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`
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`LC control no.: sh 85099890
`LCCN Permalink: https://lccn.loc.gov/sh85099890
`HEADING: Periodicals
`000 01324cz a2200337n 450
`001 4749694
`005 20120717060125.0
`008 860211 | anannbabn |b ana
`010 __ |a sh 85099890
`035 __ |a (DLC)sh 85099890
`035 __ |a (DLC)6226910
`035 __ |a (DLC)sp 85099890
`035 __ |a (DLC)314952
`040 __ |a DLC |c DLC |d DLC
`053 _0 |a AP |c General periodicals
`053 _0 |a PN4700 |b PN5650 |c History
`150 __ |a Periodicals
`360 __ |i subdivision |a Periodicals |i under specific subjects, e.g. |a Engineering--
`Periodicals; United States--History--Periodicals
`450 __ |a Journals (Periodicals)
`450 __ |a Magazines
`550 __ |w g |a Library materials
`550 __ |w g |a Mass media
`550 __ |w g |a Serial publications
`550 __ |a Newspapers
`550 __ |a Press
`670 __ |a UMI business vocab. |b (Journals)
`680 __ |i Here are entered works on the periodicals of the world and, with appropriate
`subdivisions, works on special aspects or sections of periodicals. Works on periodicals
`in a specific language, or in a specific country or larger area, are entered under the
`adjectival form of the language or area, e.g. |a Arabic periodicals; Canadian periodicals.
`906 __ |t 0420 |u te03 |v 0
`910 __ |a Proposal saved by tc03 on 05/14/2012 at 17:15:30
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`
`

`

`ATTACHMENT 1e
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 628 of 852
`
`

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`reopened to visitors via timed, ticketed entry. More.
`
`LC control no.: sh 85063723
`LCCN Permalink: https://lccn.loc.gov/sh85063723
`HEADING: Hypertension
`000 00516cz a2200205n 450
`001 4714924
`005 20120326100035.0
`008 860211i| anannbabn |a ana
`010 __ |a sh 85063723
`035 __ |a (DLC)sh 85063723
`035 __ |a (DLC)61609
`040 __ |a DLC |c DLC |d DLC
`053 _0 |a RC685.H8
`150 __ |a Hypertension
`450 __ |a Blood pressure, High
`450 __ |a High blood pressure
`450 __ |a Vascular hypertension
`550 __ |w g |a Blood circulation disorders
`906 __ |t 9106 |u fk07 |v 1
`953 __ |a xx00 |b ff04
`
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`Hikma Pharmaceuticals
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`IPR2022-00215
`
`Ex. 1013, p. 629 of 852
`
`

`

`MARC Display (Library of Congress Authorities)
`
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`
`URL: https://www.loc.gov/
`
`Mailing Address:
`101 Independence Ave,
`S.E.
`Washington, DC 20540
`
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`URL: https://catalog.loc.gov/
`
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`IPR2022-00215
`
`Ex. 1013, p. 630 of 852
`
`

`

`ATTACHMENT 1f
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 631 of 852
`
`

`

`2020073
` Re
`1221429
`place
`.5
`d
` Lang
` Ctry
` __
` ,
`
`
`1554748 No holdings in XXX - 1155 other holdings
` OCLC
`
` En
` Re
`
`c
`
`c tere
`
`Stat
`d
` ELvl
` GPub
` Ctrl
` Form
` Freq
` MRec
` Orig
` Regl
` Alph
` SrTp
` DtSt
` Dates
`010 51008753
`040 MUL $b eng $c MUL $d OCL $d UCU $d MUL $d NSD $d DLC $d NSD $d SER $d RCS $d AIP $d NSD
`$d AIP $d NSD $d AIP $d NSD $d OCL $d NSD $d NYG $d NSD $d HUL $d DLC $d NST $d OCL $d NST $d
`DLC $d CUS $d IUL $d DLC $d NSD $d OCLCQ $d DLC $d OCL $d NLGGC $d LVB $d CUS $d EEM $d
`WUOHS $d OCLCQ $d AU@ $d BLBSF $d UKMGB $d OCLCQ $d WHF $d OCLCO $d P4I $d KLH $d WIC $d
`EUW $d OCLCO $d OCLCQ $d OCLCO $d OCLCF $d OCLCO $d PRB $d MTG $d ZAS $d OCLCQ $d ATVSV
`$d IBO $d CSA $d CSJ $d TFH $d UIU $d NJR $d OCLCQ $d CSAIL $d OKS $d CAHUS $d BUF $d ZAP $d
`GILDS $d CNO $d CCH $d GZM $d MRM $d PAU $d DXU $d TORON $d OCLCO $d DCHUA $d CUI $d
`OCLCO $d OCLCA $d LGG $d W2U $d NZHMA $d U3G $d YOU $d L2U
`012 3 $b 3 $e n $i 8702 $j 4 $k 1 $l 1 $m 1
`016 7 C22640000 $2 DNLM
`016 7 009549936 $2 Uk
`019 11292471 $a 219861143 $a 818653317 $a 926189493 $a 976548462 $a 1003612187 $a
`1062027881 $a 1078053466 $a 1153416976 $a 1167041665
`022 0 0009-7322 $l 0009-7322 $y 009--7322 $y 0065-8499 $z 0069-4193 $z 0069-0406 $z 0065-8502 $2
`1
`030 CIRCAZ
`032 113720 $b USPS
`042 nsdp $a pcc
`050 00 RC681.A1 $b C5
`060 00 W1 CI743
`082 04 616.105
`090 $b
`210 0 Circulation $b (N.Y.N.Y.)
`222 0 Circulation $b (New York, N.Y.)
`245 00 Circulation.
`260 [Dallas, Tex., etc.], $b [American Heart Association, etc.]
`300 volumes $b illustrations $c 28 cm
`310 Weekly (except the first two weeks in Jan. and the last two weeks in Dec.), $b <Apr. 8, 2003-
`321 Monthly, $b 1950-
`336 text $b txt $2 rdacontent
`337 unmediated $b n $2 rdamedia
`338 volume $b nc $2 rdacarrier
`362 0 v. 1- Jan. 1950-
`510 2 Chemical abstracts $x 0009-2258
`
`197
`508
`17
`
` Srce
` Conf
` EntW
` Cont
`
`
`
`
`
`
`
`
`
`_ _
`
`
`
`__ Type
`
`__ BLvl
`
`__ S/L
`
`__ Desc
`
`
`
`__
`
` _
`_
`
` __
` __
`
`
`
`Continuing Resources
`
`a
`
`1
`
`c
`
`
`
`
`
`eng
`
`s
`
`
`
`0
`
`w
`
`
`
`txu
`
`0
`
`
`
`
`
`n
`
`a
`
`
`
`p
`
`
`
`c
`
`1950
`
`9999
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 632 of 852
`
`

`

`525 Has annual supplements with titles: Cardiovascular surgery, 1962-, and: Abstracts, 1964- ; also has
`occasional additional supplements.
`525 Supplements for 1962-63 and <1982 lack "supplement" in title.
`525 Supplements for 1987- also called: Circulation monograph, no. 1-
`555 Vols. 1-52, 1950-75. 1 v.
`580 Some supplements also issued as: American Heart Association monograph, 1962-85; and,
`Monograph (American Heart Association), 1986.
`580 Includes: Hypertension, v. 12 (published as Aug. 1964 supplement), which is also available
`separately.
`588 Latest issue consulted: Vol. 107, no. 14 (Apr. 15, 2003).
`650 0 Cardiology $v Periodicals.
`650 0 Cardiovascular system $v Periodicals.
`650 0 Hypertension $v Periodicals.
`650 2 Blood Circulation $x periodicals.
`650 2 Cardiovascular System $x periodicals.
`650 6 Cardiologie $v Périodiques.
`650 6 Sang $x Circulation $v Périodiques.
`650 6 Appareil cardiovasculaire $v Périodiques.
`650 7 44.85 cardiology. $0 (NL-LeOCL)077596765 $2 bcl
`650 7 Cardiology. $2 fast $0 (OCoLC)fst00847121
`650 7 Cardiovascular system. $2 fast $0 (OCoLC)fst00847172
`650 7 Hypertension. $2 fast $0 (OCoLC)fst00965831
`650 17 Bloedvaten. $2 gtt
`655 0 Electronic journals.
`655 4 Electronic Journals.
`655 7 Periodicals. $2 fast $0 (OCoLC)fst01411641
`655 7 Periodicals. $2 rbgenr
`710 2 American Heart Association.
`710 2 American Heart Association. $t Abstracts.
`730 0 Cardiovascular surgery.
`730 0 Circulation monograph.
`770 0 $t Cardiovascular surgery $w (DLC) 66009486 $w (OCoLC)1586259
`776 08 $i Online version: $t Circulation (Online) $x 1524-4539 $w (DLC)sn 99003671 $w
`(OCoLC)38425031
`787 1 $t Hypertension $x 0073-425X $w (DLC)sn 79005036 $w (OCoLC)1643474
`787 1 $t American Heart Association monographs $x 0065-8499 $w (DLC)sf 81001017 $w
`(OCoLC)1695120
`787 1 $t Monograph (American Heart Association) $x 0891-320X $w (DLC)sn 86003055 $w
`(OCoLC)13757741
`850 CPT $a DLC $a InU $a MBCo $a MSobPR $a N $a NjR $a OU
`856 41 $u http://www.circulationaha.org/
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 633 of 852
`
`

`

`ATTACHMENT 2
`
`(Grimsgaard)
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 634 of 852
`
`

`

`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 635 of 852
`
`

`

`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 636 of 852
`
`

`

`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 637 of 852
`
`

`

`purified
`Highly
`docosahexaenoic
`triacylglycerol-lowering
`serum fatty
`acids13
`
`acid and
`eicosapentaenoic
`have
`similar
`acid in humans
`effects
`but divergent
`
`effects
`
`on
`
`Sameline
`
`Grimsgaard,
`
`Kaare
`
`H B#{216}naa,John-Bjarne
`
`Hansen,
`
`and
`
`Arne
`
`Nord#{248}y
`
`ABSTRACT
`ester
`concentrates
`hexaenoic
`acid
`
`To
`of
`
`(DHA)
`
`phospholipid
`placebo-controlled,
`
`fatty
`
`effects
`
`the
`compare
`eicosapentaenoic
`on
`serum
`lipids,
`
`highly
`of
`(EPA)
`acid
`apolipoproteins,
`
`purified
`and
`and
`
`ethyl
`docosa-
`serum
`
`oils
`relative
`
`varying
`content
`
`in
`
`dosage
`of DHA
`
`the
`
`fatty
`
`dose
`total
`form,
`and
`acids,
`of
`data
`these
`of
`Examination
`and EPA.
`on
`acids
`fatty
`effect
`of
`n-3
`in
`serum
`factors
`is a reduction
`effects
`on
`whereas
`reported
`possible
`that
`(3-5).
`It
`is
`in
`small-
`chance
`findings
`study
`design.
`However,
`they
`metabolic
`effects
`of DHA
`
`humans,
`design
`
`we
`conducted
`intervention
`
`a double-blind,
`study.
`Healthy
`
`aged
`
`36-56
`
`y were
`
`randomly
`
`assigned
`
`g EPA/d,
`Serum
`DHA
`
`with
`in
`group
`
`mmolIL
`total
`
`or
`de-
`
`=
`
`of
`
`the
`
`ratio
`
`studies
`compartments
`both
`in
`attenuated
`proteins
`effect
`a more
`
`showed
`
`beneficial
`be
`EPA
`may
`vitro
`1 1).
`In
`effects
`that
`
`EPA
`body
`
`that
`the
`in
`metabolism
`expression
`in
`human
`of DHA
`potent
`
`on
`EPA
`
`the
`
`in
`
`subject
`DHA
`and
`
`sug-
`(9),
`than
`DHA
`and
`the
`in
`
`acids
`in
`parallel
`(n =
`men
`234)
`nonsmoking
`supplementation
`to dietary
`g DHA/d,
`3.6
`3.8
`with
`(placebo)
`triacylglycerols
`7 wk.
`for
`oil/d
`4.0
`g corn
`(P <
`creased
`(P
`group
`and
`21%
`the
`in
`0.0001)
`26%
`group.
`the
`corn
`oil
`compared
`EPA
`group
`the
`0.0001)
`in
`serum
`triacylglycerols
`decreases
`net
`significant,
`not
`Although
`in the DHA
`across
`all quartiles
`greater
`were
`consistently
`Serum
`high-density-li-
`concentrations.
`baseline
`triacylglycerol
`poprotein
`(P =
`0.0002)
`in
`increased
`0.06
`cholesterol
`cholesterol
`decreased
`DHA
`group.
`In the EPA
`group,
`serum
`A-I
`decreased
`0.15 mmol/L
`(P =
`0.04
`apolipoprotein
`and
`0.02)
`DHA
`phospholipid
`serum
`group,
`In
`the DHA
`gIL
`(P
`=
`0.0003).
`retro-
`by
`29%,
`indicating
`increased
`by
`69% and EPA
`increased
`conversion
`of DHA
`phospho-
`to EPA.
`In the EPA
`group,
`serum
`by
`15%,
`lipid
`EPA
`increased
`by
`297%
`whereas
`DHA
`decreased
`not
`elongated
`to DHA
`in
`humans.
`The
`suggesting
`that
`EPA
`is
`n-6
`of
`n-3
`to
`fatty
`acids
`increased
`in
`in
`changes
`relative
`n-6
`fatty
`the
`desaturation
`in liver
`activity
`alterations
`both DHA
`and EPA
`decrease
`conclude
`that
`effects
`on
`lipoprotein
`but
`have
`differential
`Am
`J
`Clin
`metabolism
`in
`humans.
`
`phospholipid
`serum
`whereas
`groups,
`both
`possible
`suggested
`DHA
`group. We
`triacylglycerols,
`fatty
`acid
`1997;66:649-59.
`
`acids
`in the
`serum
`and
`Nutr
`
`KEY
`aenoic
`lipids,
`
`Fatty
`WORDS
`docosahexaenoic
`acid,
`randomized
`controlled
`
`acids,
`
`n-3
`acid,
`trials
`
`acids,
`fatty
`triacylglycerols,
`
`eicosapent-
`phospho-
`
`of
`
`consistent
`most
`that
`shows
`risk
`disease
`cardiovascular
`concentration,
`triacylglycerol
`are
`less
`consistent
`other
`variables
`derive
`from
`the
`inconsistencies
`or differences
`in
`scale
`studies
`may
`also
`be attributed
`varying
`to
`EPA.
`and
`Animal
`different
`to
`differences
`selectively
`proinflammatory
`gesting
`a
`whereas
`(10,
`DHA
`different
`have
`it was
`suggested
`hypotriacylglycerolemic
`rats
`(13)
`and
`humans
`can
`be
`generalized
`design,
`however.
`is
`and
`DHA
`needed
`effects.
`Long-term
`paring
`the
`biological
`human
`volunteers
`therefore
`conducted
`controlled,
`parallel
`effects
`dietary
`or DHA
`on
`serum
`pholipid
`fatty
`acid
`
`with
`
`studies
`indicate
`triacylglycerol
`is
`primarily
`effect
`of
`n-3
`The
`(14).
`extent
`is
`constrained
`Knowledge
`of
`to
`target
`n-3
`studies
`of
`effects
`been
`not
`have
`double-blind,
`a
`intervention
`design
`supplementation
`with
`lipids,
`apolipoproteins,
`composition.
`
`accumulate
`DHA
`and
`may
`be
`thus
`and
`(6-8).
`effects
`and
`proatherogenic
`of
`endothelial
`cells,
`on
`atherosclerosis
`platelet
`inhibitor
`and
`(12),
`for
`both
`reports
`study
`in
`of EPA
`specific
`size
`com-
`EPA
`and
`14-16).
`placebo-
`evaluate
`EPA
`phos-
`
`that
`EPA
`synthesis
`responsible
`fatty
`acids
`to which
`these
`limitations
`by
`specific
`effects
`supplements
`for
`adequate
`sample
`pure
`DHA
`reported
`(10,
`randomized,
`study
`highly
`and
`
`to
`purified
`serum
`
`in
`We
`
`INTRODUCTION
`
`Accumulating
`eicosapentaenoic
`noic
`acid
`(DHA;
`variety
`cellular
`of
`lism,
`atherosclerosis,
`The
`mation
`(1).
`different
`marine
`studies
`n-3
`
`of
`
`that
`
`(EPA;
`
`indicates
`20:5n-3)
`the
`n-3
`associated
`
`of
`
`evidence
`rich
`oil,
`fish
`acid
`docosahexae-
`and
`can modify
`family,
`22:6n-3)
`lipid
`metabo-
`with
`processes
`and
`inflam-
`thrombosis,
`hypertension,
`amount
`and
`to
`EPA
`ratio
`of DHA
`the
`2).
`Earlier
`considerably
`(1,
`vary
`sources
`fatty
`acid
`supplementation
`humans
`used
`
`in
`
`in
`
`a
`
`in
`
`(cid:1) From
`Medicine,
`2 Supported
`
`Institute
`the
`University
`by
`
`and
`Medicine
`of Community
`of Troms#{248},Troms#{248},Norway.
`grants
`from
`the Norwegian
`Research
`
`the
`
`Institute
`
`of Clinical
`
`Council,
`
`Pronova
`
`AS,
`Biocare
`3 Address
`Medicine,
`Received
`Accepted
`
`Foundation.
`Research
`and Odd Berg Medical
`Institute
`reprint
`requests
`to
`S Grimsgaard,
`University
`of Troms#{248},N-9037
`Troms#{248},Norway.
`July
`16,
`1996.
`for publication
`
`April
`
`18,
`
`1997.
`
`of Community
`
`Am J Clin
`
`Nutr
`
`1997:66:649-59.
`
`Printed
`
`in USA.
`
`© 1997
`
`American
`
`Society
`
`for Clinical
`
`Nutrition
`
`649
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 638 of 852
`
`

`

`650
`
`GRIMSGAARD
`
`ET
`
`AL
`
`SUBJECTS
`
`AND METHODS
`
`Subjects
`
`and
`
`experimental
`
`design
`
`aged
`the
`1)
`
`of
`old
`
`the
`
`men
`living
`
`survey
`about
`habits,
`
`in
`(visit
`previous
`and
`their
`serum
`lipid
`seven
`men
`be-
`according
`to
`the
`nonsmokers,
`did
`consumed
`less
`and
`They
`diet.
`also
`had
`mmollL,
`diastolic
`blood
`pressure
`1993
`to undergo
`medical
`history,
`
`<
`
`a
`
`or
`
`to
`Their
`study
`and
`
`The
`ethics,
`
`according
`began
`with
`asked
`to
`which
`
`At
`
`the
`liver
`
`to Good
`a 4-mo
`continue
`their
`blood
`two
`were
`measured
`intake
`subject’s
`average
`visit.
`the
`beginning
`study,
`participants
`oil
`or
`other
`
`Clinical
`run-in
`usual
`their
`pressure
`on
`
`Prac-
`period
`diet
`and
`oc-
`of
`of
`were
`fish-oil
`
`of
`
`the
`
`a subject’s
`study,
`the
`run-in
`during
`cholesterol
`serum
`25 1 subjects,
`2 were
`concentrations
`drugs,
`and
`reasons.
`inter-
`ran-
`either
`
`1
`10
`
`group
`
`35
`they
`
`to
`
`than
`
`the
`
`to
`
`<
`
`the
`
`81.3%
`subjects,
`826
`21
`1986-1987,
`In
`y
`20-56
`aged
`women
`the
`and
`y
`old
`20-61
`in a health
`of Troms#{248},participated
`municipality
`questionnaire
`subjects
`completed
`a
`(17).
`All
`drugs,
`disease,
`and
`smoking
`diet
`use
`of
`and
`and
`nonfasting
`weight,
`blood
`pressure,
`height,
`Four
`hundred
`concentrations
`were
`measured.
`ages
`tween
`the
`of
`and
`55 were
`selected
`criteria:
`following
`reported
`being
`healthy
`not
`nonprescribed
`use
`or
`prescribed
`drugs,
`fish
`dishes
`than
`four
`per week
`in their
`usual
`serum
`cholesterol
`concentrations
`8.0
`<
`and
`blood
`pressure
`95 mm
`Hg,
`systolic
`<
`in
`then
`These
`160 mm Hg.
`men
`were
`asked
`clinical
`examination
`that
`included
`a complete
`physical
`examination,
`and
`laboratory
`tests.
`251
`invitation,
`the
`Among
`the
`349
`who
`responded
`to
`men
`and were
`recruited
`criteria
`subjects
`filled
`the
`above-mentioned
`no
`cardiovascular,
`liver,
`had
`into
`present
`study.
`They
`the
`diabetes
`mellitus;
`psycho-
`renal
`disease;
`bleeding
`disorder;
`or other
`that
`can
`influ-
`pathologic
`disease;
`alcoholism;
`disease
`metabolism,
`hemostasis.
`They
`or
`ence
`blood
`pressure,
`lipid
`did
`diets
`and
`not
`special
`expect
`change
`were
`not
`consuming
`their
`the
`study
`period.
`mean
`diet
`or
`lifestyle
`during
`(±
`age
`(range:
`36-56).
`was
`±
`SD)
`was
`44
`5
`y
`board
`of
`research
`each
`regional
`by
`approved
`the
`gave
`consent.
`subject
`informed
`study
`The
`was
`performed
`tide
`It
`requirements
`(18).
`which
`subjects
`were
`during
`during
`and
`living
`habits
`and
`fasting
`serum
`lipid
`concentrations
`casions
`(visit
`2 and
`visit
`3). Each
`nutrients
`was
`calculated
`on
`a fourth
`the
`run-in
`period
`and
`throughout
`instructed
`not
`ingest
`cod
`supplements.
`phase
`intervention
`the
`into
`For
`entry
`mean
`concentration
`triacylglycerol
`serum
`mean
`and
`be
`5.0 mmol/L
`period
`had
`<
`9.5 mmol/L.
`the
`Among
`concentration
`smokers,
`or
`triacylglycerol
`serum
`glucose
`2 had
`above
`2
`used
`cardiovascular
`inclusion
`criteria,
`consumed
`week,
`fish
`dishes
`per
`more
`three
`period
`personal
`during
`run-in
`for
`out
`dropped
`entered
`the
`double-blind,
`parallel
`234 men
`Thus,
`which
`lasted
`trial,
`vention
`for
`7 wk.
`Computer-generated
`to
`were
`used
`to
`assign
`the
`participants
`numbers
`dom
`or
`DHA/d,
`ester
`EPAJd,
`4.0
`g 90%
`ethyl
`ester
`g 95% ethyl
`4.0
`in
`The
`dietary
`supplements
`were
`administered
`g corn
`oil/d.
`4.0
`soft
`gelatin
`1 .0 g
`that
`capsules
`each
`contained
`indistinguishable
`oil
`and
`4-6
`1). Each
`IU vitamin
`E as
`an
`antioxidant
`(Table
`was
`to ingest
`asked
`two
`capsules
`in the morning
`and
`individual
`at night.
`The
`dietary
`supplements
`two
`capsules
`were
`manufac-
`Biocare
`by Pronova
`AS,
`tured
`Oslo.
`Participants
`examined
`after
`and
`two
`separate
`
`0800
`
`were
`1 1 30
`on
`
`overnight
`an
`occasions
`
`fast
`separated
`
`between
`by
`
`an
`
`TABLE
`Composition
`
`I
`
`of
`
`dietary
`
`supplements’
`
`Constituent
`
`22:6n-3
`20:5n-3
`l8:2n-6
`l8:ln-9(mg)
`Vitamin
`p-Anisidine
`Peroxide
`
`ester
`ester
`
`(mg)
`(mg)
`
`Ethyl
`Ethyl
`(mg)
`
`E (IU)
`value
`value
`(mmol/g)
`
`DHA
`
`889
`18
`0
`0
`4-6
`<35
`<0.01
`
`EPA
`
`12
`941
`0
`0
`4-fl
`<35
`<0.01
`
`Corn
`
`oil
`
`0
`0
`559
`259
`3.7
`
`-
`-
`
`were
`supplements
`I Dietary
`average
`g
`gelatin
`capsules
`of
`I .4
`supplement:
`EPA,
`eicosapentaenoic
`
`in
`given
`weight.
`acid
`
`oblong,
`indistinguishable,
`DHA,
`docosahexaenoic
`supplement.
`
`soft
`acid
`
`d, both
`
`of 3-5
`interval
`of
`supplementation
`sure
`was
`measured
`to
`ipants
`were
`asked
`cise
`before
`for
`48
`h
`in
`performed
`the middle
`compliance,
`side
`study
`pliance
`was
`assessed
`calculated
`as the
`also
`We
`measured
`tions
`at baseline
`
`(visits
`at baseline
`8). At
`(visits
`7 and
`and
`blood
`samples
`and
`abstain
`from
`alcohol
`the
`visit.
`A telephone
`the
`intervention
`and
`intercurrent
`leftover
`prescribed
`fatty
`intervention.
`
`5 and
`each
`were
`
`7 wk
`after
`and
`6)
`pres-
`blood
`visit
`Partic-
`collected.
`exer-
`strenuous
`was
`interview
`period
`to monitor
`disease.
`Com-
`capsules
`was
`capsules
`taken.
`acid
`concentra-
`
`and
`
`the
`
`of
`effects,
`by
`counting
`percentage
`the
`of
`serum
`phospholipid
`at
`end
`of
`
`and
`
`Clinical
`
`and
`
`laboratory
`
`measurements
`
`a
`
`Height
`period
`run-in
`the
`during
`measured
`was
`the
`intervention
`after
`and
`at baseline
`was measured
`subjects
`scale with
`electronic
`wearing
`light
`clothing
`an
`each
`subject’s
`habitual
`the
`intervention
`shoes.
`Before
`intake
`a
`interview
`by
`1 -h
`assessed
`during
`was
`dietary
`history
`method.
`the
`clinical
`nutritionist
`using
`models
`and containers
`were
`to estimate
`quantities.
`used
`from standard
`food
`tables
`constituents
`were
`calculated
`by
`using
`a specially
`acids
`fatty
`cover
`individual
`Each
`subject
`completed
`computer
`program
`(19-22).
`at baseline
`and
`during
`the
`administered
`questionnaire
`to monitor
`food
`habits
`and
`physical
`of
`the
`intervention
`during
`the
`intervention.
`Participants
`were
`asked
`or meat
`times
`they
`ate
`fish
`for
`dinner
`and
`how
`alcohol
`they
`consumed
`during
`the
`past
`week
`who
`alcohol
`equals
`9
`g).
`Those
`reported
`being
`20 mm,
`active
`four
`weekly
`or more
`times
`for
`or
`breath,
`sweating
`shortness
`of
`were
`categorized
`reporting
`weekly
`1-3
`times
`were
`categorized
`those
`and
`active;
`ately
`those
`reporting
`0 times
`weekly
`as
`sedentary.
`rized
`Blood
`an
`into
`antecubital
`from
`drawn
`were
`samples
`stasis.
`minimal
`using
`system
`evacuated
`tube
`pre-
`was
`Serum
`tube
`in a glass
`blood
`whole
`clotting
`Dickin-
`(Becton
`pared
`by
`room
`temperature
`at
`Meylan
`Cedex,
`France)
`I h and
`for
`son,
`#{176}C.
`15 mm at 22
`then
`centrifuging
`at 2000
`X g for
`the
`sample
`One-milliliter
`aliquots
`serum
`were
`transferred
`into
`sterile
`of
`Park
`Ridge,
`IL),
`flushed
`with
`nitro-
`2-mL
`cryovials
`(Corning,
`#{176}C.Blood
`for
`plasma
`preparation
`was
`gen,
`and
`stored
`at
`-70
`(Becton
`Dickinson)
`containing
`0.129
`collected
`into
`vacutainers
`(blood:anticoagulant
`10: 1).
`Plasma
`mol
`sodium
`citratelL
`=
`was
`at
`2000
`prepared
`by
`centrifugation
`at
`for
`15 mm
`X g
`transferred
`into
`sterile
`cryovials
`aliquots
`22
`#{176}C,
`of
`1 mL,
`
`on
`no
`
`of
`of
`
`to
`
`weight
`and
`period
`and
`nutrient
`certified
`Food
`Dietary
`that
`also
`designed
`a
`self-
`last week
`activity
`many
`units
`unit
`physically
`leading
`as
`active;
`as moder-
`catego-
`
`how
`many
`(one
`
`were
`
`an
`
`vein
`
`in
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 639 of 852
`
`(cid:18)
`

`

`EFFECTS
`
`OF
`
`INDIVIDUAL
`
`n-3
`
`FATlY
`
`ACIDS
`
`651
`
`#{176}C.All
`-70
`stored
`and
`nitrogen,
`with
`flushed
`intervention
`the
`completion
`after
`analyzed
`were
`broken.
`code
`the
`randomization
`before
`Automatic
`a Hitachi
`analyzed
`737
`lipids
`were
`Serum
`Analyzer
`Germany)
`with
`Mannheim,
`Mannheim,
`(Boehringer
`Total
`cholesterol
`was
`mea-
`manufacturer.
`from
`the
`reagents
`method
`(CHOD-PAP)
`an
`enzymatic
`colorimetric
`with
`sured
`and high-density-lipoprotein
`cholesterol
`was
`assayed
`(HDL)
`of
`lower-density
`lipopro-
`the
`same
`procedure
`precipitation
`teins
`chloride.
`Serum
`triacylglyc-
`with
`heparin
`manganese
`with
`an
`enzymatic
`color-
`erol
`concentrations
`determined
`imetric
`test
`Low-density-lipoprotein
`(LDL)
`cholesterol
`to the
`formula
`Friedewald
`was
`according
`Apolipoprotein
`(23).
`and
`apolipoprotein
`mea-
`were
`B-I
`sured
`immunochemically
`by
`rate
`nephelometry
`the Array
`using
`Protein
`System
`from
`Beckman
`Instruments
`CA).
`(Brea,
`Inc
`Fatty
`acids
`were
`measured
`extracting
`from
`by
`lipids
`total
`(cid:1).tL serum
`according
`to Folch
`et al
`(24),
`with
`phosphatidylcho-
`line
`diheptadecanoyl
`an
`internal
`standard
`(P-50l4;
`added
`as
`Sigma
`Chemical
`Company,
`St
`Louis),
`chloroform:methanol
`
`blood
`
`samples
`period
`and
`
`at
`of
`was
`on
`
`by
`
`500
`
`after
`and
`were
`(GPO-PAP).
`
`calculated
`
`A-I
`
`by
`(2:1,
`as
`mg/L)
`solid-phase
`Elut
`Bond
`transmethylation
`and
`evaporation
`dissolved
`in
`phy
`(Shimadzu
`with
`Japan)
`fitted
`internal
`diameter:
`(Raritan,
`fatty
`acid
`Chek
`Prep
`Shimadzu
`ported
`
`C-R4A
`(cid:1)mol
`
`as
`
`vol)
`an
`
`hydroxytoluene
`butylated
`solvent,
`a
`as
`were
`separated
`phospholipids
`Total
`antioxidant.
`extraction
`3 cc; Analytiche
`(size
`columns
`with
`NH2
`CA)
`City,
`Harbour
`LRC;
`Varian,
`followed
`(25),
`extraction
`into
`hexane,
`boron
`trifluoride,
`with
`acid
`methyl
`esters
`were
`to
`dryness.
`The
`fatty
`gas-liquid
`chromatogra-
`hexane
`and
`analyzed
`by
`A;
`Corporation,
`Kyoto,
`GC-l4
`Shimadzu
`length:
`(CP-Sil
`88;
`50 m,
`a capillary
`column
`from
`Chrompack
`Inc
`0.25
`mm)
`obtained
`response
`factors
`each
`Retention
`times
`and
`NJ).
`standards
`obtained
`determined
`using
`Nu-
`were
`(Elysian,
`MN).
`The
`results
`were
`integrated
`on
`are
`integrator.
`Fatty
`acid
`concentrations
`acidlL
`serum.
`
`and
`
`fatty
`
`(75
`by
`
`by
`
`for
`from
`
`a
`re-
`
`Statistical
`
`analysis
`
`SDs.
`
`the
`and
`variables
`distributed
`normally
`were
`done
`change
`linear
`model
`procedure
`at P < 0.05
`(27).
`Results
`value
`was
`P values
`in
`When
`tested.
`(28),
`the
`dure
`contrasts
`those
`Correlations
`correlation
`
`<
`
`(26).
`were
`0.05.
`
`Kruskal-Wallis
`variables.
`by
`contrasting
`when
`not
`did
`We
`considered
`Caution
`present
`the
`applying
`CI
`95%
`for which
`were
`tested
`coefficients.
`
`and
`ordinal
`for
`test
`Between-group
`comparisons
`general
`the
`SAS
`in
`groups
`F test was
`significant
`overall
`the
`adjust
`for multiple
`comparisons
`significant
`when
`two-sided
`the
`should
`be
`interpreting
`when
`study
`contrasts
`three
`because
`Tukey
`multiple-comparison
`the
`null
`the
`included
`value
`of
`the
`unadjusted
`P value
`by
`computing
`Pearson
`
`applied
`
`non-
`
`of
`
`P
`
`were
`proce-
`for
`effect
`0.03.
`>
`Spearman
`
`no
`was
`or
`
`RESULTS
`
`subjects
`out
`group
`one
`subject
`
`assigned
`randomly
`were
`period.
`intervention
`the
`intolerance
`fat
`to
`have
`found
`developed
`group
`in the EPA
`experienced
`corn
`oil
`group
`considered
`unrelated
`to
`in
`DHA
`group,
`
`a
`
`to
`One
`
`the
`three
`
`the
`
`excluded
`were
`group
`oil
`possible
`were
`exclusions
`protocol
`study
`with
`surgery
`I ), cancer
`the
`activity
`during
`are
`included
`the
`± 5,
`were
`43
`±
`kg/m2)
`EPA,
`
`2.7
`
`(in
`DHA,
`
`in
`44
`were
`and
`
`=
`
`of
`
`of
`
`and
`
`blood
`‘y-glutamyl
`creati-
`
`Three
`who
`234
`the
`of
`arm dropped
`study
`during
`was
`in
`the
`DHA
`subject
`subject
`cholecystectomy,
`after
`diarrhea,
`and
`in
`the
`one
`was
`that
`and
`vomiting
`vertigo
`individuals
`Two
`dietary
`supplements.
`in
`the
`corn
`two
`and
`in
`the
`EPA
`group,
`reasons
`for
`The
`from
`the
`analysis.
`(n
`poor
`compliance
`1 ),
`renal
`disease
`(n
`(n
`initiation
`a vasoactive
`drug
`I ),
`(n
`in amount
`physical
`1),
`and
`change
`(n
`Thus,
`subjects
`intervention
`224
`3).
`Mean
`present
`analysis.
`ages
`subjects
`of
`the
`and
`45
`± 6 y and mean
`body
`mass
`indexes
`5,
`±
`24.9
`2.6,
`25.6
`±
`2.9,
`24.6
`±
`in
`the
`oil
`corn
`There
`chemistry
`transferase,
`nine,
`and
`renin
`after
`(data
`not
`
`respectively.
`groups,
`were
`no
`significant
`(electrolytes,
`alanine
`alkaline
`phosphatase,
`C-reactive
`protein),
`dietary
`intervention
`shown).
`
`Compliance
`
`and
`
`side
`
`effects
`
`serum
`with
`
`hematology,
`in
`changes
`aminotransferase,
`albumin,
`glucose,
`DHA,
`
`bilirubin,
`or
`plasma-active
`EPA,
`or
`corn
`
`oil
`
`in the
`EPA,
`was
`with
`were
`change
`
`was
`study
`oil
`corn
`and
`poorer
`slightly
`and
`the
`EPA
`no
`within-group
`in
`serum
`
`±
`49
`groups,
`in
`
`corn
`
`DHA,
`
`±
`5, 48
`respec-
`the DHA
`oil
`groups
`correlations
`EPA,
`
`3,
`
`or
`
`and
`transient
`of
`the
`start
`group
`DHA
`initiation
`after
`the
`corn
`4% in
`reported
`was
`EPA
`group,
`
`for most
`and
`individuals
`Fifty-eight
`intervention.
`in
`the
`EPA
`and
`57%
`dietary
`sup-
`the
`A taste
`of
`group.
`by
`67% of
`subjects
`and
`3% in the
`corn
`
`of
`
`oil
`
`Diet,
`
`body
`
`weight,
`
`and
`
`physical
`
`activity
`
`The DHA,
`baseline.
`Total
`
`EPA,
`fat
`
`corn
`and
`accounted
`
`oil
`for
`
`well
`were
`groups
`30% of
`energy
`
`balanced
`intake
`
`in
`
`at
`all
`
`such
`
`examination
`serum
`of
`
`tri-
`phys-
`were
`
`the
`
`the
`at
`
`values,
`Analysis
`ln-7,
`and
`based
`on
`influencing
`of
`desatura-
`
`therefore
`Two
`analysis
`
`8,
`
`could
`
`in
`
`for
`
`serum
`fatty
`
`as means
`are expressed
`results
`All
`On
`±
`except
`all
`variables
`distributions,
`frequency
`the
`of
`as
`level
`factors
`certain
`lifestyle
`acylglycerol
`and
`alcohol
`and
`fish,
`meat,
`ical
`activity
`and
`consumption
`end
`of
`intervention.
`at
`the
`and
`at baseline
`normally
`distributed
`at
`at baseline
`the
`end
`of
`and
`Serum
`lipid
`concentrations
`as the mean
`the
`values
`obtained
`of
`intervention
`were
`calculated
`obtained
`at visits
`5 and
`6 and
`the mean
`of
`the
`values
`at
`visits
`and
`as
`value
`respectively.
`Change
`was
`calculated
`7
`obtained
`base-
`obtained
`after
`intervention
`minus
`the
`value
`as the group-wise
`line.
`Percentage
`change
`calculated
`mean
`was
`percentage
`change
`of missing
`from
`baseline.
`Because
`change
`not
`be calculated
`some
`individuals.
`of
`changes
`serum
`lipids,
`phospholipid
`16:
`sum of
`serum
`phospholipid
`acids
`are
`and
`222,
`217,
`209
`subjects,
`respectively.
`values
`outlying
`were
`excluded
`from
`the
`tion
`indexes.
`within-group
`To
`evaluate
`normally
`distributed
`variables,
`for
`ordinal
`and
`non-normally
`chi-square
`statistic
`for
`categorical
`of
`variance
`was
`used
`to
`evaluate
`between
`groups;
`the
`F test
`was
`
`used
`we
`change,
`the Wilcoxon
`distributed
`variables.
`whether
`for
`
`used
`
`t
`paired
`signed-rank
`variables,
`One-way
`change
`normally
`
`tests
`
`for
`test
`the
`
`and
`analysis
`differed
`distributed
`
`of days
`number
`The mean
`48
`±
`4 d in the DHA,
`Percentage
`compliance
`(91
`compared
`94
`There
`and
`
`and
`tively.
`6%)
`group
`±
`6%).
`±
`(both
`compliance
`between
`acid
`concentrations.
`linoleic
`effects
`mild
`were
`Side
`1-2
`wk
`after
`the
`faded
`of
`percent
`the
`subjects
`in
`experienced
`belching
`group
`compared
`with
`plements
`fish
`oil during
`the
`intervention
`in the DHA
`group,
`65%
`in the
`oil
`group.
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 640 of 852
`
`

`

`.
`Daily
`
`.
`nutnent
`
`.
`intake
`
`DHA
`
`=
`
`72)
`
`EPA
`
`(n
`
`=
`
`75)
`
`Corn
`(n =
`
`oil
`77)
`
`Energy
`
`(Id)
`
`10 370 ± 2561
`
`10 223 ± 2170
`
`(g)
`
`(g)
`(g)
`
`(mg)
`(g)
`
`(g)
`(g)
`(g)
`
`(j.Lg)
`
`Protein (g)
`Carbohydrate
`Fiber (g)
`Alcohol
`fat
`Total
`Cholesterol
`fat
`Saturated
`Monounsaturated
`Polyunsaturated
`P:S
`18:2n-6
`20:5n-3
`22:6n-3
`a-Carotene
`Retinol
`(,.Lg)
`Thiamine
`(mg)
`Riboflavin
`(mg)
`Niacin
`Vitamin
`Vitamin
`Vitamin
`
`(mg)
`C (mg)
`D (;.Lg)
`E (mg)
`
`fat
`fat
`
`(g)
`(g)
`
`±
`
`103 ± 23
`335
`± 80
`± 7.3
`24.1
`5.82
`± 6.28
`81.2
`± 32.1
`314
`102
`±
`33.6
`12.4
`27.6
`1 1.3
`±
`13.5
`± 8.4
`0.40
`0.15
`±
`10.2
`± 7.0
`0.18
`± 0.20
`0.34
`± 0.32
`2651
`±
`1902
`± 955
`1003
`1.66
`0.38
`±
`2.20
`0.70
`±
`23.6
`± 4.8
`90.0
`1.6
`±
`6.08
`± 9.77
`4.87
`1.48
`
`±
`
`±
`
`±
`
`103 ± 22
`324
`± 74
`23.2
`6.7
`6.39
`± 6.56
`81.6
`23.9
`±
`327
`± 89
`34.3
`10.9
`8.7
`28.0
`±
`12.7
`± 4.6
`0.39
`± 0.13
`9.50
`± 3.70
`0.19
`± 0.18
`0.35
`± 0.28
`2634
`±
`1284
`993
`± 717
`1.67
`0.35
`±
`2.29
`0.67
`±
`23.2
`± 4.8
`35.5
`78.6
`±
`5.33
`± 4.16
`4.96
`1.34
`
`±
`
`10 877 ± 2455
`107 ± 25
`
`± 87
`349
`7.7
`25.2
`±
`7.00
`7.04
`±
`± 27.0
`85.9
`±
`101
`334
`11.4
`35.4
`±
`± 9.6
`29.6
`± 6.1
`14.0
`± 0.13
`0.40
`± 5.1
`10.7
`± 0.21
`0.19
`± 0.32
`0.36
`±
`1905
`2749
`1031
`697
`0.43
`1.76
`±
`± 0.72
`2.31
`± 5.2
`23.8
`± 45.0
`88.9
`5.65 ± 3.81
`1.53
`5.33
`±
`
`±
`
`‘ I
`
`SD.
`±
`group:
`
`DHA,
`P:S,
`ratio
`
`docosahexaenoic
`of polyunsaturated
`
`acid
`
`acid
`
`group:
`to saturated
`
`EPA,
`
`eicosapentaenoic
`fatty
`acids.
`
`groups
`
`triacylglycerol
`the
`0.29)
`in
`the
`EPA
`triacylglycerols
`with
`change
`decreased
`26%
`group.
`The
`differ-
`was
`not
`significant
`serum
`triacylglycer-
`group
`than
`in
`triacylglycerol
`DHA
`groups
`in
`individual
`triacylglycerol
`
`con-
`DHA
`group
`
`the
`con-
`there
`n-3
`
`the
`baseline
`and
`EPA
`changes
`in
`
`serum
`
`in
`CI
`(95%
`mean
`Serum
`centrations
`0.22
`decreased
`group
`0. 1 5 mmol/L
`In
`the
`corn
`(Table
`0.11 mmol/L
`increased
`oil
`group,
`corn
`for
`the
`and
`in
`the DHA
`group
`the DHA
`ence
`between
`(P =
`However,
`0.14).
`consistently
`ols
`were
`across
`EPA
`group
`centrations
`(Table
`correlations
`were
`no
`fatty
`acids
`and
`concentrations.
`0. 15 mmolIL
`decreased
`cholesterol
`Serum
`total
`0.05)
`g/L
`A-I
`decreased
`and
`apolipoprotein
`the EPA
`group
`from
`differed
`significantly
`4). These
`changes
`Table
`0.001,
`groups.
`and
`corn
`oil
`the DHA
`group,
`In
`the
`DHA
`the
`increased
`cholesterol
`differing
`mmol/L
`0.06
`(P
`0.001),
`Hence,
`corn
`oil
`groups.
`from
`nificantly
`EPA
`and
`both
`the
`in
`there
`groups
`was
`an
`increase
`EPA
`and
`DHA
`both
`the
`to
`apolipoprotein
`A-I
`and
`a decrease
`ratio
`of HDL
`cholesterol
`in the
`ratio
`total
`cholesterol
`to HDL
`cholesterol.
`
`652
`
`2
`
`TABLE
`Composition
`
`of
`
`background
`
`diet’
`
`GRIMSGAARD
`
`ET
`
`AL
`
`weekly
`dishes
`fish
`agreement
`good
`by
`the
`obtained
`self-administered
`0.0001).
`
`before
`between
`nutritionist
`questionnaire
`
`or during
`measures
`during
`
`at
`
`Serum
`
`lipids
`
`and
`
`apolipoproteins
`
`the
`
`intervention.
`alcohol
`of
`run-in
`period
`the
`baseline
`(r
`
`=
`
`There
`consumption
`and
`by
`0.73,
`P
`
`was
`
`the
`
`=
`
`and
`4).
`
`(0.15,
`0.24)
`
`of
`
`parentheses)
`mmol/L
`in
`(0.06,
`serum
`group
`oil
`Compared
`(0.03,
`0.19).
`serum
`triacylglycerols
`21 % in
`EPA
`the
`and
`EPA
`groups
`net
`decreases
`in
`greater
`in
`DHA
`quartiles
`5).
`the
`In
`between
`changes
`
`(P <
`0.04
`
`in
`(P <
`both
`HDL
`sig-
`in
`the
`
`<
`
`of
`
`Serum
`
`phospholipid
`
`fatty
`
`acid
`
`concentrations
`
`=
`
`=
`
`the
`
`groups.
`accounted
`at baseline
`EPA
`and
`of DHA
`intake
`Dietary
`for
`intake
`in
`nutrient
`Differences
`intake.
`total
`fat
`of
`0.7%
`and
`minor
`were
`corn
`oil
`and
`the DHA,
`EPA,
`between
`not
`significant
`or
`within-
`different
`significantly
`(Table
`2). No
`between-group
`body
`to
`respect
`with
`found
`changes
`were
`during
`habits
`activity,
`or
`food
`intervention
`the
`weight,
`physical
`oil
`in the
`corn
`0.6
`kg
`by
`(Table
`3).
`Body
`weight
`increased
`group
`was
`EPA
`groups.
`There
`and
`and
`by
`0.7
`kg
`in
`the DHA
`a nonsignificant
`increase
`in the
`who
`of
`participants
`percentage
`reported
`inter-
`with
`before
`compared
`being
`sedentary
`after
`meals)
`fish
`consumption
`(dinner
`vention.
`Alcohol,
`meat,
`and
`increased
`slightly
`but
`not
`significantly
`during
`the
`intervention.
`None
`of
`the
`participants
`reported
`consuming
`more
`than
`
`three
`
`In the total
`group
`study
`serum
`dietary
`intake
`and
`and EPA
`at baseline
`were
`The
`(both
`0.0001).
`P
`DHA
`to EPA
`at baseline
`phospholipid
`ratio
`ofDHA
`the difference
`for
`between
`to EPA
`of DHA
`relative
`
`(n =
`224),
`phospholipid
`0.39
`r
`mean
`of
`was
`2.5
`to EPA
`the
`ratios),
`in serum
`
`correlations
`the
`concentrations
`r =
`and
`0.35,
`individual
`ratios
`1 .2, whereas
`±
`was
`3.8
`±
`1.6
`indicating
`phospholipids.
`
`between
`of DHA
`respectively
`of
`dietary
`the
`serum
`0.0001,
`(P =
`accumulation
`
`3
`TABLE
`lifestyle
`and
`Body weight
`(EPA),
`or corn
`oil’
`
`factors
`
`at baseline
`
`and
`
`change
`
`after
`
`7 wk of
`
`supplementation
`
`with
`
`docosahexaenoic
`
`acid
`
`(DHA),
`
`eicosapentaenoic
`
`acid
`
`DHA (n
`
`=
`
`72)
`
`EPA (n
`
`=
`
`75)
`
`Corn
`
`oil
`
`(n
`
`=
`
`77)
`
`Baseline
`
`Change
`
`Baseline
`
`Change
`
`Baseline
`
`Change
`
`(kg)
`
`Body weight
`Fish
`consumption
`Meat
`consumption
`Teetotalers
`(%)
`Alcohol
`consumption
`Physical
`activity
`Sedentary
`(%)
`Moderate
`(%)
`Active
`
`(%)
`
`(d