Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 8:32 AM
Study NCT ID:
NCT03587805
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2018-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574065', 'term': 'tralokinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 44945888', 'title': 'Clinical Disclosure', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to week 268', 'eventGroups': [{'id': 'EG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.', 'otherNumAtRisk': 1672, 'deathsNumAtRisk': 1672, 'otherNumAffected': 924, 'seriousNumAtRisk': 1672, 'deathsNumAffected': 1, 'seriousNumAffected': 151}], 'otherEvents': [{'term': 'Conjuctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 131, 'numAffected': 103}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 317, 'numAffected': 295}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 599, 'numAffected': 372}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 233, 'numAffected': 147}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 143, 'numAffected': 114}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atopic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 620, 'numAffected': 351}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atopic cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Corneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vogt-Koyanagi-Harada disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Crohn disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Haemoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Proctitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Corneal graft rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Eczema herpeticum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Encephalitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Herpes zoster pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Medical device site joint infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tonsilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Post-traumatic neck syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Intervertebral protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Jaw cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Adenoid cystic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cutaneous T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bladder metaplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Obstructive sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Atopic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'dermatitis psoriasiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Alcohol detoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1672, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1672', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266: SC injection of tralokinumab maintenance dose.The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '8119', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 0 up to Week 268', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1647', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.'}], 'classes': [{'title': 'IGA 0/1 at Week 16', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000', 'lowerLimit': '44.9', 'upperLimit': '49.8'}]}]}, {'title': 'IGA 0/1 at Week 56', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '45.9', 'upperLimit': '51.1'}]}]}, {'title': 'IGA 0/1 at Week 88', 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '51.1'}]}]}, {'title': 'IGA 0/1 at Week 104', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '49.6'}]}]}, {'title': 'IGA 0/1 at Week 136', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '51.3'}]}]}, {'title': 'IGA 0/1 at Week 152', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '44.1', 'upperLimit': '49.4'}]}]}, {'title': 'IGA 0/1 at Week 184', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '44.1', 'upperLimit': '49.3'}]}]}, {'title': 'IGA 0/1 at Week 216', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '50.0'}]}]}, {'title': 'IGA 0/1 at Week 248', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '44.1', 'upperLimit': '49.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 16 up to Week 248', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).", 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders.'}, {'type': 'SECONDARY', 'title': 'At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.'}], 'classes': [{'title': 'EASI75 at Week 16', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '79.0'}]}]}, {'title': 'EASI75 at Week 56', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '77.4'}]}]}, {'title': 'EASI75 at Week 88', 'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '77.3'}]}]}, {'title': 'EASI75 at Week 104', 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '72.3', 'upperLimit': '76.8'}]}]}, {'title': 'EASI75 at Week 136', 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '76.3'}]}]}, {'title': 'EASI75 at Week 152', 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '75.2'}]}]}, {'title': 'EASI75 at Week 184', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '74.6'}]}]}, {'title': 'EASI75 at Week 216', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '74.5'}]}]}, {'title': 'EASI75 at Week 248', 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '74.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 16 up to Week 248', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266\\*: SC injection of tralokinumab maintenance dose.\n\n\\*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1672'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '529'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COVID_19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Various reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This trial was conducted at 309 sites that screened subjects in 11 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1672', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tralokinumab, All Subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nFrom Week 2 up to Week 266\\*: SC injection of tralokinumab maintenance dose.\n\n\\*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.\n\nTralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1498', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '14.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '709', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '963', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1558', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1194', 'groupId': 'BG000'}]}]}, {'title': 'Black or african american', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}]}]}, {'title': 'American indian or alaska native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Native hawaiian or other pacific islander', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'spread': '19.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '170.3', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '26.52', 'spread': '6.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-21', 'size': 2061362, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-16T08:04', 'hasProtocol': True}, {'date': '2024-07-19', 'size': 3865067, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-09T05:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2018-07-03', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-20', 'studyFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)', 'timeFrame': 'From Week 0 up to Week 268'}], 'secondaryOutcomes': [{'measure': "Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248", 'timeFrame': 'From Week 16 up to Week 248', 'description': "The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)."}, {'measure': 'At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248', 'timeFrame': 'From Week 16 up to Week 248', 'description': 'The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '35863467', 'type': 'BACKGROUND', 'citation': 'Blauvelt A, Langley RG, Lacour JP, Toth D, Laquer V, Beissert S, Wollenberg A, Herranz P, Pink AE, Peris K, Fangel S, Gjerum L, Corriveau J, Saeki H, Warren RB, Simpson E, Reich K. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 Oct;87(4):815-824. doi: 10.1016/j.jaad.2022.07.019. Epub 2022 Jul 19.'}, {'pmid': '38563683', 'type': 'BACKGROUND', 'citation': 'Guttman-Yassky E, Kabashima K, Staumont-Salle D, Nahm WK, Pauser S, Da Rosa JC, Martel BC, Madsen DE, Ropke M, Arlert P, Steffensen L, Blauvelt A, Reich K. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 Jun;79(6):1560-1572. doi: 10.1111/all.16108. Epub 2024 Apr 2.'}, {'pmid': '36223087', 'type': 'BACKGROUND', 'citation': 'Blauvelt A, Pink A, Worm M, Langley RGB, Elewski BE, Gjerum L, Guttman-Yassky E. Outcomes of COVID-19 and Vaccination in Patients With Moderate to Severe Atopic Dermatitis Treated With Tralokinumab. JAMA Dermatol. 2022 Nov 1;158(11):1327-1330. doi: 10.1001/jamadermatol.2022.3488.'}, {'pmid': '41118053', 'type': 'DERIVED', 'citation': 'Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2025 Oct 21. doi: 10.1007/s40257-025-00985-1. Online ahead of print.'}, {'pmid': '40879371', 'type': 'DERIVED', 'citation': 'Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.'}, {'pmid': '40085349', 'type': 'DERIVED', 'citation': 'Chovatiya R, Ribero S, Wollenberg A, Park CO, Silvestre JF, Hong HC, Seneschal J, Saeki H, Thyssen JP, Oland CB, Gjerum L, Maslin D, Blauvelt A. Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol. 2025 Jul;26(4):587-601. doi: 10.1007/s40257-025-00931-1. Epub 2025 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.\n* Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.\n* Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).\n* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.\n\nExclusion Criteria:\n\n* Any condition that required permanent discontinuation of trial treatment in the parent trial.\n* More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).\n* Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.\n* Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.\n* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.\n* Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.\n* Clinically significant infection within 4 weeks prior to baseline.\n* A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.\n* Tuberculosis requiring treatment within 12 months prior to screening.\n* Known primary immunodeficiency disorder.'}, 'identificationModule': {'nctId': 'NCT03587805', 'briefTitle': 'Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials', 'orgStudyIdInfo': {'id': 'LP0162-1337'}, 'secondaryIdInfos': [{'id': '2018-000746-19', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1282-4519', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tralokinumab, all subjects', 'description': 'Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.', 'interventionNames': ['Drug: Tralokinumab']}], 'interventions': [{'name': 'Tralokinumab', 'type': 'DRUG', 'description': 'Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.', 'armGroupLabels': ['Tralokinumab, all subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36695', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92119', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94132', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93405', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site 1', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site 2', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '33172', 'city': 'Sweetwater', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.76343, 'lon': -80.37311}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33406', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31707', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47129', 'city': 'Clarksville', 'state': 'Indiana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 38.29674, 'lon': -85.75996}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40215', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '13045', 'city': 'Cortland', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.60118, 'lon': -76.18048}}, {'zip': '14845', 'city': 'Horseheads', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.16702, 'lon': -76.82051}}, {'zip': '11415', 'city': 'Kew Gardens', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -73.83097}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29420', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75225', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '05403', 'city': 'South Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.46699, 'lon': -73.17096}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B-4040', 'city': 'Herstal', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.66415, 'lon': 5.62346}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000 LIEGE', 'city': 'Liège', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '6280', 'city': 'Loverval', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.37519, 'lon': 4.47332}}, {'zip': '9990', 'city': 'Maldegem', 'country': 'Belgium', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.20737, 'lon': 3.44511}}, {'zip': 'T2J 7E1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T3E 0B2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5K 1X3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 1C3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V3V 0C6', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6H 4E1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3C 0N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'R3M 3Z4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2A 4Z9', 'city': 'Bathurst', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 47.61814, 'lon': -65.65112}}, {'zip': 'E3B 1G9', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}, {'zip': 'A1A 4Y3', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1Z2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L1S 7K8', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'M8X 1Y9', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'L8S 1G5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 3H7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6H 5L5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3P 1X3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L5H 1G9', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'P1B 3Z7', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K2C 3N2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'L4B 1A5', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'L4C 9M7', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'M3B 3S6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4W 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5A 3R6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N8W 1E6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'N8X 2G1', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H3H 1V4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4X7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'H4G 3E7', 'city': 'Verdun', 'state': 'Quebec', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.46005, 'lon': -73.57058}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '360 01', 'city': 'Karlovy Vary', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}, {'zip': '284 01', 'city': 'Kutná Hora', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.94839, 'lon': 15.26816}}, {'zip': '708 52', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '110 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '13285', 'city': 'Marseille', 'state': 'Bouches-du-Rhône', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '33 075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13500', 'city': 'Martigues', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.40735, 'lon': 5.05526}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '26000', 'city': 'Valence', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '86179', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '48455', 'city': 'Bad Bentheim', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.30066, 'lon': 7.15763}}, {'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10789', 'city': 'Berlin', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33647', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44793', 'city': 'Bochum', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '48249', 'city': 'Dülmen', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.83149, 'lon': 7.28075}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '88045', 'city': 'Friedrichshafen', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': '07548', 'city': 'Gera', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20537', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22391', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55128', 'city': 'Mainz', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '49074', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '56242', 'city': 'Selters', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.51681, 'lon': 8.28953}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '67100', 'city': 'L’Aquila', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '272-0033', 'city': 'Ichikawa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '272-0143', 'city': 'Ichikawa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '818-0083', 'city': 'Chikushino-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.49631, 'lon': 130.5156}}, {'zip': '814-0171', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '070-8610', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '060-0807', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0812', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '921-8801', 'city': 'Nonoichi-shi', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '890-0063', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '211-0063', 'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '220-6208', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '221-0825', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '560-0085', 'city': 'Toyonaka-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '136-0074', 'city': 'Koto-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '108-0014', 'city': 'Minato-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '158-0097', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '169-0075', 'city': 'Shinjuku-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '060-0033', 'city': 'Chūōku', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'zip': '060-0063', 'city': 'Chūōku', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'zip': '814-0180', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960-1295', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '501-1194', 'city': 'Gifu', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '431-3192', 'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '663-8186', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '663-8501', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '491-8558', 'city': 'Ichinomiya', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'zip': '890-8520', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '602-8566', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '020-0066', 'city': 'Morioka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '457-8510', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '080-0013', 'city': 'Obihiro', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.91722, 'lon': 143.20444}}, {'zip': '532-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site 2', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '553-0003', 'city': 'Osaka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site 1', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '583-8588', 'city': 'Osaka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '593-8324', 'city': 'Osaka', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '329-0498', 'city': 'Shimotsuke-shi', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site'}, {'zip': '105-8471', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '113-8603', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '167-0035', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '933-0871', 'city': 'Toyama', 'country': 'Japan', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '15-375', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '32-700', 'city': 'Bochnia', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 49.96905, 'lon': 20.43028}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-546', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '81-338', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '81-537', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '40-040', 'city': 'Katowice', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-033', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '30-149', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '30-510', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-011', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-147', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-559', 'city': 'Krakow', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-242', 'city': 'Lodz', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90-265', 'city': 'Lodz', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90-436', 'city': 'Lodz', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '90-752', 'city': 'Lodz', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20-406', 'city': 'Lublin', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-369', 'city': 'Poznan', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-702', 'city': 'Poznan', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '35-055', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '35-612', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '01-141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-817', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-625', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-953', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '51-318', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '51-685', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '52-416', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08915', 'city': 'Badalona', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28942', 'city': 'Fuenlabrada', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28922', 'city': 'Madrid', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '36003', 'city': 'Pontevedra', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '41007', 'city': 'Seville', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'CM20 1QX', 'city': 'Harlow', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'zip': 'HG2 7SX', 'city': 'Harrogate', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.99078, 'lon': -1.5373}}, {'zip': 'E11 1NR', 'city': 'Leytonstone', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.56856, 'lon': 0.00768}}, {'zip': 'N19 5NF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'RH1 5RH', 'city': 'Redhill', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 51.24048, 'lon': -0.17044}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'S10 2RX', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'zip': 'WS2 9PS', 'city': 'Walsall', 'country': 'United Kingdom', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.58528, 'lon': -1.98396}}], 'overallOfficials': [{'name': 'Medical expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}