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7. International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium–Glucose Cotransporter (SGLT) Inhibitors

Author

Danne, Thomas, Garg, Satish, Peters, Anne L, Buse, John B, Mathieu, Chantal, Pettus, Jeremy H, Alexander, Charles M, Battelino, Tadej, Ampudia-Blasco, F Javier, Bode, Bruce W, Cariou, Bertrand, Close, Kelly L, Dandona, Paresh, Dutta, Sanjoy, Ferrannini, Ele, Fourlanos, Spiros, Grunberger, George, Heller, Simon R, Henry, Robert R, Kurian, Martin J, Kushner, Jake A, Oron, Tal, Parkin, Christopher G, Pieber, Thomas R, Rodbard, Helena W, Schatz, Desmond, Skyler, Jay S, Tamborlane, William V, Yokote, Koutaro, and Phillip, Moshe

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Obesity, Diabetes, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Metabolic and endocrine, Good Health and Well Being, Consensus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Ketoacidosis, Glucose, Humans, Hypoglycemic Agents, Risk Management, Sodium, Sodium-Glucose Transporter 2 Inhibitors, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract

Sodium-glucose cotransporter (SGLT) inhibitors are new oral antidiabetes medications shown to effectively reduce glycated hemoglobin (A1C) and glycemic variability, blood pressure, and body weight without intrinsic properties to cause hypoglycemia in people with type 1 diabetes. However, recent studies, particularly in individuals with type 1 diabetes, have demonstrated increases in the absolute risk of diabetic ketoacidosis (DKA). Some cases presented with near-normal blood glucose levels or mild hyperglycemia, complicating the recognition/diagnosis of DKA and potentially delaying treatment. Several SGLT inhibitors are currently under review by the U.S. Food and Drug Administration and European regulatory agencies as adjuncts to insulin therapy in people with type 1 diabetes. Strategies must be developed and disseminated to the medical community to mitigate the associated DKA risk. This Consensus Report reviews current data regarding SGLT inhibitor use and provides recommendations to enhance the safety of SGLT inhibitors in people with type 1 diabetes.

Published
2019

8. Impact of glycaemic status on the cardiac effects of empagliflozin when initiated immediately after myocardial infarction: A post‐hoc analysis of the EMMY trial

Author

Sourij, Caren, primary, Oulhaj, Abderrahim, additional, Aziz, Faisal, additional, Tripolt, Norbert J., additional, Aberer, Felix, additional, Pferschy, Peter N., additional, Postula, Marek, additional, Drexel, H., additional, Benedikt, Martin, additional, Kolesnik, Ewald, additional, Pieber, Thomas R., additional, Bugger, Heiko, additional, von Lewinski, Dirk, additional, and Sourij, Harald, additional

Published
2024
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9. Incidence of Diabetes Mellitus and Its Impact on Outcomes in Patients Undergoing Surgical Pancreatectomy for Non-Malignant and Malignant Pancreatobiliary Diseases—A Retrospective Analysis

Author

Schranz, Anna, primary, Sternad, Christoph, additional, Aziz, Faisal, additional, Wagner, Doris, additional, Kornprat, Peter, additional, Sucher, Robert, additional, Jost, Philipp J., additional, Wölfler, Albert, additional, Pieber, Thomas R., additional, Sourij, Harald, additional, Riedl, Jakob M., additional, and Aberer, Felix, additional

Published
2023
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10. Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial

Author

Ludvik, Bernhard, Prager, Rudolf, Paulweber, Bernhard, Ebenbichler, Christoph F, Keymeulen, B, De Block, C, Grossman, Loren, Houlden, Robyn, Perron, Patrice, Ransom, Thomas, Senior, Peter, Weisnagel, S. John, Woo, Vincent, Dumas, Richard, Thompson, David, Vilsbøll, Tina, Gram, Jeppe, Juhl, Claus Bogh, Hukkanen, Janne, Lahtela, Jorma, Niskanen, Leo, O'Shea, Donal, O'Brien, Timothy, Sreenan, Seamus, Wainstein, Julio, Phillip, Moshe, Knobler, Hilla, Dotta, Francesco, Piatti, Pier Marco, Roberto, Trevisan, Gnasso, Agostino, Gulseth, Hanne, Cooper, John, Pankowska, Ewa, Lukaszewicz, Monika, Wolnik, Bogumił, Manita, Isabel, Marques, Olinda, Roque, Cristina, Príncipe, Rosa Maria, Neves, Celestino, Heitor, Susana, Ruyatkina, L, Dvoryashina, Irina, Vagapova, Gulnar, Belousova, Lidiya, Sergeeva-Kondrachenko, Marina, Peskov, Andrey, Frolova, Elena, Golovach, Albina, Kunitsyna, Marina, Krasnopeeva (Kabachkova), Natalia, Ipatko, Irina, De la Cuesta, Carmen, Tinahones, Francisco José, Rigla, Mercedes, Merino, Juan Francisco, Gómez, Luis Alberto, Fernández, Mercè, Simó, Rafael, Rydén, Mikael, Jendle, Johan, Filipsson, Karin, Eliasson, Björn, Mankovsky, Borys, Lymar, Iurii, Sokolova, Liubov, Myshanych, Galyna, Zlova, Tetiana, Vlasenko, Maryna, Kuskalo -, Petro, Courtney, Hamish, Dayan, Colin, English, Patrick, Heller, Simon, Johnson, Andrew B, Nair, Sunil, Leslie, R. D, Narendran, P, Oliver, Nick, Ramtoola, Shenaz, Shaw, Jim, Viljoen -, Adie, Al-Karadsheh, Amer, Dostou, Jean Marie, Gangi, Sumana, Gottlieb, Peter, Jerkins, Terri, Magnotti, Michael, Marks, Jennifer, Nakhle, Samer, Bonabi, Gholamreza, Myers, Lyle, Pratley, Richard, Hagopian, William, Pettus, Jeremy, von Scholten, Bernt Johan, Wesley, Johnna D, Kreiner, Frederik F, von Herrath, Matthias, Bain, Stephen C, Bode, Bruce, Clausen, Jesper Ole, Coppieters, Ken, Gaysina, Leylya, Gumprecht, Janusz, Hansen, Troels Krarup, Mathieu, Chantal, Morales, Cristobal, Mosenzon, Ofri, Segel, Stine, Tsoukas, George, and Pieber, Thomas R

Published
2021
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11. Study protocol for assessing the user acceptance, safety and efficacy of a tablet-based workflow and decision support system with incorporated basal insulin algorithm for glycaemic management in participants with type 2 diabetes receiving home health care: A single-centre, open-label, uncontrolled proof-of-concept study

Author

Libiseller, Angela, Kopanz, Julia, Lichtenegger, Katharina M., Mader, Julia K., Truskaller, Thomas, Lackner, Bettina, Aberer, Felix, Pandis, Marlene, Reinisch-Gratzer, Johanna, Ambrosch, Gisela C., Sinner, Frank, Pieber, Thomas R., and Donsa, Klaus

Published
2020
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13. Glucagon-Like Peptide-1 Receptor Agonism Improves Nephrotoxic Serum Nephritis by Inhibiting T-Cell Proliferation

Author

Moschovaki Filippidou, Foteini, Kirsch, Alexander H., Thelen, Matthias, Kétszeri, Máté, Artinger, Katharina, Aringer, Ida, Schabhüttl, Corinna, Mooslechner, Agnes A., Frauscher, Bianca, Pollheimer, Marion, Niedrist, Tobias, Meinitzer, Andreas, Drucker, Daniel J., Pieber, Thomas R., Eller, Philipp, Rosenkranz, Alexander R., Heinemann, Akos, and Eller, Kathrin

Published
2020
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14. Functional Metagenomics of Spacecraft Assembly Cleanrooms: Presence of Virulence Factors Associated with Human Pathogens

Author

Bashir, Mina, Ahmed, Mahjabeen, Weinmaier, Thomas, Ciobanu, Doina, Ivanova, Natalia, Pieber, Thomas R, and Vaishampayan, Parag A

Subjects
Microbiology, Biological Sciences, Infectious Diseases, Infection, cleanroom, pathogens, indoor environments, microbiome, spacecraft, virulence factors, Acinetobacter, functional metagenomics, Environmental Science and Management, Soil Sciences, Medical microbiology
Abstract

Strict planetary protection practices are implemented during spacecraft assembly to prevent inadvertent transfer of earth microorganisms to other planetary bodies. Therefore, spacecraft are assembled in cleanrooms, which undergo strict cleaning and decontamination procedures to reduce total microbial bioburden. We wanted to evaluate if these practices selectively favor survival and growth of hardy microorganisms, such as pathogens. Three geographically distinct cleanrooms were sampled during the assembly of three NASA spacecraft: The Lockheed Martin Aeronautics' Multiple Testing Facility during DAWN, the Kennedy Space Center's Payload Hazardous Servicing Facility (KSC-PHSF) during Phoenix, and the Jet Propulsion Laboratory's Spacecraft Assembly Facility during Mars Science Laboratory. Sample sets were collected from the KSC-PHSF cleanroom at three time points: before arrival of the Phoenix spacecraft, during the assembly and testing of the Phoenix spacecraft, and after removal of the spacecraft from the KSC-PHSF facility. All samples were subjected to metagenomic shotgun sequencing on an Illumina HiSeq 2500 platform. Strict decontamination procedures had a greater impact on microbial communities than sampling location Samples collected during spacecraft assembly were dominated by Acinetobacter spp. We found pathogens and potential virulence factors, which determine pathogenicity in all the samples tested during this study. Though the relative abundance of pathogens was lowest during the Phoenix assembly, potential virulence factors were higher during assembly compared to before and after assembly, indicating a survival advantage. Decreased phylogenetic and pathogenic diversity indicates that decontamination and preventative measures were effective against the majority of microorganisms and well implemented, however, pathogen abundance still increased over time. Four potential pathogens, Acinetobacter baumannii, Acinetobacter lwoffii, Escherichia coli and Legionella pneumophila, and their corresponding virulence factors were present in all cleanroom samples. This is the first functional metagenomics study describing presence of pathogens and their corresponding virulence factors in cleanroom environments. The results of this study should be considered for microbial monitoring of enclosed environments such as schools, homes, hospitals and more isolated habitation such the International Space Station and future manned missions to Mars.

Published
2016

15. Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans

Author

Stekovic, Slaven, Hofer, Sebastian J., Tripolt, Norbert, Aon, Miguel A., Royer, Philipp, Pein, Lukas, Stadler, Julia T., Pendl, Tobias, Prietl, Barbara, Url, Jasmin, Schroeder, Sabrina, Tadic, Jelena, Eisenberg, Tobias, Magnes, Christoph, Stumpe, Michael, Zuegner, Elmar, Bordag, Natalie, Riedl, Regina, Schmidt, Albrecht, Kolesnik, Ewald, Verheyen, Nicolas, Springer, Anna, Madl, Tobias, Sinner, Frank, de Cabo, Rafael, Kroemer, Guido, Obermayer-Pietsch, Barbara, Dengjel, Jörn, Sourij, Harald, Pieber, Thomas R., and Madeo, Frank

Published
2019
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19. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial

Author

Akın, S, Aladağ, N, Arif, A A, Aronne, L J, Aronoff, S, Ataoglu, E, Baik, S H, Bays, H, Beckett, P L, Berker, D, Bilz, S, Bode, B, Braun, E W, Buse, J B, Canani, L H S, Cho, Y M, Chung, C H, Colin, I, Condit, J, Cooper, J, Delgado, B, Eagerton, D C, El Ebrashy, I N, El Hefnawy, M H M F, Eliaschewitz, F G, Finneran, M P, Fischli, S, Fließer-Görzer, E, Geohas, J, Godbole, N A, Golay, A, Gorban de Lapertosa, S, Gross, J L, Gulseth, H L, Helland, F, Høivik, H O, Issa, C, Kang, E S, Keller, C, Khalil, S H A, Kim, N H, Kim, I J, Klaff, L J, Laimer, M, LaRocque, J C, Lederman, S N, Lee, K-W, Litchfield, W R, Manning, M B, Mertens, A, Morawski, E J, Murray, A V, Nicol, P R, O'Connor, T M, Oğuz, A, Ong, S, Özdemir, A, Palace, E M, Palchick, B A, Pereles-Ortiz, J, Pieber, T, Prager, R, Preumont, V, Riffer, E, Rista, L, Rudofsky, G, Sarı, R, Scheen, A, Schultes, B, Seo, J A, Shelbaya, S A, Sivalingam, K, Sorli, C H, Stäuble, S, Streja, D A, T'Sjoen, G, Tetiker, T, Van Gaal, L, Vercammen, C, Warren, M L, Weinstein, D L, Weiss, D, White, A, Winnie, M, Wium, C, Yavuz, D, Pieber, Thomas R, Bode, Bruce, Mertens, Ann, Cho, Young Min, Christiansen, Erik, Hertz, Christin L, Wallenstein, Signe O R, and Buse, John B

Published
2019
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20. Pharmacokinetic and pharmacodynamic properties of once‐weekly insulin icodec in individuals with type 2 diabetes.

Author

Pieber, Thomas R., Asong, Marisse, Fluhr, Gabriele, Höller, Vera, Kristensen, Niels R., Larsen, Jonas H., Ribel‐Madsen, Rasmus, Svehlikova, Eva, Vinther, Siri, Voortman, Margarete, and Haahr, Hanne

Subjects
*TYPE 2 diabetes, *INSULIN derivatives, *PHARMACOKINETICS, *INSULIN, *GLUCOSE clamp technique, *BODY mass index, *BLOOD sugar
Abstract

Aims: To characterize the pharmacokinetic and pharmacodynamic properties of once‐weekly insulin icodec in type 2 diabetes (T2D). Materials and Methods: In an open‐label trial, 46 individuals with T2D (18‐75 years; body mass index 18.0‐38.0 kg/m2; glycated haemoglobin ≤75 mmol/mol [≤9%]; basal insulin‐treated) received subcutaneous once‐weekly icodec for ≥8 weeks at individualized doses, aiming at a pre‐breakfast plasma glucose concentration of 4.4 to 7.0 mmol/L (80‐126 mg/dL) on the last three mornings of each weekly dosing interval. Frequent blood sampling to assess total serum icodec concentration (ie, albumin‐bound and unbound) occurred from first icodec dose until 35 days after last dose. Icodec trough concentrations following initiation of once‐weekly dosing were predicted by pharmacokinetic modelling. During the final 3 weeks of icodec treatment, while at steady state, the icodec glucose‐lowering effect was assessed in three glucose clamps (target 7.5 mmol/L [135 mg/dL]): 0 to 36, 40 to 64 and 144 to 168 h post‐dose, thus covering the initial, middle and last part of the 1‐week dosing interval. Glucose‐lowering effect during a complete dosing interval was predicted by pharmacokinetic‐pharmacodynamic modelling. Results: Model‐predicted icodec steady state was attained after 3 to 4 weeks. At steady state, model‐predicted daily proportions of glucose‐lowering effect on days 1 to 7 of the 1‐week dosing interval were 14.1%, 16.1%, 15.8%, 15.0%, 14.0%, 13.0% and 12.0%, respectively. Icodec duration of action was at least 1 week in all participants. Once‐weekly icodec was overall safe and well tolerated in the current trial. Conclusions: The pharmacokinetic and pharmacodynamic characteristics of icodec in individuals with T2D support its potential as a once‐weekly basal insulin. [ABSTRACT FROM AUTHOR]

Published
2023
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27. Effects of vitamin D supplementation on FGF23: a randomized-controlled trial

Author

Trummer, Christian, Schwetz, Verena, Pandis, Marlene, Grübler, Martin R., Verheyen, Nicolas, Gaksch, Martin, Zittermann, Armin, März, Winfried, Aberer, Felix, Steinkellner, Julia, Friedl, Claudia, Brandenburg, Vincent, Voelkl, Jakob, Alesutan, Ioana, Obermayer-Pietsch, Barbara, Pieber, Thomas R., Tomaschitz, Andreas, and Pilz, Stefan

Published
2019
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28. AMH in men: Higher serum levels associated with healthy male aging

Author

Tandl, Veronika, primary, Haudum, Christoph W., additional, Eberhard, Katharina, additional, Hutz, Barbara, additional, Kolesnik, Ewald, additional, Schmidt, Albrecht, additional, Zirlik, Andreas, additional, von, Lewinski Dirk, additional, Scherr, Daniel, additional, Verheyen, Nicolas, additional, Pieber, Thomas R., additional, and Obermayer-Pietsch, Barbara, additional

Published
2023
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29. En route to sarcopenia biomarkers: dp-ucMGP in relation to muscle mass and function

Author

Tandl, Veronika, primary, Schweighofer, Natascha, additional, Trummer, Olivia, additional, Haudum, Christoph W., additional, Lind, Alice F., additional, Kolesnik, Ewald, additional, Mursic, Ines, additional, Scherr, Daniel, additional, Zirlik, Andreas, additional, Pieber, Thomas R., additional, Verheyen, Nicolas D., additional, and Obermayer-Pietsch, Barbara, additional

Published
2023
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31. Urinary C-Peptide to Creatinine Ratio (UCPCR) as Indicator for Metabolic Risk in Apparently Healthy Adults—A BioPersMed Cohort Study

Author

Reintar, Sharmaine, primary, Pöchhacker, Magdalena, additional, Obermayer, Anna, additional, Eberhard, Katharina, additional, Zirlik, Andreas, additional, Verheyen, Nicolas, additional, von Lewinski, Dirk, additional, Scherr, Daniel, additional, Hutz, Barbara, additional, Haudum, Christoph W., additional, Pieber, Thomas R., additional, Sourij, Harald, additional, and Obermayer-Pietsch, Barbara, additional

Published
2023
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36. Towards Personalization of Diabetes Therapy Using Computerized Decision Support and Machine Learning: Some Open Problems and Challenges

Author

Donsa, Klaus, Spat, Stephan, Beck, Peter, Pieber, Thomas R., Holzinger, Andreas, Hutchison, David, Series editor, Kanade, Takeo, Series editor, Kittler, Josef, Series editor, Kleinberg, Jon M., Series editor, Mattern, Friedemann, Series editor, Mitchell, John C., Series editor, Naor, Moni, Series editor, Pandu Rangan, C., Series editor, Steffen, Bernhard, Series editor, Terzopoulos, Demetri, Series editor, Tygar, Doug, Series editor, Weikum, Gerhard, Series editor, Holzinger, Andreas, editor, Röcker, Carsten, editor, and Ziefle, Martina, editor

Published
2015
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39. Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes

Author

Svehlikova, Eva, primary, Ashcroft, Nicole L., additional, Gatschelhofer, Christina, additional, Gerring, David, additional, Höller, Vera, additional, Jezek, Jan, additional, Lackner, Bettina, additional, Lawrence, Fiona, additional, Pillai, Vijay, additional, Ratzer, Maria, additional, Urschitz, Martina, additional, Wolf, Michael, additional, and Pieber, Thomas R., additional

Published
2023
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40. Integrated safety and efficacy analysis of dasiglucagon for treatment of severe hypoglycaemia in individuals with type 1 diabetes

Author

Heller, Simon, primary, Battelino, Tadej, additional, Bailey, Timothy S., additional, Pieber, Thomas R., additional, Hövelmann, Ulrike, additional, Plum‐Mörschel, Leona, additional, Melgaard, Anita E., additional, Aronson, Ronnie, additional, DiMeglio, Linda A., additional, Johansen, Thue, additional, and Danne, Thomas, additional

Published
2023
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41. Glucose Metabolism and Metabolomic Changes in Response to Prolonged Fasting in Individuals with Obesity, Type 2 Diabetes and Non-Obese People—A Cohort Trial

Author

Tripolt, Norbert J., primary, Hofer, Sebastian J., additional, Pferschy, Peter N., additional, Aziz, Faisal, additional, Durand, Sylvère, additional, Aprahamian, Fanny, additional, Nirmalathasan, Nitharsshini, additional, Waltenstorfer, Mara, additional, Eisenberg, Tobias, additional, Obermayer, Anna M. A., additional, Riedl, Regina, additional, Kojzar, Harald, additional, Moser, Othmar, additional, Sourij, Caren, additional, Bugger, Heiko, additional, Oulhaj, Abderrahim, additional, Pieber, Thomas R., additional, Zanker, Matthias, additional, Kroemer, Guido, additional, Madeo, Frank, additional, and Sourij, Harald, additional

Published
2023
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42. Hospital diabetes management (Update 2023)

Author

Mader, Julia K., primary, Brix, Johanna M., additional, Aberer, Felix, additional, Vonbank, Alexander, additional, Resl, Michael, additional, Hochfellner, Daniel A., additional, Ress, Claudia, additional, Pieber, Thomas R., additional, Stechemesser, Lars, additional, and Sourij, Harald, additional

Published
2023
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43. Rosiglitazone Reverses Inflammation in Epididymal White Adipose Tissue in Hormone-Sensitive Lipase-Knockout Mice

Author

Kotzbeck, Petra, primary, Taschler, Ulrike, additional, Haudum, Christoph, additional, Foessl, Ines, additional, Schoiswohl, Gabriele, additional, Boulgaropoulos, Beate, additional, Bounab, Kaddour, additional, Einsiedler, Johanna, additional, Pajed, Laura, additional, Tilp, Anna, additional, Schwarz, Anna, additional, Eichmann, Thomas O., additional, Obermayer-Pietsch, Barbara, additional, Giordano, Antonio, additional, Cinti, Saverio, additional, Zechner, Rudolf, additional, and Pieber, Thomas R., additional

Published
2023
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47. Dp-ucMGP as a Biomarker in Sarcopenia

Author

Schweighofer, Natascha, primary, Haudum, Christoph W., additional, Trummer, Olivia, additional, Lind, Alice, additional, Kolesnik, Ewald, additional, Mursic, Ines, additional, Schmidt, Albrecht, additional, Scherr, Daniel, additional, Zirlik, Andreas, additional, Pieber, Thomas R., additional, Verheyen, Nicolas, additional, and Obermayer-Pietsch, Barbara, additional

Published
2022
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