Participation à un essai clinique sur un médicament

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  • 7/29/2019 Participation un essai clinique sur un mdicament

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    CM W]OK EG]TSGUAOZ

    ^GZTOCO^GTOAH ]H MSSGO CKOHOW]MS]Z ]H FDOCGFMHT

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    CAFFMHT SM EGOT KG ZMCBMZCBM S] ]H HA]UMG] FDOCGFMHT1((((((((((((((((p ( 3

    W]AO SMZT KG ZMCBMZCBM1((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p ( 4

    W]MKKMS SAHT KMS IGZGHTOMS1 ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p ( =

    W]MST&CM W]]H CAHSMHTMFMHT KOJZM MT CKGOZ 1 ((((((((((((((((((((((((((((((((((((((((((p ( 5

    G]ZMP&UA]S GCCS G] FMOKKM]Z TZGOTMFMHT1 ((((((((((((((((((((((((((((((((((((((((((((((((((((((p ( 9

    ^A]ZW]AO CAF^GZM&T&AH ^K]SOM]ZS TZGOTMFMHTS DGHS ]H MSSGO 1 (((((((((p ( 2

    CAFFMHT SAHT CAHSTOT]S KMS IZA]^MS DM TZGOTMFMHT 1 "ZGHDAFOSGTOAH/ ((((p ( ?

    W]MST W]]H MSSGO A]UMZT1(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 >

    W])MST&CM W])]H MSSGO MH DA]JKM GUM]IKM*1 (((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 >

    W]MST&CM W]]H MSSGO CAHTZM ^KGCMJA 1(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 7

    CAFFMHT UA]S DCODMZ1 (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 :

    ^M]T&AH ZME]SMZ DM ^GZTOCO^MZ ]H MSSGO 1((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 :

    ^M]T&AH SAZTOZ D]H MSSGO CKOHOW]M 1(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 3W]MKW]MS W]MSTOAHS ^ASMZ S]Z KM DZA]KMFMHT DM KG ZMCBMZCBM (((p (7 4

    W]M SM ^GSSM&T&OK G^ZS KMSSGO 1(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 =

    KMS ZS]KTGTS DM KMSSGO ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 =

    ^A]Z MH SGUAOZ ^K]S (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((p (7 5

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    CAFFMHT SM EGOTKG ZMCBMZCBMS]Z ]H HA]UMG]FDOCGFMHT1 Kg fosm gu paoht d)uh hauvmgu fdocgfmht mst kahium "7: ghs mhfaymhhm/< Sur mhvorah 7>>>> fdocgfmhts patmhtomks sujossght taus kmstmsts hcmssgorms+ uh smuk smrg dospahojkm gu eohgk paur trgotmr dms pgtomhts(

    Kms prmforms pbgsms dm tmst saht meemctums paur jomh cahhgtrm kmspraprots du praduot( Ah rgkosm mhsuotm dms tmsts dm taxocakaiom+ quo sahtofpass paur taus kms cghdodgts fdocgfmhts( Cms tmsts saht meemctus mhihrgk sur k)ghofgk mt pmrfmttmht dm cahhgtrm k)meemt du praduot sur uh ar&ighosfm vovght geoh dm pauvaor kofohmr kms sujstghcms quo smrgomht traptaxoqums(

    Karsqum kms rsuktgts ajtmhus kgsuotm dm cms doeermhts tmsts km pmr&fmttmht+ km praduot pmut trm tmstcbmz k)baffm(

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    Kg rmcbmrcbm mst ohdospmhsgjkm gu prairs dmssaohs(

    Kg fdmcohm hm sgot pgs iuror cmrtgohms fg&kgdoms( Kms cbmrcbmurs daovmht trauvmr dm hau&vmkkms strgtioms tbrgpmutoqums "hauvmgu fdo&cgfmht+ hauvmkkm gssacogtoah dm fdocgfmhts/paur fomux saoihmr cms fgkgdoms(

    Gvght dm prapasmr cms hauvmgux trgotmfmhts tautms kms pmrsahhms cahcmrhms+ ok egut s)gs&surmr qu)oks saht meeocgcms mt jomh takrs( Oks dao&

    vmht dahc trm tmsts pgr dms mssgos ckohoqums(Taus kms fdocgfmhts caffmrcogkoss aht egotkaj`mt dmssgos ckohoqums(

    Dgutrms typms dm rmcbmrcbm pmuvmht gusso trmcahcmrhs pgr dms mssgos 0 uhm ftbadm dm dogi&hastoc+ uhm tmcbhoqum cboruriocgkm+ du fgtromkfdoca&cboruriocgk

    ]h mssgo ckohoqum+ karsquok cahcmrhm uh fdo&cgfmht+ mst uhm rmcbmrcbm paur vgkumr au pr&

    cosmr kmeemt duh trgotmfmht(

    ]h mssgo ckohoqum pmut trm prapas tautmskms pmrsahhms saueerght dm kg fgkgdom cahcmrhmmt rpahdght gux crotrms deohos pgr kg rmcbmrcbm(

    Kg pgrtocopgtoah vakahtgorm uh mssgo ckohoqummst utokm taus( Mkkm mst gusso utokm kg pmrsahhmquo y pgrtocopm+ mh pgrtocukomr qughd kms trgotmfmhtsdospahojkms mt caffmrcogkoss h)aht pgs pmrfosd)ajtmhor k)meemt gttmhdu au aht t fgk takrs(Mkkm pmut gusso pmrfmttrm d)gccdmr uh hauvmgutrgotmfmht prafmttmur dghs dm jahhms cahdotoahsdm scurot(

    Kg pgrtocopgtoah vakahtgorm uh mssgo mst gussoutokm tautms kms pmrsahhms quo saht gttmohtms dmkg ffm fgkgdom( Kms trgotmfmhts dgu`aurdbuoaht t fos gu paoht ircm gux rmcbmrcbms ght&romurms+ mt kms trgotmfmhts dm dmfgoh saht fos gupaoht ircm gux rmcbmrcbms dgu`aurdbuo( Ah hmpmut cmpmhdght pgs igrghtor qumkkm gppartm uhrmk jheocm gu pgrtocopght+ cgr so ah km sgvgot+ okhy gurgot pgs jmsaoh dm egorm cmttm rmcbmrcbm 0cmst km prohcopm dgutbmhtoqum ohcmrtotudm (

    W]AO SMZTKGZMCBMZCBM1

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    W]MKKMSSAHTKMS IGZGHTOMS1Gvght dm caffmhcmr uhm rmcbmrcbm+ km prafatmur* rgssmfjkm mt tudomtaut cm quo mst cahhu dm kg fgkgdom mt dm sms trgotmfmhts mxostghts(

    Dms cafots dm pratmctoah dms pmrsahhms "C^^/ saht cbgris dm rmvaor+dm egah tatgkmfmht ohdpmhdghtm+ k)mhsmfjkm du pratacakm* mt du drau&kmfmht dm k)mssgo( Kg rmcbmrcbm hm djutmrg qu)mh cgs d)gvos egvargjkm duC^ (

    Mh pkus dm kgvos du Cafot dm ^ratmctoah dms ^mrsahhms+ kGimhcm Hg&toahgkm dm Scurot dms fdocgfmhts mt dms praduots dm sght "GHSF/* rm&

    igrdm igkmfmht taus kms kfmhts dm kg rmcbmrcbm mt pmut+ so tautms kmscahdotoahs dm scurot hm saht pgs rmfpkoms+ sappasmr uhm tudm( C)mstuhm tgpm suppkfmhtgorm dm vgkodgtoah(

    Kg rmcbmrcbm sm egot saus kg cahduotm d)quopms dm fdmcohs "gppmksohvmstoigtmurs*/ cafptmhtms+ earfms mt mxprofmhtms quo cahhgossmhtgvmc prcosoah kg fgkgdom+ kms trgotmfmhts mxostghts mt kms cahdotoahsrmquosms paur cahduorm uhm rmcbmrcbm

    Gvght km djut duh mssgo ckohoqum+ km prafatmur daot gvaor cahtrgctuhm gssurghcm mh rmspahsgjokot covokm cauvrght kms vmhtumks daffgims

    sujos pgr kms pgtomhts au su`mts sgohs pgrtocopght kmssgo(

    * Uaor p(75 ^aur mh sgvaor pkus(

    =

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    Km fdmcoh ohvmstoigtmur daot vaus mxpkoqumr k)ms&sgo guqumk ok vaus prapasm dm pgrtocopmr+ sms fa&dgkots prgtoqums dm draukmfmht gohso qum kmsvmhtumkkms cahtrgohtms mt meemts ohdsorgjkms gt&tmhdus( Sms mxpkocgtoahs smraht cafpktms pgr

    uh dacufmht crot 0 km earfukgorm dohearfgtoah(Cm dacufmht rmiraupm taus kms kfmhts dohear&fgtoah hcmssgorms kg cafprbmhsoah dm kmssgogeoh dm vaus pmrfmttrm dm pauvaor mxprofmr vatrmohtrt au hah y pgrtocopmr( Ok vaus smrg dmfghddm km korm+ dm pasmr tautms vas qumstoahs gu f&dmcoh mh cbgrim dm ktudm mt dm prmhdrm vmh&tumkkmfmht uh tmfps dm rekmxoah gvght dm vausdcodmr( Uaus tms kojrm dm pgrtocopmr au hah kmssgo(

    Kg soihgturm du cahsmhtmfmht gttmstm dm kgcafprbmhsoah dm k)mhigimfmht mt dm vatrm gc&card pgrtocopmr k)mssgo( Ok mst ofprgtovmfmhtsoih gvght km djut dm k)mssgo(

    K)gjsmhcm dm vatrm cahsmhtmfmht ohtmrdot vatrmpgrtocopgtoah k)mssgo

    W]MST&CMW]]H CAHSMHTMFMHTKOJZM MT CKGOZ1

    So vaus gccmptmz dm pgrtocopmr+ vatrm cahsmhtm&fmht* kojrm mt ckgor dmvrg mhsuotm trm rmcumokkopgr km fdmcoh ohvmstoigtmur mh cbgrim dm ktudm(Uaus dmvmz soihmr km earfukgorm dm cahsmhtmfmhtckgor+ ok mst kg prmuvm crotm qum vaus gvmz caf&

    pros cm qum kah vaus prapasm mt qum vaus gccmp&tmz dm pgrtocopmr kg rmcbmrcbm(

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    So ah vaus prapasm uh mssgo ckohoqum+ c)mstpaur gfkoarmr km trgotmfmht dm kg fgkgdom dmvatrm fgkgdom dghs km eutur

    Kg pgrtocopgtoah gux mssgos pmut pmrfmttrmd)gccdmr rgpodmfmht uh hauvmgu trgotmfmhtprafmttmur

    Wum vaus saymz dghs uh mssgo ckohoqum auhah+ vatrm tgt dm sght pmut taut fafmht h&cmssotmr uhm gdgptgtoah au uh cbghimfmht dmtrgotmfmht( Cm cbghimfmht au cmttm gdgptgtoahpmuvmht sm egorm du egot dm k)gppgrotoah d)uh gutrm

    prajkfm dm sght au du egot d)meemts smcahdgormsohdsorgjkms dus gu trgotmfmht tmst dghs km cgdrmdm k)mssgo(

    Dghs taus kms cgs+ km fdmcoh ohvmstoigtmurs)mhigim pasmr km fmokkmur dogihastoc paur kmfmokkmur trgotmfmht gdgpt cbgqum cgs( Ok daot vaus

    dkovrmr kms fmokkmurs saohs passojkms( Kmssgo cko&hoqum hm km dcbgrim pgs dm sms rmspahsgjokots(

    G]ZMP&UA]S

    GCCS G] FMOKKM]ZTZGOTMFMHT1

    Uatrm soihgturm hm dcbgrim pgs km fdmcohohvmstoigtmur* dm sah dmvaor dm vaus gppartmr kmsfmokkmurs saohs passojkms

    Cm cahsmhtmfmht mst uhm ajkoigtoah kigkm mtso km fdmcoh ohvmstoigtmur hm km rmcumokkm pgs+ ok

    s)mxpasm dm svrms sghctoahs(

    Kg soihgturm du cahsmhtmfmht ckgor pmrfmtvatrm mhtrm dghs kmssgo( Ok vaus mst tau`aurs pas&sojkm+ taut fafmht+ d)grrtmr vatrm pgrtocopgtoah uh mssgo ckohoqum sghs gvaor vaus `ustoeomr( Cmtgrrt hgurg pgs dm cahsqumhcm sur vatrm prosmmh cbgrim pgr kquopm fdocgkm(vatrm mheght pgrkquopm fdocgkm(

    *Uaor p(75^aur mh sgvaor pkus(

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    ^A]ZW]AOCAF^GZM&T&AH^K]SOM]ZS TZGOTMFMHTS

    DGHS ]H MSSGO 1Geoh dm sgvaor so uh hauvmgu fdocgfmht vg trmgusso jah au ffm fmokkmur qu)uh trgotmfmhtd` mxostght "meeocgcot+ takrghcm/+ ok mst ohdos&pmhsgjkm dm egorm dms cafpgrgosahs dm cms doe&ermhts trgotmfmhts pgr uh mssgo ckohoqum(

    ^kusomurs iraupms dm pmrsahhms saht gohso trgots

    mh pgrgkkkm pgr kms fdocgfmhts qum k)ah sau&bgotm cafpgrmr(

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    CAFFMHT

    SAHT CAHSTOT]SKMS IZA]^MSDM TZGOTMFMHT 1"ZGHDAFOSGTOAH/Dghs uh mssgo cafpgrgtoe mhtrm uh hauvmgufdocgfmht mt uh fdocgfmht d` cahhu+ kmspmrsahhms pgrtocopght kmssgo saht trgotms so&fuktghfmht dghs dms iraupms dm trgotmfmht doe&ermhts( Cbgcuh dms iraupms prmhd uh dms fdo&cgfmhts qum k)ah saubgotm cafpgrmr(

    ^aur pauvaor pgrtocopmr k)mssgo+ vaus dmvmz r&pahdrm dms crotrms prcos quo aht t deohos

    dghs km pratacakm* dm k)tudm(Gprs gvaor vroeo qum vaus rpahdmz cmscrotrms dots d)koiojokot+ mt gprs gvaor rmcumokkovatrm cahsmhtmfmht ckgor+ vaus paurrmz trm oh&ckus dghs k)mssgo(

    ^aur igrghtor k)aj`mctovot du fdmcoh+ cm h)mstpgs kuo quo cbaosot km iraupm dghs kmqumk vaus tmsohckus(

    Dms kostms aht t prgkgjkmfmht tgjkoms pgrkm prafatmur dm k)mssgo paur cahstotumr dmsiraupms dm trgotmfmht "hauvmgu fdocgfmht qumk)ah tmstm au fdocgfmht d` mxostght/

    Km typm dm trgotmfmht qum vaus rmcmvrmz mstdtmrfoh pgr torgim gu sart ohearfgtoqum( C)mstcm qum k)ah gppmkkm kg rghdafosgtoah+ fat quovomht dm rghdafosmr+ bgsgrd mh ghikgos(

    Km torgim gu sart hmst pgs uhm pracdurm gr&jotrgorm+ cmst km smuk faymh dm igrghtor uhm caf&pgrgosah scomhtoeoqumfmht gccmptgjkm mhtrm dmuxiraupms dm pgtomhts(

    Km trgotmfmht qum vaus rmcmvrmz kg suotm dmcm torgim gu sart ohearfgtoqum smrg gppkoqu mtcahtrk pgr km fdmcoh ohvmstoigtmur quo km suot(

    *Uaor p(75 ^aur mh sgvaor pkus(

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    W]MST&CMW]]H MSSGOA]UMZT1

    W])MST&CMW])]H MSSGOMH DA]JKMGUM]IKM*1

    Dghs uh mssgo auvmrt+ km fdmcoh mt vauscahhgossmz k)mhsmfjkm dms fdocgfmhts qumvaus prmhmz(

    Dghs cmrtgohs cgs+ k)mssgo mst cahduot mh daujkmgvmuikm( kg doeermhcm d)uh mssgo auvmrt+ ho kmfdmcoh+ ho km pmrsahhmk saoihght ho vaus hmsgvmz so vaus rmcmvmz km hauvmgu fdocgfmhtqum k)ah tmstm au uh fdocgfmht quo mxostm d`mt quo mst caffmrcogkos au uh pkgcmja(

    Kg tmcbhoqum dm k)mssgo mh daujkm gvmuikm mstutokosm paur votmr qum kg pmrsahhm fgkgdm+ kmfdmcoh mt km pmrsahhmk saoihght hm saomht oh&ekumhcs pgr uhm apohoah &proaro qu)oks paurrgomhtgvaor vos vos dm tmk au tmk fdocgfmht(

    *Uaor p(75 ^aur mh sgvaor pkus(

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    W]MST&CMW]]H MSSGOCAHTZM^KGCMJA1OO y g dmux sartms d)mssgos 0

    Karsqu)ok mxostm d` uh trgotmfmht dm vatrmfgkgdom "dot trgotmfmht dm rermhcm/ k)mssgo vgcafpgrmr uh hauvmgu fdocgfmht cm trgotm&

    fmht dm rermhcmKarsqu)ok h)mxostm pgs dm trgotmfmht dm rermhcm+k)mssgo vg cafpgrmr km hauvmgu fdocgfmht uhpraduot quo g kg ffm gppgrmhcm fgos quo hmcahtomht pgs kg fakcukm tmstm+ km pkgcmja(

    Zomh hmfpcbm quuhm pmrsahhm prmhght kmpkgcmja au km hauvmgu fdocgfmht hgot gccs dgutrms trgotmfmhts so sah tgt dm sghtkmxoim(

    Sok y g dms rgosahs dm crgohdrm uh dsgvghtgimrmk paur kms pmrsahhms pgrtocopght kmssgo+ qumkqum saot km iraupm dm trgotmfmht "pkgcmja au f&docgfmht tmst/+ dms pracdurms prcosms dm sartomdm ktudm daovmht trm prvums dghs km pratacakm(

    Dghs cm cgs+ vaus pauvmz rmcmvaor uh hauvmgutrgotmfmht+ dot trgotmfmht dm rmcaurs( Ok mst dahh+smkah kms tmrfms prvus dghs km pratacakm dm kms&sgo+ du egot dm kmeeocgcot `uim ohsueeosghtm du

    trgotmfmht rmu dghs kmssgo au dmeemts ohdsorg&jkms guxqumks ok egudrgot fmttrm eoh(

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    ^M]T&AHZME]SMZ DM

    ^GZTOCO^MZ ]H MSSGO 1

    Gvght dm prmhdrm vatrm dcosoah+ ok mst ofpartght dm 0

    korm gttmhtovmfmht kms dacufmhts rmfos+

    hm pgs bsotmr prmhdrm pkus dm rmhsmoihmfmhts"gssacogtoahs dm pgtomhts+ fdmcoh trgotght/

    qumstoahhmr km fdmcoh quo vaus prapasm k)mssgo(Ok daot rpahdrm tautms vas qumstoahs

    dmfghdmr k)gvos dm vatrm fdmcoh bgjotumk+ sok)mssgo vaus mst prapas pgr uh gutrm fdmcoh+

    prmhdrm km tmfps dm rekcbor karsqu)ok h)y gpgs d)urimhcm

    dghs kms sotugtoahs d)urimhcm+ km tmfps dm kgrekmxoah daot trm gdgpt kg sotugtoah(

    Auo+ vaus pauvmz rmeusmr dm pgrtocopmr uh mssgo(

    Cmkg hm cbghimrg mh romh k)mhigimfmht dmk)quopm fdocgkm ofpkoqum dghs vatrm trgotmfmht

    CAFFMHTUA]S DCODMZ1

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    ^M]T&AHSAZTOZ

    D]H MSSGOCKOHOW]M1Auo+ ok vaus mst passojkm d)grrtmr taut fafmht vatrm pgrtocopgtoah uh mssgo+ sghs gvaor km `ustoeomr+ so kms cahdotoahs dm saohs km pmrfmttmht(Hghfaohs+ paur vatrm tgt dm sght+ ok mst ohdospmhsgjkm qum vaus ohearfomzkm fdmcoh ohvmstoigtmur dm vatrm dcosoah( Cmkuo&co dcodmrg dm kg fmokkmurmprosm mh cbgrim fdocgkm(

    Dm ffm+ km fdmcoh ohvmstoigtmur+ s)ok km `uim hcmssgorm+ pmut kuogusso dcodmr d)grrtmr vatrm pgrtocopgtoah k)mssgo taut fafmht gprsvaus mh gvaor ohearf( Dms pracdurms prcosms dm sartom dm k)mssgo sahtprvums dghs km pratacakm( Cmt grrt h)gurg pgs dm cahsqumhcm sur vatrmprosm mh cbgrim pgr k)quopm fdocgkm(

    ]h hauvmgu trgotmfmht+ dot trgotmfmht dm rmcaurs pmut trm dahh smkahkms tmrfms prvus dghs km pratacakm dm k)mssgo(

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    W]MKW]MSW]MSTOAHS S]Z

    KM DZA]KMFMHTDM KG ZMCBMZCBM Wumk trgotmfmht fm prapasm&t&ah 1

    Mst&cm uhm rmcbmrcbm egotm cahtrm uh trgotmfmhtdm rermhcm au gvmc uh pkgcmja 1

    kg eoh dm k)mssgo+ paurrgo&`m cahtohumr km trgotmfmhtqum `m vgos rmcmvaor dghs k)mssgo 1

    Wumks saht kg erqumhcm+ km komu mt kg durmdms cahsuktgtoahs mt dms baspotgkosgtoahs 1

    Wumks typms d)mxgfmhs smraht prgtoqus 1

    Wumks saht kms ohcahvhomhts mt kms rosqums 1

    Wum egorm so uh prajkfm survomht 1

    Wumkkm mst kg durm dm k)mssgomt caffmht mh cahhgtrm kms rsuktgts 1

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    W]M SM ^GSSM&T&OK

    G^ZS KMSSGO 1

    KMS ZS]KTGTSDM KMSSGO

    kossum duh mssgo ckohoqum+ kms vakahtgorms sgohs au kms pgtomhts quo ahtt ofpkoqus cahtohumht trm suovos pgr uhm quopm fdocgkm(

    Tautms kms ohearfgtoahs cahcmrhght kms pgrtocopghts kmssgo rmstmrahtcaheodmhtomkkms cgr mkkms saht cauvmrtms pgr km smcrmt fdocgk(

    Tautm pmrsahhm gyght pgrtocop uh mssgo ckohoqumjheocom duh draot dgccs gux cahckusoahs dmkmssgo guqumk mkkm g pgrtocop+ tmk qum km stopukm kmdraot erghgos( ^aur cmkg+ mkkm pmut sgdrmssmr gufdmcoh ohvmstoigtmur quo kg suovo pmhdghtktudm( Ok mst passojkm igkmfmht dm cahsuktmr kmsrmiostrms dms mssgos ckohoqums quo pujkomht kms r&suktgts ikajgux dms mssgos "rpmrtaorm dms mssgosckohoqums dm kGHSF/(

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    ^aurmh sgvaor

    pkusGimhcm Hgtoahgkm dm scurot(

    du fdocgfmht "GHSF/(

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