Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00141518
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway', 'Sweden']}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'D002230', 'term': 'Carbidopa'}, {'id': 'D007582', 'term': 'Jejunostomy'}], 'ancestors': [{'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004766', 'term': 'Enterostomy'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010030', 'term': 'Ostomy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Events presented are treatment-emergent (those with a start date beyond or equal to first day of study treatment but within 7 days [for adverse events] or 30 days [for serious adverse events] after last study drug intake). Treatment period was 36 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'otherNumAtRisk': 36, 'otherNumAffected': 29, 'seriousNumAtRisk': 36, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'otherNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'otherNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Toxic nodular goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Implant site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrointestinal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Device connection issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 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'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 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'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Deep brain stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Device therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Drug therapy changed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Medical device change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Medical device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pelvic floor repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Therapy regimen changed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Total Score, Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '52.1', 'spread': '16.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Total Score, Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '42.5', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '44.0', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '48.2', 'spread': '18.4', 'groupId': 'OG002'}]}]}, {'title': 'Part I, Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Part I, Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Part II, Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '15.4', 'spread': '5.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Part II, Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '12.2', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '6.0', 'groupId': 'OG002'}]}]}, {'title': 'Part III, Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '24.4', 'spread': '11.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Part III, Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '21.5', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '23.5', 'spread': '11.5', 'groupId': 'OG002'}]}]}, {'title': 'Part IV, Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '9.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Part IV, Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.5', 'groupDescription': 'Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Month 12', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'PRIMARY', 'title': 'Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.26', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.919', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.02', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.29', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Month 12', 'description': 'The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'PRIMARY', 'title': 'EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.20', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 19, 17', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.18', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.24', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Month 12', 'description': "The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.'}, {'type': 'PRIMARY', 'title': 'Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}, {'units': 'Patient-months per Study Arm', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}, {'value': '2204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '78418', 'spread': '42028', 'groupId': 'OG000'}, {'value': '75521', 'spread': '73296', 'groupId': 'OG001'}, {'value': '82177', 'spread': '53728', 'groupId': 'OG002'}, {'value': '78464', 'spread': '56772', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Total monthly costs include\n\n* Direct medical costs (inpatient care, outpatient care, and drug costs \\[including Duodopa cost and cost of concomitant anti-PD medication\\]).\n* Direct non-medical costs (nursing home, home help, personal assistance, informal care \\[from family member or friend\\] and transportation to inpatient, outpatient visits and nursing home).\n* Indirect costs (sick-leave and early retirement due to PD \\[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\\]).\n\nThe average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.', 'unitOfMeasure': 'SEK 2010', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient-months per Study Arm', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Monthly Drug Costs Per Participant, SEK 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}, {'units': 'Patient-months per Study Arm', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}, {'value': '2204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '39382', 'spread': '16733', 'groupId': 'OG000'}, {'value': '34417', 'spread': '10494', 'groupId': 'OG001'}, {'value': '37679', 'spread': '15196', 'groupId': 'OG002'}, {'value': '37339', 'spread': '14725', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.', 'unitOfMeasure': 'SEK 2010', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient-months per Study Arm', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}, {'units': 'Patient-months per Study Arm', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}, {'value': '2204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '3825', 'spread': '9394', 'groupId': 'OG000'}, {'value': '4552', 'spread': '11819', 'groupId': 'OG001'}, {'value': '3607', 'spread': '8648', 'groupId': 'OG002'}, {'value': '4002', 'spread': '10069', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.', 'unitOfMeasure': 'SEK 2010', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient-months per Study Arm', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Direct Monthly Non-medical Costs Per Participant, SEK 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}, {'units': 'Patient-months per Study Arm', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}, {'value': '2204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '19274', 'spread': '26485', 'groupId': 'OG000'}, {'value': '27439', 'spread': '61656', 'groupId': 'OG001'}, {'value': '25008', 'spread': '42455', 'groupId': 'OG002'}, {'value': '23398', 'spread': '44698', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.', 'unitOfMeasure': 'SEK 2010', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient-months per Study Arm', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for \\< 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month -3; n=15/37', 'categories': [{'measurements': [{'value': '17032', 'spread': '20911', 'groupId': 'OG000'}]}]}, {'title': 'Month 0; n=23/67', 'categories': [{'measurements': [{'value': '14109', 'spread': '19823', 'groupId': 'OG000'}]}]}, {'title': 'Month 1; n=23/67', 'categories': [{'measurements': [{'value': '14109', 'spread': '19823', 'groupId': 'OG000'}]}]}, {'title': 'Month 2; n=22/65', 'categories': [{'measurements': [{'value': '13896', 'spread': '19746', 'groupId': 'OG000'}]}]}, {'title': 'Month 3; n=23/65', 'categories': [{'measurements': [{'value': '14543', 'spread': '19971', 'groupId': 'OG000'}]}]}, {'title': 'Month 4; n=23/65', 'categories': [{'measurements': [{'value': '14543', 'spread': '19971', 'groupId': 'OG000'}]}]}, {'title': 'Month 5; n=22/65', 'categories': [{'measurements': [{'value': '13896', 'spread': '19746', 'groupId': 'OG000'}]}]}, {'title': 'Month 6; n=21/65', 'categories': [{'measurements': [{'value': '13250', 'spread': '19498', 'groupId': 'OG000'}]}]}, {'title': 'Month 7; n=24/65', 'categories': [{'measurements': [{'value': '15512', 'spread': '20433', 'groupId': 'OG000'}]}]}, {'title': 'Month 8; n=24/63', 'categories': [{'measurements': [{'value': '16005', 'spread': '20566', 'groupId': 'OG000'}]}]}, {'title': 'Month 9; n=22/62', 'categories': [{'measurements': [{'value': '14569', 'spread': '19978', 'groupId': 'OG000'}]}]}, {'title': 'Month 10; n=22/62', 'categories': [{'measurements': [{'value': '14569', 'spread': '19978', 'groupId': 'OG000'}]}]}, {'title': 'Month 11; n=22/62', 'categories': [{'measurements': [{'value': '14399', 'spread': '19785', 'groupId': 'OG000'}]}]}, {'title': 'Month 12; n=22/62', 'categories': [{'measurements': [{'value': '14399', 'spread': '19785', 'groupId': 'OG000'}]}]}, {'title': 'Month 13; n=22/62', 'categories': [{'measurements': [{'value': '14230', 'spread': '19681', 'groupId': 'OG000'}]}]}, {'title': 'Month 14; n=22/62', 'categories': [{'measurements': [{'value': '14569', 'spread': '19978', 'groupId': 'OG000'}]}]}, {'title': 'Month 15; n=22/61', 'categories': [{'measurements': [{'value': '14808', 'spread': '20055', 'groupId': 'OG000'}]}]}, {'title': 'Month 16; n=22/61', 'categories': [{'measurements': [{'value': '14808', 'spread': '20055', 'groupId': 'OG000'}]}]}, {'title': 'Month 17; n=22/61', 'categories': [{'measurements': [{'value': '14463', 'spread': '19758', 'groupId': 'OG000'}]}]}, {'title': 'Month 18; n=22/61', 'categories': [{'measurements': [{'value': '14463', 'spread': '19758', 'groupId': 'OG000'}]}]}, {'title': 'Month 19; n=22/60', 'categories': [{'measurements': [{'value': '14704', 'spread': '19834', 'groupId': 'OG000'}]}]}, {'title': 'Month 20; n=20/59', 'categories': [{'measurements': [{'value': '13529', 'spread': '19411', 'groupId': 'OG000'}]}]}, {'title': 'Month 21; n=20/58', 'categories': [{'measurements': [{'value': '13763', 'spread': '19497', 'groupId': 'OG000'}]}]}, {'title': 'Month 22; n=18/57', 'categories': [{'measurements': [{'value': '12530', 'spread': '18980', 'groupId': 'OG000'}]}]}, {'title': 'Month 23; n=18/57', 'categories': [{'measurements': [{'value': '12530', 'spread': '18980', 'groupId': 'OG000'}]}]}, {'title': 'Month 24; n=17/56', 'categories': [{'measurements': [{'value': '12003', 'spread': '18727', 'groupId': 'OG000'}]}]}, {'title': 'Month 25; n=16/54', 'categories': [{'measurements': [{'value': '12059', 'spread': '18966', 'groupId': 'OG000'}]}]}, {'title': 'Month 26; n=18/54', 'categories': [{'measurements': [{'value': '13615', 'spread': '19637', 'groupId': 'OG000'}]}]}, {'title': 'Month 27; n=16/53', 'categories': [{'measurements': [{'value': '12683', 'spread': '19471', 'groupId': 'OG000'}]}]}, {'title': 'Month 28; n=15/53', 'categories': [{'measurements': [{'value': '11890', 'spread': '19106', 'groupId': 'OG000'}]}]}, {'title': 'Month 29; n=16/53', 'categories': [{'measurements': [{'value': '12683', 'spread': '19471', 'groupId': 'OG000'}]}]}, {'title': 'Month 30; n=16/53', 'categories': [{'measurements': [{'value': '12683', 'spread': '19471', 'groupId': 'OG000'}]}]}, {'title': 'Month 31; n=15/50', 'categories': [{'measurements': [{'value': '12604', 'spread': '19448', 'groupId': 'OG000'}]}]}, {'title': 'Month 32; n=14/50', 'categories': [{'measurements': [{'value': '11763', 'spread': '19055', 'groupId': 'OG000'}]}]}, {'title': 'Month 33; n=14/50', 'categories': [{'measurements': [{'value': '11763', 'spread': '19055', 'groupId': 'OG000'}]}]}, {'title': 'Month 34; n=14/49', 'categories': [{'measurements': [{'value': '12003', 'spread': '19176', 'groupId': 'OG000'}]}]}, {'title': 'Month 35; n=14/49', 'categories': [{'measurements': [{'value': '12003', 'spread': '19176', 'groupId': 'OG000'}]}]}, {'title': 'Month 36; n=15/49', 'categories': [{'measurements': [{'value': '12432', 'spread': '19137', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36', 'description': 'Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.', 'unitOfMeasure': 'SEK 2010', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.'}, {'type': 'SECONDARY', 'title': 'Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; 23, 18, 15', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; 25, 20, 17', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 18', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '74.4', 'spread': '15.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '80.4', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '74.4', 'spread': '11.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '77.9', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '72.2', 'spread': '15.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '75.2', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '72.2', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '79.2', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '70.6', 'spread': '13.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '77.2', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '75.8', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '74.0', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '69.4', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '72.2', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '68.0', 'spread': '15.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '70.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '71.8', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '67.7', 'spread': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '66.7', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '64.2', 'spread': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 18', 'categories': [{'measurements': [{'value': '68.9', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '62.2', 'spread': '17.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Schwab and England scale was used to rate the subject\'s best "on" period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). "On" time is when PD symptoms are well controlled by the drug.', 'unitOfMeasure': 'percentage score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '28.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '27.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '28.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '28.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '28.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '27.9', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '27.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '28.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '27.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '27.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '27.2', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '27.9', 'spread': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '27.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.'}, {'type': 'SECONDARY', 'title': 'MMSE Orientation Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '9.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '9.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '9.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '9.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '9.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '9.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '9.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '9.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '9.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MMSE Registration Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MMSE Attention and Calculation Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MMSE Recall Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MMSE Language Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '8.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '8.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '8.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '8.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '8.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '8.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '10.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '9.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '10.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '10.5', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '8.8', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '6.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '8.6', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '10.6', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '10.1', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '7.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 13', 'categories': [{'measurements': [{'value': '12.0', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '12.2', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '11.6', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Reported Sadness Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Apparent Sadness Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Inner Tension Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Reduced Sleep Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Reduced Appetite Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Concentration Difficulties Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Lassitude Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Inability to Feel Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Pessimistic Thoughts Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 13', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'MADRS Suicidal Thoughts Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=26, 0, 0', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 19, 16', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=27, 22, 17', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': "Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '33.6', 'spread': '10.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 20, 17', 'categories': [{'measurements': [{'value': '27.1', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '36.6', 'spread': '15.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=22, 20, 18', 'categories': [{'measurements': [{'value': '24.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '34.0', 'spread': '15.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=24, 20, 17', 'categories': [{'measurements': [{'value': '27.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '35.5', 'spread': '16.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=23, 20, 16', 'categories': [{'measurements': [{'value': '25.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '35.1', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=23, 19, 17', 'categories': [{'measurements': [{'value': '28.8', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '19.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=22, 18, 16', 'categories': [{'measurements': [{'value': '28.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '34.1', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 14', 'categories': [{'measurements': [{'value': '30.3', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=21, 16, 12', 'categories': [{'measurements': [{'value': '33.5', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '34.4', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=20, 15, 11', 'categories': [{'measurements': [{'value': '36.8', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '39.2', 'spread': '18.0', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=25, 21, 17', 'categories': [{'measurements': [{'value': '36.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '40.3', 'spread': '17.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-6.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.6', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.0', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.2', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.6', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.126', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.9', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.3', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.203', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.9', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.733', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.2', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.414', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14.3', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.534', 'groupIds': ['OG000'], 'paramType': 'mean change from baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14.9', 'groupDescription': 'Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Mobility Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '55.7', 'spread': '20.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '38.8', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=23, 20, 18', 'categories': [{'measurements': [{'value': '36.0', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '22.8', 'groupId': 'OG001'}, {'value': '50.6', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '39.5', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=24, 20, 17', 'categories': [{'measurements': [{'value': '40.2', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '52.8', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '41.0', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '45.3', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '54.4', 'spread': '32.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 18, 16', 'categories': [{'measurements': [{'value': '40.9', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '25.6', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '29.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '46.0', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '49.5', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '50.9', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '57.3', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '43.0', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '61.1', 'spread': '28.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 21, 17', 'categories': [{'measurements': [{'value': '55.6', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '22.2', 'groupId': 'OG001'}, {'value': '61.6', 'spread': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '38.7', 'spread': '21.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 20, 18', 'categories': [{'measurements': [{'value': '32.1', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '46.5', 'spread': '26.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '26.9', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '42.8', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '41.7', 'spread': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '31.8', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '43.7', 'spread': '23.2', 'groupId': 'OG001'}, {'value': '42.1', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '29.8', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '42.2', 'spread': '21.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '34.7', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '45.6', 'spread': '26.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '33.2', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '45.8', 'spread': '24.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '37.1', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '41.9', 'spread': '24.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '38.8', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '48.5', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '46.5', 'spread': '28.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '45.4', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '54.5', 'spread': '29.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '43.4', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '53.4', 'spread': '24.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '35.3', 'spread': '19.3', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '30.9', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '37.7', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=23, 22, 18', 'categories': [{'measurements': [{'value': '24.8', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '19.6', 'groupId': 'OG001'}, {'value': '35.4', 'spread': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 20, 18', 'categories': [{'measurements': [{'value': '31.3', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '35.9', 'spread': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '33.0', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '34.8', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '29.0', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '32.1', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '32.6', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '31.9', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '33.1', 'spread': '16.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 16, 12', 'categories': [{'measurements': [{'value': '33.9', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '31.3', 'spread': '18.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '39.7', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '21.0', 'groupId': 'OG001'}, {'value': '38.6', 'spread': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '39.4', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '24.4', 'groupId': 'OG001'}, {'value': '39.7', 'spread': '21.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Stigma Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '24.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '16.2', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '16.1', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '20.8', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '15.5', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '24.6', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 19, 17', 'categories': [{'measurements': [{'value': '17.8', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '25.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '15.6', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '15.8', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '14.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=21, 17, 12', 'categories': [{'measurements': [{'value': '16.4', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '20.5', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '19.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '19.5', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '23.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Social Support Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27,0,0', 'categories': [{'measurements': [{'value': '8.3', 'spread': '15.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 17', 'categories': [{'measurements': [{'value': '10.3', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '10.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 17', 'categories': [{'measurements': [{'value': '12.7', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=24, 20, 16', 'categories': [{'measurements': [{'value': '10.2', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=23, 20, 17', 'categories': [{'measurements': [{'value': '12.1', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=22, 20, 16', 'categories': [{'measurements': [{'value': '12.7', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '18.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 14', 'categories': [{'measurements': [{'value': '15.7', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '21.7', 'spread': '15.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '18.2', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '18.3', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '29.5', 'spread': '26.7', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '21.8', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '27.9', 'spread': '25.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Cognition Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '30.6', 'spread': '15.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '22.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '33.7', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '24.2', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '32.3', 'spread': '20.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=24, 21, 18', 'categories': [{'measurements': [{'value': '25.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '30.6', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '21.5', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '26.8', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '33.8', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '28.6', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '30.1', 'spread': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '24.7', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '27.5', 'spread': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 16, 12', 'categories': [{'measurements': [{'value': '31.5', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '45.7', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '24.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=20, 15, 11', 'categories': [{'measurements': [{'value': '34.1', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '30.7', 'spread': '19.7', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=25, 22, 17', 'categories': [{'measurements': [{'value': '31.5', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '34.9', 'spread': '19.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Communication Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '32.4', 'spread': '21.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '24.1', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '35.2', 'spread': '18.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '24.7', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '22.2', 'groupId': 'OG001'}, {'value': '31.9', 'spread': '19.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=24, 21, 18', 'categories': [{'measurements': [{'value': '24.0', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '22.0', 'groupId': 'OG001'}, {'value': '33.8', 'spread': '19.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '25.3', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '21.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '29.7', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '33.8', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '31.6', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '29.7', 'spread': '20.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '28.2', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '30.6', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '33.7', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '41.7', 'spread': '26.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '33.7', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '37.9', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '34.0', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '40.2', 'spread': '18.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Baseline (Month -3); n=27, 0, 0', 'categories': [{'measurements': [{'value': '42.6', 'spread': '19.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '41.7', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '43.1', 'spread': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '38.5', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '44.0', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=24, 21, 18', 'categories': [{'measurements': [{'value': '38.9', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '39.4', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '36.3', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '41.2', 'spread': '24.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 12; n=25, 20, 17', 'categories': [{'measurements': [{'value': '39.3', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '46.6', 'spread': '27.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '38.5', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '24.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '42.9', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '25.8', 'groupId': 'OG001'}, {'value': '38.9', 'spread': '23.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '42.8', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '34.7', 'spread': '27.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '42.9', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint; n=26, 22, 17', 'categories': [{'measurements': [{'value': '42.6', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '39.7', 'spread': '24.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=14, 13, 7', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.188', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '41.2', 'spread': '19.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '35.4', 'spread': '11.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '23.4', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '20.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '26.4', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '23.0', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '25.6', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '21.9', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '20.9', 'spread': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '23.9', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '15.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '19.5', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '11.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '25.3', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '23.8', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '24.0', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '23.5', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '21.1', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '21.4', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '17.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '29.1', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '22.0', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '23.4', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '16.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '21.6', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '11.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '35.1', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '31.5', 'spread': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '24.7', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '30.7', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '21.4', 'groupId': 'OG001'}, {'value': '27.1', 'spread': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '24.8', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.107', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. "Off" time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day.', 'unitOfMeasure': "percentage of 'off' time", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '40.2', 'spread': '16.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '40.3', 'spread': '14.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '58.4', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '55.2', 'spread': '27.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '61.8', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '46.5', 'spread': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '61.6', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '22.8', 'groupId': 'OG001'}, {'value': '49.8', 'spread': '28.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '62.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '55.0', 'spread': '26.4', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '57.7', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '55.8', 'spread': '31.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '62.2', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '57.3', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '53.2', 'spread': '29.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '60.5', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '47.9', 'spread': '29.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '59.7', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '59.5', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '50.8', 'spread': '29.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '61.1', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '57.5', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '49.0', 'spread': '32.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '59.5', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '63.0', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '51.4', 'spread': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '61.9', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '55.2', 'spread': '27.1', 'groupId': 'OG001'}, {'value': '51.1', 'spread': '33.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '61.5', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '52.5', 'spread': '31.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '61.3', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '59.5', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '41.3', 'spread': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '62.3', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '64.8', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '49.3', 'spread': '27.5', 'groupId': 'OG001'}, {'value': '58.6', 'spread': '26.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '62.4', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '56.9', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '26.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '54.5', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '51.9', 'spread': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '59.1', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '55.1', 'spread': '28.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '52.9', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '23.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '56.0', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '46.2', 'spread': '25.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. "On" time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last \\_\\_ hours.', 'unitOfMeasure': "percentage of 'on' time", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '18.6', 'spread': '12.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '24.3', 'spread': '14.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '18.2', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '17.8', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '17.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '17.4', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '19.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '12.0', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '24.5', 'spread': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '14.4', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '16.5', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '21.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '16.7', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '24.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '15.9', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '25.8', 'spread': '22.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '15.6', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '28.5', 'spread': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '20.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '26.5', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '13.6', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '27.2', 'spread': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '16.2', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '17.0', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '22.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '20.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '27.4', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '9.6', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '15.8', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '11.8', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '14.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '14.5', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '10.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '18.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '16.2', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '16.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '15.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '16.2', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '21.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last \\_\\_ hours.", 'unitOfMeasure': "percentage of 'dyskinetic' time", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; 19, 19, 13', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; 16, 19, 11', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; 23, 20, 16', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.191', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.847', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. \'Self-assessment\' scores were -3 (Off) to +3 (dyskinetic). \'Off\' time is when PD symptoms are not adequately controlled by the drug. \'Dyskinetic\' time is time with involuntary muscle movement. "0" is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to "0" means improvement, everything more away from "0" means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '39.9', 'spread': '12.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '39.7', 'spread': '11.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '44.4', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '40.6', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '43.5', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '40.3', 'spread': '13.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '46.8', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '46.3', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '47.4', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '43.2', 'spread': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '50.7', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '48.0', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '50.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '43.0', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '47.6', 'spread': '12.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '47.2', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '45.7', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '48.1', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '15.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '49.3', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '48.7', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '46.6', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '46.6', 'spread': '18.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '44.0', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '46.7', 'spread': '18.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '46.9', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '45.9', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '47.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '38.7', 'spread': '14.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '47.6', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '41.5', 'spread': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '49.4', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '49.3', 'spread': '22.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '49.5', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '52.6', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '46.3', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '44.7', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '51.4', 'spread': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '45.5', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '41.8', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '43.1', 'spread': '16.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '43.6', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '41.4', 'spread': '15.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds.", 'unitOfMeasure': 'taps/20 seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '70.7', 'spread': '16.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '71.9', 'spread': '14.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '71.4', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '63.8', 'spread': '13.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '70.1', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '65.2', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '73.4', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '63.5', 'spread': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '70.0', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '65.8', 'spread': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '67.6', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '64.8', 'spread': '17.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '65.7', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '66.7', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '67.0', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '65.8', 'spread': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '65.4', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '69.9', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '67.5', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '68.7', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '61.5', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '64.7', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '60.4', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '58.9', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '65.8', 'spread': '13.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '61.2', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '61.4', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '62.3', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '61.9', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '64.4', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '62.4', 'spread': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '66.3', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '66.8', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '67.3', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '67.9', 'spread': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '60.7', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '60.3', 'spread': '19.3', 'groupId': 'OG001'}, {'value': '61.2', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '50.3', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '63.6', 'spread': '11.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '63.7', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '59.3', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '60.1', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '60.3', 'spread': '13.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.599', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as \\_\\_\\_\\_. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?).", 'unitOfMeasure': 'percentage of tapping accuracy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '74.6', 'spread': '13.9', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '73.7', 'spread': '14.7', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '83.7', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '15.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '80.4', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '73.2', 'spread': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '83.1', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '68.8', 'spread': '22.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '81.3', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '69.3', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '87.1', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '74.2', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '73.3', 'spread': '20.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '87.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '73.6', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '73.0', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '86.4', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '78.2', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '77.1', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '86.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '78.8', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '75.6', 'spread': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '87.0', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '74.6', 'spread': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '81.8', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '72.4', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '81.3', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '77.9', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '25.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '82.1', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '72.1', 'spread': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '85.7', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '20.6', 'groupId': 'OG001'}, {'value': '69.0', 'spread': '18.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '85.3', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '82.0', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '70.0', 'spread': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '87.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '79.8', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '88.6', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '80.6', 'spread': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '77.9', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '81.0', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '70.7', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '77.9', 'spread': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '79.5', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '70.4', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '68.0', 'spread': '19.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '74.6', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '22.2', 'groupId': 'OG001'}, {'value': '67.5', 'spread': '20.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.208', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields.", 'unitOfMeasure': 'percentage of accurate taps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '24.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '24.2', 'spread': '4.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '26.3', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '22.7', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '26.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '27.2', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '28.3', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '28.2', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '27.0', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '27.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '23.8', 'spread': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '26.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '26.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '24.9', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '26.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '27.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '22.7', 'spread': '5.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '26.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '23.8', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '27.4', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '27.9', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '26.5', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '25.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '26.3', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '25.1', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; 23, 20, 16', 'categories': [{'measurements': [{'value': '25.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '23.0', 'spread': '6.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.073', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.", 'unitOfMeasure': 'taps/20 seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '92.0', 'spread': '14.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '91.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '94.6', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '92.6', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '92.9', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '92.3', 'spread': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '90.5', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '89.2', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '89.1', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '92.5', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '89.8', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '95.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '89.0', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '90.5', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '94.6', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '89.2', 'spread': '11.6', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '91.2', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '90.8', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '91.8', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '92.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '92.2', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '90.7', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '90.6', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '91.2', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '92.5', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '89.2', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '90.2', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '88.8', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '86.8', 'spread': '13.9', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '91.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '92.1', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '85.4', 'spread': '15.4', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '91.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '92.2', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '89.0', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '92.9', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '90.7', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '95.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '90.5', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '93.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '91.2', 'spread': '7.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '83.5', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '89.7', 'spread': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '82.1', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '88.4', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '88.8', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '87.8', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '87.5', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '87.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '86.7', 'spread': '9.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps.", 'unitOfMeasure': 'percentage of accurate taps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'SECONDARY', 'title': 'Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Morning, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Day, Baseline (Month -3); n=20, 0, 0', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Baseline for Duodopa non-naive participants was not done.', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 0; n=19, 20, 15', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 3; n=19, 18, 13', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 3; n=19, 19, 13', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 6; n=16, 19, 11', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 9; n=16, 17, 9', 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 12; n=16, 16, 9', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 18; n=15, 14, 10', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 24; n=13, 13, 7', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 30; n=9, 9, 5', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Month 36; n=6, 11, 5', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Day, Month 36; n=5, 11, 5', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Morning, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Day, Endpoint; n=23, 20, 16', 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.208', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for morning scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline to Month 12 for day scores', 'statisticalMethod': 'Wilcoxon tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UPDRS Total Score up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '43.1', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '46.2', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '47.8', 'spread': '16.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '42.4', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '16.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '43.3', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '47.4', 'spread': '13.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; 5, 20, 17', 'categories': [{'measurements': [{'value': '40.8', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '48.1', 'spread': '17.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '45.2', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '48.5', 'spread': '18.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '44.5', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '52.7', 'spread': '15.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '47.1', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '47.4', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '50.2', 'spread': '19.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '46.2', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '54.0', 'spread': '25.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=27, 22, 18', 'categories': [{'measurements': [{'value': '47.9', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '55.0', 'spread': '23.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UPDRS Part I Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=27, 22, 18', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UPDRS Part II Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '12.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '12.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '15.0', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '12.4', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '11.8', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '13.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '12.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '14.0', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '16.9', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '13.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=27, 22, 18', 'categories': [{'measurements': [{'value': '14.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UPDRS Part III Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '22.0', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '22.4', 'spread': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '21.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 20, 18', 'categories': [{'measurements': [{'value': '21.5', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '19.9', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '21.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '23.3', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '21.4', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '9.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=23, 17, 13', 'categories': [{'measurements': [{'value': '23.1', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '22.0', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '15.8', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=27, 22, 17', 'categories': [{'measurements': [{'value': '23.1', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '13.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'UPDRS Part IV Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 22, 18', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '6.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 17', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=23, 18, 15', 'categories': [{'measurements': [{'value': '6.3', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 13', 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 16, 12', 'categories': [{'measurements': [{'value': '6.4', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=26, 22, 18', 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D Descriptive Systems Summary Index Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 18, 15', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.52', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.25', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=26, 22, 17', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.46', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D Visual Analog Scale (VAS) Score, up to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'OG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'classes': [{'title': 'Month 0; n=27, 22, 18', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'Month 3; n=24, 22, 18', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Month 6; n=25, 21, 18', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Month 9; n=25, 20, 17', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Month 18; n=24, 20, 16', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.27', 'groupId': 'OG002'}]}]}, {'title': 'Month 24; n=21, 17, 15', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Month 30; n=22, 17, 12', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Month 36; n=21, 15, 11', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Endpoint visit; n=26, 22, 17', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'FG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'FG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Safety Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Full Analysis Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent Prior to Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'BG001', 'title': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'BG002', 'title': 'Duodopa Non-naïve ≥ 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '65.4', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2005-08-30', 'resultsFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-06', 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'UPDRS Total Score up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability."}, {'measure': 'UPDRS Part I Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability."}, {'measure': 'UPDRS Part II Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability."}, {'measure': 'UPDRS Part III Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability."}, {'measure': 'UPDRS Part IV Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability."}, {'measure': 'EQ-5D Descriptive Systems Summary Index Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.'}, {'measure': 'EQ-5D Visual Analog Scale (VAS) Score, up to Month 36', 'timeFrame': 'Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'"}], 'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12", 'timeFrame': 'Baseline (Month -3), Month 12', 'description': "The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability."}, {'measure': 'Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12', 'timeFrame': 'Baseline (Month -3), Month 12', 'description': 'The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).'}, {'measure': 'EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12', 'timeFrame': 'Baseline (Month -3), Month 12', 'description': "The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state."}, {'measure': 'Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Total monthly costs include\n\n* Direct medical costs (inpatient care, outpatient care, and drug costs \\[including Duodopa cost and cost of concomitant anti-PD medication\\]).\n* Direct non-medical costs (nursing home, home help, personal assistance, informal care \\[from family member or friend\\] and transportation to inpatient, outpatient visits and nursing home).\n* Indirect costs (sick-leave and early retirement due to PD \\[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\\]).\n\nThe average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.'}, {'measure': 'Monthly Drug Costs Per Participant, SEK 2010', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.'}, {'measure': 'Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.'}, {'measure': 'Direct Monthly Non-medical Costs Per Participant, SEK 2010', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants', 'description': 'Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.'}, {'measure': 'Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010', 'timeFrame': 'Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36', 'description': 'Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.'}], 'secondaryOutcomes': [{'measure': 'Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.'}, {'measure': 'Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.'}, {'measure': 'Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.'}, {'measure': 'Schwab and England Scale: Best "On" Period Stage From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Schwab and England scale was used to rate the subject\'s best "on" period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). "On" time is when PD symptoms are well controlled by the drug.'}, {'measure': 'Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.'}, {'measure': 'MMSE Orientation Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.'}, {'measure': 'MMSE Registration Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.'}, {'measure': 'MMSE Attention and Calculation Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.'}, {'measure': 'MMSE Recall Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.'}, {'measure': 'MMSE Language Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.'}, {'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).'}, {'measure': 'MADRS Reported Sadness Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.'}, {'measure': 'MADRS Apparent Sadness Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.'}, {'measure': 'MADRS Inner Tension Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.'}, {'measure': 'MADRS Reduced Sleep Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well."}, {'measure': 'MADRS Reduced Appetite Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.'}, {'measure': 'MADRS Concentration Difficulties Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration."}, {'measure': 'MADRS Lassitude Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.'}, {'measure': 'MADRS Inability to Feel Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.'}, {'measure': 'MADRS Pessimistic Thoughts Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.'}, {'measure': 'MADRS Suicidal Thoughts Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.'}, {'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36", 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms."}, {'measure': 'PDQ-39 Mobility Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Stigma Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Social Support Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Cognition Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Communication Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness."}, {'measure': 'Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. "Off" time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day.'}, {'measure': 'Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. "On" time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last \\_\\_ hours.'}, {'measure': 'Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last \\_\\_ hours."}, {'measure': 'Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': 'The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: \'walking\', \'satisfied\', \'dyskinesia\', and \'off\' and two objectively-measured: \'tapping\' and \'spiral\'. Each of the items was assessed in the morning and during the day. \'Self-assessment\' scores were -3 (Off) to +3 (dyskinetic). \'Off\' time is when PD symptoms are not adequately controlled by the drug. \'Dyskinetic\' time is time with involuntary muscle movement. "0" is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to "0" means improvement, everything more away from "0" means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).'}, {'measure': 'Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds."}, {'measure': 'Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as \\_\\_\\_\\_. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?)."}, {'measure': 'Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields."}, {'measure': 'Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds."}, {'measure': 'Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps."}, {'measure': 'Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36', 'timeFrame': 'Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)', 'description': "The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best."}]}, 'conditionsModule': {'keywords': ['Health economics,Quality of life'], 'conditions': ["Advanced Idiopathic Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Advanced idiopathic Parkinson's disease\n\nExclusion Criteria:\n\n\\- Other diseases which might influence compliance or participation in the study"}, 'identificationModule': {'nctId': 'NCT00141518', 'acronym': 'DAPHNE', 'briefTitle': "Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia", 'orgStudyIdInfo': {'id': 'S187.4.001'}, 'secondaryIdInfos': [{'id': '2005-002654-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duodopa Naïve', 'description': 'Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'interventionNames': ['Drug: Levodopa-carbidopa intestinal gel (LCIG)', 'Device: CADD-Legacy® 1400 ambulatory infusion pump', 'Device: percutaneous endoscopic gastrostomy tube (PEG tube)', 'Device: jejunal extension tube (J-tube)']}, {'type': 'EXPERIMENTAL', 'label': 'Duodopa Non-naïve < 2 Years', 'description': 'Duodopa non-naïve participants treated with Duodopa for \\< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'interventionNames': ['Drug: Levodopa-carbidopa intestinal gel (LCIG)', 'Device: CADD-Legacy® 1400 ambulatory infusion pump', 'Device: percutaneous endoscopic gastrostomy tube (PEG tube)', 'Device: jejunal extension tube (J-tube)']}, {'type': 'EXPERIMENTAL', 'label': 'Duodopa Non-naïve ≥ 2 years', 'description': 'Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \\[100-200 mg levodopa\\]); the continuous maintenance dose (usually 2-6 mL/hour \\[40-120 mg levodopa/hour\\]); and extra bolus doses, adjusted individually.', 'interventionNames': ['Drug: Levodopa-carbidopa intestinal gel (LCIG)', 'Device: CADD-Legacy® 1400 ambulatory infusion pump', 'Device: percutaneous endoscopic gastrostomy tube (PEG tube)', 'Device: jejunal extension tube (J-tube)']}], 'interventions': [{'name': 'Levodopa-carbidopa intestinal gel (LCIG)', 'type': 'DRUG', 'otherNames': ['DUOPA™ (carbidopa and levodopa Enteral Suspension)', 'DUODOPA®', 'ABT-SLV187'], 'armGroupLabels': ['Duodopa Naïve', 'Duodopa Non-naïve < 2 Years', 'Duodopa Non-naïve ≥ 2 years']}, {'name': 'CADD-Legacy® 1400 ambulatory infusion pump', 'type': 'DEVICE', 'armGroupLabels': ['Duodopa Naïve', 'Duodopa Non-naïve < 2 Years', 'Duodopa Non-naïve ≥ 2 years']}, {'name': 'percutaneous endoscopic gastrostomy tube (PEG tube)', 'type': 'DEVICE', 'armGroupLabels': ['Duodopa Naïve', 'Duodopa Non-naïve < 2 Years', 'Duodopa Non-naïve ≥ 2 years']}, {'name': 'jejunal extension tube (J-tube)', 'type': 'DEVICE', 'armGroupLabels': ['Duodopa Naïve', 'Duodopa Non-naïve < 2 Years', 'Duodopa Non-naïve ≥ 2 years']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lars Bergmann, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}