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Charlotte Höybye Department of Endocrinology and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden

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Beverly M K Biller Neuroendocrine Unit, Massachusetts General Hospital, Massachusetts General Hospital, Boston, Massachusetts, USA

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Jean-Marc Ferran Qualiance ApS, Copenhagen, Denmark

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Murray B Gordon Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA

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Nicky Kelepouris US Medical Affairs-Rare Endocrine Disorders, Novo Nordisk, Inc, Plainsboro, New Jersey, USA

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Navid Nedjatian Global Medical Affairs – Rare Endocrine Disorders, Novo Nordisk Health Care AG, Zurich, Switzerland

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Anne H Olsen Epidemiology, Novo Nordisk A/S, Soborg, Denmark

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Matthias M Weber Unit of Endocrinology, 1, Medical Department, University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Mainz, Germany

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for AGHD (GH treated) who were enrolled in two non-interventional, multicentre studies: the NordiNet ® International Outcome Study (IOS) and the American Norditropin ® Studies: Web-Enabled Research (ANSWER) Program ( 16 , 17 ). The CV risks of

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Alexander A L Jorge Unidade de Endocrinologia-Genetica, LIM/25, Disciplina de Endocrinologia da Faculdade de Medicina da Universidade de Sao Paulo (FMUSP), Sao Paulo, Brazil

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Thomas Edouard Endocrine, Bone Diseases, and Genetics Unit, Children’s Hospital, Toulouse University Hospital, RESTORE INSERM UMR1301, Toulouse, France

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Mohamad Maghnie Department of Pediatrics, IRCCS Istituto Giannina Gaslini, Genova, Italy
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Genova, Italy

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Alberto Pietropoli Novo Nordisk Health Care AG, Global Medical Affairs Biopharm, Zürich, Switzerland

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Nicky Kelepouris Novo Nordisk Inc., Clinical, Medical and Regulatory Biopharm-RED, Plainsboro, New Jersey, USA

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Alicia Romano Department of Pediatrics, New York Medical College, Valhalla, New York, USA

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Martin Zenker Institute of Human Genetics & Department of Pediatrics, University Hospital, Otto-von-Guericke University Magdeburg, Magdeburg, Germany

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Reiko Horikawa Department of Endocrine and Metabolism, National Center for Child Health and Development, Tokyo, Japan

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mutation ( 9 , 18 ). Norditropin® (somatropin; Novo Nordisk A/S) is a recombinant human GH (rhGH) that is used as replacement therapy in patients with GHD or to treat a number of other conditions characterized by insufficient growth (US Food and Drug

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Robert Rapaport Ichan School of Medicine, New York, New York, USA

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Peter A Lee Penn State College of Medicine, Hershey, Pennsylvania, USA

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Judith L Ross Thomas Jefferson University, Philadelphia, Pennsylvania, USA
Nemours/DuPont Hospital for Children, Wilmington, Delaware, USA

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Paul Saenger Winthrop University Hospital, Mineola, New York, USA

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Vlady Ostrow Novo Nordisk Inc., Plainsboro, New Jersey, USA

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Giuseppe Piccoli Novo Nordisk Inc., Plainsboro, New Jersey, USA

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developed as practical tools to estimate the response to GH therapy for the diagnosis of growth hormone deficiency (GHD) ( 19 ), SGA ( 20 ) and ISS ( 21 ). The non-interventional American Norditropin Studies: Web-Enabled Research (ANSWER) Program was

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Alicia Romano Department of Pediatrics, New York Medical College, Valhalla, New York, USA

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Juan Pablo Kaski Centre for Inherited Cardiovascular Diseases, Great Ormond Street Hospital & UCL Institute of Cardiovascular Science, London, UK

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Jovanna Dahlgren Department of Paediatrics, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden

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Nicky Kelepouris US Medical Affairs, Novo Nordisk Inc., Plainsboro, New Jersey, USA

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Alberto Pietropoli Global Medical Affairs, Novo Nordisk Health Care AG, Zurich, Switzerland

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Tilman R Rohrer Department of Pediatric Endocrinology, University Children’s Hospital, Saarland University Medical Center, Homburg, Germany

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Michel Polak Paediatric Endocrinology, Diabetology and Gynaecology Department, Hôpital Universitaire Necker Enfants-Malades, AP-HP, Université de Paris, Imagine Institute, Paris, France

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good safety profile ( 6 , 7 ). Norditropin® (Novo Nordisk A/S) is currently the only GH replacement therapy approved internationally for the treatment of short stature in children with NS (in the United States, Canada, European Union, UK, Japan, Israel

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Régis Coutant Department of Pediatric Endocrinology and Diabetology, Reference Center for Rare Pituiatry Diseases, University Hospital of Angers, Angers, France

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Maithé Tauber Reference Center for the Prader-Willi syndrome and other rare obesities with feeding disorders (PRADORT), Children Hospital, CHU Toulouse, Toulouse, France
Pediatric team of the Clinical Investigation Center 9302/INSERM, Hospital of Children, Toulouse, France
Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), INSERM UMR1291 - CNRS UMR5051 - Université Toulouse III, Toulouse, France

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Béatrice Demaret GRANDIR - French Growth Disorders Association, Asnières-sur-Seine, France

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Robin Henocque Pfizer France, Paris France

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Yves Brault Pfizer France, Paris France

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François Montestruc eXYSTAT, Malakoff, France

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Olivier Chassany Health Economics Clinical Trial Unit (URC-ECO), Hospital of Hotel-Dieu, AP-HP, Paris, France
Patient-Reported Outcomes Unit (PROQOL), UMR 1123, University Paris Cité, INSERM, Paris, France

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Michel Polak Hôpital Universitaire Necker Enfants Malades, Pediatric Endocrinology, Gynecology and Diabetology, Imagine Institute, INSERM U1163, Cochin Institute, INSERM U1016, Centre de référence des pathologies endocriniennes rares de la croissance et du développement, Université de Paris Cité, Paris, France

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the QOLITHOR Study Group
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the QOLITHOR Study Group

(%)  Norditropin FlexPro® 32 (44.4%) 41 (36.6%) 26 (28.6%) 99 (36.0%) 20 (45.5%) 26 (37.7%) 19 (35.8%) 65 (39.2%)  Saizen® 22 (30.6%) 19 (17.0%) 20 (22.0%) 61 (22.2%) 14 (31.8%) 15 (21.7%) 11 (20.8%) 40 (24.1%)  Omnitrope

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Esben Thyssen Vestergaard Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark
Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark
Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Morten B Krag Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Morten M Poulsen Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Steen B Pedersen Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Niels Moller Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark
Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Jens Otto Lunde Jorgensen Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark
Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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Niels Jessen Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark
Medical Research Laboratories, Department of Endocrinology and Diabetes, Department of Pediatrics, Department of Endocrinology and Diabetes, Institute of Clinical Medicine, Aarhus University, Norrebrogade 44, DK-8000 Aarhus C, Denmark

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immediately before and immediately after an 8-day treatment period with either GH (Norditropin SimplexX; Novo Nordisk; 2 mg s.c. at 1000 h, last injection on day 7) or placebo (saline) injections in a randomized, double-blind, crossover manner. The study

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Nathalie Ly Department of Endocrinology and Reproductive Medicine, Reference Center for Rare Endocrine Diseases of Growth and Development, Reference Center for Gynecological Rare Diseases, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Paris, France
EndoERN, APHP Consortium Pitie Salpetriere Hospital, Necker Hospital, Paris, France

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Sophie Dubreuil Department of Endocrinology and Reproductive Medicine, Reference Center for Rare Endocrine Diseases of Growth and Development, Reference Center for Gynecological Rare Diseases, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Paris, France
EndoERN, APHP Consortium Pitie Salpetriere Hospital, Necker Hospital, Paris, France

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Philippe Touraine Department of Endocrinology and Reproductive Medicine, Reference Center for Rare Endocrine Diseases of Growth and Development, Reference Center for Gynecological Rare Diseases, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Paris, France
EndoERN, APHP Consortium Pitie Salpetriere Hospital, Necker Hospital, Paris, France
Sorbonne University, Paris, France

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Höybye C Carroll P Gordon MB Birkegård AC Kelepouris N Nedjatian N Weber MM . Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin

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Kennett Sprogøe Ascendis Pharma A/S, Hellerup, Denmark

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Eva Mortensen Ascendis Pharma, Inc., Palo Alto, California, USA

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David B Karpf Ascendis Pharma, Inc., Palo Alto, California, USA

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Jonathan A Leff Ascendis Pharma, Inc., Palo Alto, California, USA

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-0526 ) 10.1210/jc.2007-0526 6 Pawlikowska-Haddal A . Growth hormone therapy with norditropin (somatropin) in growth hormone deficiency. Expert Opinion on Biological Therapy 2013 13 927 – 932 . ( doi:10.1517/14712598.2013.795941 ) 10

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Pinaki Dutta
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Bhuvanesh Mahendran Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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K Shrinivas Reddy Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Jasmina Ahluwalia Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Kim Vaiphei Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Rakesh K Kochhar Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Prakamya Gupta Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Anand Srinivasan Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Mahesh Prakash Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Kanchan Kumar Mukherjee Department of Endocrinology, Internal Medicine, Cardiology, Hematology, Histopathology, Gastroenterology, Neurosurgery, Pharmacology, Radiodiagnosis, 4th Floor, F Block, Post Graduate Institute of Medical Education and Research, Nehru Hospital, Chandigarh 160012, India

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Viral N Shah
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Girish Parthan
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Anil Bhansali
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. Acknowledgements The authors are thankful to Dr R J Dash Ex-Prof & Head, Department of Endocrinology, PGIMER, Chandigarh, India for manuscript editing and valuable suggestions. We also thank Novo Nordisk India Ltd for the generous gift of Norditropin Simplex

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Alessandro Ciresi Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy

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Stefano Radellini Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy

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Valentina Guarnotta Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy

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Maria Grazia Mineo Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy

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Carla Giordano Section of Endocrinology, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy

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.1210/jc.2005-0981 ) 10.1210/jc.2005-0981 30 Cohen P Bright GM Rogol AD Kappelgaard AM Rosenfeld RG & American Norditropin Clinical Trials Group . Effects of dose and gender on the growth and growth factor response to GH in GH

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