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Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial.

Ulf Teichgräber, Thomas Lehmann, René Aschenbach, Dierk Scheinert, Thomas Zeller, Klaus Brechtel, Erwin Blessing, Michael Lichtenberg, Sebastian Sixt, Steffen Brucks, Ulrich Beschorner, Christof Tobias Klumb, Markus Thieme, ,

AIMS:Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA). METHODS AND RESULTS:This multicentre trial randomly assigned 171 patients with stenotic and occlusive ... Read more >>

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2020, 15(18):e1633-e1640]

Cited: 3 times

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Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.

Ulf Teichgräber, Thomas Lehmann, René Aschenbach, Dierk Scheinert, Thomas Zeller, Klaus Brechtel, Erwin Blessing, Michael Lichtenberg, Peter von Flotow, Britta Heilmeier, Sebastian Sixt, Steffen Brucks, Christian Erbel, Ulrich Beschorner, Michael Werk, Vicenç Riambau, Andreas Wienke, Christof Tobias Klumb, Markus Thieme,

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). ... Read more >>

Radiology (Radiology)
[2020, 295(2):478-487]

Cited: 3 times

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The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes.

Thomas Zeller, Antonio Micari, Dierk Scheinert, Iris Baumgartner, Marc Bosiers, Frank E G Vermassen, Martin Banyai, Mehdi H Shishehbor, Hong Wang, Marianne Brodmann, ,

<h4>Objectives</h4>The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial.<h4>Background</h4>Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2020, 13(4):431-443]

Cited: 2 times

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Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.

Michael Lichtenberg, Frank Breuckmann, Veronika Kramer, Stefan Betge, Sebastian Sixt, Birgit Hailer, Sigrid Nikol, Jawed Arjumand, Guenther Wittenberg, Jörg Teßarek, Claus Nolte-Ernsting,

Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2019, 48(5):425-432]

Cited: 0 times

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Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease.

Erik Groot Jebbink, Suzanne Holewijn, Michel Versluis, Frederike Grimme, Jan Willem Hinnen, Sebastian Sixt, John F Angle, Walter Dorigo, Michel M P J Reijnen,

<h4>Purpose</h4>To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis.<h4>Materials and methods</h4>A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2019, 26(1):31-40]

Cited: 0 times

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Systematic review with meta-analysis: portal vein recanalisation and transjugular intrahepatic portosystemic shunt for portal vein thrombosis.

Susana G Rodrigues, Sebastian Sixt, Juan G Abraldes, Andrea De Gottardi, Christoph Klinger, Jaime Bosch, Iris Baumgartner, Annalisa Berzigotti,

<h4>Background</h4>Transjugular intrahepatic portosystemic shunt has been increasingly used in patients with portal vein thrombosis to obtain patency, but evidenced-based decisions are challenging.<h4>Aim</h4>To evaluate published data on efficacy and safety of endovascular therapy in portal vein thrombosis.<h4>Methods</h4>Systematic search of PubMed, ISI, Scopus, and Embase for studies (in English, until October 2017) ... Read more >>

Aliment Pharmacol Ther (Alimentary pharmacology & therapeutics)
[2019, 49(1):20-30]

Cited: 9 times

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[Update on the current diagnosis and therapy of peripheral arterial occlusive disease].

Kerstin A Schürch, Sebastian Sixt, Christina Jeanneret, Corina R Canova,

Update on the current diagnosis and therapy of peripheral arterial occlusive disease <b>Abstract.</b> The prevalence of peripheral arterial disease (PAOD) increases with age and overall due to demographic trends. The symptoms severely reduce the quality of life. The 5-year mortality rate is even twice as high as in patients without ... Read more >>

Ther Umsch (Therapeutische Umschau. Revue therapeutique)
[2018, 75(8):478-488]

Cited: 0 times

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Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.

Thomas Zeller, Ralf Langhoff, Krishna J Rocha-Singh, Michael R Jaff, Erwin Blessing, Beatrice Amann-Vesti, Marek Krzanowski, Patrick Peeters, Dierk Scheinert, Giovanni Torsello, Sebastian Sixt, Gunnar Tepe, ,

<h4>Background</h4>Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.<h4>Methods and results</h4>DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon ... Read more >>

Circ Cardiovasc Interv (Circulation. Cardiovascular interventions)
[2017, 10(9):]

Cited: 23 times

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Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

Hans Krankenberg, Thomas Zeller, Maja Ingwersen, Josefin Schmalstieg, Hans Martin Gissler, Sigrid Nikol, Iris Baumgartner, Nicolas Diehm, Estell Nickling, Stefan Müller-Hülsbeck, Rainer Schmiedel, Giovanni Torsello, Willibald Hochholzer, Christian Stelzner, Klaus Brechtel, Wulf Ito, Ralph Kickuth, Erwin Blessing, Marcus Thieme, Jaroslaw Nakonieczny, Thomas Nolte, Ragnar Gareis, Harald Boden, Sebastian Sixt,

<h4>Objectives</h4>Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted.<h4>Background</h4>So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), ... Read more >>

JACC Cardiovasc Interv (JACC. Cardiovascular interventions)
[2017, 10(16):1694-1704]

Cited: 15 times

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Does exercise training impact clock genes in patients with coronary artery disease and type 2 diabetes mellitus?

Eva Steidle-Kloc, Martin Schönfelder, Edith Müller, Sebastian Sixt, Gerhard Schuler, Wolfgang Patsch, Josef Niebauer,

<h4>Background</h4>Recent findings revealed negative effects of deregulated molecular circadian rhythm in coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM). Physical exercise training (ET) has been shown to promote anti-diabetic and anti-atherogenic responses in skeletal muscle of these patients, but the role of the circadian clock-machinery remains unknown. This ... Read more >>

Eur J Prev Cardiol (European journal of preventive cardiology)
[2016, 23(13):1375-1382]

Cited: 7 times

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Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.

Marc Bosiers, Dierk Scheinert, Jeroen M H Hendriks, Christian Wissgott, Patrick Peeters, Thomas Zeller, Marianne Brodmann, Robert Staffa, ,

<h4>Objective</h4>The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent ... Read more >>

J Vasc Surg (Journal of vascular surgery)
[2016, 64(1):109-116]

Cited: 4 times

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German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease.

Dierk Scheinert, Andrej Schmidt, Thomas Zeller, Stefan Müller-Hülsbeck, Sebastian Sixt, Henrik Schröder, Norbert Weiss, Dominik Ketelsen, Jens Ricke, Sabine Steiner, Kenneth Rosenfield,

<h4>Purpose</h4>To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease.<h4>Methods</h4>Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2016, 23(3):409-416]

Cited: 10 times

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Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial.

Hans Krankenberg, Thilo Tübler, Maja Ingwersen, Michael Schlüter, Dierk Scheinert, Erwin Blessing, Sebastian Sixt, Arne Kieback, Ulrich Beschorner, Thomas Zeller,

<h4>Background</h4>Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain.<h4>Methods and results</h4>One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic ... Read more >>

Circulation (Circulation)
[2015, 132(23):2230-2236]

Cited: 51 times

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Duplex ultrasound assessment of native stenoses in the superficial femoral and popliteal arteries: a comparative study examining the influence of multisegment lesions.

Richard-Roland Macharzina, Simon F Schmid, Ulrich Beschorner, Elias Noory, Aljoscha Rastan, Werner Vach, Uwe Schwarzwälder, Sebastian Sixt, Karlheinz Bürgelin, Franz-Josef Neumann, Thomas Zeller,

<h4>Purpose</h4>To evaluate duplex ultrasonography (DUS) in the assessment of femoropopliteal stenoses comparing a single native stenosis (SNS) to multisegmental native stenoses (MNS).<h4>Methods</h4>Among the 1284 patients treated for atherosclerotic occlusive disease involving the femoropopliteal segment between November 2002 and November 2012, 139 patients (97 men; mean age 68±8 years) with 142 ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2015, 22(2):254-260]

Cited: 2 times

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German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

Hans Krankenberg, Thilo Tübler, Sebastian Sixt, Matthias Fischer, Rainer Schmiedel, Karl-Ludwig Schulte, Jörn O Balzer, Arne Kieback, Eduard Fiehn, Günther Wittenberg, Tammam Ali, Christiane Tiefenbacher, Thomas Jahnke, Hermann J Steinkamp, Karl Wegscheider, András Treszl, Maja Ingwersen, Thomas Zeller,

<h4>Purpose</h4>To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.<h4>Methods</h4>Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2014, 21(4):463-471]

Cited: 12 times

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Elevated cardiac troponin T is associated with higher mortality and amputation rates in patients with peripheral arterial disease.

Birgit Linnemann, Thilo Sutter, Eva Herrmann, Sebastian Sixt, Aljoscha Rastan, Uwe Schwarzwaelder, Elias Noory, Karlheinz Buergelin, Ulrich Beschorner, Thomas Zeller,

<h4>Objectives</h4>The aim of the present study was to evaluate whether elevated cardiac troponin T (cTnT) was independently associated with an increased all-cause mortality or risk of cardiovascular events and amputation among patients with peripheral arterial disease (PAD).<h4>Background</h4>PAD patients often have impaired renal function, and the blood concentration of cardiac troponin ... Read more >>

J Am Coll Cardiol (Journal of the American College of Cardiology)
[2014, 63(15):1529-1538]

Cited: 14 times

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Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.

Ulrich Beschorner, Hans Krankenberg, Dierk Scheinert, Horst Sievert, Thilo Tübler, Sebastian Sixt, Elias Noory, Aljoscha Rastan, Roland Macharzina, Thomas Zeller,

<h4>Background</h4>To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis.<h4>Patients and methods</h4>33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious ... Read more >>

Vasa (VASA. Zeitschrift fur Gefasskrankheiten)
[2013, 42(2):127-133]

Cited: 11 times

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Re: "Initial experience with the 5×300-mm Proteus Embolic Capture Angioplasty balloon in the treatment of peripheral vascular disease". Reply.

Thomas Zeller, Andrej Schmidt, Aljoscha Rastan, Elias Noory, Sebastian Sixt, Dierk Scheinert,

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2013, 20(2):252-253]

Cited: 1 time

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Angioplasty and provisional stent treatment of common femoral artery lesions.

Robert F Bonvini, Aljoscha Rastan, Sebastian Sixt, Ulrich Beschorner, Elias Noory, Thomas Schwarz, Marco Roffi, Pierre-André Dorsaz, Uwe Schwarzwälder, Karlheinz Bürgelin, Roland Macharzina, Thomas Zeller,

<h4>Purpose</h4>Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment.<h4>Materials and methods</h4>A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous ... Read more >>

J Vasc Interv Radiol (Journal of vascular and interventional radiology : JVIR)
[2013, 24(2):175-183]

Cited: 15 times

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Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries.

Sebastian Sixt, Oscar Gerardo Carpio Cancino, András Treszl, Ulrich Beschorner, Roland Macharzina, Aljoscha Rastan, Hans Krankenberg, Franz-Josef Neumann, Thomas Zeller,

<h4>Background</h4>Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon ... Read more >>

J Vasc Surg (Journal of vascular surgery)
[2013, 58(3):682-686]

Cited: 36 times

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Endovascular treatment for extensive aortoiliac artery reconstruction: a single-center experience based on 1712 interventions.

Sebastian Sixt, Hans Krankenberg, Charlotte Möhrle, Mathias Kaspar, Thilo Tübler, Aljoscha Rastan, Klaus Brechtel, Roland Macharzina, Franz-Josef Neumann, Thomas Zeller,

<h4>Purpose</h4>To determine the clinical and technical outcomes following endovascular therapy for aortoiliac occlusive disease, including complex reconstruction of the aortic bifurcation.<h4>Methods</h4>A retrospective database search identified 1184 consecutive patients (864 men; mean age 64±10 years) who underwent 1712 procedures to treat target lesions in the distal aorta and iliac arteries from ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2013, 20(1):64-73]

Cited: 13 times

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Endovascular repair of ascending aortic aneurysm by transapical approach and periscope technique.

Hans Krankenberg, Ralf Bader, Sebastian Sixt, Thilo Tübler, Carsten Schwencke, Dietmar Kivelitz, Ashrat Rad, Michael Caspary, Thomas Zeller,

<h4>Purpose</h4>To demonstrate transapical stent-graft implantation for the treatment of an ascending aortic aneurysm simultaneously using the "periscope" technique for all supra-aortic branches.<h4>Technique</h4>The treatment plan is demonstrated in a 67-year-old man with prior ascending aortic replacement and known ascending aortic aneurysm who presented with acute severe chest pain. Computed tomographic angiography ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2013, 20(1):13-17]

Cited: 10 times

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Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.

Thomas Zeller, Antonio M Kambara, Samuel M Moreira, Eliyahu Atar, Alexander Chulsky, Yoav Turgeman, Sebastian Sixt, Gunnar Tepe, Aljoscha Rastan, Maurice Buchbinder,

<h4>Purpose</h4>To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery.<h4>Methods</h4>The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement ... Read more >>

J Endovasc Ther (Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists)
[2012, 19(2):131-139]

Cited: 6 times

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Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.

Aljoscha Rastan, Klaus Brechtel, Hans Krankenberg, Rainer Zahorsky, Gunnar Tepe, Elias Noory, Uwe Schwarzwälder, Roland Macharzina, Thomas Schwarz, Karlheinz Bürgelin, Sebastian Sixt, Thilo Tübler, Franz-Josef Neumann, Thomas Zeller,

<h4>Objectives</h4>The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions.<h4>Background</h4>There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this ... Read more >>

J Am Coll Cardiol (Journal of the American College of Cardiology)
[2012, 60(7):587-591]

Cited: 59 times

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Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial.

Aljoscha Rastan, Gunnar Tepe, Hans Krankenberg, Rainer Zahorsky, Ullrich Beschorner, Elias Noory, Sebastian Sixt, Thomas Schwarz, Klaus Brechtel, Catherine Böhme, Franz-Josef Neumann, Thomas Zeller,

<h4>Aims</h4>Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in ... Read more >>

Eur Heart J (European heart journal)
[2011, 32(18):2274-2281]

Cited: 88 times

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