Clinical Trial Protocol

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    N`mcmnf` Urmf` Zratana`

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    Ua fcswor f n`mcmnf` prai`odUa gfmc cow kcaw`oego fiaut f cow ar ostfi`msh

    troftdoct

    Ua suppart f n`fmd-lar gfmcmcg gavorcdoct rogu`ftary fppravf`

    -lar dfrkotmcg f erug, eovmno, ar tonhcmquo

    Why ea f n`mcmnf` trmf`1

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    F n`mcmnf` trmf` pratana` nactfmcs f stuey p`fc ac whmnh tho n`mcmnf`

    ifsoe

    MNH gumeo`mcos stfto2

    F eanudoct thft eosnrmios tho aibontmvo(s), eosmgc, dothaea`agy

    nacsmeorftmacs fce argfcmzftmac al f trmf`

    Uho pratana` usuf``y f`sa gmvos tho ifnkgrauce fce rofsac tho trm

    naceuntoe, iut thoso nau`e io pravmeoe mc athor eanudocts rolo

    tho pratana` (sunh fs fc mcvostmgftars iranhuro).

    Whft ms f pratana`1

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    Mcstrunts stuey tofd ac oxfnt`y whft ta ea

    Oxp`fmcs tho stuey ta tho autsmeo war`e

    Zravmeos f rovmowfi`o eanudoct lar

    conossfry fppravf`s

    whft ms tho purpaso1

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    Othmns

    ^nmoctmlmn vf`memty fce mctogrmty

    Doemnf` ro`ovfcno

    Yogu`ftary fce doemna `ogf` mssuos

    Nasts

    Gumemcg prmcnmp`os

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    aMctraeuntmac fce rftmacf`o

    a

    ^tuey aibontmvos2 prmdfry fce sonacefryaAvorf`` stuey eosmgc

    a^tuey l`aw shoot

    aOcra``doct nrmtormf

    a^ponmlmn stuey pranoeuros

    aYfceadmzftmac

    aMctorvoctmacaAutnado dofsurodocts

    aZratana` eovmftmacs

    aEftf fcf`ysms fce stftmstmns

    aOthmnf` nacsmeorftmacs (Eon`frftmac al Ho`smckm)

    Fcftady al f typmnf` stuey pratana

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    O`odoct Zurpaso6. Yosofrnh quostmacs Whft quostmacs wm`` tho stuey feeross19. mgcmlmnfcno (ifnkgrauce) Why fro thoso quostmacs mdpartfct1>. Eosmgc

    Umdo lrfdoOpmeodma`agmn fpprafnh

    Haw ms tho stuey strunturoe1

    5. ^uibonts

    ^o`ontmac nrmtormf^fdp`mcg eosmgc

    Wha fro tho suibonts fce haw wm`` thoy i

    ?. \frmfi`os

    Zroemntar vfrmfi`osNaclaucemcg vfrmfi`osAutnado vfrmfi`os

    Whft dofsurodocts wm`` io dfeo1

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    Dfbar hofemcgs mc f pratanaUmt`o

    Mcvostmgftars, mcstmtutmacf` fllm`mftmacs, & quf`mlmnftmacs

    ^uddfry/Fistrfnt

    6. Mctraeuntmac

    @mtorfturo rovmow; Datmvftmac lar tho stuey (prai`od); Zurpaso; ponmlmn aibontmvos; Mdp`odo

    9. Dothaes

    Eolmcmtmac al tords; tuey eosmgc; tuey papu`ftmac fce sfdp`mcg; Dofsurodocts; Zm`at stue

    >. @agmstmns fce tmdo snhoeu`o

    Yospacsmim`mtmos al mcvostmgftars fce al stfll; Umdo snhoeu`o

    5. Eftf dfcfgodoct fce fcf`ysms

    ?. Yosaurnos

    Fvfm`fi`o rosaurnos; Iuegot fce iuegot datmvftmac

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    Nadpacocts al f rosofrnh prapaF. Umt`o pfgoI. Ufi`o al nactocts

    N. FistrfntE. Zrabont Eosnrmptmac

    6. Mctraeuntmac9. Zrai`od stftodoct fce smgcmlmnfcno>. Gaf`s fce aibontmvos5. Dothaes fce pranoeuros

    ?. Ovf`uftmac

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    Dfmc pratana` o`odocts

    Uho fiavo pratana` aut`mcos hfvo thoso fs dfmc o`od

    Zapu`ftmac

    Vuostmac

    Yo`ovfcno

    ^tuey eosmgc fce vfrmfi`os Umdolrfdo

    Ua uceorstfce thoso, wo cooe ta rovmsmt sadoopmeodma`agy

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    Umt`o pfgo2

    Zratana` tmt`o, pratana` meoctmlymcg cudior fce efto. Fcy fdoced

    shau`e f`sa iofr tho fdocedoct cudior(s) fce efto(s).

    Cfdo fce feeross al tho spacsar fce dacmtar(ml athor thfc tho sp

    Naclmeoctmf`mty stftodoct

    Ufi`o al nactocts

    Ofsy rolorocno taa`

    Gocorf` mclardftmac

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    Uypmnf` Mcn`usmac nrmtormf

    ^uibont dust hfvo emsofso al mctorost

    ^uibont dust hfvo f nortfmc fdauct al emsofso

    ^uibont dust uceorstfce stuey fce fgroo ta pfrtmnmpf

    Athor

    Uypmnf` oxn`usmac nrmtormf

    ^uibont dust cat io ac fc fntmvo troftdoct

    ^uibont dust cat io f``orgmn ta mctorvoctmac

    Zrogcfcny, irofstlooemcg nhm`e

    Athor

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    ^uibont mcn`usmac nrmtormf.

    ^uibont oxn`usmac nrmtormf.

    ^uibont wmtherfwf` nrmtormf (m.o., tordmcftmcg mcvostmgftmacf` praeunt troft

    troftdoct) fce pranoeuros sponmlymcg2

    (f) Whoc fce haw ta wmtherfw suibonts lrad tho trmf`/ mcvostmgftmacf` prae

    troftdoct.

    (i) Uho typo fce tmdmcg al tho eftf ta io na``ontoe lar wmtherfwc suibonts.

    (n) Whothor fce haw suibonts fro ta io rop`fnoe.

    (e) Uho la``aw-up lar suibonts wmtherfwc lrad mcvostmgftmacf` praeunt trof

    troftdoct.

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    7.Fssossdoct al Ollmnfny

    ^ponmlmnftmac al tho ollmnfny pfrfdotors.

    Dothaes fce tmdmcg lar fssossmcg, ronaremcg, fce fcf`yzmcg ollmnfny pfr

    8. Fssossdoct al ^floty

    ^ponmlmnftmac al sfloty pfrfdotors.

    Uho dothaes fce tmdmcg lar fssossmcg, ronaremcg, fce fcf`yzmcg sfloty

    pfrfdotors.Zranoeuros lar o`mnmtmcg roparts al fce lar ronaremcg fce ropartmcg fevo

    fce mctornurroct m``cossos.

    Uho typo fce eurftmac al tho la``awup al suibonts fltor fevorso ovoc

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    =. ^tftmstmns

    _soe ta eotordmco tho smgcmlmnfcno al tho stuey eftf ifsoe ac `fws al prF`sa usoe ta eotordmco tho pawor al f stuey (m.o. cudior al pftmocts cooe

    ronrumt)

    F eosnrmptmac al tho stftmstmnf` dothaes ta io odp`ayoe, Mcn`uemcg tmdmcg

    p`fccoe mctormd fcf`ysms.

    Uho cudior al suibonts p`fccoe ta io ocra``oe. Mc du`tmnoctor trmf`s, tho

    ocra``oe suibonts prabontoe lar ofnh trmf` smto shau`e io sponmlmoe.Yofsac lar nhamno al sfdp`o smzo, mcn`uemcg rol`ontmacs ac tho pawor al th

    n`mcmnf` bustmlmnftmac.

    Nrmtormf lar tho tordmcftmac al tho trmf`.

    Zranoeuro lar fnnauctmcg lar dmssmcg, ucusoe, fce spurmaus eftf.

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    Zranoeuros lar ropartmcg fcy eovmftmac(s) lrad tho armgmcf` stftmstmnf` p`f

    eovmftmac(s) lrad tho armgmcf` stftmstmnf` p`fc shau`e io eosnrmioe fce bust

    pratana` fce/ar mc tho lmcf` ropart, fs fppraprmfto).

    Uho so`ontmac al suibonts ta io mcn`ueoe mc tho fcf`ysos (o.g.. f`` rfcead

    f`` easoe suibonts, f`` o`mgmi`o suibonts, ovf`uftofi`o suibonts).

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    6:. Emront Fnnoss ta ^aurno Eftf Eanudocts

    Uho spacsar shau`e ocsuro thft mt ms sponmlmoe mc tho pratana` ar athor wr

    fgroodoct thft tho mcvostmgftar(s)/mcstmtutmac(s) wm`` pordmt trmf`- ro`ftoe

    fuemts, MYI/MON rovmow, fce rogu`ftary mcspontmac(s) iy pravmemcg emront f

    saurno eftf/eanudocts.

    66. Vuf`mty Nactra` fce Vuf`mty Fssurfcno

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    69. Othmns

    Eosnrmptmac al othmnf` nacsmeorftmacs ro`ftmcg ta tho trmf`.

    6>. Eftf Hfce`mcg fce Yonarekoopmcg

    65. Lmcfcnmcg fce Mcsurfcno

    Lmcfcnmcg fce mcsurfcno fro feerossoe mc f sopfrfto fgroodoc

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    6?. Zui`mnftmac Za`mnyZui`mnftmac pa`mny, ml cat feerossoe mc f sopfrfto fgroodoct.

    6

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