October 11–14, 2023, Hybrid Meeting

European Academy of Dermatology and Venereology (EADV)

September 07–10, 2022, Hybrid Meeting

European Academy of Dermatology and Venereology (EADV)

European Academy of Dermatology and Venereology (EADV)

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Remibrutinib (LOU064) showed good stability of response in patients with chronic spontaneous urticaria: A novel exploratory analysis of data from the Phase 2b study

M. Maurer, A.M. Giménez-Arnau, V. Jain, A. Reich, C-E. Ortmann, P. Walsh,
S. Haemmerle
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Remibrutinib, an oral, highly selective BTKi in development for CSU: Analysis of safety data from the completed Phase 2 studies in inflammatory immune-mediated diseases

A.M. Giménez-Arnau, T. Chitnis, M. Williams, L. Airas, S. Saini, M. Hide, G. Sussman, J. Nakahara, R. Bermel, T. Dörner, B. Loop, V. DeLasHeras, R. Willi, B.C. Kieseier,
S. Haemmerle, R. Siegel, B. Cenni, H. Wiendl, M. Maurer, X. Montalban, A. Zharkov
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Remibrutinib treatment improves itch, sleep and activity in chronic spontaneous urticaria patients: Phase 2b study results

A.M. Giménez-Arnau, C. Hsu, R. Snyder, L. Clore, V. Jain, K. Lheritier, P. Walsh,
S. Haemmerle, M. Wells, I. Nikolaev, M. Maurer
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Remibrutinib (LOU064) treatment decreases disease activity in patients with chronic spontaneous urticaria: Post hoc analysis from the Phase 2b study

A.M. Giménez-Arnau, M. Maurer, R. Snyder, C-E. Ortmann, B. Suryawanshi,
I. Nikolaev, M. Kuruvilla, S. Haemmerle
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Remibrutinib provides fast and clinically important improvement of CSU disease activity: Post-hoc analysis from the Phase 2b study

M. Maurer, A.M. Giménez-Arnau, J. Jacobs, S. Savic, C-E. Ortmann, B. Suryawanshi, I. Nikolaev, M. Wells, S. Haemmerle
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Remibrutinib improves chronic spontaneous urticaria in patients irrespective of previous anti-IgE treatment: Results from a Phase 2b study

M. Maurer, A. Greiner, S. Guduri, J. Leflein, S. Haemmerle, K. Lheritier, P. Walsh,
I. Nikolaev, A.M. Giménez-Arnau
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Urticaria Voices: The use of patient-reported outcome measures for monitoring chronic spontaneous urticaria in clinical practice

J.A. Bernstein, P. Laires, M-M. Balp, P. Saraswat, T. Raftery, J. McCarthy, M. Dricu,
T.A. Winders, K. Weller
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Urticaria Voices: Patients’ perspective on the negative impact of chronic spontaneous urticaria on their lives as well as their treatment goals

K. Weller, P. Laires, M-M. Balp, T. Raftery, P. Saraswat, J. McCarthy, M. Dricu,
T.A. Winders, J.A. Bernstein
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Urticaria Voices: Opportunity for greater shared treatment decision-making by leveraging the existing high-quality relationship between patients and physicians

T.A. Winders, P. Laires, M-M. Balp, P. Saraswat, J. McCarthy, T. Raftery, M. Dricu,
J.A. Bernstein, K. Weller
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Remission and relapse profiles in chronic urticaria using real-world data​

M-M. Balp, I. Pivneva, A. Danyliv, K. Chen, T. Cornwall , J. Signorovitch, D. Patil,
R.K. Kohli, T. Severin, W. Soong, A.M. Marsland
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Burden of angioedema in patients with chronic spontaneous urticaria in EU5 and US

M-M. Balp, K. Krupsky, L. Balkaran. Bridget, S. Gupta, C. Lienhard, D. Patil, R.K. Kohli, F. Tétart, T. El-Shanawany, J. Reed
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Burden of chronic spontaneous urticaria relative to psoriasis and atopic dermatitis in Japan

M-M. Balp, M. Hide, A. Uda, F. Maki, R.K. Kohli, S. Gupta, K. Krupsky, B.L. Balkaran
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Characterization of chronic spontaneous urticaria among patients in EU5, US and Japan

M-M. Balp, K. Krupsky, B.L. Balkaran, S. Gupta, C. Lienhard, D. Patil, R.K. Kohli,
A. Uda, F. Maki, F. Tétart, T. El-Shanawany, J. Reed, M. Hide
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Patient-reported symptom burden in chronic inducible urticaria: Post hoc analysis of baseline data from a Phase 3 clinical trial

D. Whalley, M-M. Balp, S. Yarr, M. Porter, A. Barve

Symposia

From Past to Present: What’s next for CSU?

M. Maurer, E. Kocatürk Göncü and M. Metz

Video icon Symposia

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Welcome and introduction

M. Maurer
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Exploring the Past: Approaches to Chronic Urticaria Care

M. Maurer
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Current Guidelines in CSU Management

E. Kocatürk Göncü
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What’s New in Management: Future of Personalised Medicine

M. Metz
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Q&A and Panel Discussion

M. Maurer, E. Kocatürk Göncü and M. Metz
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Remibrutinib (LOU064) versus placebo in CSU patients: Study design of the two Phase 3 clinical trials, REMIX-I and REMIX-II

M. Maurer, A. Giménez-Arnau, S. Saini, M. Lebwohl, G. Sussman, M. Hide, K. Lheritier, A. Zharkov, A. Barron, K. Cook, E-D. Martzloff, S. Haemmerle
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No increased rate of infections and infestations with remibrutinib (LOU064) in Phase 2 studies in patients with chronic spontaneous urticaria

M. Metz, A. Giménez-Arnau, M. Maurer, A. Tolcachier, S. Haemmerle, K. Lheritier, A. Zharkov
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Remibrutinib (LOU064) treatment improves quality of life in patients with chronic spontaneous urticaria

M. Maurer, A. Giménez-Arnau, V. Jain, J. Tillinghast, A. Tolcachier, S. Nigen, K. Hayama, K. Lheritier, P. Walsh, S. Haemmerle
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Remibrutinib demonstrates faster time to complete urticaria control in patients with chronic spontaneous urticaria compared with placebo

M. Maurer, P. Yamauchi, H. Kanavy, A. Giménez-Arnau, J. Reed, P. Staubach, K. Lheritier, P. Walsh, I. Nikolaev, S. Haemmerle, M. Lebwohl
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Long-term safety and tolerability of remibrutinib (LOU064) in Phase 2b study in chronic spontaneous urticaria patients

A. Giménez-Arnau, M. Maurer, M. Metz, V. Jain, P. Walsh, K. Lheritier, S. Hugot, H. Zouater, S. Haemmerle, A. Zharkov
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Remibrutinib (LOU064) reduces the use of rescue medication in patients with chronic spontaneous urticaria: Findings from a Phase 2b study

M. Maurer, J. Reed, P. Staubach, K. Lheritier, P. Walsh, V. Meti, I. Nikolaev, S. Haemmerle, A. Giménez-Arnau
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Efficacy and safety of ligelizumab in patients with chronic spontaneous urticaria: Results of two Phase 3 randomized controlled trials

M. Maurer, A. M. Giménez-Arnau, G. Sussman, R. Saini, M. Hide, L. F. Ensina, V. Varanasi, A. Barve, E. Scosyrev, A. Burciu, E. Hua, M. Patekar, T. Severin
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Angioedema control with ligelizumab in patients with chronic spontaneous urticaria correlates with improvement of health-related quality-of-life

M. Metz, A. Gimenez-Arnau, M. Maurer, K. Sitz, M. Hide, C-E Ortmann, M-M. Balp, T. Severin
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Assessing contextual factors to guide an implementation science study aiming to improve management of patients with chronic spontaneous urticaria

P. A. Laires, M. Bartezaghi, O. Bonavita, E. Peruzzi, G. Dasari, N. Janssens, V. Herrera, E. Gibbons, J. N. Hill, C. Smith, I. Nikolaev, S. D. Geest
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Low quality of life scores on the urticaria control test are associated with poor response to antihistamines in real-world data

A. Rajan, P. A. Laires, N. Janssens, S. Rizvi, S. Smeets, A. Giménez-Arnau, K. Weller
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The lower the urticaria control test score is the higher the probability of poor response to antihistamines will be: Analysis from worldwide real-world data (AWARE study)

P. A. Laires, A. Rajan, N. Janssens, S. Rizvi, S. Smeets, K. Weller, A. Giménez-Arnau
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Urticaria voices: Design of a real-world study on the burden of chronic urticaria from patients’ and physicians’ perspectives

L. Pedro, M-M. Balp, K. Weller, T. A. Winders, J. A. Bernstein, J. E. M. O’Donoghue, J. Kleebach, L. Christen, S. Smeets
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Burden of angioedema in patients with chronic spontaneous urticaria amongst the five European countries

M-M. Balp, K. Krupsky, B. L. Balkaran, S. Gupta, C. Lienhard, J. Loh, J. M. Rodriguez Barrios, A. Romero, D. Patil, S. Walsh, R. K. Kohli, F. Tétart, T. El-Shanawany, J. Reed
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Prevalence, clinical profile and burden of chronic inducible urticaria in EU5, US and Japan

M-M. Balp, K. Krupsky, B. L. Balkaran, S. Gupta, C. Lienhard, J. Loh, J. M. Rodriguez Barrios, A. Romero, D. Patil, S. Walsh, R. K. Kohli, A. Uda, F. Maki, F. Tétart, T. El-Shanawany, J. Reed, M. Hide
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Comparative economic burden of chronic spontaneous urticaria, psoriasis and atopic dermatitis in the US

D. Patil, M-M. Balp, K. Freedle, S. Walsh, K. Krupsky, B. L. Balkaran, S. Gupta, A. Romero, B. J. Williams, W. Soong
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Humanistic burden of chronic spontaneous urticaria relative to psoriasis and atopic dermatitis in the US

K. Freedle, M-M. Balp, D. Patil, S. Walsh, K. Krupsky, B. L. Balkaran, S. Gupta, A. Romero, W. Soong, B. J. Williams
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Predicting time to clinical remission in chronic urticaria: Can it be done with a simplified model?

P. Irina, M-M. Balp, Y. Geissbühler, T. Severin, S. Smeets, J. Signorovitch, T. Cornwall, A. Danyliv, S. Walsh, W. Soong, A-M. Marsland
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The CHOICE study: A real world study assessing patient insights and preferences towards injectable biologic treatments for CSU in USA, Germany and Spain

A. M. Giménez-Arnau, M-M. Balp, J. O’Donoghue, S. Smeets, S. Walsh, S. Morrison, L. Christen, M. Maurer, T. Winders, J. Bernstein

Symposia

Reimagining immunology: The path to optimized management of chronic spontaneous urticaria

M. Maurer, S. Ferrucci and S. F. Thomsen

Video icon Symposia

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Welcome and introduction

M. Maurer
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The path to optimized management of chronic spontaneous urticaria

M. Maurer, S. Ferrucci and S. F. Thomsen
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Q&A

M. Maurer, S. Ferrucci and S. F. Thomsen

2021

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Ligelizumab shows good stability of response in patients with chronic spontaneous urticaria: A novel exploratory analysis of urticaria flare-ups

M. Maurer, A. M. Giménez-Arnau, M. Metz, K. Sitz, S. Acharya, N. Barbier, A. Barve, T. Severin
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Complete symptom control in patients with chronic spontaneous urticaria is associated with an improvement in health-related quality of life: Data from the phase 2b ligelizumab study

J. A. Bernstein, A. Giménez-Arnau, M. Maurer, P. Staubach, N. Barbier, E. Hua, Y. Joubert, M. M. Balp, T. Severin
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A composite score combining symptoms with QoL to evaluate complete control of urticaria with ligelizumab

A. M. Giménez-Arnau, J. A. Bernstein, M. Hide, M. Maurer, K. Sitz, G. Sussman, P. Terradas-Montana, N. Barbier, T. Severin
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Efficacy, safety and pharmacokinetics of ligelizumab: Results from a dedicated Phase 2b study in adolescent patients with chronic spontaneous urticaria

B. E. Sekerel, P. Staubach, M. Alvaro-Lozano, M. Maurer, M. Ben-Shoshan, A. Drollmann, A. Bienczak, M. Porter, T. Liu, A. Burciu, T. Severin
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The Bruton’s tyrosine kinase inhibitor remibrutinib (LOU064) in chronic spontaneous urticaria: Top line results of a phase 2b dose-finding study

M. Maurer, W. Berger, A. M. Giménez-Arnau, K. Hayama, V. Jain, A. Reich,
S. Haemmerle, K. Lheritier, P. Walsh, S. Xia, J. Storim
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Clinical profiles of adult and paediatric patients with chronic spontaneous urticaria: A real-world study in the United States

M. Balp, Y. Geissbühler, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong
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Clinical profiles of adult and paediatric patients with chronic inducible urticaria: A real-world study in the United States

Y. Geissbühler, M. Balp, A. Mcconnon, J. Schäl, J. Gomme, P. A. Laires, S. J. McKenna, W. Soong
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Early and sustained treatment with omalizumab significantly improves quality of life in patients with chronic spontaneous urticaria: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M. Balp, K. Weller
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Complete control of wheals and itch in CSU significantly correlates with better sleep quality: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M. Balp, K. Weller
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Complete control of wheals and itch in CSU significantly correlates with better patients´ quality of life: Analysis from a worldwide real-world database (AWARE study)

P. A. Laires, N. Janssens, A. Kandra, N. Barbier, C. E. Ortmann, S. Smeets, M. M Balp, K. Weller

Symposia

Targeting complete CSU control: Current state of the art and future perspectives

A. M. Giménez-Arnau, R. Saini and J. Reed

Slides  Video icon Symposia

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The patient journey in CSU: The challenges we face

A. M. Giménez-Arnau
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Optimizing patient outcomes in CSU: Could new biologics help achieve this?

R. Saini
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Exploring novel pathways in the journey to complete CSU control

J. Reed

2020

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Treatment with ligelizumab achieves a higher complete response rate in chronic spontaneous urticaria patients originally treated with omalizumab

M. Maurer; A. Giménez-Arnau; W. Soong; J.A. Bernstein; G. Sussmann; M. Metz; M. Hide; K. Sitz; E. Hua; A. Barve; T. Severin; R. Janocha
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Quality of life improvements are correlated with improved disease control: Results from ligelizumab treatment in chronic spontaneous urticaria patients with angioedema

A Giménez-Arnau, M. Maurer, W. Soong, J.A. Bernstein, G. Sussman, M. Metz, M. Hide, K. Sitz, E. Hua, P. Gupta, A. Barve, T. Severin, R. Janocha, M.M. Balp
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High proportion of patients with moderate to severe chronic spontaneous urticaria achieved complete response with ligelizumab: Data from the phase 2b study

J. A. Bernstein, M. Maurer, A. Giménez -Arnau, W. Soong, G. Sussman, M. Metz, K. Sitz, M. Hide, E. Hua, A. Barve, T. Severin, R. Janocha
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Efficacy of ligelizumab in chronic spontaneous urticaria patients inadequately controlled with omalizumab; sub-analysis of the Phase 2 program

M. Metz, M. Hide, G. Sussmann, K. Sitz, M. Maurer, T. Severin, R. Janocha, E. Hua
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Complete symptom control in chronic spontaneous urticaria patients leads to improved sleep and quality of life: Results from the Phase 2b ligelizumab study

A. Giménez-Arnau; M. Maurer, J.A. Bernstein, N. Barbier, E. Hua, T. Severin, R. Janocha, M-M. Balp
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In chronic spontaneous urticaria, response to ligelizumab is determined by baseline disease activity and duration, and patient's body mass index: An exploratory multivariate analysis

M. Maurer, A. Giménez-Arnau, G. Sussmann, W. Soong, J.A. Bernstein, E. Hua, T. Liu,
A. Barve, R. Janocha, T. Severin
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Ligelizumab achieves fast control of symptoms in more patients with chronic spontaneous urticaria compared with omalizumab: Analysis of the first 12 weeks of the Phase 2b study

M. Maurer, A. Giménez-Arnau, W. Soong, M. Hide, J.A. Bernstein, E. Hua, A. Barve,
T. Severin, R. Janocha

Symposia

Redefining patient care in chronic spontaneous urticaria

M. Maurer, A. Giménez-Arnau, A. Eggel

Video icon Symposia

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Be AWARE: Learnings from real-world evidence

A. Giménez-Arnau
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IgE inhibition in CSU: Not all anti-IgEs are born equal

A. Eggel
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IgE implications: How does this benefit patients with CSU?

M. Maurer

2019

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Results from the phase 2b study demonstrate that ligelizumab achieves sustained control of CSU symptoms during treatment-free follow-up

S. Savic, Sussman G, J.A. Bernstein, J. Hebert, C. Katelaris, E. Hua, A. Barve, T. Severin, R. Janocha
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Re-treatment with ligelizumab achieves high rates of completely- and well-controlled symptoms in chronic spontaneous urticaria

M. Metz, D.R. Baker, C.Y. Chu, I. Danilycheva, E. Hua, A. Barve, K. Kobayashi,
R. Janocha, T. Severin
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Dose-finding Phase 2 study to evaluate efficacy and safety of the novel BTK inhibitor LOU064 in patients with CSU inadequately controlled by H1-antihistamines

J. Storim, K. Lheritier, S. Hugot, P. End, B. Bieth, B. Cenni, M. Kaul, A. Gimenez-Arnau, M. Maurer, T. Severin

2018

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Ligelizumab achieves rapid onset of action, improved and sustained efficacy compared with omalizumab in patients with chronic spontaneous urticaria not adequately controlled by H1-antihistamines

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, E. Hua, M.M. Balp,
T. Severin, R. Janocha
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Burden of chronic spontaneous urticaria remains high - Baseline patient characteristics from a Phase 2b study with ligelizumab

M. Maurer, A. Giménez -Arnau, G. Sussman, J. Loeffler, A. Barve, E. Hua, M.M. Balp, T. Severin, R. Janocha
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