Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Phase: PHASE2
Conditions: Coronavirus, Covid19
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

$9HUVLRQ/2$0DU
,1'1XPEHU
3DJHRI
$&7*1(7:25.&225',1$7,1*&(17(5
6RFLDO	6FLHQWLILF6\VWHPV
*HRUJLD$YHQXHWK)ORRU
6LOYHU6SULQJ0'
3KRQH
)D[
/(77(52)$0(1'0(17
'$7(
0DUFK
72
$3ULQFLSDO,QYHVWLJDWRUVDQG6LWH6WDII
)520
$3URWRFRO7HDP
68%-(&7
/HWWHURI$PHQGPHQWIRU3URWRFRO$9HUVLRQ
7KHIROORZLQJLQIRUPDWLRQDIIHFWVWKH$VWXG\DQGPXVWEHIRUZDUGHGWR\RXULQVWLWXWLRQDO
UHYLHZERDUG,5%HWKLFVFRPPLWWHH(&DVVRRQDVSRVVLEOHIRUWKHLULQIRUPDWLRQDQGUHYLHZ
7KLV/HWWHURI$PHQGPHQW/2$PXVWEHDSSURYHGE\\RXU,5%(&EHIRUHLPSOHPHQWDWLRQ
7KHIROORZLQJLQIRUPDWLRQPD\DOVRDIIHFWWKH6DPSOH,QIRUPHG&RQVHQW<RXU,5%(&LV
UHVSRQVLEOHIRUGHWHUPLQLQJWKHSURFHVVRILQIRUPLQJSDUWLFLSDQWVRIWKHFRQWHQWVRIWKLV/2$
<RXUVLWHZLOOUHFHLYHWKLV/2$DORQJZLWKWKH33'QRWLILFDWLRQOHWWHUZLWKLQVWUXFWLRQVIRU
LPSOHPHQWDWLRQDW\RXUVLWH3OHDVHSURYLGH33'ZLWKWKHVLJQHG/2$8SRQUHFHLYLQJILQDO,5%(&
DQGDQ\RWKHUDSSOLFDEOHUHJXODWRU\HQWLW\DSSURYDOVIRUWKLV/2$SOHDVHSURYLGHWKHDSSURYDOVWR
33'33'ZLOOSURYLGHDQDPHQGPHQWIROORZXSOHWWHUWR\RXUVLWHSULRUWRLPSOHPHQWDWLRQ
33'ZLOOVXEPLWD/2$UHJLVWUDWLRQSDFNHWWRWKH'$,'63URWRFRO5HJLVWUDWLRQ2IILFH352DWWKH
5HJXODWRU\6XSSRUW&HQWHURQEHKDOIRIWKHVLWHV6LWHVZLOOUHFHLYHDUHJLVWUDWLRQQRWLILFDWLRQIRU
WKH/2$RQFHWKH'$,'6352YHULILHVWKDWDOOUHTXLUHG/2$UHJLVWUDWLRQGRFXPHQWVKDYHEHHQ
UHFHLYHGDQGDUHFRPSOHWH$Q/2$UHJLVWUDWLRQQRWLILFDWLRQIURPWKH'$,'6352LVQRWUHTXLUHG
SULRUWRLPSOHPHQWLQJWKH/2$$FRS\RIWKH/2$UHJLVWUDWLRQQRWLILFDWLRQDORQJZLWKWKLVOHWWHU
DQGDQ\,5%(&FRUUHVSRQGHQFHVKRXOGEHUHWDLQHGLQWKHVLWH¶VUHJXODWRU\ILOH
7KHIROORZLQJDUHFKDQJHVQRWHGLQEROGRUVWULNHWKURXJKWR$9HUVLRQGDWHG)HEWLWOHG
³$GDSWLYH3ODWIRUP7UHDWPHQW7ULDOIRU2XWSDWLHQWVZLWK&29,'$GDSW2XW&29,'´7KHVHFKDQJHV
ZLOOEHLQFOXGHGLQWKHQH[WYHUVLRQRIWKH$SURWRFROLILWLVDPHQGHGDWDIXWXUHGDWH
2Q)HEUXDU\DSODQQHGUHYLHZRIWKHVWXG\ZDVFRQGXFWHGE\WKHVWXG\¶VH[WHUQDO'DWDDQG
6DIHW\0RQLWRULQJ%RDUG'60%,QIRUPDWLRQIURPSDUWLFLSDQWVZKRUHFHLYHGHLWKHU6$%RU
FDVLULYLPDESOXVLPGHYLPDEZDVUHYLHZHG7KH'60%IRXQGWKDWEHFDXVHWKHUHKDYHEHHQVRIHZ
KRVSLWDOL]DWLRQVDQGGHDWKVLQWKHVWXG\HYHQLIPRUHSHRSOHSDUWLFLSDWHGLQWKHVWXG\WRPHHWWKHSODQQHG
VDPSOHVL]HRIZHUHHQUROOHGLWZRXOGQRWEHSRVVLEOHWRNQRZLI6$%ZRUNVWRSUHYHQW
KRVSLWDOL]DWLRQVDQGGHDWKVIRU&29,'%DVHGRQWKLVWKH'60%UHFRPPHQGHGWRVWRSHQUROOPHQWWR
WKHSKDVH,,,HYDOXDWLRQRI6$%IRURSHUDWLRQDOIXWLOLW\DQGWKH1,+WKH6SRQVRUDFFHSWHGWKLV
UHFRPPHQGDWLRQ,QDGGLWLRQZLWKWKHFXUUHQWHSLGHPLRORJ\RI&29,'LWZDVGHWHUPLQHGE\WKH
6SRQVRUDQGWKHSURWRFROWHDPWKDWWKHSKDVH,,,HYDOXDWLRQRI61*ZRXOGQRWEHSXUVXHGZLWKLQWKH
$&7,9$SODWIRUPDOWHUQDWLYHSODWIRUPVWRFRQWLQXHLQYHVWLJDWLRQRI61*ZLOOLQVWHDGEH
H[SORUHG7KXVWKLV/2$LVEHLQJLPSOHPHQWHGWRQRWHWKDWWKHVWXG\ZLOOFORVHWRIXUWKHUHQUROOPHQW
3DUWLFLSDQWVWKDWDUHFXUUHQWO\HQUROOHGDQGRQVWXG\VKRXOGFRQWLQXHWREHIROORZHGWKURXJKHQGRIVWXG\
:HHNDVSHUWKHSURWRFRO

$9HUVLRQ/2$0DU
,1'1XPEHU
3DJHRI

 6HFWLRQ9LWDO6WDWXV&KHFNV

9LWDOVWDWXVFRQWDFWVDQGRWKHUUHSRUWHGLQIRUPDWLRQVKRXOGEHUHFRUGHGRQWKHH&5)VZLOOEH
GRFXPHQWHGLQWKHVWXG\FKDUWDWHDFKWLPHSRLQWSHUWKH62(7KHRXWFRPHRIWKHILQDOYLWDO
VWDWXVFKHFNDWZKLFKWKHSDUWLFLSDQW¶VVWDWXVRIDOLYHKRVSLWDOL]HGRUGHDGLVYHULILHGPXVWEH
UHFRUGHGRQWKHH&5)V

 $33(1',;,,6$03/(,1)250('&216(17±3+$6(,,,0$,135272&2/QHZILUVWSDUDJUDSK

127(1RDGGLWLRQDOSDUWLFLSDQWVZLOOEHHQUROOHGLQWR$&7,9$7KLVYHUVLRQRIWKH
FRQVHQWLVUHWDLQHGIRUDUFKLYDOSXUSRVHV

 $33(1',;9,,,6$03/(,1)250('&216(17)25678'<'58*$='$'0,1,67(5('
9,$,175$9(1286,1)86,21

D 5LVNV$VVRFLDWHGZLWK$='QHZSDUDJUDSKV
,QWZRVWXGLHVRI$='FDOOHGWKH3529(17VWXG\DQGWKH7$&./(VWXG\DVPDOO
QXPEHURIVHULRXVHYHQWVKDSSHQHGLQYROYLQJKHDUWRUEORRGYHVVHOSUREOHPVVXFKDV
KHDUWDWWDFNRUKHDUWIDLOXUH0RUHSHRSOHZKRJRW$='KDGWKHVHHYHQWVWKDQ
SDUWLFLSDQWVWKDWJRWSODFHERLQWKHVHVWXGLHV,QWKH3529(17VWXG\RXWRIWKH
SHRSOHZKRJRW$='KDGRQHRIWKHVHHYHQWVFRPSDUHGWRRIWKHSHRSOHZKR
JRWSODFHER,QWKH7$&./(VWXG\WKHUHZHUHRIWKHVHW\SHRIHYHQWVLQWKHJURXSWKDW
JRW$='DQGLQWKHSODFHERJURXS

$OORIWKRVHWKDWKDGWKHVHHYHQWVZHUHDWKLJKULVNIRUKHDUWUHODWHGHYHQWV0RVWKDGKHDUW
SUREOHPVEHIRUHWKH\VWDUWHGWKHVWXG\:HGRQ¶WNQRZLIWKHVHHYHQWVZHUHFDXVHGE\
$='RUQRWDQGWKH\KDSSHQHGDWGLIIHUHQWWLPHVDIWHUSHRSOHJRWWKHGUXJRUSODFHER
7KHVHHYHQWVGLGQRWKDSSHQLQDQRWKHU$='VWXG\FDOOHG67250&+$6(5

,QWKH3529(17VWXG\$='ZRUNHGYHU\ZHOODWVWRSSLQJ&29,'/RRNLQJDWWKH
JRRGDQGEDGWKH)'$DSSURYHGDQ(PHUJHQF\8VH$XWKRUL]DWLRQ(8$IRUWKLVGUXJIRU
VWRSSLQJ&29,'RQ'HFHPEHU7KH)'$VDZWKHGDWDDERXWWKHVHHYHQWVEHIRUH
WKH\DSSURYHGLW

E (IIHFWRQ)XWXUH9DFFLQDWLRQ
7KHUHLVDFKDQFHWKDW$='FRXOGLQWHUIHUHZLWKKRZ\RXUERG\UHVSRQGVWRD&29,'
YDFFLQHZKLOHLWLVLQ\RXUV\VWHP6WXGLHVVKRZ$='FDQUHPDLQLQWKHERG\IRU
PRUHWKDQGD\V+RZHYHUWKH86&HQWHUVIRU'LVHDVH&RQWURODQG3UHYHQWLRQ&'&
FXUUHQWO\UHFRPPHQGVWKDW&29,'YDFFLQDWLRQGRHVQRWQHHGWREHGHOD\HGIROORZLQJ
UHFHLSWRIPRQRFORQDODQWLERGLHVOLNH$='7KH86&HQWHUVIRU'LVHDVH&RQWURODQG
3UHYHQWLRQ&'&FXUUHQWO\UHFRPPHQGVWKDWSHRSOHZDLWDWOHDVWGD\VDIWHU
UHFHLYLQJDQWLERG\WUHDWPHQWEHIRUHUHFHLYLQJD&29,'YDFFLQHEHFDXVHVRPHDQWLERGLHV
UHPDLQLQWKHERG\IRUDERXWGD\VDQGWKHUHLVDFKDQFHWKDWWKHVHDQWLERGLHVFRXOGLQWHUIHUH
ZLWKKRZ\RXUERG\UHVSRQGVWRWKHYDFFLQHGXULQJWKRVHGD\V6RPHRIWKHDQWLERGLHVLQWKLV
VWXG\LQFOXGLQJ$='DUHGHVLJQHGWRUHPDLQLQWKHERG\IRUORQJHUWKDQGD\V$OWKRXJK
WKHUHLVQRIXUWKHUJXLGDQFHDYDLODEOHWKHUHLVDFKDQFHWKDWWKHVHORQJHUODVWLQJPRQRFORQDO
DQWLERGLHVFRXOG

 $33(1',;;6$03/(,1)250('&216(17)25678'<'58*$='$'0,1,67(5('$6
$1,175$086&8/$5,1-(&7,21

D 5LVNV$VVRFLDWHGZLWK$='QHZSDUDJUDSKV
,QWZRVWXGLHVRI$='FDOOHGWKH3529(17VWXG\DQGWKH7$&./(VWXG\DVPDOO
QXPEHURIVHULRXVHYHQWVKDSSHQHGLQYROYLQJKHDUWRUEORRGYHVVHOSUREOHPVVXFKDV
KHDUWDWWDFNRUKHDUWIDLOXUH0RUHSHRSOHZKRJRW$='KDGWKHVHHYHQWVWKDQ
SDUWLFLSDQWVWKDWJRWSODFHERLQWKHVHVWXGLHV,QWKH3529(17VWXG\RXWRIWKH

$9HUVLRQ/2$0DU
,1'1XPEHU
3DJHRI

SHRSOHZKRJRW$='KDGRQHRIWKHVHHYHQWVFRPSDUHGWRRIWKHSHRSOHZKR
JRWSODFHER,QWKH7$&./(VWXG\WKHUHZHUHRIWKHVHW\SHRIHYHQWVLQWKHJURXSWKDW
JRW$='DQGLQWKHSODFHERJURXS

$OORIWKRVHWKDWKDGWKHVHHYHQWVZHUHDWKLJKULVNIRUKHDUWUHODWHGHYHQWV0RVWKDGKHDUW
SUREOHPVEHIRUHWKH\VWDUWHGWKHVWXG\:HGRQ¶WNQRZLIWKHVHHYHQWVZHUHFDXVHGE\
$='RUQRWDQGWKH\KDSSHQHGDWGLIIHUHQWWLPHVDIWHUSHRSOHJRWWKHGUXJRUSODFHER
7KHVHHYHQWVGLGQRWKDSSHQLQDQRWKHU$='VWXG\FDOOHG67250&+$6(5

,QWKH3529(17VWXG\$='ZRUNHGYHU\ZHOODWVWRSSLQJ&29,'/RRNLQJDWWKH
JRRGDQGEDGWKH)'$DSSURYHGDQ(PHUJHQF\8VH$XWKRUL]DWLRQ(8$IRUWKLVGUXJIRU
VWRSSLQJ&29,'RQ'HFHPEHU7KH)'$VDZWKHGDWDDERXWWKHVHHYHQWVEHIRUH
WKH\DSSURYHGLW

E (IIHFWRQ)XWXUH9DFFLQDWLRQ
7KHUHLVDFKDQFHWKDW$='FRXOGLQWHUIHUHZLWKKRZ\RXUERG\UHVSRQGVWRD&29,'
YDFFLQHZKLOHLWLVLQ\RXUV\VWHP6WXGLHVVKRZ$='FDQUHPDLQLQWKHERG\IRU
PRUHWKDQGD\V+RZHYHUWKH86&HQWHUVIRU'LVHDVH&RQWURODQG3UHYHQWLRQ&'&
FXUUHQWO\UHFRPPHQGVWKDW&29,'YDFFLQDWLRQGRHVQRWQHHGWREHGHOD\HGIROORZLQJ
UHFHLSWRIPRQRFORQDODQWLERGLHVOLNH$='7KH86&HQWHUVIRU'LVHDVH&RQWURODQG
3UHYHQWLRQ&'&FXUUHQWO\UHFRPPHQGVWKDWSHRSOHZDLWDWOHDVWGD\VDIWHU
UHFHLYLQJDQWLERG\WUHDWPHQWEHIRUHUHFHLYLQJD&29,'YDFFLQHEHFDXVHVRPHDQWLERGLHV
UHPDLQLQWKHERG\IRUDERXWGD\VDQGWKHUHLVDFKDQFHWKDWWKHVHDQWLERGLHVFRXOGLQWHUIHUH
ZLWKKRZ\RXUERG\UHVSRQGVWRWKHYDFFLQHGXULQJWKRVHGD\V6RPHRIWKHDQWLERGLHVLQWKLV
VWXG\LQFOXGLQJ$='DUHGHVLJQHGWRUHPDLQLQWKHERG\IRUORQJHUWKDQGD\V$OWKRXJK
WKHUHLVQRIXUWKHUJXLGDQFHDYDLODEOHWKHUHLVDFKDQFHWKDWWKHVHORQJHUODVWLQJPRQRFORQDO
DQWLERGLHVFRXOGLQWHUIHUHZLWKKRZ\RXUERG\UHVSRQGVWRWKHYDFFLQHHYHQLI\RXZDLWDWOHDVW
GD\VIRUWKHYDFFLQH

 $33(1',;;,,19(67,*$7,21$/$*(17,1+$/(',17(5)(521ȕD61*ILUVWSDUDJUDSK

127(3KDVH,,,HYDOXDWLRQRI61*ZLOOEHLQLWLDWHGXQGHUDIXWXUHSURWRFROYHUVLRQDQGQRW
SURWRFRO9HUVLRQQRWEHLQLWLDWHGLQ$&7,9$

 $33(1',;;96$%$17,6$56&29+80$1,00812*/2%8/,1,175$9(12867&
%29,1('(5,9('QHZILUVWSDUDJUDSK

127()ROORZLQJWKHILUVWLQWHULPDQDO\VLVDQG'60%UHYLHZRIWKHSKDVH,,,HYDOXDWLRQRI6$%
XQGHUSURWRFROYHUVLRQIXUWKHUHQUROOPHQWWR6$%SKDVH,,,KDVEHHQWHUPLQDWHGGXH
WRRSHUDWLRQDOIXWLOLW\3UHYLRXVO\HQUROOHGSDUWLFLSDQWVZLOOFRQWLQXHWREHIROORZHGWKURXJK
HQGRIVWXG\DVSHUWKHSURWRFRO

 $33(1',;;9,6$03/(,1)250('&216(17)253$57,&,3$1765$1'20,=('72678'<
'58*6$%25&$6,5,9,0$%3/86,0'(9,0$%QHZVHFWLRQWLWOH

D 1HZLQWURGXFWRU\SDUDJUDSKV

127(7KLVUHYLVHGVDPSOHLQIRUPHGFRQVHQWLVLQWHQGHGIRUSDUWLFLSDQWVWKDWHQUROOHG
XQGHUSURWRFRO9DQGZHUHUDQGRPL]HGWR6$%RUFDVLULYLPDESOXVLPGHYLPDE

<RXUHFHLYHGHLWKHU$VWXG\GUXJWKDW\RXPLJKWEHDVVLJQHGWRLQWKLVVWXG\LVRQHRIWZRGRVHV
RIWKH6$%RUWKHSODFHERFDVLULYLPDESOXVLPGHYLPDEDOVRNQRZQDV5(*(1&29DV
SDUWRIWKH$&7,9$VWXG\7KHSXUSRVHRIWKLVFRQVHQWIRUPLVWRVKDUHQHZ
LQIRUPDWLRQZLWK\RXWKDWLVLPSRUWDQWIRU\RXWRNQRZ(DFKGRVHRI6$%LVFRQVLGHUHGD
VHSDUDWHVWXG\GUXJLQWKHWULDO


$9HUVLRQ/2$0DU
,1'1XPEHU
3DJHRI

7KHUHLVQRZDQHZYDULDQWW\SHRIWKH6$56&R9YLUXVWKDWKDVEHFRPHYHU\FRPPRQ
DURXQGWKHZRUOGWKH2PLFURQYDULDQW$YDULDQWPHDQVWKDWSDUWVRIWKHYLUXVKDYH
FKDQJHG$VDUHVXOWRIWKHVHFKDQJHVFDVLULYLPDESOXVLPGHYLPDELVQRWH[SHFWHGWR
ZRUNDJDLQVWWKH2PLFURQYLUXVDQGLVQRORQJHUDXWKRUL]HGE\WKH)'$IRUWUHDWPHQWRI
&29,'LQSDUWVRIWKH86ZKHUH2PLFURQLVFRPPRQ%HFDXVHRIWKLVWKH$&7,9
VWXG\ZDVFKDQJHGWRQRORQJHUJLYHFDVLULYLPDESOXVLPGHYLPDEWRSDUWLFLSDQWV

2Q)HEUXDU\DSODQQHGUHYLHZRIWKHVWXG\ZDVFRQGXFWHGE\D'DWDDQG6DIHW\
0RQLWRULQJ%RDUGDJURXSRIH[SHUWVVHSDUDWHIURPWKHVWXG\WHDPWKDWUHYLHZVKRZWKH
VWXG\LVJRLQJ,QIRUPDWLRQIURPSDUWLFLSDQWVZKRUHFHLYHGHLWKHU6$%RU
FDVLULYLPDESOXVLPGHYLPDEZDVUHYLHZHG7KH\IRXQGWKDWEHFDXVHWKHUHKDYHEHHQVR
IHZKRVSLWDOL]DWLRQVDQGGHDWKVLQWKHVWXG\HYHQLIPRUHSHRSOHSDUWLFLSDWHLQWKHVWXG\
LWZRXOGQRWEHSRVVLEOHWRNQRZLI6$%ZRUNVWRSUHYHQWKRVSLWDOL]DWLRQVDQGGHDWKV
IRU&29,')RUWKLVUHDVRQWKHVWXG\ZLOOQRWFRQWLQXHWRHQUROOXSWRWKHRULJLQDO
SODQQHGIRUWKHVWXG\7KHH[SHUWPRQLWRULQJJURXSGLGQRWILQGDQ\VDIHW\FRQFHUQVQHZ
RUZRUULVRPHULVNVIRUVHULRXVVLGHHIIHFWV:HDVNWKDW\RXFRQWLQXHWRIROORZXSZLWK
YLVLWVIRUWKHVWXG\VRWKDWWKHVWXG\VWDIIDQGVWXG\WHDPFDQFRQWLQXHWRPRQLWRUIRUVLGH
HIIHFWVDQGXQGHUVWDQGLIWKHGUXJVUHFHLYHGLQWKHVWXG\KHOSRWKHUV\PSWRPVVXFKDV
ODWHRUORQJODVWLQJV\PSWRPVIURP&29,'

E ,)<28$5(,17+(6(&21'3$572)7+(678'<3+$6(,,,&203$5,62172
3/$&(%2$1'5(&(,9('6$%QHZVHFWLRQWLWOH

F 6WXG\9LVLWRQ'D\DQG:HHN
x
<RXZLOOKDYHEORRGGUDZQ7KLVEORRGZLOOEHXVHGIRUWKHIROORZLQJWHVWV
o
OHYHOVRIWKHGUXJ
o
OHYHOVRIDQWLERGLHVWRWKHGUXJ\RXUERG\¶VLPPXQHUHVSRQVHWRWKHGUXJ

G :+$7$5(7+(5,6.62)7+(678'<'58*66$%"QHZVHFWLRQWLWOH

H (IIHFWRQ)XWXUH9DFFLQDWLRQIRU%RWK6$%DQG&DVLULYLPDE3OXV,PGHYLPDE
7KH86&HQWHUVIRU'LVHDVH&RQWURODQG3UHYHQWLRQ&'&UHFHQWO\FKDQJHGWKHLUJXLGDQFHDV
RI)HEUXDU\WRVD\WKDWSHRSOHZKRKDYHUHFHLYHGDQWLERG\WUHDWPHQWIRU&29,'FDQ
UHFHLYHD&29,'YDFFLQHDWDQ\WLPHDQGGRQRWKDYHWRZDLWIRUDSHULRGDIWHUUHFHLYLQJWKH
DQWLERG\WUHDWPHQW,WLVSRVVLEOHWKDWWKHOHYHOVRIDQWLERGLHVJHQHUDWHGE\YDFFLQDWLRQPD\EH
ORZHULQSHRSOHZKRUHFHLYHGDQDQWLERG\WUHDWPHQWEHIRUHYDFFLQDWLRQWKDQLQSHRSOHZKRGLGQRW
UHFHLYHDQDQWLERG\WUHDWPHQWEHIRUHYDFFLQDWLRQEXWLWLVQRWNQRZQLIWKLVPHDQV\RXZLOOQRWEH
DVSURWHFWHGIURPIXWXUH&29,'DQGWKH&'&UHFRPPHQGVSURFHHGLQJZLWKYDFFLQDWLRQ
6$%DQGFDVLULYLPDESOXVLPGHYLPDELVDQDUHH[SHULPHQWDODQWLERG\WUHDWPHQWVDQGLWLV
QRWNQRZQLIUHFHLYLQJ6$%HLWKHURIWKHPDIIHFWVKRZ\RXZLOOUHVSRQGWR&29,'
YDFFLQHV

I
$5(7+(5(5,6.65(/$7('7235(*1$1&<$1'%5($67)((',1*)256$%"QHZ
VHFWLRQWLWOH

 $33(1',;;,;6,*1$785(3$*(±678'<'58*6

D &RQVHQWIRUPVDGGHQGDIRUWKHIROORZLQJVWXG\GUXJVZHUHUHYLHZHGLQLWLDOLIUHYLHZHGZLWK\RX

E BBBBBLQLWLDOV6$%25&$6,5,9,0$%3/86,0'(9,0$%,175$9(1286
$'0,1,675$7,21

 $3URWRFRO6LJQDWXUH3DJH363LVDSSHQGHGIRUVXEPLVVLRQWR'$,'63URWRFRO5HJLVWUDWLRQ6\VWHP
'356DVSDUWRIWKH/2$UHJLVWUDWLRQSDFNHW




$9HUVLRQ/2$0DU
,1'1XPEHU
3DJHRI

$GDSWLYH3ODWIRUP7UHDWPHQW7ULDOIRU2XWSDWLHQWVZLWK&29,'$GDSW2XW&29,'

6,*1$785(3$*(

,ZLOOFRQGXFWWKHVWXG\LQDFFRUGDQFHZLWKWKHSURYLVLRQVRIWKLVSURWRFRODQGDOODSSOLFDEOHSURWRFRO
UHODWHGGRFXPHQWV,DJUHHWRFRQGXFWWKLVVWXG\LQFRPSOLDQFHZLWK8QLWHG6WDWHV86+HDOWKDQG
+XPDQ6HUYLFHUHJXODWLRQV&)5DSSOLFDEOH86)RRGDQG'UXJ$GPLQLVWUDWLRQUHJXODWLRQV
VWDQGDUGVRIWKH,QWHUQDWLRQDO&RQIHUHQFHRQ+DUPRQL]DWLRQ*XLGHOLQHIRU*RRG&OLQLFDO3UDFWLFH(
,QVWLWXWLRQDO5HYLHZ%RDUG(WKLFV&RPPLWWHHGHWHUPLQDWLRQVDOODSSOLFDEOHLQFRXQWU\VWDWHDQGORFDO
ODZVDQGUHJXODWLRQVDQGRWKHUDSSOLFDEOHUHTXLUHPHQWVHJ861DWLRQDO,QVWLWXWHVRI+HDOWK'LYLVLRQRI
$,'6DQGLQVWLWXWLRQDOSROLFLHV





3ULQFLSDO,QYHVWLJDWRUBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

3ULQW7\SH




6LJQHGBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB'DWHBBBBBBBBBBBBB

1DPH7LWOH




