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`ixlcompleie and uamzliabie data. By 1"CK«’§CW’i11g.§ Figureg 3, 4, and 5 {cm gages 16-48 of t'hi:~:
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`in this s::c.ii011 is data p1‘:3,<3e11t&:*.{f in ;’-‘x}?epv.311di>~: A of {he
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`in Appauriix 78 of tha *C§11r:(ls:rseu Dec§arai;3'm'::
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`my data on the silmmatograms §a'!:3a:1:2d “p3 (,‘:8~4’” {"0 “1:.=3Gis‘~7”’ and cam only
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`make out fa“-.:Ent images on tha m111a%nde:r oftiac figurzss presented in Appendix B effhe GLLr;€:s31‘sr:~:1a
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`absrsmscz :3? data in She (3-Lmdersen 3)ec3a:'aEi{:.r1 for the e=;hyE 6.i.‘.-f.’.‘T.ai". axizmst GEE. szgperbzz krili lipid
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`sa;rI1;*3}s3::. {see G'L311(‘§f3I’S6E} Dec.1a::3.:L§01:
`
`5}. The fact that no data was generateci far éhese
`
`expe1‘i131entai sampies siaggests tixai the experimezzxt was not comiua’:u:(i caramiiy {see Gundcrsran
`
`Declaration, Appmiiix
`
`pp.
`
`’i{§~«1’e’ for <:§1r0111at0g1':-Jmis Eaba-1334:‘:
`
`P3€}8~4,°’
`
`“S2m'spEe
`
`P3G8—5,’“ and “S-ampica P3{3S—f3”}.
`
`in fact, {:‘:und&:rs5:r: E1:ims€:Efstais°.2s
`
`£113.? the cxpcwiazzenzt “shouid
`
`jr_:_§;3;§__b_§§g1”;}g§m_e§_:;3oussh time for ‘-this”
`
`Gundersen 33:::cE:a;'atim': *1] 5;
`
`empiaasis misled‘).
`
`Ftlrthfitx‘, on page 2 01" Eiixhifii 2 01°
`
`Gu1':<5ie1'sen Deciaratioia, G1mde1‘st3:1
`
`that “$5.2 anal}.-'sis cf the Samples 1:00}; piacszs ‘be’-:wt:s~:-.21 28 Septamber aaad 4 Céctoher‘ 231 L1."
`
`'E‘hemf<31'e, ail witixin the: spam oE'j1::at five b=.13in.t:s.s dz;-.ysn_ the flair.-1 was acqL1ia'£:d, the ciaéa was
`
`a.n3.,‘ayzed, 2; raporf was gem31‘ated, and 2. :i£:c:‘.iaraii0n rega1'£}*;ng anaiysis osfthe data was wrifissng A
`
`oooé/:05
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`000005
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`Attélrsaey E3:‘;£E«;et Na}. I\lEEiPN~[)(} 1132 U S 3 E 3(3fiI§~2<)1 3
`SE-.1‘§:d Nu. 13.r”189f?§4
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`c«::mpEi::a.tefi -s:xp€:1*i11*2em:2.;} amfysis such
`
`this ‘wouid mquire far mcmz: ‘iéme ifi‘;
`
`:.‘.oa1dL1ctc-:d
`
`=_{}I“0p€r’}y. These f’2.ct.<,:
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`21 rush€—;d. e:<peri:‘nent and fiZ3;£a anafiyskal
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`The Gzmdmzgen Dam .S'z.;f‘é;‘3 Fmm ffze Mernory
`
`16.
`
`It
`
`is net only 4:(}1'1‘vc31’:i:IC>13a1 {mt 3330 11e—cessa1'y, when Coxzd‘-.1Cting mass spectn:-zlietify
`
`§:x»n=::‘in.1er1t$fi
`
`.1
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`3:‘
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`‘ta run s0‘we1¥;—m}1v {a/§«:,~‘a “b1ank”‘ or “;‘x:v:*r3.i;i\r*t':”3 <:-antrois at ‘tins. bewi.ra:1i1‘:sz of an
`
`seriment r?s;‘=,§..‘U§=_€.3l__‘v.5f§L*E£CaEsll%fa,..l~’E;h§13§§__§§li«i£2135$niii£1:§iZ§§_§E__§?EiIZ§{§13EE31§E§__§§?.§Ei§_§;____§§_EiE1€i§EZ§§Ei__£iQ§§__Ei§2I
`
`p_;_1;gvi<;‘;.r;: these cmzsiai coirrrois.
`
`Y7.
`
`Tl1r;:se s'_m1}'.‘r‘i§=.d ::.csntm"is are csruciai ‘mcaxise the}; a':cr1'1'ec.‘£ for a techalicrsd difficuity in £11953
`4
`am’.
`
`spe{:§'.:‘<‘.~:‘r:aEr_§,r knovm as the “mc:1‘mry §:ffea‘:‘x” or ‘°ca3fi;y—c>vs:r cafiksct.
`
`For iz'1stan{;e:, L‘on‘:ami11a;:1‘t
`
`specieg fmm a preceding e>:pes'i1n=211ta311:n skews the subsfiquent pmfiéas.
`
`18.
`
`This dcfic.ic:1c:y sf
`
`GLmders<~m Declaration is ;2n*a;:!gAf’ied
`
`Gum;%=31*sen <~:mp1<2ys
`
`muitipkt 1‘eaCfim1 mc311itm'°ir;g,
`
`(-R/i§{..®.E)q a highly seixsitiw: techriiqw: Lzsssai
`
`to detecé vets}; 5rm:zr’£
`
`qa-arzzrzriiies Q;*"5;’g2':ai.3 As the df3‘{f3CE.iC‘>‘;1 is wzry smsitive, any cmss—c-:s11Ea:nénaEiG21 (sf si_;3:3ci(»:s may
`
`completely bi‘-.11“ actuai data.
`
`'1"here€i';re,
`
`the failure 0“? G'u1:de:‘s6:'1 10 ‘.-'“‘&.111 so-1'vs::11i~0n.1_y cantmig, in
`
`a xrarry sez1s1'tiw.:: mass specimnaeiry ansiilmi, casis significani‘ dmzbt umyza the réata pycsentcd in the
`
`i)ecEarat:iG11.
`
`G‘:md:’:rse313’s failure if: c0n‘:mI and €»{)i'i‘8C’E, for the 'me111C-ry effect, in my Qpéniml, p'z‘0h3E31y
`
`rs::.<2.u}.teC§ in im:.c;sr;.'ect c0:m:1usi0r;s regarding fine. id t:11ti;:"§<:ai:’o1'1 of E;3‘Q£)V'L::'E£:S‘.r 0:15: camaot, §1},f:ri3f¢1)Tt";,
`
`e::~;cEu.<i<L*. with any cemfkiezaszs that
`
`sslgj-naiza 3"01n the puaiaffiive or fit‘-f(“)1‘€§1C:‘3
`
`s§emda:‘ds we-re mt
`
`<:2:rried~o\rer to sézqtiarzaéiiai azzmpia mus, \«vhia‘.'h w<,n.I§d z"é:':>.u}i'. in false p<,>si-tive data.
`
`Ft).-3.’ insxtaxice, in
`
`the ciaia pregenéed in the chr0mat0g:“am3 of “‘Samjpk: 1¥’3{}8—E5” and ‘“Samp}e P3{}%§—l€:" {same
`
`€.X::)é‘}\‘i§_?i€:E:’.?‘a1
`
`<;o:'1d:é‘t.‘;o11s5 see Gu::dsrse;1 Declamiion, Appsznciix Be 13. 23} thszrss.
`
`mns£de:.‘ab1e
`
`diffezexaces
`
`in ‘-She peak‘
`
`illifiilsififis ebsmved ’\’*.a'hE;‘I"c“: om: wouid expect essentiaiiy sis'11.iiar
`
`’ it is :'<‘:spect?5,\1}y noted £1121: S€1E].‘:6 0f the s:2z;1p1§:s did :10: arxriw: in the Eaiaoramry where the }u:1cie:se11 D€C}3‘r'3?i{3}1
`experinzeznis were ‘Lmde1':a§<c-tn umii S<:pte:11ber
`2011. This wamld ieavc: 21 maximum of three b’-.2s;im:ss days; :0
`generate data, azmyze data, mile a repcr:'t._ and v.»ri.t{-: a fi.ec1a:'a1é<>z: r<:ga«1réing zmaiysis of these 5-an1pk—:s,
`'1
`
`"i)£:.€zmi1;az.i(>:r1 of Ci3,¥1'3r’(?"v’(fE‘ ami §Tc:m‘t:=.m§nation
`(.15.,
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`Hi);-§‘i1<:.<=:
`Sam
`CE2ra):nat<2g:‘aphic 4¢\s:says." The .!c3:.:z*me? 2{‘2€}'E;
`(3) Afliciiest 42., A,_§}§3€E3(§iX B.
`
`for
`
`Sp:~:s:h'(3n1etz'y«~Basasi
`
`‘ Sec, (:1 I-}'.17:im§' :2; mi, Cum-an? T2’:-sncis in Qtzantitaiive Proteomics, J. fiiazss. 53:23:23;-m.=z., 44 E133‘): 163?—1r‘5If={) {.'2.E}{1'
`Appexxdix C.
`
`0006166
`
`000006
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`

`
`’1E:::1si'Eies. Ei{3we\r‘er, in the 1°<;~:'1m:1; the peak il‘;i'.S§1Sit}’" £5 in the TEEES of theusands, whiie in the
`
`Eatten,
`
`{he
`
`ini:a=:a1si‘ry’
`
`is
`
`in the Km lmndreds
`
`{comp-arts,
`
`fin‘
`
`exa111pE§:.,
`
`ihe ‘-aarioan
`
`<:h:'03‘namg:'a:1'1s sf be-L}‘1). Cfivezx this highly (i£1‘:1in:Es11c3d iutenaiiy,
`
`r.t»'.~:;"mm reaissxmbly .:%—:«:cEude tiara‘:
`
`pi:-s..~3iE3iEii‘_y that the higher signais bied into the suiass-@2511? :'s.m°:2. rccsuits via the m.£:mm;y effect. A
`
`s0}venE.—c-nly cma‘§;1‘0E, which GunC§:31"se:1 failed to run, mméazi have axciudeii the 111e;:m0;'y efbxzzt,
`
`20.
`
`Fuxfiler,
`
`a1*:m:E1e1' poisntial m.anif<-:st~atio:3 of the “1nem<.3ry saffracé" is saw. in the highly
`
`vzzriabks re'££:n:i4_m fimes 1:s:‘es<t1is‘s::d in the €3m1::}crs<::.1:
`
`i}:«:<:1.:a.a2'-1’-:1-:31"; far what is alleged ie be tbs:
`
`same compoumi. For iusianwzc, sefiecmag 2: rammm pair of £3§}I‘{}}'i‘J:3.'i{3§’,T£13'}’1Sq 1:116 butmm traces 01°
`
`*‘Sa1n;sEe P308--1” and “Sample P3{3=8~-'?.,°” are §,s=.1rpm"t:3d tea be the same chemicai species, yet have
`
`disparata 1:'e£s11tios.'2.
`
`timasss. 0?‘ 35.1.81 and 3.747 rnmuatesi,
`
`rs:$pec.tix-'e1§,2. This
`
`3 retezniiun [§1§’1r'3
`
`d.a3viatio11 ef 91-339 ‘:0 26 sc:c<md.s.
`
`'"£‘he:1‘efm'e, in one run {“Samp§:-2 £~"3GE’§-~1“”} {E16 same cmnpeund
`
`is ab0'u‘1 E{}‘.’/i» sifswer tEm.;1 in-T aimihez“ {“Sa.mp1e P3{3S~’?”},
`
`in my 0pini<m,, this ':§3”:{_?i.I.§I,i
`
`:10? E36.
`
`Becaxise of {3us1de1*scn’s failure to run the solvent csisntml, E canmst exciada the mezzmry effect,
`
`in fact, these data are aise izzaiiczfiéve 01*‘ two differ<:3:t.i' chemical species i11eom:ct1y labeled ‘ny
`
`Gu11de"s€:11 as the 33.1112 chezaiicai specirss,
`
`The i'}':,u»2d(»:a~'5en Dara .3z.g4{f"e:-‘s From Paar I€es0:’ua‘z'0n.
`
`2}.
`
`{§L‘=r1d€rsr3;.1
`
`aiso prssaizma f3X[J£’.Ti1‘R”1.t“:1}i£}J data peaks thai are 110% time sharp and ck:-a1'1y
`
`defineci. peaks ihat
`
`mflective of {$162111 Ci11‘:3mat0g,:‘ap11}'.
`
`011 {E16 i;011t:'a1'y, {E16 peakg shmv 3
`
`312001“ ra=::2.ofanim ihai
`
`{hat m~..1itip3e Sp€3Cif:S may be gismsazaat.
`
`22.
`
`F-:>ri1'1stance, the expe:*i:'x1:3ma} runs iabzfied. "‘Samp,’ae P3G8~3 Q’ “Sampic: P308—2,,” “fSa:1113i::
`
`P3G8~3,” “Sampie P':’.~08»14,’“ and "‘ESan1}:s'§_e E’3{38~16"’ are pams::u‘E2::}y bamad zmd asy:':1me:t:'éc:a1,
`
`whic-E2 is; §ru'Ei<:a‘f,i\«'e of 3. p0p:1Ea*ai0;1 of unlmown species in a ‘“pcak”’ as oppmsasfi to a siilgie
`
`spscias.
`
`in c9:ntrast,
`
`6. stlngie speczies,
`
`is expecéed to give a siaarp gweak in théi form of 1% Eight
`
`Ga:13sian~shapc:d curve;
`
`23.
`
`in ss.nmnar§,g it is my BpiI'1iU11 that the Gunderse;1 Declaraiicwal suffars from a number‘ 03“
`
`xiieficimcies, incimfizag inccrrect and u.m“e‘iiab1£: {lai‘a, rushed a':>:+s:c:u1i<"m, and :~:xTpe;~1-imcmtai
`
`:3::mrs
`
`which rctn¢;‘ict3:
`
`::0;a<:'iu:::ic>ns cexzapieteiy u:1;'£:‘ii23?;sEE= and not credible. As an €:>;p<:::“:
`
`E
`
`::;2:mrmt give
`
`the resuits paesemed in me Gjumiersen d€C§§1TEi§‘i§)}3. any wczight.
`
`0006707
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`000007
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`Attm~;:0§’ flocket N0. NEE?N—OG1,"G2US 3 °s663~2
`Seriai N0. EH3.
`; 89,7153-
`
`O33
`
`Thfi ‘White Beciztratian 0%“ Mav 33. 283.}. §.’§'f’:S{:§liS Smmd Raw {Ema and 3 Reawnabie
`
`(Envy;-iii Cfsmtiusieu.
`
`24.
`
`I hzwe:
`
`:.~:f%s0
`
`r<~:::u;i
`
`3
`the: Deciarzxiion cf Bari L. White E’h.£l3.
`
`that
`
`mbmitteci
`
`in thsa
`
`}3';‘0secutim1 0'f't‘ne
`
`g_>at:3:1i011 May 31, 201% and I he1v0‘-13:36:11
`
`to provide an é11depcndent
`
`0va’Euaéia;3n of the <:0r:‘ect:1ess (3%? its a:0a1c:1'usi0:1s.
`-v
`De<;Iara'i‘.~£0n pwovides data. that is c:xpa:1*i1nem:aE§v siyuznd am} has a 1‘aEia‘:3Ee £:<:rm:Ius%.0n.
`
`L.3n.Eike. the (3ux‘:ci<3rs.e.n E}€:r:1arai'é0r1,,
`
`{E16 Whiie
`
`3. LzmEe1‘st:;111fi. Dr. White‘s czmclusiim to be that it is his "“api11i0n that the Beaudoiaa Oil
`
`1*‘:'acti0~11s re€E:ived and {ester} by {Emu} da not atgmtain PLS [p110sph;31ipids} wiflch have attaclaed
`
`10 *-sham BSA and DHA, EPA and EPA, DHA and EPA, 0;’ EPA and B}-SA; at the dai'e::tio:1 Eémits
`
`Liescribed [LCf:‘»'1S and MSJMS fi0;..:1niqus3s}."’
`
`"£‘ha>.z‘<~:f(:s1'e., Dr. White esouid not find any species
`
`{hat comic} be definitiveiy identifieii
`
`ihtase discicsed and <:E:=;;3ms:-d in the ‘.348 pa‘f,c':n.t. This
`
`3,
`
`rsas.~:€_ma1:1Ee c.oa‘m.3usim1based on ‘L110 exparixnental dam.
`
`26,
`
`E§€3m.a::
`
`cm‘r:1‘:1e:‘.Laz‘"3,*' an the W}1iie Dec:Ea1'ati011 of May 31, 2310 is heipfui
`
`fur
`
`112‘1dcrsta11di11g ii.
`
`27“
`
`First, it my expert 0pfi11£c>;1 thaé the raw a2.7ma ceiiecteai by Br. W’hi:ei:
`
`C€31"§’e€)C;I
`
`{lass
`
`not suffer from the many flaws seen £21: Gunderseafs <ia.i':»1.
`
`28.
`
`Secanfi, Dr.
`
`\?\r’AE*1ite.’s Deciaraiion of May 3}, 2{}3{) does have a couple 0?‘
`
`‘m1'.n0r
`
`i7mf(2rp:*(:*:‘.»:2f'.i12c:' ¢:r1“0rs that $0 _:_g_g_i_' affmt £333 *v‘aiédéij~,«‘ of the {aw data 01‘ the overall eonchzsion (ale;
`
`that Dr.
`
`‘vV§1i§:e: ceufid 120$, w:':‘hin the limits of ris.=:*;ecti0n._ fim any Spembs that ¢.0'u1d be
`
`:'1s:'fin.iti.w:?Iy id =0‘m.f3e—d as fiigase disciased and cE.ai1m:d
`
`tE1e. ‘S48 patem}.
`
`A fiysf n'1inar envy 3105 in Figure 10 0f the {)6-.c1a1'a’zi<_m ofbr. Rfifihite 01” E\-4.33;’ 33, 2.{}1(}.
`
`E
`
`undersEan_d that? this 2.‘”:gum=: was §11c1'e;1da3c§ because Ehrga 291 1 Beauduin oi} cfdri amt pmduce producii
`
`iuns suszh Eh:-It E531‘.
`
`\?v’}1i‘03 cacr-01:7‘; :10: identify’ species that :night have beer: *i;h0se discicased and
`
`cfiaéxned in ihe ‘.348 paient.
`
`I132“. Whéia iricludefi Figures 9 and ii in suppofi 0f this c«;mciusi031,
`
`H<3\a.='ever, it appears that because Dr. Whiie xiii} not detect cha1‘act&1'istic pmciaxct rims thai are
`
`::1s:erEe~;“i
`
`to defi.nit:i'v‘e}y i:*§emi.fy‘ €113
`
`,=Z‘;:»:t’ry acidr~3 a0tEa:<:3u=:d
`
`3.0 the ph0sp}10'§ipiCEs at the moiecruiar
`
`weights of 826 am’ 853 he iiiciuded, fiaif 0c¢1';:§:2::'§s0:1, Fig‘-;n':=: IO, °‘1°rm~n a prexréous Be3.uri{)in 0&1?”
`
`2: “a"epr::se:1ta.tiw: F»/§S.r‘}‘vE&1 s§3::c:‘tru.m ft»? :5; Ejphosphatidyiciaoiintzé with a 21101000301‘ ion at m/.2
`
`O0O(§)8
`
`000008
`
`

`
`8'43.” See White D-s:c.Ea1'ati0n 0%‘ May 31, 2811, FigL1:'<a H} iegenci and
`
`12. This figure Shows
`
`Mmz‘. a SpaL‘.§(-:;~_‘: ai the vueight of a ;3E1asph.o}ipi6i of EEK» EPA would 10:33: Eike if it ccsuid be
`
`fi"ag1‘na12ée{3
`
`that pwsiucé isms c.0u.1d bsi: destecifid. This
`
`why Dr. Vfl1'ite r:;epa1‘ai§:d this
`
`figure from the aiE3ez‘s in
`
`12 of the 'Whiie I)ee:?§e1ratim.1, wE3i.c11 states: “.:‘viSx'i"~AS speattra for a
`
`:'<2pm>.se11'tativ2 Besauda-£11 Oil F1~ac’du-11 samjshs are showxl in i¥‘i<gures;
`
`ii»--93 and 11.
`
`.i§*‘ig“:11‘e
`
`'30 is a
`
`ieinpirzasis zaeidxé-'3}. This, to 2.:m“:, is 2: clear izxclécation tE‘1a’e" Dr, White décié mi? iufend. $0 presaiai
`
`Figgum 10 as part of ihe expe:*im:.=.nta1
`
`up-{an wéaicia he was Qpining in May, 20:}. This is
`
`‘bolstered by a stat’:=:.me:T1t in Hm figire legend 05 Figure E0, in whida it is sta.te.ci Ehai ths: 3.11a§yze:d
`
`s:.«m1pie is “fmm a ;g:"eviaus Beaudein ail.”
`
`in fas:r;, Dr. White aiso imflucied the date of the
`
`e;xpe:‘in’§en=; in ?.'i:1c ::g:p:3r1m“: ::m°m=.rs ufc-:21a:.E1 ofthe sgaazctra imtiuxied in the. fi set. Figure: 30 9f
`
`the Whit»: Eéeclamtiorx 0:” Ma r 31. 201} has the ‘i2{b<:’E “%I}E3E3a~:~.c€}'?”
`,
`
`indicatixrr that it
`.5
`
`is»; from a
`
`’E)ecem‘;:e:; ;>(}€}9 ex.per1'men1i w§1i‘:c ali of the etimg f.Egu1"es {1»-‘.}‘, 11} 11am: {Eats 13.19213 of Ami‘: or
`
`_i\-€331, 2{}1i., iildicatiilg, that they are fmm the expemilasiiis Cf}fl”m‘JiSSii31'1€C.
`
`for prosecmicm 1")? the
`
`‘.348 patem‘.
`
`311}.
`
`E have reviewed an expemzleniai §'epm't
`
`'fm,m ‘the 2{}()E? +.=:xt:‘acri:io11 {.A;3§3e31dix B} and
`
`cm1<:§u.d.<-3 iimf, E3e::a.u'::t°. C>f1”hc-: aixpr:fiI1.n@11ta£ (")1‘I”O£‘S in r§:p1'csduc:i:1g Ba:-zmcioin, {hit 2809 Sfi1E‘1j._§§Ef‘.S {Ff
`
`‘f3igu;*e 10 are
`
`“Be2:ud0’i.r1 m‘1.°’
`
`’E‘h::s, Dr. White’s sta:e1‘ne12tt§ms: Figure "EU is “fmm p;1f_§_y'_j§_‘g_§
`
`§3e:’:aud.0.ix1 m1” is témmemas. As aiatscxfaed in the c:x:p€;1*i:m:nta1
`
`1'§.’.§.",1{)I‘t, the pm~::edL:re remzwmi the:
`
`water from the ml and did ma’: adfiquaateiy beat.
`
`'I'i':ers3fc3§’e2 it wauicii he e7<p.e<:i.ied ma: 3:115: 01'} 6:?‘
`
`Figure 10 .<.~‘.irxm>u:2, en0ug,E'1 m/z 826 5p:;~:€.is:s
`
`In aikmr pr<3du<:t inn :§e:ectim1 {See Apgenaiéx E3).
`
`3
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