJWKLVSHULRGLQFOXGH
$GGLWLRQDO&OLQLFDO$VVHVVPHQWVDQG2EVHUYDWLRQ
x
5HSHDWOLYHUFKHPLVWULHVZLWKLQKRXUV$/7$67$/37%/LQFDVHVRI7%/
![8/1RU$67$/7PXFKJUHDWHUWKDQ[8/1UHWHVWLQJVKRXOGEHSHUIRUPHG
ZLWKLQKRXUV
 6XEMHFWVVKRXOGEHPRQLWRUHGDWOHDVWWZLFHZHHNO\WHVWLQJIUHTXHQF\PD\
GHFUHDVHWRRQFHSHUZHHNRUOHVVLIODERUDWRU\DEQRUPDOLWLHVVWDELOL]HRUWKH,3
KDVEHHQGLVFRQWLQXHG$1'WKHVXEMHFWLVDV\PSWRPDWLF
x
2EWDLQ37,15IUDFWLRQDWHGELOLUXELQDQGDQ\RWKHUSRWHQWLDOO\UHOHYDQWODERUDWRU\
HYDOXDWLRQVRIOLYHUIXQFWLRQRUGLVHDVH
x
2EWDLQFRPSOHWHEORRGFRXQW&%&ZLWKGLIIHUHQWLDOWRDVVHVVIRUHRVLQRSKLOLD
x
2EWDLQDSSURSULDWHEORRGVDPSOLQJIRUSKDUPDFRNLQHWLFDQDO\VLVLIWKLVKDVQRW
DOUHDG\EHHQFROOHFWHG


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
x
2EWDLQDPRUHGHWDLOHGKLVWRU\RI
 3ULRUDQGRUFRQFXUUHQWGLVHDVHVRULOOQHVV
 ([SRVXUHWRHQYLURQPHQWDODQGRULQGXVWULDOFKHPLFDODJHQWV
 6\PSWRPVLIDSSOLFDEOHLQFOXGLQJULJKWXSSHUTXDGUDQWSDLQ
K\SHUVHQVLWLYLW\W\SHUHDFWLRQVIDWLJXHQDXVHDYRPLWLQJDQGIHYHU
 3ULRUDQGRUFRQFXUUHQWXVHRIDOFRKROUHFUHDWLRQDOGUXJVDQGVSHFLDOGLHWV
 &RQFRPLWDQWPHGLFDWLRQVLQFOXGLQJQRQSUHVFULSWLRQPHGLFLQHV	KHUEDODQG
GLHWDU\VXSSOHPHQWV
x
,QLWLDWHIXOOYLUDODQGDXWRLPPXQHKHSDWLWLVHYDOXDWLRQVHURORJLHVIRUKHSDWLWLV$%&
'((SVWHLQ%DUU9LUXV+HUSHV6LPSOH[9LUXVHWFHYDOXDWHIRURWKHUSRWHQWLDO
FDXVHVRI',/,LQFOXGLQJEXWQRWOLPLWHGWR1$6+K\SR[LFLVFKHPLFKHSDWRSDWK\
DQGELOLDU\WUDFWGLVHDVH
x
2EWDLQJDVWURHQWHURORJ\RUKHSDWRORJ\FRQVXOW
x
3HUIRUPDSSURSULDWHOLYHULPDJLQJRUELRSV\LIFOLQLFDOO\LQGLFDWHGVWURQJO\FRQVLGHU
WKHVHWHVWVLQFDVHVRIFRQFXUUHQWWUDQVDPLQDVHDQG7%/HOHYDWLRQDVVSHFLILHGLQ
6HFWLRQ
x
)ROORZWKHVXEMHFWXQWLODOOODERUDWRU\DEQRUPDOLWLHVUHWXUQWREDVHOLQHRUQRUPDO7KH
³FORVHREVHUYDWLRQSHULRG´VKRXOGFRQWLQXHIRUDPLQLPXPRIZHHNVDIWHUGUXJ
GLVFRQWLQXDWLRQ
7KHSRWHQWLDO',/,HYHQWDQGDGGLWLRQDOLQIRUPDWLRQVXFKDVPHGLFDOKLVWRU\FRQFRPLWDQW
PHGLFDWLRQVDQGODERUDWRU\UHVXOWVPXVWEHFDSWXUHGLQFRUUHVSRQGLQJH&5)V


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL[&6DPSOH6HULRXV$GYHUVH(YHQW)RUP'212786(


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/




3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/
$SSHQGL['3UHJQDQF\DQG/DFWDWLRQ1RWLILFDWLRQ:RUNVKHHWV














































3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
&21),'(17,$/



Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 1 of 2 
CONFIDENTIAL 
 
 
Amendment 6 
 
Title:  A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the 
Long-term Safety and Efficacy of AMG 145 
Amgen Protocol Number: 20120138 
EudraCT Number: 2012-004357-83 
OSLER 2  
Open Label Study of Long Ter
 
 
m Evaluation Against LDL-C Trial 
 
Amendment 1 Date :  12 February 2013 
Amendment 2 Date:  30 April 2013 
Superseding Amendment 2 Date:  23 May 2013 
Amendment 3 Date:  15 November 2013 
Superseding Amendment 3 Date:  15 February 2014 
Superseding Amendment 3 Date:  24 February 2014 
Amendment 4 Date:  15 April 2014 
Amendment 5 Date:  19 December 2014 
Amendment 6 Date:  03 April  2015 
 
Rationale: 
This document provides the rationale and detailed list of changes for Amendment 6, 
dated 03 April 2015, from Amendment 5 of the study protocol, dated 19 December 2014. 
The purpose of the amendment is to: 
• 
Update exclusion criteria to include methods of effective birth control in the 
protocol language 


Product:  Evolocumab 
Protocol Number:  20120138 
Date:  03 April 2015 
Page 2 of 2 
CONFIDENTIAL 
 
 
Description of Changes: 
Section: Header 
Replace: 
19 December 2014 
With: 
03 April 2015 
Section: Coverpage 
Add: 
Amendment 6 Date:  03 April 2015 
Section: 4.2 Exclusion Criteria 
Second Criterion, Bullet point 2 
Replace: 
o Acceptable methods of effective contraception are defined in the ICF.  Where 
required by local laws, regulations and/or guidelines, additional 
country-specific requirements are outlined in a country-specific protocol 
supplement. 
With: 
o Acceptable methods of effective birth control include: sexual 
abstinence (when this is in line with the preferred and usual lifestyle of 
the subject [periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), declaration of abstinence for 
the duration of a trial, and withdrawal are not acceptable methods of 
contraception]), surgical contraceptive methods (vasectomy or bilateral 
tubal ligation), use of hormonal birth control methods (pills, shots, 
implants or patches), intrauterine devices (IUDs), or two (2) barrier 
methods (each partner must use one barrier method) with  
spermicide – males must use a condom with spermicide; females must 
choose either a diaphragm with spermicide, OR cervical cap with 
spermicide, OR contraceptive sponge with spermicide. Note: Additional 
medications given during treatment with evolocumab may alter the 
contraceptive requirements. These additional medications may require 
an increase in the number of contraceptive methods and/or length of 
time that contraception is to be utilized after the last dose of 
protocol-required therapies. The investigator is to discuss these 
contraceptive changes with the study subject.  


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH'HFHPEHU
3DJHRI
&21),'(17,$/

$PHQGPHQW

7LWOH$0XOWLFHQWHU&RQWUROOHG2SHQODEHO([WHQVLRQ2/(6WXG\WR$VVHVVWKH
/RQJWHUP6DIHW\DQG(IILFDF\RI$0*
$PJHQ3URWRFRO1XPEHU
(XGUD&71XPEHU
26/(5
2SHQ/DEHO6WXG\RI/RQJ7HU

P(YDOXDWLRQ$JDLQVW/'/&7ULDO
$PHQGPHQW'DWH'HFHPEHU
5DWLRQDOH
7KLVGRFXPHQWSURYLGHVWKHUDWLRQDOHDQGGHWDLOHGOLVWRIFKDQJHVIRU$PHQGPHQW
GDWHG'HFHPEHUIURPDPHQGPHQWRIWKHVWXG\SURWRFROGDWHG
$SULO
7KHSXUSRVHRIWKHDPHQGPHQWLVWR
x
([WHQGWKHWUHDWPHQWGXUDWLRQRIWKHVWXG\E\DQDGGLWLRQDO\HDUWRIXUWKHU
FKDUDFWHUL]HWKHVDIHW\DQGWROHUDELOLW\RIHYRORFXPDE$0*RYHU\HDUVRI
H[SRVXUHFRQVLVWHQWZLWKWKHSULPDU\REMHFWLYHIRUWKLVVWXG\
x
8SGDWHWKHH[SHFWHGVDPSOHVL]HWRDFFRXQWIRUDGGLWLRQDOVWXGLHVWKDWDUH
VFKHGXOHGWRFRPSOHWHWRSHUPLWWKHWLPHO\DQDO\VLVDQGGLVFORVXUHRIUHVXOWV
5DWKHUWKDQH[WHQGWKHGXUDWLRQRIRWKHUVWXGLHVDOORZLQJSDWLHQWVLQWRWKLVRSHQ
ODEHOH[WHQVLRQVWXG\ZLOOFRQWULEXWHWRWKHHYLGHQFHIRUVDIHW\DQGWROHUDELOLW\RI
XSWR\HDUVRIH[SRVXUHRIHYRORFXPDE
x
8SGDWHWKHVFKHGXOHRIDVVHVVPHQWVDQGVFKHPDIRUFODULILFDWLRQDQGHDVHRI
XVH
x
8SGDWHH[FOXVLRQFULWHULDUHJDUGLQJHIIHFWLYHPHWKRGVRIELUWKFRQWUROWRDOLJQZLWK
FXUUHQW$PJHQVWDQGDUGVLWLVQRWHGWKDWWKLVFKDQJHLVQRWDFRQVHTXHQFHRID
FKDQJHLQWKHVDIHW\SURILOHRIHYRORFXPDE
x
&ODULI\GHILQLWLRQRI,QYHVWLJDWLRQDO3URGXFW,3DVFRPELQDWLRQSURGXFWRI
HYRORFXPDE$0*DQGGHYLFHZLWKWHUP,QYHVWLJDWLRQDO0HGLFLQDO3URGXFW
,03XVHGWRUHIHUWRHYRORFXPDE$0*WRDOLJQZLWKVWDQGDUGVSURYLGHGE\
&0&6DIHW\
x
&ODULI\UHSRUWLQJSURFHVVIRUDGYHUVHHYHQWVDQGVHULRXVDGYHUVHHYHQWV
x
8SGDWHSURFHVVIRU3UHJQDQF\DQG/DFWDWLRQ5HSRUWLQJ
x
5HPRYHWKHH[WHUQDOGDWDPRQLWRULQJFRPPLWWHH'0&IROORZLQJWKH'0&¶V
H[SUHVVHGSUHIHUHQFHWRQRWUHYLHZRSHQODEHOXQFRQWUROOHGVDIHW\GDWD6DIHW\
PRQLWRULQJZLOOFRQWLQXHWREHSHUIRUPHGE\$0*(1(YHQWKRXJKUHYLHZRIWKLV
VSHFLILFVWXG\ZRXOGQRORQJHUIDOOXQGHUGLUHFW'0&UHYLHZWKH'0&ZLOO
FRQWLQXHWRFRQVLGHUWKHWRWDOLW\RIGDWDIURPDOOVWXGLHV$Q\HPHUJLQJVDIHW\
FRQVLGHUDWLRQVLGHQWLILHGE\$0*(1ZRXOGEHGLVFXVVHGZLWKWKH'0&DQGWKH


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH'HFHPEHU
3DJHRI
&21),'(17,$/

FRPPLWWHHZRXOGLQFRUSRUDWHWKDWGDWDZKHQPDNLQJLWVUHFRPPHQGDWLRQVWR
$0*(1
x
0LQRURWKHUXSGDWHVFODULILFDWLRQVDQGFRUUHFWLRQV


3URGXFW(YRORFXPDE
3URWRFRO1XPEHU
'DWH$SULO
3DJHRI
$PHQGPHQW

7LWOH$0XOWLFHQWHU&RQWUROOHG2SHQODEHO([WHQVLRQ2/(6WXG\WR$VVHVVWKH
/RQJWHUP6DIHW\DQG(IILFDF\RI$0*
$PJHQ3URWRFRO1XPEHU
(XGUD&71XPEHU
26/(5
2SHQ/DEHO6WXG\RI/RQJ7HU
x
8SGDWHWKHVFKHGXOHRIDVVHVVPHQWVVFKHPDIRUFODULILFDWLRQDQGHDVHRIXVH
P(YDOXDWLRQ$JDLQVW/'/&7ULDO



$PHQGPHQW'DWH$SULO

5DWLRQDOH
7KLVGRFXPHQWSURYLGHVWKHUDWLRQDOHDQGGHWDLOHGOLVWRIFKDQJHVIRU$PHQGPHQW
GDWHG$SULOIURPVXSHUVHGLQJDPHQGPHQWRIWKHVWXG\SURWRFROGDWHG
)HEUXDU\
7KHSXUSRVHRIWKHDPHQGPHQWLVWR
x
$GGDSDWLHQWTXHVWLRQQDLUHIRUSDWLHQWVH[SHULHQFLQJDFKDQJHLQWKHGHYLFH
XVHGWRGHOLYHU$0*
x
0LQRURWKHUXSGDWHVFODULILFDWLRQVDQGFRUUHFWLRQV


3URGXFW$0*
3URWRFRO1XPEHU
'DWH)HEUXDU\
3DJHRI
$PHQGPHQW

7LWOH$0XOWLFHQWHU&RQWUROOHG2SHQODEHO([WHQVLRQ2/(6WXG\WR$VVHVVWKH
/RQJWHUP6DIHW\DQG(IILFDF\RI$0*
$PJHQ3URWRFRO1XPEHU
(XGUD&71XPEHU
26/(5
2SHQ/DEHO6WXG\RI/RQJ7HU

P(YDOXDWLRQ$JDLQVW/'/&7ULDO
*RDO$FKLHYHPHQWDIWHU8WLOL]LQJDQDQWL3&6.DQWLERG\LQ6WDWLQ,QWROHUDQW
6XEMHFWV
$PHQGPHQW'DWH1RYHPEHU
6XSHUVHGLQJ$PHQGPHQW'DWH)HEUXDU\
6XSHUVHGLQJ$PHQGPHQW'DWH)HEUXDU\
5DWLRQDOH
7KLVGRFXPHQWSURYLGHVWKHUDWLRQDOHDQGGHWDLOHGOLVWRIFKDQJHVIRU$PHQGPHQW
GDWHG)HEUXDU\IURPVXSHUVHGLQJDPHQGPHQWRIWKHVWXG\SURWRFROGDWHG
0D\
7KHSXUSRVHRIWKHDPHQGPHQWLVWR
x
$GG9LWDPLQ(UHIOH[WHVWLQJWRWKHSURWRFROLQFDVHVZKHUH/'/&LVPJG/
x
$GGODQJXDJHIRUWKHXVHRIWKHP/SHUVRQDOLQMHFWRU7KHP/3HUVRQDO
,QMHFWRUZLOORQO\EHPDGHDYDLODEOHIRUXVHLQWKLVVWXG\RQFHLWKDVEHHQ
GHWHUPLQHGWKDWWKHLQWHQGHGXVHUSRSXODWLRQIRU$0*FDQVDIHO\DQG
HIIHFWLYHO\XVHWKHGHYLFHLQFOLQLFDOWULDOVXQGHUJXLGDQFHRIVWXG\LQYHVWLJDWRUV
x
7KHVFKHGXOHRIDVVHVVPHQWVDQGVFKHPDZHUHFODULILHGDQGFKDQJHGLQIRUPDW
WREHHDVLHUWRXVH
x
7KHERG\RIWKHSURWRFRODQGVFKHGXOHRIDVVHVVPHQWVZHUHXSGDWHGDQGPDGH
FRQVLVWHQW
x
7KHYLVLWVFKHGXOHZDVFODULILHGWROLVWWKHH[DFWWLPLQJRIWKHYLVLWUHSODFLQJ
UHIHUHQFHWRTXDUWHUO\YLVLWV
x
7KHSURWRFROQRZUHIHUHQFHVWKHODWHVW,%
x
7KHSURWRFROQRZLQFOXGHV³,QYHVWLJDWRU5HVSRQVLELOWLHVIRU'DWD&ROOHFWLRQ´
x
1RQFRURQDU\UHYDVFXODUL]DWLRQVZLOOQRORQJHUEHFROOHFWHGXSGDWHWREH
FRQVLVWHQWZLWK'0&FKDUWHU
x
0LQRURWKHUXSGDWHVFODULILFDWLRQVDQGFRUUHFWLRQV


Product:  AMG 145 
Protocol Number:  20120138 
Date:  23 May 2013 
Page 1 of 1 
 
Amendment 2 - Superseding Amendment 
Protocol Title:  “A Multicenter, Controlled, Open-label 
Extension (OLE) Study to Assess the Long-term Safety 
and Efficacy of AMG 145” 
Amgen Protocol Number AMG 145  20120138 
 
Amendment Date: 
23 May 2013 
Rationale: 
This protocol is being amended to support feedback received from VHP to include a 
minor administrative change to Protocol Amendment 2.   
 
Description of Changes: 
Section:  Study Schema 
Changes:   
• 
Addition of one blue triangle on Day 1 indicating in-clinic administration of IP.   


Product:  AMG 145 
Protocol Number:  20120138 OSLER 2  
Date:  12 February 2013 
Page 1 of 27 
 
Amendment 1 
Protocol Title:  “A Multicenter, Controlled, Open-label 
Extension (OLE) Study to Assess the Long-term Safety 
and Efficacy of AMG 145” 
Amgen Protocol Number AMG 145  20120138 
 
Amendment Date: 
12 February 2013 
Rationale: 
This protocol is being amended to support feedback received from FDA and our Data 
Monitoring Committee (DMC) to include a standard of care (SOC) group for the first 
year.  Doing so increases the scientific rigor of the study and reduces undue relatedness 
and causality of adverse events in subjects receiving AMG 145. 
Additional major changes include: 
 
Reduction to 2 years duration – to facilitate cost containment as 2+ year data will 
be captured through other OLE/Outcomes studies.   
 
Inclusion of Q2W dose regimen – for consistency with other Phase 3 studies and 
opportunity to allow subjects to experience different dosing regimens  
 
Alignment of assessments with other approved longer term AMG 145 studies, eg, 
118 - for consistency with other Phase 3 studies and pooling of data  
 
Addition of extra visits for AMG 145 naïve subjects requiring training on use of 
prefilled AI/pen – to improve opportunity for successful in-home use 
administration of AMG 145 

SAP_001.pdf: 
3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
,17(5,067$7,67,&$/$1$/<6,63/$1
)RU6WXG\3KDVH2SHQODEHO([WHQVLRQ2/(
3URWRFRO1XPEHU

9HUVLRQ

'DWH
1RYHPEHU
$XWKRUV
1&71XPEHU
7KLV1&7QXPEHUKDVEHHQDSSOLHGWRWKHGRFXPHQWIRU
SXUSRVHVRISRVWLQJRQFOLQLFDOWULDOVJRY
PPD


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
7DEOHRI&RQWHQWV
3DJH
7DEOHRI$EEUHYLDWLRQV 
 
,QWURGXFWLRQ 
 
2EMHFWLYHV 
 
(QGSRLQWV 
 
3ULPDU\(QGSRLQW 
 
6HFRQGDU\(QGSRLQWV 
 
([SORUDWRU\(QGSRLQWV 
 
2WKHU6DIHW\(QGSRLQWV 
 
+\SRWKHVLV 
 
'HILQLWLRQV 
 
6WXG\7LPH3RLQWV 
 
'HPRJUDSKLFDQG%DVHOLQH5HODWHG'HILQLWLRQV 
 
2WKHU6WXG\5HODWHG'HILQLWLRQV 
 
$QDO\VLV6XEVHWV 
 
'DWD6FUHHQLQJDQG$FFHSWDQFH 
 
*HQHUDO3ULQFLSOHV 
 
'DWD+DQGOLQJDQG(OHFWURQLF7UDQVIHURI'DWD 
 
+DQGOLQJRI0LVVLQJDQG,QFRPSOHWH'DWD 
 
3DWWHUQVRI0LVVLQJ'DWD 
 
0LVVLQJ/LSLG3DQHO(QGSRLQW 
 
+DQGOLQJRI,QFRPSOHWH'DWHV 
 
'HWHFWLRQRI%LDV 
 
2XWOLHUV 
 
'LVWULEXWLRQDO&KDUDFWHULVWLFV 
 
9DOLGDWLRQRI6WDWLVWLFDO$QDO\VHV 
 
6WDWLVWLFDO0HWKRGVRI$QDO\VLV 
 
*HQHUDO3ULQFLSOHV 
 
6XEMHFW3DWLHQW$FFRXQWDELOLW\ 
 
'HPRJUDSKLFDQG%DVHOLQH&KDUDFWHULVWLFV 
 
(QGSRLQW$QDO\VHV 
 
$QDO\VHVRI3ULPDU\(QGSRLQW 
 
$QDO\VHVRI6HFRQGDU\(QGSRLQWV 
 
$QDO\VHVRI([SORUDWRU\(QGSRLQWV 
 
$QDO\VHVRI/DERUDWRU\0HDVXUHPHQWV 
 
$QDO\VHVRI9LWDO6LJQV 


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
 
$QDO\VHVRI$QWL$0*$QWLERG\)RUPDWLRQ 
 
([SRVXUHWR,QYHVWLJDWLRQDO3URGXFW 
 
([SRVXUHWR&RQFRPLWDQW0HGLFDWLRQVRI,QWHUHVW 
 
/LWHUDWXUH&LWDWLRQV5HIHUHQFHV 
 
$SSHQGLFHV 

/LVWRI$SSHQGLFHV
$SSHQGL[$$QDO\WLFDO6WXG\:HHN$VVLJQPHQWV 



3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
7DEOHRI$EEUHYLDWLRQV
$EEUHYLDWLRQRU7HUP
'HILQLWLRQ([SODQDWLRQ
$(
$GYHUVHHYHQW
$+$1+/%,
$PHULFDQ+HDUW$VVRFLDWLRQ1DWLRQDO+HDUW/XQJDQG%ORRG
,QVWLWXWH
$/7
$ODQLQHDPLQRWUDQVIHUDVH
$SR$
$SROLSRSURWHLQ$
$SR%
$SROLSRSURWHLQ%
$67
$VSDUWDWHDPLQRWUDQVIHUDVH
&.
&UHDWLQHSKRVSKRNLQDVH
&65
&OLQLFDOVWXG\UHSRUW
&7&$(
1&,&RPPRQ7HUPLQRORJ\7UHDWPHQW&ROODERUDWLRQ
&9
&DUGLRYDVFXODU
H&5)
(OHFWURQLF&DVH5HSRUW)RUP
(2,3
(QGRILQYHVWLJDWLRQDOSURGXFW
(26
(QGRIVWXG\
+E$F
*O\FDWHGKHPRJORELQ
+'/&
+LJKGHQVLW\OLSRSURWHLQFKROHVWHURO
KV&53
+LJKVHQVLWLYLW\&UHDFWLYHSURWHLQ
,$$6
,QWHULP$OO,3SHULRG$QDO\VLV6HW
,&2$6
,QWHULP62&&RQWUROOHGSHULRG$QDO\VLV6HW
,15
,QWHUQDWLRQDOQRUPDOL]HGUDWLR
,3
,QYHVWLJDWLRQDOSURGXFW$0*
,956
,QWHUDFWLYHYRLFHUHVSRQVHV\VWHP
/'/&
/RZGHQVLW\OLSRSURWHLQFKROHVWHURO
/)7
/LYHU)XQFWLRQ7HVW
/SD
/LSRSURWHLQD
0HG'5$
0HGLFDOGLFWLRQDU\IRUUHJXODWRU\DFWLYLWLHV
2/(
2SHQODEHOH[WHQVLRQ
40
(YHU\PRQWK
4:
(YHU\ZHHNV
62&
6WDQGDUGRIFDUH
6$3
6WDWLVWLFDODQDO\VLVSODQ
7,$
7UDQVLHQWLVFKHPLFDWWDFN
8/1
8SSHUOLPLWRIQRUPDO
9/'/&
9HU\ORZGHQVLW\OLSRSURWHLQFKROHVWHURO


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

,QWURGXFWLRQ
7KHSXUSRVHRIWKLVLQWHULP6$3LVWRSUHVSHFLI\LQWHULPDQDO\VHVWRVXSSRUWUHJXODWRU\
ILOLQJV7KHDQDO\VLVVWUDWHJ\LVFRQVLVWHQWZLWKWKHSURWRFROVSHFLILHGDQDO\VLV$QDO\VHV
ZLOOEHSHUIRUPHGEDVHGRQGDWDVHWVRIDQRQJRLQJVWXG\HQWLWOHG$
0XOWLFHQWHU&RQWUROOHG2SHQODEHO2/(6WXG\WR$VVHVVWKH/RQJWHUP6DIHW\DQG
(IILFDF\RI$0*ODWHVWDPHQGPHQWLV$35

2EMHFWLYHV
7KHREMHFWLYHIRUWKLVDQDO\VLVLVWRVXPPDUL]HWKHVDIHW\DQGOLSLGGDWDFROOHFWHGXSWRD
FXWRIIGDWHUHSRUWHGLQWKHWDEOHRXWSXWVIRUVXEMHFWVUROOHGRYHUIURPSDUHQWVWXGLHVLQWR
WKHH[WHQVLRQVWXG\$OOGDWDSULRUWRWKHGDWDFXWGDWHZLOOEHFROOHFWHG
FKHFNHGDQGTXHULHGLQWKHVLPLODUIDVKLRQDVWKHILQDOGDWDEDVHORFN

(QGSRLQWV

3ULPDU\(QGSRLQW
6XEMHFWLQFLGHQFHRI$GYHUVH(YHQWV$(V

6HFRQGDU\(QGSRLQWV
x
3HUFHQWFKDQJHIURPEDVHOLQHLQ/'/&DWHDFKYLVLWZLWKSODQQHGOLSLG
PHDVXUHPHQWV
x
&KDQJHIURPEDVHOLQHLQ/'/&DWHDFKYLVLWZLWKSODQQHGOLSLGPHDVXUHPHQWV
x
3HUFHQWFKDQJHIURPSDUHQWVWXG\(26LQ/'/&DWHDFKYLVLWZLWKSODQQHGOLSLG
PHDVXUHPHQWV
x
&KDQJHIURPSDUHQWVWXG\(26LQ/'/&DWHDFKYLVLWZLWKSODQQHGOLSLG
PHDVXUHPHQWV

([SORUDWRU\(QGSRLQWV
x
6XEMHFWLQFLGHQFHRIDGMXGLFDWHGHYHQWVDQGQRQFRURQDU\UHYDVFXODUL]DWLRQ
R 'HDWKDOOFDXVHFDUGLRYDVFXODU
R &DUGLDFLVFKHPLFHYHQWVP\RFDUGLDOLQIDUFWLRQKRVSLWDOL]DWLRQIRU
XQVWDEOHDQJLQDFRURQDU\UHYDVFXODUL]DWLRQ
R +RVSLWDOL]DWLRQIRUKHDUWIDLOXUH
R &HUHEURYDVFXODUHYHQWVWUDQVLHQWLVFKHPLFDWWDFNVWURNH
R 1RQFRURQDU\UHYDVFXODUL]DWLRQ
x
&KDQJHDQGSHUFHQWFKDQJHIURPEDVHOLQHDQGIURPSDUHQWVWXG\(26DWHDFK
VFKHGXOHGYLVLWLQHDFKRIWKHIROORZLQJOLSLGDQGRWKHUODESDUDPHWHUV
R 1RQ+'/&
R $SR%
R 7RWDOFKROHVWHURO+'/&UDWLR
R 7RWDOFKROHVWHURO


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
R $SR%$SR$UDWLR
R /SD
R 7ULJO\FHULGHV
R +'/&
R 9/'/&
R $SR$
R +LJKVHQVLWLYLW\&UHDFWLYHSURWHLQKV&53

2WKHU6DIHW\(QGSRLQWV
x
&KDQJHVIURPEDVHOLQHLQVDIHW\ODERUDWRU\YDOXHVLQFOXGLQJ+E$FDQGYLWDO
VLJQVDWHDFKVFKHGXOHGYLVLW
x
'HYHORSPHQWRIDQWL$0*DQWLERGLHV

+\SRWKHVLV
7KHSULPDU\FOLQLFDOK\SRWKHVLVLVWKDWORQJWHUPH[SRVXUHRI$0*ZLOOEHVDIHDQG
ZHOOWROHUDWHGLQVXEMHFWVZLWKSULPDU\K\SHUOLSLGHPLDDQGVXEMHFWVZLWKPL[HG
G\VOLSLGHPLD

'HILQLWLRQV

6WXG\7LPH3RLQWV
%DVHOLQH
)RUYDULDEOHVRWKHUWKDQVH[UDFHFRXQWU\UHJLRQDQGEDVHOLQHPHWDEROLFV\QGURPH
EDVHOLQHLVGHILQHGDVWKHSDUHQWVWXG\EDVHOLQH1RWHWKDWEDVHOLQHPHWDEROLFV\QGURPH
ZLOOEHXVLQJSDUHQWVWXG\EDVHOLQHLQIRUPDWLRQEXWZLWKXSGDWHGVH[DQGUDFHIURPWKH
H[WHQVLRQVWXG\GDWD
)LUVW'RVH'DWH
)RUVXEMHFWVUDQGRPL]HGWR$0*62&WKHILUVWGRVHGDWHLVWKHILUVWGDWHDWZKLFK
WKHVXEMHFWZDVDGPLQLVWHUHG,3)RUVXEMHFWVUDQGRPL]HGWR62&WKHILUVWGRVHGDWHLV
WKHILUVWGDWHDWZKLFKWKHVXEMHFWZDVDGPLQLVWHUHG,3DWRUDIWHUWKH:HHNFOLQLFDO
YLVLW
(QGRI,QYHVWLJDWLRQDO3URGXFW(2,3'DWH
,IDVXEMHFWKDVFRPSOHWHGRUGLVFRQWLQXHG,3WKH(2,3GDWHLVWKHGDWHUHFRUGHGRQWKH
ILQDO,3GRVHGDWHH&5)
(QGRI6WXG\(26'DWH
)RUHDFKVXEMHFWWKH(QGRI6WXG\'DWHLVWKHGDWHUHFRUGHGRQWKH(QGRI6WXG\H&5)


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
(QUROOPHQW'DWH
7KHHQUROOPHQWGDWHIRUDVXEMHFWLVHLWKHUWKHVXEMHFW¶V(26GDWHIRUWKHSDUHQWVWXG\RU
WKHGDWHWKDWVXEMHFWKDVVLJQHGWKH,&)IRU6WXG\ZKLFKHYHULVODWHU
5DQGRPL]DWLRQ'DWH
7KHUDQGRPL]DWLRQGDWHIRUHDFKVXEMHFWLVWKHGDWHWKHLQYHVWLJDWRURUGHVLJQHH
FRQILUPVLQWKH,956WKDWWKHVXEMHFWKDVPHWDOOHOLJLELOLW\FULWHULDDQGLVUDQGRPL]HG
6WXG\'D\
)RUVXEMHFWVUDQGRPL]HGWR$0*62&DUPDQGUHFHLYHGDWOHDVWRQHGRVHRI
$0*6WXG\'D\LVGHILQHGDVWKHILUVWGD\WKDW$0*LVDGPLQLVWHUHGGXULQJ
WKLVVWXG\
)RUVXEMHFWVUDQGRPL]HGWR62&RQO\DUPRUUDQGRPL]HGWR$0*62&DUPEXW
QHYHUUHFHLYHG$0*6WXG\'D\LVGHILQHGDVWKHGD\RIUDQGRPL]DWLRQ
6WXG\'D\
)RUHDFKVXEMHFWDQGIRUDJLYHQVWXG\YLVLWGDWHVWXG\GD\LVGHILQHGDVWKHQXPEHURI
GD\VVLQFH6WXG\'D\
6WXG\GD\ VWXG\YLVLWGDWH±6WXG\'D\GDWH
,IWKHGDWHRILQWHUHVWLVSULRUWRWKH6WXG\'D\

6WXG\GD\ VWXG\YLVLWGDWH±6WXG\'D\GDWH
62&&RQWUROOHGSHULRG
7KHVWDUWRIWKH62&&RQWUROOHGSHULRGLV6WXG\'D\
)RUWKHHQGRIWKH62&&RQWUROOHGSHULRG
x
,IDVXEMHFWLVDGPLQLVWHUHGDGRVHRI,3DW:HHNWKHGD\SULRUWRWKHZHHN
,3GDWHLVWKHHQGRIWKH62&&RQWUROOHGSHULRG
x
,IDVXEMHFWLVQRWDGPLQLVWHUHGDGRVHRI,3DW:HHNWKH62&&RQWUROOHG
SHULRGZLOOHQGWKHHDUOLHVWRI6WXG\'D\WKH(26GDWHRUGDWDFXWRIIGDWH
$OO,3SHULRG
6XEMHFWVZLWK(26GDWHVRUGDWDFXWRIIGDWHVHQGRI62&&RQWUROOHGSHULRGGDWHVZLOO
KDYHPLVVLQJVWDUWDQGHQGRI$OO,3SHULRGGDWHV


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
2WKHUZLVH
x
$OO,3SHULRGVWDUWGDWH HQGRI62&&RQWUROOHGSHULRGGDWH
x
$OO,3SHULRGHQGGDWH (26GDWHRUWKHGDWDFXWRIIGDWHZKLFKHYHURFFXUUHG
HDUOLHU

'HPRJUDSKLFDQG%DVHOLQH5HODWHG'HILQLWLRQV
&KDQJHDEVROXWHFKDQJHIURP%DVHOLQH
7KHDULWKPHWLFGLIIHUHQFHEHWZHHQDSRVWUDQGRPL]DWLRQYDOXHDQGEDVHOLQHIRUDJLYHQ
WLPHSRLQW
&KDQJHIURPEDVHOLQH SRVWUDQGRPL]DWLRQYDOXH±EDVHOLQHYDOXH
3HUFHQW&KDQJHIURP%DVHOLQH
7KHSHUFHQWFKDQJHIURPEDVHOLQHIRUDJLYHQYDULDEOHDWDJLYHQWLPHSRLQWLVGHILQHG
DV
[FKDQJHIURPEDVHOLQHEDVHOLQHYDOXH
&KDQJHDEVROXWHFKDQJHIURP3DUHQW(26
7KHDULWKPHWLFGLIIHUHQFHEHWZHHQDSRVWHQUROOPHQWYDOXHDQGWKHODVWOLSLG
PHDVXUHPHQWXVHGLQWKHSULPDU\DQDO\VLVRIWKHSDUHQWVWXG\
&KDQJHIURPSDUHQW(26 SRVWHQUROOPHQWYDOXH±ODVWREVHUYHGOLSLGPHDVXUHPHQW
XVHGLQSDUHQWSULPDU\DQDO\VLVZKHUHWKHODVWREVHUYHGOLSLGPHDVXUHPHQWXVHGLQWKH
SDUHQWSULPDU\DQDO\VLVZLOOEHWKHZHHNYDOXHREVHUYHGLQVWXG\WKH
ZHHNYDOXHREVHUYHGLQVWXG\DQGWKHZHHNYDOXHREVHUYHGLQRWKHU
VWXGLHV,IWKHREVHUYDWLRQLVPLVVLQJWKHVXEMHFWZLOOEHH[FOXGHGIURPFKDQJHIURP
SDUHQW(26DQDO\VLVRIWKHSDUWLFXODUDQDO\WH
3HUFHQW&KDQJHIURP3DUHQW(26
7KHSHUFHQWFKDQJHIURPSDUHQW(26IRUDJLYHQYDULDEOHDWDJLYHQWLPHSRLQWLVGHILQHG
DV
[FKDQJHIURPSDUHQW(26ODVWOLSLGPHDVXUHPHQWXVHGLQSDUHQWSULPDU\
DQDO\VLV

2WKHU6WXG\5HODWHG'HILQLWLRQV
$QDO\WLFDO6WXG\:HHN$VVLJQPHQWV
$QDO\WLFDOZLQGRZVZLOOEHXVHGWRDVVLJQSDUDPHWHUVWRVWXG\ZHHNV7KH$OJRULWKPLV
SURYLGHGLQ$SSHQGL[$


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
,3([SRVXUH3HULRGLQ0RQWKV
,3([SRVXUH >PLQ(2,3GDWHGD\V(26GDWHGDWDFXWRIIGDWH±)LUVWGRVHGDWH
@)RUVXEMHFWVUDQGRPL]HGWR62&WUHDWPHQWGXULQJWKH
62&&RQWUROOHGSHULRGWKHILUVWGRVHGDWHLVHTXLYDOHQWWRWKHILUVWGRVHGDWHGXULQJWKH
$OO,3SHULRG
6WXG\([SRVXUH3HULRGLQ0RQWKV
)RUHDFKUDQGRPL]HGVXEMHFW6WXG\([SRVXUH3HULRG >PLQ(26GDWHGDWDFXWRIIGDWH
±HQUROOPHQWGDWH@
,3([SRVXUHLQ0RQWKV 'XULQJWKH 62&&RQWUROOHGSHULRG
)RUVXEMHFWVUDQGRPL]HGWR$0*62&DUPDQGUHFHLYHGDWOHDVWRQHGRVHRI
$0*LQWKH62&&RQWUROOHGSHULRG,3([SRVXUHGXULQJWKH62&&RQWUROOHGSHULRG
 >PLQ(2,3GDWHGD\VHQGRI62&&RQWUROOHGSHULRG±6WXG\'D\@
$Q\,3H[SRVXUHZLOOEHFRQVLGHUHGDV1$
)RUVXEMHFWVUDQGRPL]HGWR62&RUUDQGRPL]HGWR$0*62&DQGQRWGRVHGLQ
WKH62&&RQWUROOHGSHULRG,3([SRVXUHGXULQJWKH62&&RQWUROOHGSHULRG 1$
,3([SRVXUHLQ0RQWKV'XULQJWKH$OO,3SHULRG
)RUHDFKUDQGRPL]HGVXEMHFWLQWKH,QWHULP$OO,3SHULRG$QDO\VLV6HW,3([SRVXUH
GXULQJWKH$OO,3SHULRG
 >PLQ(2,3GD\VHQGRI$OO,3SHULRG±VWDUWGDWHRI$OO,3SHULRG@
,IWKHDERYHFDOFXODWLRQLVWKHQVHWWR
6WXG\([SRVXUHLQ0RQWKV'XULQJWKH62&&RQWUROOHGSHULRG
)RUHDFKUDQGRPL]HGVXEMHFW6WXG\([SRVXUH3HULRGIRUWKH62&&RQWUROOHGSHULRG
 >HQGRI62&&RQWUROOHGSHULRGGDWH±VWDUWRIWKH62&&RQWUROOHGSHULRG@

6WXG\([SRVXUHLQ0RQWKV'XULQJWKH$OO,3SHULRG
)RUHDFKUDQGRPL]HGVXEMHFWWKDWUHFHLYHGDGRVHRI,3GXULQJWKH$OO,3SHULRG
6WXG\([SRVXUH3HULRGIRUWKH$OO,3SHULRG >HQGRI$OO,3SHULRG±VWDUWRIWKH$OO,3
SHULRG@


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
$GYHUVH(YHQWV,QFOXGHGLQWKH6XPPDU\7DEOHV
$QDGYHUVHHYHQWLVLQFOXGHGLQ62&&RQWUROOHGSHULRGVXPPDULHVLILWRFFXUVGXULQJWKH
62&&RQWUROOHGSHULRGDQGWKHVXEMHFWLVLQWKH,QWHULP62&&RQWUROOHGSHULRG$QDO\VLV
6HW
$QDGYHUVHHYHQWLVLQFOXGHGLQ$OO,3SHULRGVXPPDULHVLILWRFFXUVGXULQJWKH$OO,3
SHULRGDQGWKHVXEMHFWLVLQWKH,QWHULP$OO,3SHULRG$QDO\VLV6HW
6H[
)RUVXEMHFWVWKDWHQUROOLQDQH[WHQVLRQVWXG\WKHVXEMHFW¶VVH[LVWKHVH[UHFRUGHGRQ
WKHH[WHQVLRQVWXG\H&5))RURWKHUVXEMHFWVWKHVXEMHFW¶VVH[LVWKHVH[UHFRUGHGRQ
WKHSDUHQWVWXG\H&5)
5DFH
)RUVXEMHFWVWKDWHQUROOLQDQH[WHQVLRQVWXG\WKHVXEMHFW¶VUDFHLVWKHUDFHUHFRUGHGRQ
WKHH[WHQVLRQVWXG\H&5))RURWKHUVXEMHFWVWKHVXEMHFW¶VUDFHLVWKHUDFHUHFRUGHGRQ
WKHSDUHQWVWXG\H&5)
&RXQWU\DQG5HJLRQ
)RUVXEMHFWVWKDWHQUROOLQDQH[WHQVLRQVWXG\WKHVXEMHFW¶VFRXQWU\DQGUHJLRQDUHWKRVH
UHFRUGHGLQWKHH[WHQVLRQVWXG\)RURWKHUVXEMHFWVWKHVXEMHFW¶VFRXQWU\DQGUHJLRQDUH
WKRVHUHFRUGHGLQWKHSDUHQWVWXG\
%DVHOLQH0HWDEROLF6\QGURPH
)RUHDFKVXEMHFWZLWKRXWW\SHGLDEHWHVPHOOLWXVPHWDEROLFV\QGURPHLVLGHQWLILHGE\
WKHSUHVHQFHRIRUPRUHRIWKHFRPSRQHQWVOLVWHGEHORZPRGLILHG$+$1+/%,
FULWHULD6XEMHFWVZLWKW\SHGLDEHWHVFDQQRWEHFDWHJRUL]HGDVKDYLQJPHWDEROLF
V\QGURPH


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
5LVN)DFWRU
'HILQLQJ/HYHO
(OHYDWHGZDLVWFLUFXPIHUHQFH
1RQ$VLDQ
0HQ
:RPHQ
$VLDQ
0HQ
:RPHQ


FP
FP

FP
FP
7ULJO\FHULGHV
PJG/
+'/FKROHVWHURO
0HQ
:RPHQ

PJG/
PJG/
%ORRGSUHVVXUH
6%3PP+JRU'%3PP+J
25+\SHUWHQVLRQFKHFNHGµ\HV¶RQ&90HGLFDO
+LVWRU\H&5)
)DVWLQJJOXFRVH
PJG/
/HYHO7UHDWPHQW*URXS
$OOWDEOHVLQWKLVLQWHULPDQDO\VLVZLOOEHVXPPDUL]HGE\UDQGRPL]HGJURXS
$0*62&YV62&DORQH6LQFHVXEMHFWVUHFHLYHGHLWKHU$0*RUFRQWURO
WUHDWPHQWLQSDUHQWVWXG\WKHWDEOHVZLOOEHIXUWKHUFDWHJRUL]HGXVLQJWKHIROORZLQJ
OHYHOVSDUHQWVWXG\WUHDWPHQWJURXSFXUUHQWVWXG\WUHDWPHQWJURXS
³$0*$0*62&´³$0*62&2QO\´³&RQWURO$0*62&´DQG
³&RQWURO62&2QO\´

$QDO\VLV6XEVHWV
,QWHULP62&&RQWUROOHGSHULRG$QDO\VLV6HW
7KH,QWHULP62&&RQWUROOHGSHULRG$QDO\VLV6HW,&2$6ZLOOLQFOXGHDOOVXEMHFWV
UDQGRPL]HGLQWKLVVWXG\ZKRKDYHDWOHDVWZHHNVRISRWHQWLDOIROORZXSHJVXEMHFWV
IRUZKRP'DWD&XWRII'DWH6WXG\'DWHIRU6WXG\'D\!GD\VWKHUHVWULFWLRQ
RQSRWHQWLDOIROORZXSLVWRSUHYHQWRSHUDWLRQDOELDVWKDWPD\RFFXUE\WKHLQFUHDVHG
IUHTXHQF\RIYLVLWVGXULQJWKHILUVWZHHNVRIWKHVWXG\6XEMHFWVZLOOEHDQDO\]HG
DFFRUGLQJWRWKHWUHDWPHQWJURXSWRZKLFKWKH\ZHUHUDQGRPL]HGGXULQJWKH
62&&RQWUROOHGSHULRG$OOGDWDIURPWKH62&&RQWUROOHGSHULRGZLOOEHVXPPDUL]HG
UHJDUGOHVVRISRVVLEOH,3GLVFRQWLQXDWLRQ


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
,QWHULP$OO,3SHULRG$QDO\VLV6HW
7KH,QWHULP$OO,3SHULRG$QDO\VLV6HW,$$6ZLOOLQFOXGHDOOVXEMHFWVWKDWZHUH
UDQGRPL]HGLQWKLVVWXG\DQGGRVHGZLWK,3DQGRQVWXG\LQWKH$OO,3SHULRG'DWDZLOO
EHVXPPDUL]HGDQDO\]HGIURPWKHVWDUWRIWKH$OO,3SHULRGWR(26RUWKHGDWDFXWRII
ZKLFKHYHURFFXUVILUVW

'DWD6FUHHQLQJDQG$FFHSWDQFH

*HQHUDO3ULQFLSOHV
7KHREMHFWLYHRIWKHGDWDVFUHHQLQJLVWRDVVHVVWKHTXDQWLW\TXDOLW\DQGVWDWLVWLFDO
FKDUDFWHULVWLFVRIWKHGDWDUHODWLYHWRWKHUHTXLUHPHQWVRIWKHSODQQHGDQDO\VHV

'DWD+DQGOLQJDQG(OHFWURQLF7UDQVIHURI'DWD
$PJHQ¶V&OLQLFDO'DWD0DQDJHPHQWGHSDUWPHQWZLOOSURYLGHDOOGDWDWREHXVHGLQWKH
SODQQHGDQDO\VHV7KLVVWXG\ZLOOXVHWKH5$9(GDWDEDVH
$OOGDWDFROOHFWHGLQWKHH&5)ZLOOEHH[WUDFWHGIURP5$9(3URWRFROGHYLDWLRQVZLOOEH
WUDQVIHUUHGIURPH&OLQLFDO'HWDLOVRQGDWDWUDQVIHUZLOOEHSURYLGHGLQWKH'DWD7UDQVIHU
3ODQ

+DQGOLQJRI0LVVLQJDQG,QFRPSOHWH'DWD

3DWWHUQVRI0LVVLQJ'DWD
6XEMHFWVPD\EHPLVVLQJVSHFLILFGDWDSRLQWVIRUYDULRXVUHDVRQV,QJHQHUDOGDWDPD\
EHPLVVLQJGXHWRDVXEMHFW¶VHDUO\ZLWKGUDZDOIURPVWXG\DPLVVHGYLVLWRU
QRQHYDOXDELOLW\RIDGDWDSRLQWRUDQHQGSRLQWDWDSDUWLFXODUSRLQWLQWLPH$OODWWHPSWV
ZLOOEHPDGHWRFDSWXUHPLVVLQJRUSDUWLDOGDWDIRUWKLVWULDOSULRUWRWKHGDWDFXWRIIGDWH
7KHIUHTXHQF\DQGSDWWHUQRIPLVVLQJGDWDIRUVHOHFWHGHQGSRLQWVZLOOEHDVVHVVHG
WKURXJKGHVFULSWLYHVXPPDULHVRIWKHPHDVXUHPHQWVRYHUWLPH

0LVVLQJ/LSLG3DQHO(QGSRLQW
7KHUHZLOOEHQRLPSXWDWLRQIRUPLVVLQJOLSLGSDQHOHQGSRLQWV

+DQGOLQJRI,QFRPSOHWH'DWHV
$OODGYHUVHHYHQWVZLOOEHLQFOXGHGLQDGYHUVHHYHQWVVXPPDULHVZLWKWKHIROORZLQJ
H[FHSWLRQVDGYHUVHHYHQWVZLWKFRPSOHWHGDWHVRFFXUULQJRXWVLGHWKHGHILQLWLRQV
HVWDEOLVKHGLQ6HFWLRQDQGDGYHUVHHYHQWVZLWKSDUWLDOO\PLVVLQJGDWHVIRUZKLFK
WKHUHLVVXIILFLHQWLQIRUPDWLRQWRGHWHUPLQHWKHHYHQWRFFXUUHGRXWVLGHWKHVHGHILQLWLRQV
)RUSDUWLDOO\PLVVLQJGDWHVRUFRPSOHWHO\PLVVLQJGDWHVIRUZKLFKLWLVLPSRVVLEOHWR
GHWHUPLQHZKHWKHUWKHHYHQWRFFXUUHGRXWVLGHWKHVHGHILQLWLRQVWKHHYHQWZLOOEHWUHDWHG
DVRFFXUULQJGXULQJWKH62&&RQWUROOHGSHULRG


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
&RQFRPLWDQWPHGLFDWLRQZLWKSDUWLDOO\PLVVLQJGDWHVZLOOEHLPSXWHGDVGHVFULEHGEHORZ
x
,I\HDULVDYDLODEOHEXWGD\DQGPRQWKDUHPLVVLQJWKHGD\DQGPRQWKIRUWKH
VWDUWGDWHZLOOEHVHWWRWKHVWRI-DQXDU\RIWKHRQVHW\HDU
x
,I\HDUDQGPRQWKDUHDYDLODEOHEXWGD\LVPLVVLQJWKHGD\ZLOOEHVHWWRWKHVWRI
WKHPRQWKRIWKHRQVHW\HDU

'HWHFWLRQRI%LDV
$IDFWRUWKDWPD\ELDVWKHUHVXOWVRIWKHVWXG\LVPDMRUSURWRFROGHYLDWLRQVOLNHO\WRLPSDFW
WKHDQDO\VLVDQGLQWHUSUHWDWLRQRIWKHHQGSRLQWV,PSRUWDQWSURWRFROGHYLDWLRQVOLNHO\WR
LPSDFWWKHDQDO\VLVDQGLQWHUSUHWDWLRQRIWKHHQGSRLQWVZLOOEHWDEXODWHGLQWKH&OLQLFDO
6WXG\5HSRUW&65
,IDQ\VHQVLWLYLW\DQDO\VHVDUHUHTXLUHGWRHYDOXDWHSRWHQWLDOELDVHVLQWKHVWXG\¶V
FRQFOXVLRQVWKHVRXUFHVRIWKHSRWHQWLDOELDVHVDQGUHVXOWVRIWKHVHQVLWLYLW\DQDO\VHV
ZLOOEHGRFXPHQWHGLQWKH&65

2XWOLHUV
9DULRXVPHWKRGVLQFOXGLQJXQLYDULDWHVXPPDULHVKLVWRJUDPVVFDWWHUSORWVER[SORWV
DQGOLQHJUDSKVZLOOEHXVHGWRLGHQWLI\RXWOLHUVLQNH\YDULDEOHV([WUHPHGDWDSRLQWVZLOO
EHLGHQWLILHGGXULQJWKHUHYLHZRIWKHGDWDSULRUWRGDWDEDVHVQDSVKRW6XFKGDWDSRLQWV
ZLOOEHUHYLHZHGZLWKFOLQLFDOGDWDPDQDJHPHQWWRHQVXUHDFFXUDF\8QOHVVVSHFLILHG
RWKHUZLVHDOODQDO\VHVZLOOLQFOXGHRXWOLHUVLQWKHGDWD6HQVLWLYLW\DQDO\VHVPD\EH
XQGHUWDNHQLIH[WUHPHRXWOLHUVIRUDYDULDEOHDUHREVHUYHG

'LVWULEXWLRQDO&KDUDFWHULVWLFV
7KHUHDUHQRGLVWULEXWLRQDOUHTXLUHPHQWVIRUWKHSODQQHGDQDO\VHV7KHUHIRUHQR
DVVHVVPHQWZLOOEHPDGH

9DOLGDWLRQRI6WDWLVWLFDO$QDO\VHV
3URJUDPVZLOOEHGHYHORSHGDQGPDLQWDLQHGDQGRXWSXWZLOOEHYHULILHGLQDFFRUGDQFH
ZLWKFXUUHQWULVNEDVHGTXDOLW\FRQWUROSURFHGXUHV
7DEOHVILJXUHVDQGOLVWLQJVZLOOEHSURGXFHGZLWKYDOLGDWHGVWDQGDUGPDFURSURJUDPV
ZKHUHVWDQGDUGPDFURVFDQSURGXFHWKHVSHFLILHGRXWSXWV
7KHSURGXFWLRQHQYLURQPHQWIRUVWDWLVWLFDODQDO\VHVFRQVLVWVRI$PJHQVXSSRUWHG
YHUVLRQVRIVWDWLVWLFDODQDO\VLVVRIWZDUHIRUH[DPSOHWKH6$66\VWHP


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

6WDWLVWLFDO0HWKRGVRI$QDO\VLV

*HQHUDO3ULQFLSOHV
6WDWLVWLFDODQDO\VHVLQWKLVRSHQODEHOH[WHQVLRQVWXG\ZLOOEHGHVFULSWLYH6XEMHFW
GLVSRVLWLRQGHPRJUDSKLFVDQGEDVHOLQHFKDUDFWHULVWLFVZLOOEHVXPPDUL]HG
6XPPDU\VWDWLVWLFVIRUFRQWLQXRXVYDULDEOHVZLOOLQFOXGHWKHQXPEHURIVXEMHFWVPHDQ
PHGLDQVWDQGDUGGHYLDWLRQRUVWDQGDUGHUURUILUVWDQGWKLUGTXDUWLOHVPLQLPXPDQG
PD[LPXP)RUFDWHJRULFDOYDULDEOHVWKHIUHTXHQF\DQGSHUFHQWDJHZLOOEHJLYHQ
$OODQDO\VHVZLOOEHFDUULHGRXWVHSDUDWHO\IRUWKH,&2$6DQGWKH,$$6DQDO\VLVVHWV
XQOHVVVSHFLILHGRWKHUZLVH7KHUHZLOOEHQRLPSXWDWLRQIRUPLVVLQJGDWD'HDWKVDQG
PDMRUFDUGLRYDVFXODUHYHQWVIURPWKLVDQGRWKHUSKDVHVWXGLHVZLOOEHDGMXGLFDWHGE\
DQLQGHSHQGHQW&OLQLFDO(YHQWV&RPPLWWHH&(&WRIDFLOLWDWHDJJUHJDWHGDQDO\VHV
DFURVVWKHSURJUDP7KHVHHYHQWVDGMXGLFDWHGE\WKH&(&LQFOXGH

GHDWKE\DQ\FDXVH

FDUGLRYDVFXODUGHDWK

P\RFDUGLDOLQIDUFWLRQ

KRVSLWDOL]DWLRQIRUXQVWDEOHDQJLQD

FRURQDU\UHYDVFXODUL]DWLRQ

VWURNH

KRVSLWDOL]DWLRQIRUKHDUWIDLOXUH

WUDQVLHQWLVFKHPLFDWWDFN7,$
,QDGGLWLRQQRQFRURQDU\UHYDVFXODUL]DWLRQVZLOOEHFROOHFWHG

6XEMHFW3DWLHQW$FFRXQWDELOLW\
7KHQXPEHUDQGSHUFHQWRIVXEMHFWVZKRZHUHUDQGRPL]HGUHFHLYHG,3FRPSOHWHG,3
GLVFRQWLQXHGLQYHVWLJDWLRQDOSURGXFWDQGUHDVRQVIRUGLVFRQWLQXLQJFRPSOHWHGVWXG\DQG
GLVFRQWLQXHGVWXG\DQGUHDVRQVIRUGLVFRQWLQXLQJZLOOEHVXPPDUL]HGE\WUHDWPHQWJURXS
DQGIRUWKH62&FRQWUROOHGDQG$OO,3SHULRGVVHSDUDWHO\DVZHOODVRYHUDOO

'HPRJUDSKLFDQG%DVHOLQH&KDUDFWHULVWLFV
$OOEDVHOLQHWDEOHVZLOOEHVXPPDUL]HGE\UDQGRPL]HGWUHDWPHQWDQGIRUDOOVXEMHFWVLQ
WKH,&2$6DQG,$$6%DVHOLQHWDEOHVZLOOVXPPDUL]HWKHIROORZLQJEDVHOLQH
FKDUDFWHULVWLFVGHPRJUDSKLFVFDUGLRYDVFXODUPHGLFDOKLVWRU\DQGODERUDWRU\
SDUDPHWHUV


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

(QGSRLQW$QDO\VHV

$QDO\VHVRI3ULPDU\(QGSRLQW
7KH0HGLFDO'LFWLRQDU\IRU5HJXODWRU\$FWLYLWLHV0HG'5$YHUVLRQRUODWHUZLOOEH
XVHGWRFRGHDOODGYHUVHHYHQWV$(WRDV\VWHPRUJDQFODVVDQGDSUHIHUUHGWHUP$OO
DQDO\VHVZLOOEHSHUIRUPHGVHSDUDWHO\IRUWKH,&2$6DQG,$$6DQDO\VLVVHWV
6XEMHFWLQFLGHQFHRIDGYHUVHHYHQWVVHULRXV$(VDQG$(VOHDGLQJWRZLWKGUDZDORI
LQYHVWLJDWLRQDOSURGXFWZLOOEHWDEXODWHGE\V\VWHPRUJDQFODVVDQGSUHIHUUHGWHUPLQ
GHVFHQGLQJRUGHURIIUHTXHQF\
6XPPDULHVRIDGYHUVHHYHQWVDQGVHULRXV$(VRFFXUULQJLQDWOHDVWRIWKHVXEMHFWV
E\SUHIHUUHGWHUPLQDQ\WUHDWPHQWDUPZLOOEHSURYLGHGLQGHVFHQGLQJRUGHURI
IUHTXHQF\
,QFLGHQFHRI$(VUHODWHGWRDGHYLFHZLOOEHWDEXODWHGE\SUHIHUUHGWHUPLQGHVFHQGLQJ
RUGHURIIUHTXHQF\E\WUHDWPHQWJURXS
6XEMHFWLQFLGHQFHRIDGYHUVHHYHQWVDVVRFLDWHGZLWKOLSLGORZHULQJWKHUDSLHV
x
'LDEHWHVUHODWHG
x
0XVFOHUHODWHG
x
/LYHUUHODWHG
DVVRFLDWHGZLWKLQMHFWDEOHSURWHLQWKHUDSLHV
x
,QMHFWLRQVLWHUHDFWLRQV
x
+\SHUVHQVLWLYLW\RUDOOHUJLFUHDFWLRQV
DQGSRWHQWLDOKHSDWLWLV&LQIHFWLRQVZLOOEHVXPPDUL]HGE\FDWHJRU\DQGSUHIHUUHG
WHUP

$QDO\VHVRI6HFRQGDU\(QGSRLQWV
7KHVHFRQGDU\HQGSRLQWVIRUSHUFHQWFKDQJHDQGDEVROXWHFKDQJHIURPEDVHOLQHZLOOEH
VXPPDUL]HGIRUHDFKVFKHGXOHGYLVLW7KHVHVHFRQGDU\HQGSRLQWDQDO\VHVZLOOEH
UHSHDWHGXVLQJFKDQJHIURPSDUHQW(26DQGSHUFHQWFKDQJHIURPSDUHQW(26DQG
VXPPDUL]HGZLWKGHVFULSWLYHVWDWLVWLFVDWHDFKVFKHGXOHGYLVLW$OODQDO\VHVZLOOEH
SHUIRUPHGVHSDUDWHO\IRUHDFKRIWKH,&2$6DQG,$$6DQDO\VLVVHWV


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

$QDO\VHVRI([SORUDWRU\(QGSRLQWV
$OODQDO\VHVZLOOEHSHUIRUPHGVHSDUDWHO\E\62&FRQWUROOHGSHULRGDQG$OO,3SHULRG
6XEMHFWLQFLGHQFHRIDGMXGLFDWHG&9HQGSRLQWVDQGQRQFRURQDU\UHYDVFXODUL]DWLRQZLOO
EHVXPPDUL]HG
7KHSHUFHQWFKDQJHDQGFKDQJHIURPEDVHOLQHLQODERUDWRU\EDVHGH[SORUDWRU\
HQGSRLQWVDWHDFKVFKHGXOHGYLVLWZLOOEHVXPPDUL]HG)RUFRQWLQXRXVH[SORUDWRU\
HQGSRLQWVWUHDWPHQWJURXSVXPPDU\VWDWLVWLFVQXPEHURIVXEMHFWVPHDQPHGLDQ
VWDQGDUGGHYLDWLRQRUVWDQGDUGHUURUILUVWDQGWKLUGTXDUWLOHVPLQLPXPDQGPD[LPXPDW
DOOVFKHGXOHGYLVLWVZLOOEHFDOFXODWHG

$QDO\VHVRI/DERUDWRU\0HDVXUHPHQWV
'HVFULSWLYHVWDWLVWLFVZLOOEHSURYLGHGIRUDFWXDOYDOXHVDQGFKDQJHVIURPEDVHOLQHLQ
HDFKDSSOLFDEOHODERUDWRU\SDUDPHWHUDWHDFKSURWRFROVSHFLILHGVFKHGXOHGYLVLW
/DERUDWRU\DQDO\WHVDUHSURYLGHGLQWKHSURWRFRO7DEOH/DEVKLIWWDEOHXVLQJWKH
&7&$(YRUODWHUJUDGLQJZLOOEHXVHGIRUWKHVHOHFWDQDO\WHVRILQWHUHVWZKHQ
DSSOLFDEOH6KLIWWDEOHVZLOOEHSURYLGHGIRUWKH62&&RQWUROOHGSHULRGDQGWKH$OO,3
SHULRG7KHUHVXOWVZLOOEHEDVHGRQWKHPD[LPXPLHZRUVWVKLIWIURPSDUHQWEDVHOLQH
WRWKHHQGRIWKH62&&RQWUROOHGSHULRGDQGIURPWKHSDUHQWEDVHOLQHWRHQGRIWKH$OO,3
SHULRGUHVSHFWLYHO\
,QDGGLWLRQ&.DQGOLYHUIXQFWLRQWHVW/)7DEQRUPDOLWLHVZLOOEHDVVHVVHGE\WKH
LQFLGHQFHGXULQJWKH62&&RQWUROOHGSHULRGDQGGXULQJWKH$OO,3SHULRG
x
&.![8/1
x
&.![8/1
x
$/7RU$67![8/1
x
$/7RU$67![8/1
x
7RWDOELOLUXELQ![8/1
x
$/7RU$67![8/1DQG7RWDOELOLUXELQ![8/1RU,15!

$QDO\VHVRI9LWDO6LJQV
6\VWROLFDQGGLDVWROLFEORRGSUHVVXUHDQGKHDUWUDWHZLOOEHVXPPDUL]HGXVLQJGHVFULSWLYH
VWDWLVWLFVDWHDFKVFKHGXOHGYLVLW


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

$QDO\VHVRI$QWL$0*$QWLERG\)RUPDWLRQ
7KHGHYHORSPHQWRIDQWL$0*DQWLERGLHVELQGLQJDQGQHXWUDOL]LQJDWDQ\WLPHZLOO
EHUHSRUWHG

([SRVXUHWR,QYHVWLJDWLRQDO3URGXFW
'HVFULSWLYHVWDWLVWLFVZLOOEHSURGXFHGWRGHVFULEHWKHSDWLHQWPRQWKH[SRVXUHWR
LQYHVWLJDWLRQDOSURGXFWE\WUHDWPHQWJURXSIRUERWKWKH,&2$6DQG,$$6VHWVDVZHOODV
RYHUDOO([SRVXUHGHILQLWLRQVDUHSURYLGHGLQ6HFWLRQ

([SRVXUHWR&RQFRPLWDQW0HGLFDWLRQVRI,QWHUHVW
7KHQXPEHUDQGSURSRUWLRQRIVXEMHFWVUHFHLYLQJWKHOLSLGUHJXODWLQJPHGLFDWLRQVRI
LQWHUHVWDW6WXG\'D\DQGSRVW6WXG\'D\ZLOOEHVXPPDUL]HGE\FDWHJRU\DQG
SUHIHUUHGWHUPIRUHDFKWUHDWPHQWJURXSDVFRGHGE\WKH:RUOG+HDOWK2UJDQL]DWLRQ
'UXJ:+2'58*GLFWLRQDU\


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

/LWHUDWXUH&LWDWLRQV5HIHUHQFHV
$OEHUWL.*00HWDO+DUPRQL]LQJWKH0HWDEROLF6\QGURPH$-RLQW,QWHULP6WDWHPHQWRI
WKH,QWHUQDWLRQDO'LDEHWHV)HGHUDWLRQ7DVN)RUFHRQ(SLGHPLRORJ\DQG3UHYHQWLRQ
1DWLRQDO+HDUW/XQJDQG%ORRG,QVWLWXWH$PHULFDQ+HDUW$VVRFLDWLRQ:RUOG+HDUW
)HGHUDWLRQ,QWHUQDWLRQDO$WKHURVFOHURVLV6RFLHW\DQG,QWHUQDWLRQDO$VVRFLDWLRQIRUWKH
6WXG\RI2EHVLW\&LUFXODWLRQ
*UXQG\60HWDO'LDJQRVLVDQG0DQDJHPHQWRIWKH0HWDEROLF6\QGURPH$Q$PHULFDQ
+HDUW$VVRFLDWLRQ1DWLRQDO+HDUW/XQJDQG%ORRG,QVWLWXWH6FLHQWLILF6WDWHPHQW
&LUFXODWLRQ


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH

$SSHQGLFHV


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
$SSHQGL[$$QDO\WLFDO6WXG\:HHN$VVLJQPHQWV
6HOHFWHGHQGSRLQWVZLOOEHVXPPDUL]HGE\VFKHGXOHGVWXG\YLVLWVLQGHVFULSWLYHDQDO\VHV
6LQFHWKHDFWXDOYLVLWVPD\QRWH[DFWO\FRLQFLGHZLWKWKHLUVFKHGXOHGYLVLWGD\WKHDFWXDO
YLVLWGD\LVPDSSHGWRWKHVWXG\YLVLWJHQHUDOO\E\QRQRYHUODSSLQJFRQVHFXWLYHLQWHUYDOV
FRYHULQJWKHHQWLUHWLPHFRQWLQXXPZLWKVFKHGXOHGYLVLWWLPHEHLQJWKHFHQWHURIHDFK
LQWHUYDO7KHPDSSLQJLQWHUYDOVIRUDOOGLVWLQFWVFKHGXOHVDUHVXPPDUL]HGLQWKHIROORZLQJ
WDEOHV:HHNPDSSLQJGRHVQRWSHUWDLQWRSDUHQWVWXG\ZHHNPDSSLQJ'DWD
IURPWKHSDUHQWVWXGLHVZLOOXVHWKHRULJLQDODQDO\WLFDOZHHNVLQWKHLQGLYLGXDO
VWXG\6$3V
+DQGOLQJPXOWLSOHUHFRUGVDVVLJQHGWRDQDQDO\WLFDOVWXG\ZHHN
,IWKHUHLVPRUHWKDQRQHUHFRUGLQDVWXG\ZHHNLQWHUYDOWKHDQDO\WLFDOUHFRUGIRUWKDW
VSHFLILFVWXG\ZHHNZLOOEHGHILQHGDVWKHUHFRUGFORVHVWWRWKHVFKHGXOHGVWXG\GD\RI
WKDWVSHFLILFVWXG\ZHHNîVWXG\ZHHN,IWZRUHFRUGVDUHHTXLGLVWDQWIURPWKH
VFKHGXOHGGD\WKHQWKHHDUOLHUUHFRUGZLOOEHFKRVHQ,IWKHUHDUHPXOWLSOHUHFRUGVRQ
WKHVDPHGD\WKHODVWUHFRUGZLOOEHXVHG
6FKHGXOHG9LVLW:HHN 9LWDO6LJQVIRU$0*62&JURXS

9LWDOVLJQVIRU62&RQO\JURXS

:HHN


:HHN
@

:HHN
@

:HHN
@

:HHN
@
@
:HHN
@
(QGRI62&FRQWUROOHGSHULRG@
:HHN
@

:HHN
@
:HHN
(QGRI62&FRQWUROOHGSHULRG@ 


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
6FKHGXOHG
9LVLW:HHN
9LWDO6LJQVIRU$0*62&UDQGRPL]HGJURXS

9LWDOVLJQVIRU62&$ORQH

:HHN
>%HJLQQLQJRI$OO,3SHULRG@
>%HJLQQLQJRI$OO,3
SHULRG@
:HHN

@
:HHN

@
:HHN

@
:HHN

@
:HHN
@
@
:HHN
@
@
:HHN
@
@
:HHN
@
@
:HHN
@
@
:HHN
!
!


3URGXFW$0*
,QWHULP6WDWLVWLFDO$QDO\VLV3ODQ
'DWHG1RYHPEHU
3DJH
6FKHGXOHG
9LVLW:HHN
6XEMHFWVUDQGRPL]HGWR$0*RU6XEMHFWVUDQGRPL]HGWR62&WKDWZHUH
UDQGRPL]HGWR$0*LQSDUHQWVWXG\
)DVWLQJSODVPDOLSLGV$SR$
$SR%9LWDPLQ(&KHPLVWU\
+HPDWRORJ\
$QWL$0*DQWLERGLHV
8ULQDO\VLV8ULQHPLFURDOEXPLQ
+E$F
%RG\:HLJKWKV&53
:HHN



:HHN
@
@

:HHN
(QGRI62&&RQWUROOHG
SHULRG@
(QGRI62&
&RQWUROOHGSHULRG@

:HHN
>%HJLQQLQJRI$OO,3SHULRG@
>%HJLQQLQJRI$OO,3
SHULRG@
>%HJLQQLQJRI$OO,3
SHULRG@
:HHN



:HHN
@


:HHN
!
!
!
6FKHGXOHG
9LVLW:HHN
6XEMHFWVUDQGRPL]HGWR62&WKDWZHUHUDQGRPL]HGWRFRQWUROLQWKHSDUHQWVWXG\
)DVWLQJSODVPDOLSLGV$SR$$SR%
9LWDPLQ(&KHPLVWU\+HPDWRORJ\
$QWL$0*DQWLERGLHV8ULQDO\VLV
8ULQHPLFURDOEXPLQ
+E$F
%RG\ZHLJKW
KV&53
:HHN



:HHN
@
@

:HHN
(QGRI62&&RQWUROOHGSHULRG@
(QGRI62&
&RQWUROOHGSHULRG@

:HHN
>%HJLQQLQJRI$OO,3SHULRG@
>%HJLQQLQJRI$OO,3
SHULRG@
>%HJLQQLQJRI$OO,3
SHULRG@
:HHN
@
@

:HHN



:HHN
@


:HHN
!
!
!