https://mb.cision.com/Public/18595/3569596/9ab3ec56ee1724e0_800x800ar.png
** First Presentations of Phase 3 Data for Bimekizumab Across the Full Spec=
trum of Axial Spondyloarthritis to be Shared at EULAR 2022
------------------------------------------------------------
=C2=B7 New data from BE MOBILE 1 and BE MOBILE 2 show that bimekizumab achi=
eved consistent improvements versus placebo in signs and symptoms across th=
e full spectrum of axial spondyloarthritis (axSpA), including non-radiograp=
hic axSpA (nr-axSpA) and ankylosing spondylitis (AS)
=C2=B7 Treatment with bimekizumab delivered clinically meaningful efficacy =
outcomes in nr-axSpA and AS, as measured by the proportion of patients achi=
eving the primary endpoint (ASAS40) and all ranked secondary endpoints vers=
us placebo
Brussels (Belgium), 23 May 2022 =E2=80=93 8:30 am (CEST) =E2=80=93 UCB, a g=
lobal pharmaceutical company, today announced new 24-week data from two Pha=
se 3 studies, BE MOBILE 1 and BE MOBILE 2, evaluating bimekizumab in the tr=
eatment of active non-radiographic axial spondyloarthritis (nr-axSpA) and a=
ctive ankylosing spondylitis (AS).^1,2=C2=A0Both studies met their primary =
and all ranked secondary endpoints at week 16, with statistical significanc=
e, demonstrating improvements versus placebo in the signs and symptoms of d=
isease across the full spectrum of axSpA with consistent outcomes for patie=
nts with nr-axSpA and patients with AS.^1,2 The safety profile of bimekizum=
ab in both studies was consistent with safety data seen in previous studies=
with no new observed safety signals.^1,2 =C2=A0=C2=A0
UCB also announced today new post-hoc analyses from the open-label extensio=
n of the Phase 2b BE AGILE study, in which bimekizumab showed maintenance o=
f clinical responses over three years in patients with active AS.^3 Data fr=
om all three studies will be presented at the European Congress of Rheumato=
logy, EULAR 2022, in Copenhagen, Denmark, June 1=E2=80=934. Bimekizumab is =
not approved for use in nr-axSpA or AS by any regulatory authority worldwid=
e. The safety and efficacy of bimekizumab in nr-axSpA and AS have not been =
established.
=E2=80=9CWe are pleased to share the first detailed data from our Phase 3 c=
linical program of bimekizumab in non-radiographic axSpA and ankylosing spo=
ndylitis, which showcase the clinical potential of bimekizumab to improve p=
atient outcomes across the full spectrum of this debilitating disease,=E2=
=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutio=
ns and Head of U.S., UCB. =E2=80=9CPeople with axSpA often live with the co=
ndition for many years before diagnosis, with limited options available tod=
ay to treat non-radiographic axSpA. We are driven to bring differentiated s=
olutions that address unmet needs, and these results are an important step =
in our mission, setting the foundation for future regulatory discussions.=
=E2=80=9D=C2=A0
BE MOBILE 1 and BE MOBILE 2: Phase 3 Study Results (24 weeks)^1,2
In BE MOBILE 1 and BE MOBILE 2, patients treated with bimekizumab (160 mg e=
very 4 weeks [Q4W]) achieved statistically significant and clinically meani=
ngful improvements in the signs and symptoms of axSpA, as defined by the pr=
imary endpoint measure of Assessment of SpondyloArthritis International Soc=
iety 40 (ASAS40) at week 16 compared to placebo.^1,2 =C2=A0Response rates i=
ncreased to week 24 and a rapid achievement of ASAS40 response was seen for=
patients switching from placebo to bimekizumab at week 16.^1,2=C2=A0
=C2=B7 BE MOBILE 1 (nr-axSpA): At week 16, 47.7 percent (n=3D61/128) of bim=
ekizumab-treated patients achieved ASAS40 versus 21.4 percent (n=3D27/126) =
with placebo (p<0.001).^1=C2=A0
=C2=B7 BE MOBILE 2 (AS): At week 16, 44.8 percent (n=3D99/221) of bimekizum=
ab-treated patients achieved ASAS40 versus 22.5 percent (n=3D25/111) with p=
lacebo (p<0.001).^2=C2=A0
=E2=80=9CToday=E2=80=99s findings from the BE MOBILE 1 and BE MOBILE 2 stud=
ies provide clear evidence supporting the potential of bimekizumab in both =
nr-axSpA and AS, and highlight the meaningful clinical outcomes that can be=
achieved by targeting IL-17F in addition to IL-17A. Patients with nr-axSpA=
and AS have a similar burden of disease and a treatment that could potenti=
ally show consistent outcomes across the full spectrum of disease is encour=
aging,=E2=80=9D said Professor Atul Deodhar, MD, MRCP, Professor of Medicin=
e, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science Un=
iversity, Portland, OR, U.S.
In both studies, at week 16, patients treated with bimekizumab achieved sta=
tistically significant improvements in all ranked secondary endpoints compa=
red with placebo, including ASAS partial remission (ASAS-PR), disease activ=
ity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (=
BASDAI), physical function as measured by the Bath Ankylosing Spondylitis F=
unctional Index (BASFI), and quality of life as measured by Ankylosing Spon=
dylitis Quality of Life (ASQoL) questionnaire.^1,2=C2=A0
BE MOBILE 1 (nr-axSpA):=C2=A0
=C2=B7 At week 16, 25.8 percent (n=3D33/128) of bimekizumab-treated patient=
s achieved ASAS-PR versus 7.1 percent (n=3D9/126) of patients with placebo =
(p<0.001).^1=C2=A0
=C2=B7 At week 16, mean change from baseline in BASDAI (-3.1 bimekizumab ve=
rsus -1.5 placebo, p<0.001).^1
=C2=B7 At week 16, mean change from baseline in BASFI (-2.5 bimekizumab ver=
sus -1.0 placebo, p<0.001).^1=C2=A0
=C2=B7 At week 16, mean change from baseline in ASQoL (-5.2 bimekizumab ver=
sus -2.5 placebo, p<0.001).^1
BE MOBILE 2 (AS):=C2=A0
=C2=B7 At week 16, 24.0 percent (n=3D53/221) of bimekizumab-treated patient=
s achieved ASAS-PR versus 7.2 percent (n=3D8/111) of patients with placebo =
(p<0.001).^2
=C2=B7 At week 16, mean change from baseline in BASDAI (-2.9 bimekizumab ve=
rsus -1.9 placebo, p<0.001).^2=C2=A0
=C2=B7 At week 16, mean change from baseline in BASFI (-2.2 bimekizumab ver=
sus -1.1 placebo, p<0.001).^2=C2=A0
=C2=B7 At week 16, mean change from baseline in ASQoL (-4.9 bimekizumab ver=
sus -3.2 placebo, p<0.001).^2
Other efficacy outcomes in BE MOBILE 1 and BE MOBILE 2 included changes in =
Ankylosing Spondylitis Disease Activity Score (ASDAS) states, and changes i=
n inflammation in the sacroiliac joints and spine as measured by Magnetic R=
esonance Imaging (MRI).^1,2 At the start of both studies, almost all patien=
ts (>97 percent) had high or very high disease activity.^1,2 At week 24, in=
both studies, approximately half of the patients treated with bimekizumab =
from the start of each study achieved ASDAS low disease activity defined as=
ASDAS<2.1.^1,2 Treatment with bimekizumab also resulted in substantial red=
uctions in inflammation in the sacroiliac joints and spine for both AS and =
nr-axSpA patients at week 16.^1,2=C2=A0
Professor D=C3=A9sir=C3=A9e van der Heijde, Professor of Rheumatology, Leid=
en University Medical Center, Leiden, the Netherlands, said, =E2=80=9CPatie=
nts with axSpA live with a range of debilitating symptoms including chronic=
back pain and difficulties performing everyday tasks. These interim result=
s from the BE MOBILE 1 and BE MOBILE 2 studies are encouraging, showing tha=
t treatment with bimekizumab versus placebo improved signs and symptoms, re=
duced disease activity and inflammation, and improved physical function. We=
look forward to the 52-week results from these studies expected later this=
year.=E2=80=9D
In BE MOBILE 1, the most common treatment emergent adverse events (TEAEs) o=
ver 16 weeks with bimekizumab were nasopharyngitis (9.4 percent), upper res=
piratory tract infection (7.0 percent) and oral candidiasis (3.1 percent).^=
1 =C2=A0In BE MOBILE 2, the most common TEAEs over 16 weeks were nasopharyn=
gitis (7.7 percent), headache (4.1 percent) and oral candidiasis (4.1 perce=
nt).^2 Up to 16 weeks, the incidence of serious adverse events was low with=
bimekizumab in both studies (0 percent in BE MOBILE 1 and 1.8 percent in B=
E MOBILE 2).^1,2 In BE MOBILE 1, no cases of inflammatory bowel disease (IB=
D) were reported with patients taking bimekizumab.1 In BE MOBILE 2, two IBD=
cases (0.9 percent) occurred in patients treated with bimekizumab.^2
BE AGILE Phase 2b Open-Label Extension: 3 Year Study Results^3=C2=A0
Post-hoc analyses of the Phase 2b BE AGILE study and its open-label extensi=
on showed that treatment with bimekizumab (160 mg Q4W) provided maintenance=
of clinical responses over three years (156 weeks) in patients with active=
AS who initially responded at week 12, and irrespective of the initial dos=
ing regimen (160 mg Q4W, [N=3D60] or 320 mg Q4W, [N=3D61].^3 At week 12, 40=
.3 per-cent of patients had achieved low disease activity (ASDAS<2.1), and =
89.2 percent of these patients maintained this low level of disease activit=
y at week 156.^3 =C2=A0Efficacy measured by ASAS40 response was also sustai=
ned over three years, with 47.1 percent of patients having achieved ASAS40 =
at week 12, 64.9 percent at week 48 and 71.9 percent at week 156.^3 =C2=A0
Notes to editors :
About BE MOBILE 1 =C2=A0 =C2=A0
BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled,=
parallel-group, Phase 3 study designed to evaluate the efficacy and safety=
of bimekizumab in the treatment of adult patients with active nr-axSpA.^1 =
The study is ongoing with 24-week results presented above. For additional d=
etails on the study, visit BE MOBILE 1 on clinicaltrials.gov (https://clini=
caltrials.gov/ct2/show/NCT03928704) .^4
About BE MOBILE 2
BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled,=
parallel-group, Phase 3 study designed to evaluate the efficacy and safety=
of bimekizumab in the treatment of adult patients with active AS.^2 The st=
udy is ongoing with 24-week results presented above. For additional details=
on the study, visit BE MOBILE 2 on clinicaltrials.gov (https://www.clinica=
ltrials.gov/ct2/show/NCT03928743) .^5
About BE AGILE and the open-label extension study (BE AGILE 2)
BE AGILE was a multicenter, Phase 2b, randomized, double-blind, placebo-con=
trolled, parallel-group, dose-ranging study to evaluate the efficacy and sa=
fety of bimekizumab in patients with active ankylosing spondylitis (AS).^6 =
BE AGILE 2 is a multicenter, open-label extension study to evaluate the lon=
g term safety and efficacy of bimekizumab in patients with active AS. =C2=
=A0For additional details, visit BE AGILE 2 on clinicaltrials.gov (https://=
www.clinicaltrials.gov/ct2/show/NCT03355573) .^7
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA=
and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA=
), is a chronic, immune-mediated, inflammatory disease.^8=C2=A0 nr-axSpA is=
defined clinically by the absence of definitive x-ray evidence of structur=
al damage to the sacroiliac joints.^8 AxSpA is a painful condition that pri=
marily affects the spine and the joints linking the pelvis and lower spine =
(sacroiliac joints).^8 The leading symptom of axSpA in a majority of patien=
ts is inflammatory back pain that improves with exercise, but not with rest=
.^8 Other common clinical features frequently include anterior uveitis, ent=
hesitis, peripheral arthritis, psoriasis, inflammatory bowel disease and da=
ctylitis.^8 The overall prevalence of axSpA is 0.3 percent to 1.3 percent o=
f adults.^9,10=C2=A0Approximately half of all patients with axSpA are patie=
nts with nr-axSpA.^8 AxSpA onset usually occurs before the age of 45.^8 App=
roximately 10 to 40 percent of patients with nr-axSpA progress to ankylosin=
g spondylitis over 2 to 10 years.^8 =C2=A0
About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^11,14 Bimekizumab is in=
Phase 3 clinical development for the treatment of active axSpA with 24-wee=
k interim analysis results from the BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 =
(AS) studies to be presented at EULAR 2022.^1,2 In addition, bimekizumab is=
in Phase 3 clinical development for the treatment of active psoriatic arth=
ritis with 24-week interim analysis from the BE OPTIMAL study and 16-week a=
nalysis from the BE COMPLETE study to be presented at EULAR 2022.^12,13=C2=
=A0=C2=A0
About BIMZELX^=C2=AE=E2=96=BC(bimekizumab) in the European Union /European =
Economic Area=C2=A0
In the European Union (EU)/European Economic Area (EEA) BIMZELX^=C2=AE is i=
ndicated for the treatment of moderate to severe plaque psoriasis in adults=
who are candidates for systemic therapy.^14=C2=A0=C2=A0
BIMZELX^=C2=AE=E2=96=BC(bimekizumab) EU/EEA Important Safety Information in=
Psoriasis
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).=C2=A0
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
Cases of new or exacerbations of inflammatory bowel disease have been repor=
ted with bimekizumab. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al management should be initiated. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld be discontinued immediately and appropriate therapy initiated.=C2=A0
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other =
side effects, full safety and prescribing information. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
EU summary of product characteristics date of revision March 2022.
Last accessed: May 2022.
=E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. =
This will allow quick identification of new safety information. Healthcare =
professionals are asked to report any suspected adverse reactions=C2=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=C2=A0
About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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e actual results, financial condition, performance or achievements of UCB, =
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or implied by such forward-looking statements contained in this press relea=
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roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
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e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
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ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
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or commercially successful as UCB may have believed at the start of such p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
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policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
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ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
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UCB is following the worldwide developments diligently to assess the financ=
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ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
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References
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afety from BE MOBILE 1, a phase 3, multicentre, randomised, placebo-control=
led study. To be presented at EULAR 2022 =C2=A0in Copenhagen, Denmark, June=
1-4.
=C2=A0
2. van der Heijde D, Baraliakos X, Dougados M et al. Bimekizumab in patient=
s with active ankylosing spondylitis: 24-week efficacy and safety from BE M=
OBILE 2, a phase 3, multicentre, randomised, placebo-controlled study. To b=
e presented at EULAR 2022 =C2=A0in Copenhagen, Denmark, June 1-4.
3. Navarro-Comp=C3=A1n V, Rudwaleit M, de Peyrecave N et al. Maintenance of=
response to bimekizumab over 3 years of treatment in patients with active =
ankylosing spondylitis: post-hoc analyses from the BE AGILE study and its o=
pen-label extension. To be presented at EULAR 2022 in Copenhagen, Denmark, =
June 1-4.
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izumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE =
MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704. =
=C2=A0Last accessed: May 2022.
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May 2022
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terleukin-17A and interleukin-17F With Bimekizumab in Patients With Active =
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y of Bimekizumab in Subjects With Ankylosing Spondylitis (BE AGILE 2). Avai=
lable at: https://www.clinicaltrials.gov/ct2/show/NCT03355573. Last accesse=
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8. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed C=
are. Am J Manag Care. 2019;25:S319-S330.
9. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in=
the United States: estimates from a cross-sectional survey. Arthritis Care=
Res. 2012;64(6):905-910.
10. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyl=
oarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Dis=
ord. 2015;21(16):392.
11. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, a humanized monoclonal antibody and selective dual inhibitor of=
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-=
1001.
12. ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizu=
mab in the Treatment of Subjects with Active Psoriatic Arthritis (BE OPTIMA=
L). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=
=3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: May 2022.
13. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bime=
kizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE CO=
MPLETE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03896581 =
Last accessed: May 2022.
14. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. htt=
ps://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-produc=
t-information_en.pdf. Last accessed: May 2022.
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