AEs n SAEs

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    AF (Ahvfrsf fvfets) Hfokekt

    4

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    AF

    Ae AF ks a uekquf rfprfsfetatkie io a spfdkokd fvfet usfh oir l

    hidulfetatkie aeh sdkfetkokd aeacysfs.

    Fadb AF tfrl ks lappfh ti a LfhHPA v ?.> tfrl aeh dihf.

    Talf tfrl aeh dihf usfh ke Japae aeh tbf FV.

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    Ahvfrsf Fvfet dae `f

    ^byskdac skmes aeh sylptils

    A`eirlac ca`iratiry vacufs

    Dbaemfs ke vktac skmes, pbyskdac fxalkeatkie, ir ie ae fcfdtridarhkimral

    Ae kedrfasf ke tbf orfqufedy ir ketfeskty (wirsfekem) io a diehktkie ir tbat was prfsfet `foirf stuhy fericclfet

    Dilpckdatkies oril a surmfry ir pridfhurf

    Ko tbfrf ks aey hiu`t wbftbfr ae fvfet diestktutfs ae AF, kt sbiuch `f trfa

    sudb6

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    ^rf-fxkstkem diehktkies

    Bypfrtfeskie Hka`ftfs

    Diedilktaet lfhkdatkies

    Aetkdiamucaets

    Ttfrikhs

    Itbfr dausfs Xraesouskie rfadtkies

    Addkhfetac kejurkfs

    Pfpirtkem aeh mrahkem ae AF sklpcy rfpirts tbat ae fvfet iddurrfh aesfrkiusefss io tbf fvfet.

    Xbf dckekdkae lust asskme attrk`utkie io tbf fvfet, fktbfr ti tbf ketfrvfetsilftbkem fcsf.

    ?

    Xbfrf arf luctkpcf dausfs io A

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    Tiurdfs io AFs

    Acc hkrfdtcy i`sfrvfh fvfets

    Fvfets hksdivfrfh aotfr qufstkiekem tbf su`jfdt

    Fvfets spietaefiuscy vicuetffrfh `y tbf su`jfdt

    Ca`iratiry, FGM ir itbfr tfst rfsucts

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    Hfokektkie : uefxpfdtfh ahvfrsf fv

    Aey AHP, tbf spfdkokdkty ir sfvfrkty io wbkdb ks eit dieskstfet wktb tbf d

    kevfstkmatir `ridburf.

    Vefxpfdtfh as usfh ke tbks hfokektkie, rfofrs ti ae ahvfrsf fxpfrkfedf tb

    eit `ffe prfvkiuscy i`sfrvfh( kedcuhfh ke tbf kevfstkmatir `ridburf) ratbf

    pfrspfdtkvf io sudb fxpfrkfedf eit `fkem aetkdkpatfh oril tbf pbarladi

    pripfrtkfs io tbf pbarladfutkdac prihudt.

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    ;

    ]bat ks Taofty Turvfkccaed

    Xbf Hftfdtkie, lfhkdac laeamflfet aeh rfpirtkem io ahvfrsf fvfets assi

    wktb ae kevfstkmatkieac prihudt ke addirhaedf wktb tbf pritidic, a

    dilpckaedf wktb MD^ aeh appckda`cf rfmucatiry rfqukrflfets

    Kt pcays a gfy ricf ke Dckekdac Xrkacs

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    AF arf Diccfdtfh Hurkem Xrkacs

    ^ritfdt saofty io patkfets ke tbf dckekdac trkacs, tbriumb appriprkatf lihkok

    io stuhy pritidics, klprivflfet ke stuhy hfskme aeh pridfhurfs a

    efdfssary, tfrlkeatkie iosu`jfdts kevicvflfet ir fvfe tfrlkeatkie io tbf

    Klprivf uehfrstaehkem io tbf ivfracc saofty priokcf io tbf prihudt

    Fvacuatf tbf `fefokts aeh rksgs io a hrum

    ^rivkhf keoirlatkie oir tbf padgamf kesfrt ko a hrum ks largftfh

    Dilpcy wktb rfmucatiry rfqukrflfets

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    Hfokektkie: Tfrkius Ahvfrsf Fv

    Ae AF `fdilfs sfrkius wbfe kt:

    Pfsucts ke Hfatbs

    Ks ckof tbrfatfekem k.f. su`jfdt at kllfhkatf rksg io hfatb oril tbf rfad

    kt iddurrfh f.m. aeapbycadtkd sbidg (eit accfrmkd rfadtkie)

    Pfsucts ke ke-patkfet bispktackzatkie ir priciematkie io fxkstkem bispktack

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    Pfsucts ke a pfrskstfet ir skmekokdaet hksa`kckty ir kedapadkty k.f. hksruptkie

    su`jfdts a`kckty ti darry iut eirlac ckof ouedtkies f.m. alputatkie io cfm

    Ks a diemfektac aeilacy ir `krtb hfofdt

    Ks aey itbfr klpirtaet lfhkdac fvfets, `asfh upie appriprkatf l

    juhmlfet, tbat lay jfiparhkzf tbf su`jfdt ir lay rfqukrf lfhkdac ir s

    ketfrvfetkie ti prfvfet ir avfrt ief io tbf iutdilfs ckstfh a`ivf

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    Tfrkius vs. Tfvfr

    Tfrkiusefss

    Tfrvfs as a mukhf oir hfokekem rfmucatiry rfpirtkem i`ckmatkies7 `asfh

    fvfet iutdilf

    Tfvfrkty

    Hfsdrk`fs tbf ketfeskty io tbf fvfet f.m. lkch, lihfratf, sfvfrf

    F.m. A sfvfrf bfahadbf lay eit `f sfrkius, a lkch strigf rfsuctkem ke hks

    ks sfrkius.

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    AF Fvacuatkie aeh Pfpirt

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    AF Fvacuatkie aeh Pfpirt

    Pfpirtkem Acc AFs ke acc trfatlfet mriups lust `f mrahfh oir sfvfrkt

    assfssfh oir rfcatkiesbkp ti stuhy prihudt

    Acc AFs ke acc trfatlfet mriups lust `f rfpirtfh ie AF dasf rfpirt oirls

    AF tfrl

    Iesft hatf

    Tfvfrkty

    Pfcatkiesbkp ti stuhy prihudt

    Ttuhy prihudt ahlkekstratkie

    Ttatus/iutdilf aeh hatf

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    1?

    Mrahfs

    Mrahf rfofrs ti tbf sfvfrkty io tbf AF.

    Xbf DXDAF (Dillie Xfrlkeicimy Drktfrka oir Ahvfrsf Fvfets) v4.> h

    Mrahfs 1 tbriumb 6 wktb uekquf dckekdac hfsdrkptkies io sfvfrkty oir fadb AF

    ie tbks mfefrac mukhfckef:

    Mrahf 1 : Lkch AF

    Mrahf 0 : Lihfratf AF

    Mrahf 4 : Tfvfrf AF

    Mrahf 8 : Ckof-tbrfatfekem ir hksa`ckem AF

    Mrahf 6 : Hfatb rfcatfh ti AF

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    ^byskdkae Pfspiesk`kckty Pfmarhkem Attrk`u

    ^byskdkaes arf ti hidulfet tbf rfcatkiesbkp (AXXPK@VXKIE) io tbf pri

    ketfrvfetkie ti fadb fvfet.

    Hfskmeatkem ae fvfet as trfatlfet rfcatfh (ir eit) ks hief twi ways:

    1.@y tbf trfatkem DCKEKDKAE:

    Oirlac asskmelfet pfr ahvfrsf fvfet rfpirtkem oirl (ueckgfcy, pi

    ftd.,) at tbf tklf io dckekdac fvacuatkie.

    0. @y Kevfstkmatirs:

    Catfr ke ammrfmatf hata rfvkfw aeh rfpirtkem `y tbf Kevfstkmatirs.

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    Attrk`utkie Ttaeharhs

    1.Verfcatfh: Xbf Ahvfrsf Fvfet ks dcfarcy eit rfcatfh ti tbf kevfstkm

    amfet(s)

    0.Veckgfcy: Xbf Ahvfrsf Fvfet ks hiu`touccy rfcatfh ti tbf kevfstkmatkieac amf

    4.^issk`cf: Xbf Ahvfrsf Fvfet lay `f rfcatfh ti tbf kevfstkmatkieac amfet(s)

    8.^ri`a`cf: Xbf Ahvfrsf Fvfet ks ckgfcy rfcatfh ti tbf kevfstkmatkieac amfet(s

    6.Hfokektf: Xbf Ahvfrsf Fvfet ks dcfarcy rfcatfh ti tbf kevfstkmatkieac amfet(s

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    1;

    Tpiesirs Pfspiesk`kckt

    Fxpfhktfh tbf rfpirtkem io acc sfrkius, uefxpfdtfh AHP ti acc died

    Kevfstkmatirs, Pfmucatiry Autbirkty aeh Ftbkds Dillkttff

    ^frkihkd su`lksskie io acc saofty uphatfs ti rfmucatiry autbirkty

    h c o ` h

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    0>

    Mukhfckefs oir su`lkttkem sfrkius ahvfrsf fv

    Oir prf-largft hrum

    Kevfstkmatir ti KP@

    ueaetkdkpatfh pri`cfls kevicvkem rksgs ti su`jfdts ir itbfrsprilptcy

    Veaetkdkpatfh ahvfrsf hfvkdf foofdts ---ei catfr tbae 1> wirgkem hays

    Acc ahvfrsf hrum rfadtkies tbat arf sfrkius aeh uefxpfdtfh wktbdacfehar hays io tbf kevfstkmatir cfarekem tbf fvfet.

    Kevfstkmatir ti spiesir

    Aey ahvfrsf fvfet tbat lay rfasiea`cy `f rfmarhfh as dausfh `y ir prdausfh `y tbf hrumkllfhkatfcy

    Veaetkdkpatfh ahvfrsf hfvkdf foofdts ---ei catfr tbae 1> wirgkem hays

    Tfrkius ahvfrsf fvfets --kllfhkatfcy

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    Oir ^rf-largft hrum

    Tpiesir ti OHA

    Aey ahvfrsf fxpfrkfedf assidkatfh wktb tbf usf io tbf hrum aeh ks sfrki

    uefxpfdtfhwktbke 16 hays io tbf spiesirs kektkac rfdfkpt io tbf keoirlatkie

    Aey uefxpfdtfh oatac ir ckof tbrfatfekemwktbke = dacfehar hays

    Veaetkdkpatfh ahvfrsf hfvkdf foofdts ---wktbke 1> wirgkem hays

    Oir pist-largft hrum

    Oatac/ ckof-tbrfatfekemwktbke = dacfehar hays

    Tfrkius, uefxpfdtfhwktbke 16 dacfehar hays

    ^ g k

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    ^ist largftkem rfpirt

    _icuetary systfl io rfpirtkem `y bfactb priofsskieacs ir diesulfrs

    Dae rfpirt `y pbief , `y oax (OHA 46>>A oirl) ir ieckef

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    Gfy ^ikets ti Pflfl`f

    Tu`jfdt saofty ks paraliuet ke dckekdac trkacs

    Hkoofrfedfs ftwffe dckekdac pradtkdf aeh dckekdac trkacs wbfe rfpirtkem ahv

    fvfets

    Hfokektkies usfh ke ahvfrsf fvfet rfpirtkem arf rfmucatiry hfokektkies, eit

    dckekdac hfokektkies

    Ahvfrsf fvfets tbat arf sfrkius aeh rfcatfh rfqukrf fxpfhktfh rfpirtkem tb

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    Acc kevfstkmatirs wirgkem wktbke kevfstkmatkieac hrum lust `f keoirlfh io ae

    fvfet wktb tbf hrum tbat ks sfrkius, rfcatfh aeh uefxpfdtfh

    Kevfstkmatir lust keoirl tbf KP@ io aey KEH saofty rfpirts

    ^ritidics sbiuch dietake fxpckdkt hkrfdtkies oir diccfdtkem, assfsskem aeh rfp

    ahvfrsf fvfets

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