Drug information for ADVICOR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 20MG;1GM Prescription  (Reference Drug) LOVASTATIN; NIACIN lovastatin-niacin combination ABBOTT 21249
2012-04-23 Letter

2012-04-20 Label

2011-01-27 Letter

2011-01-25 Label

2010-04-06 Letter

2010-04-02 Label

2008-04-16 Letter

2008-01-23 Review

2007-09-26 Review

2006-05-01 Label

2006-05-01 Label

2006-05-01 Label

2006-05-01 Letter

2006-05-01 Letter

2006-05-01 Letter

2004-05-26 Review

2003-11-13 Letter

2001-12-17 Letter

2001-12-17 Label
TABLET, EXTENDED RELEASE; ORAL 20MG;500MG Prescription  (Reference Drug) LOVASTATIN; NIACIN lovastatin-niacin combination ABBOTT   "
TABLET, EXTENDED RELEASE; ORAL 20MG;750MG Prescription  (Reference Drug) LOVASTATIN; NIACIN lovastatin-niacin combination ABBOTT   "
TABLET, EXTENDED RELEASE; ORAL 40MG;1GM Prescription  (Reference Drug) LOVASTATIN; NIACIN lovastatin-niacin combination ABBOTT   "

Drug Adverse Effects information for ADVICOR

Role code Indications Reaction # Reports
PS ATRIAL FIBRILLATION ERYTHEMA 2
PS ATRIAL FIBRILLATION FLUSHING 2
PS BIOPSY BLOOD VESSEL ABNORMAL ERYTHEMA 1
PS BIOPSY BLOOD VESSEL ABNORMAL FLUSHING 1
PS BLOOD CHOLESTEROL FLUSHING 1
PS BLOOD CHOLESTEROL INCREASED AMNESIA 1
PS BLOOD CHOLESTEROL INCREASED ARTERIAL OCCLUSIVE DISEASE 1
PS BLOOD CHOLESTEROL INCREASED ARTHRALGIA 1
PS BLOOD CHOLESTEROL INCREASED DIVERTICULUM 1
PS BLOOD CHOLESTEROL INCREASED FEELING HOT 1
PS BLOOD CHOLESTEROL INCREASED FLUSHING 1
PS BLOOD CHOLESTEROL INCREASED HYPERHIDROSIS 1
PS BLOOD CHOLESTEROL INCREASED MYALGIA 2
PS BLOOD CHOLESTEROL INCREASED POOR QUALITY SLEEP 1
PS BLOOD CHOLESTEROL INCREASED SEXUAL DYSFUNCTION 1
PS BLOOD CHOLESTEROL INCREASED SWEAT DISCOLOURATION 1
PS BLOOD CHOLESTEROL INCREASED TERMINAL INSOMNIA 1
PS BLOOD PRESSURE BLOOD URIC ACID INCREASED 1
PS BLOOD TRIGLYCERIDES INCREASED BLOOD URIC ACID INCREASED 1
PS DYSLIPIDAEMIA GOUT 1
PS GASTRIC DISORDER ERYTHEMA 1
PS GASTRIC DISORDER FLUSHING 1
PS GASTROOESOPHAGEAL REFLUX DISEASE GOUT 1
PS HIGH DENSITY LIPOPROTEIN DECREASED FLUSHING 1
PS HYPERLIPIDAEMIA PAIN 1
PS HYPERTENSION SWEAT DISCOLOURATION 1
PS LOW DENSITY LIPOPROTEIN INCREASED FLUSHING 1
PS PAIN SWEAT DISCOLOURATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION ARTERIAL OCCLUSIVE DISEASE 11
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD URIC ACID INCREASED 3
PS PRODUCT USED FOR UNKNOWN INDICATION DIVERTICULUM 11
PS PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA 3
PS PRODUCT USED FOR UNKNOWN INDICATION FEELING HOT 3
PS PRODUCT USED FOR UNKNOWN INDICATION FLUSHING 16
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION MYALGIA 11
PS PROPHYLAXIS ERYTHEMA 1
PS PROPHYLAXIS FLUSHING 1
PS PROSTATOMEGALY ERYTHEMA 1
PS PROSTATOMEGALY FLUSHING 1
SS HIGH DENSITY LIPOPROTEIN DECREASED FLUSHING 1
SS LOW DENSITY LIPOPROTEIN INCREASED FLUSHING 1
C ANTICOAGULANT THERAPY MUSCULOSKELETAL PAIN 1
C ANTICOAGULANT THERAPY MYALGIA 1
C ANTICOAGULANT THERAPY NECK PAIN 1
C ANTICOAGULANT THERAPY PLATELET COUNT DECREASED 1
C ARRHYTHMIA MUSCULOSKELETAL PAIN 1
C ARRHYTHMIA MYALGIA 1
C ARRHYTHMIA NECK PAIN 1
C ARRHYTHMIA PLATELET COUNT DECREASED 1
C ATRIAL FIBRILLATION MUSCULOSKELETAL PAIN 1
C ATRIAL FIBRILLATION MYALGIA 1
C ATRIAL FIBRILLATION NECK PAIN 1
C ATRIAL FIBRILLATION PLATELET COUNT DECREASED 1
C BLOOD CHOLESTEROL MUSCULOSKELETAL PAIN 2
C BLOOD CHOLESTEROL MYALGIA 2
C BLOOD CHOLESTEROL NECK PAIN 2
C BLOOD CHOLESTEROL PLATELET COUNT DECREASED 2
C BLOOD CHOLESTEROL INCREASED DECREASED APPETITE 2
C BLOOD CHOLESTEROL INCREASED HEADACHE 2
C BLOOD CHOLESTEROL INCREASED HOT FLUSH 2
C BLOOD CHOLESTEROL INCREASED HYPOAESTHESIA 2
C BLOOD CHOLESTEROL INCREASED OEDEMA PERIPHERAL 2
C BLOOD CHOLESTEROL INCREASED PARAESTHESIA 2
C BLOOD CHOLESTEROL INCREASED SKIN ODOUR ABNORMAL 1
C BLOOD CHOLESTEROL INCREASED SKIN TIGHTNESS 2
C BLOOD PRESSURE MUSCULOSKELETAL PAIN 1
C BLOOD PRESSURE MYALGIA 1
C BLOOD PRESSURE NECK PAIN 1
C BLOOD PRESSURE PLATELET COUNT DECREASED 1
C BONE NEOPLASM MALIGNANT ACTINIC KERATOSIS 1
C BONE NEOPLASM MALIGNANT ANAEMIA 1
C BONE NEOPLASM MALIGNANT ANXIETY 1
C BONE NEOPLASM MALIGNANT AORTIC ARTERIOSCLEROSIS 1
C BONE NEOPLASM MALIGNANT ARACHNOID CYST 1
C BONE NEOPLASM MALIGNANT ARTERIAL STENOSIS 1
C BONE NEOPLASM MALIGNANT ARTHRALGIA 1
C BONE NEOPLASM MALIGNANT BACK PAIN 1
C BONE NEOPLASM MALIGNANT BASAL CELL CARCINOMA 1
C BONE NEOPLASM MALIGNANT BASAL GANGLIA INFARCTION 1
C BONE NEOPLASM MALIGNANT BLOOD ALKALINE PHOSPHATASE INCREASED 1
C BONE NEOPLASM MALIGNANT BLOOD CALCIUM DECREASED 1
C BONE NEOPLASM MALIGNANT BLOOD CREATININE INCREASED 1
C BONE NEOPLASM MALIGNANT BLOOD SODIUM DECREASED 1
C BONE NEOPLASM MALIGNANT BLOOD UREA INCREASED 1
C BONE NEOPLASM MALIGNANT BONE DISORDER 1
C BONE NEOPLASM MALIGNANT BONE EROSION 1
C BONE NEOPLASM MALIGNANT BONE FORMATION INCREASED 1
C BONE NEOPLASM MALIGNANT BONE PAIN 1
C BONE NEOPLASM MALIGNANT BREATH ODOUR 1
C BONE NEOPLASM MALIGNANT CEREBRAL ATROPHY 1
C BONE NEOPLASM MALIGNANT CHEST PAIN 1
C BONE NEOPLASM MALIGNANT CONSTIPATION 1
C BONE NEOPLASM MALIGNANT CONVULSION 1
C BONE NEOPLASM MALIGNANT COUGH 1
C BONE NEOPLASM MALIGNANT DEFORMITY 1
C BONE NEOPLASM MALIGNANT DILATATION ATRIAL 1
C BONE NEOPLASM MALIGNANT DISORIENTATION 1
C BONE NEOPLASM MALIGNANT DIVERTICULUM INTESTINAL 1
C BONE NEOPLASM MALIGNANT DYSPEPSIA 1
C BONE NEOPLASM MALIGNANT DYSPHONIA 1
C BONE NEOPLASM MALIGNANT DYSPNOEA EXERTIONAL 1
C BONE NEOPLASM MALIGNANT EMOTIONAL DISTRESS 1
C BONE NEOPLASM MALIGNANT FALL 1
C BONE NEOPLASM MALIGNANT FATIGUE 1
C BONE NEOPLASM MALIGNANT GASTROOESOPHAGEAL REFLUX DISEASE 1
C BONE NEOPLASM MALIGNANT GINGIVAL BLEEDING 1
C BONE NEOPLASM MALIGNANT GINGIVAL SWELLING 1
C BONE NEOPLASM MALIGNANT GLOSSODYNIA 1
C BONE NEOPLASM MALIGNANT GYNAECOMASTIA 1
C BONE NEOPLASM MALIGNANT HAEMATOCRIT DECREASED 1
C BONE NEOPLASM MALIGNANT HAEMOGLOBIN DECREASED 1
C BONE NEOPLASM MALIGNANT HEADACHE 1
C BONE NEOPLASM MALIGNANT HEARING IMPAIRED 1
C BONE NEOPLASM MALIGNANT HERPES ZOSTER 1
C BONE NEOPLASM MALIGNANT HYPOAESTHESIA 1
C BONE NEOPLASM MALIGNANT INCREASED UPPER AIRWAY SECRETION 1
C BONE NEOPLASM MALIGNANT INFECTION 1
C BONE NEOPLASM MALIGNANT INGROWING NAIL 1
C BONE NEOPLASM MALIGNANT INJURY 1
C BONE NEOPLASM MALIGNANT INSOMNIA 1
C BONE NEOPLASM MALIGNANT INTERVERTEBRAL DISC PROTRUSION 1
C BONE NEOPLASM MALIGNANT LETHARGY 1
C BONE NEOPLASM MALIGNANT LOOSE TOOTH 1
C BONE NEOPLASM MALIGNANT METASTASES TO BONE 1
C BONE NEOPLASM MALIGNANT MICTURITION URGENCY 1
C BONE NEOPLASM MALIGNANT MOUTH ULCERATION 1
C BONE NEOPLASM MALIGNANT MUSCLE SPASMS 1
C BONE NEOPLASM MALIGNANT MUSCULOSKELETAL DISCOMFORT 1
C BONE NEOPLASM MALIGNANT MYALGIA 1
C BONE NEOPLASM MALIGNANT NAIL DISCOLOURATION 1
C BONE NEOPLASM MALIGNANT NAIL DISORDER 1
C BONE NEOPLASM MALIGNANT NASAL CONGESTION 1
C BONE NEOPLASM MALIGNANT NEOPLASM MALIGNANT 1
C BONE NEOPLASM MALIGNANT NEPHROLITHIASIS 1
C BONE NEOPLASM MALIGNANT NOCTURIA 1
C BONE NEOPLASM MALIGNANT OBESITY 1
C BONE NEOPLASM MALIGNANT OEDEMA 1
C BONE NEOPLASM MALIGNANT OEDEMA PERIPHERAL 1
C BONE NEOPLASM MALIGNANT ONYCHOMYCOSIS 1
C BONE NEOPLASM MALIGNANT OSTEOARTHRITIS 1
C BONE NEOPLASM MALIGNANT OSTEONECROSIS OF JAW 1
C BONE NEOPLASM MALIGNANT PAIN 1
C BONE NEOPLASM MALIGNANT PAIN IN EXTREMITY 1
C BONE NEOPLASM MALIGNANT PAIN IN JAW 1
C BONE NEOPLASM MALIGNANT PARAESTHESIA 1
C BONE NEOPLASM MALIGNANT PERIPHERAL VASCULAR DISORDER 1
C BONE NEOPLASM MALIGNANT PHYSICAL DISABILITY 1
C BONE NEOPLASM MALIGNANT POLYP 1
C BONE NEOPLASM MALIGNANT PROSTATIC SPECIFIC ANTIGEN INCREASED 1
C BONE NEOPLASM MALIGNANT PULMONARY HYPERTENSION 1
C BONE NEOPLASM MALIGNANT RED BLOOD CELL COUNT DECREASED 1
C BONE NEOPLASM MALIGNANT RENAL IMPAIRMENT 1
C BONE NEOPLASM MALIGNANT RHINITIS ALLERGIC 1
C BONE NEOPLASM MALIGNANT SCAR 1
C BONE NEOPLASM MALIGNANT SCARLET FEVER 1
C BONE NEOPLASM MALIGNANT SENSITIVITY OF TEETH 1
C BONE NEOPLASM MALIGNANT SINUSITIS 1
C BONE NEOPLASM MALIGNANT SQUAMOUS CELL CARCINOMA 1
C BONE NEOPLASM MALIGNANT STUPOR 1
C BONE NEOPLASM MALIGNANT SUBDURAL HAEMATOMA 1
C BONE NEOPLASM MALIGNANT TOBACCO ABUSE 1
C BONE NEOPLASM MALIGNANT TONGUE ULCERATION 1
C BONE NEOPLASM MALIGNANT TOOTH ABSCESS 1
C BONE NEOPLASM MALIGNANT TRICUSPID VALVE INCOMPETENCE 1
C BONE NEOPLASM MALIGNANT URINARY INCONTINENCE 1
C BONE NEOPLASM MALIGNANT URINARY TRACT INFECTION 1
C BONE NEOPLASM MALIGNANT URINE ABNORMALITY 1
C BONE NEOPLASM MALIGNANT VERTEBRAL FORAMINAL STENOSIS 1
C CARDIAC OPERATION AORTIC THROMBOSIS 3
C CARDIAC OPERATION ARRHYTHMIA 3
C CARDIAC OPERATION AZOTAEMIA 3
C CARDIAC OPERATION CARDIAC FAILURE CONGESTIVE 3
C CARDIAC OPERATION CARDIAC OUTPUT DECREASED 3
C CARDIAC OPERATION CARDIOGENIC SHOCK 3
C CARDIAC OPERATION CEREBELLAR ISCHAEMIA 3
C CARDIAC OPERATION CHOLELITHIASIS 3
C CARDIAC OPERATION DEEP VEIN THROMBOSIS 3
C CARDIAC OPERATION ENCEPHALOPATHY 3
C CARDIAC OPERATION ENDOTRACHEAL INTUBATION 3
C CARDIAC OPERATION GASTROINTESTINAL HAEMORRHAGE 3
C CARDIAC OPERATION HAEMATOMA 3
C CARDIAC OPERATION HAEMOLYSIS 3
C CARDIAC OPERATION HEPATIC FAILURE 3
C CARDIAC OPERATION LIVER DISORDER 3
C CARDIAC OPERATION PNEUMONIA 3
C CARDIAC OPERATION PULMONARY HYPERTENSION 3
C CARDIAC OPERATION RENAL FAILURE ACUTE 3
C CARDIAC OPERATION SEPTIC SHOCK 3
C CARDIAC OPERATION SERRATIA BACTERAEMIA 3
C CARDIAC OPERATION STAPHYLOCOCCAL BACTERAEMIA 3
C CARDIAC OPERATION THROMBOCYTOPENIA 3
C DEEP VEIN THROMBOSIS AORTIC THROMBOSIS 1
C DEEP VEIN THROMBOSIS ARRHYTHMIA 1
C DEEP VEIN THROMBOSIS AZOTAEMIA 1
C DEEP VEIN THROMBOSIS CARDIAC FAILURE CONGESTIVE 1
C DEEP VEIN THROMBOSIS CARDIAC OUTPUT DECREASED 1
C DEEP VEIN THROMBOSIS CARDIOGENIC SHOCK 1
C DEEP VEIN THROMBOSIS CEREBELLAR ISCHAEMIA 1
C DEEP VEIN THROMBOSIS CHOLELITHIASIS 1
C DEEP VEIN THROMBOSIS DEEP VEIN THROMBOSIS 1
C DEEP VEIN THROMBOSIS ENCEPHALOPATHY 1
C DEEP VEIN THROMBOSIS ENDOTRACHEAL INTUBATION 1
C DEEP VEIN THROMBOSIS GASTROINTESTINAL HAEMORRHAGE 1
C DEEP VEIN THROMBOSIS HAEMATOMA 1
C DEEP VEIN THROMBOSIS HAEMOLYSIS 1
C DEEP VEIN THROMBOSIS HEPATIC FAILURE 1
C DEEP VEIN THROMBOSIS LIVER DISORDER 1
C DEEP VEIN THROMBOSIS PNEUMONIA 1
C DEEP VEIN THROMBOSIS PULMONARY HYPERTENSION 1
C DEEP VEIN THROMBOSIS RENAL FAILURE ACUTE 1
C DEEP VEIN THROMBOSIS SEPTIC SHOCK 1
C DEEP VEIN THROMBOSIS SERRATIA BACTERAEMIA 1
C DEEP VEIN THROMBOSIS STAPHYLOCOCCAL BACTERAEMIA 1
C DEEP VEIN THROMBOSIS THROMBOCYTOPENIA 1
C ENDOMETRIOSIS DECREASED APPETITE 1
C ENDOMETRIOSIS HEADACHE 1
C ENDOMETRIOSIS HOT FLUSH 1
C ENDOMETRIOSIS HYPOAESTHESIA 1
C ENDOMETRIOSIS OEDEMA PERIPHERAL 1
C ENDOMETRIOSIS PARAESTHESIA 1
C ENDOMETRIOSIS SKIN TIGHTNESS 1
C HYPERCHOLESTEROLAEMIA ABDOMINAL PAIN 1
C HYPERCHOLESTEROLAEMIA ASTHENIA 1
C HYPERCHOLESTEROLAEMIA CHILLS 1
C HYPERCHOLESTEROLAEMIA FEBRILE NEUTROPENIA 1
C HYPERTENSION DECREASED APPETITE 1
C HYPERTENSION HEADACHE 1
C HYPERTENSION HOT FLUSH 1
C HYPERTENSION HYPOAESTHESIA 1
C HYPERTENSION OEDEMA PERIPHERAL 1
C HYPERTENSION PARAESTHESIA 1
C HYPERTENSION SKIN TIGHTNESS 1
C MENORRHAGIA COLITIS ULCERATIVE 1
C MENORRHAGIA DEEP VEIN THROMBOSIS 1
C MENORRHAGIA HYPERTENSION 1
C MENORRHAGIA INFECTION 1
C MENORRHAGIA PULMONARY EMBOLISM 1
C MENORRHAGIA THROMBOPHLEBITIS SUPERFICIAL 1
C METASTATIC MALIGNANT MELANOMA ABDOMINAL PAIN 3
C METASTATIC MALIGNANT MELANOMA ASTHENIA 3
C METASTATIC MALIGNANT MELANOMA CHILLS 3
C METASTATIC MALIGNANT MELANOMA FEBRILE NEUTROPENIA 3
C MULTIPLE SCLEROSIS BLOOD GLUCOSE INCREASED 2
C MULTIPLE SCLEROSIS OEDEMA PERIPHERAL 2
C PAIN APPLICATION SITE DISCOLOURATION 1
C PAIN APPLICATION SITE ERYTHEMA 1
C PAIN APPLICATION SITE VESICLES 1
C PAIN DECREASED APPETITE 1
C PAIN HEADACHE 1
C PAIN HOT FLUSH 1
C PAIN HYPOAESTHESIA 1
C PAIN OEDEMA PERIPHERAL 1
C PAIN PARAESTHESIA 1
C PAIN SKIN TIGHTNESS 1
C PAIN SURGERY 1
C PRODUCT USED FOR UNKNOWN INDICATION AORTIC THROMBOSIS 123
C PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE DISCOLOURATION 7
C PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE ERYTHEMA 7
C PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE VESICLES 7
C PRODUCT USED FOR UNKNOWN INDICATION ARRHYTHMIA 123
C PRODUCT USED FOR UNKNOWN INDICATION AZOTAEMIA 123
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE CONGESTIVE 123
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC OUTPUT DECREASED 123
C PRODUCT USED FOR UNKNOWN INDICATION CARDIOGENIC SHOCK 123
C PRODUCT USED FOR UNKNOWN INDICATION CEREBELLAR ISCHAEMIA 123
C PRODUCT USED FOR UNKNOWN INDICATION CHOLELITHIASIS 123
C PRODUCT USED FOR UNKNOWN INDICATION DEEP VEIN THROMBOSIS 123
C PRODUCT USED FOR UNKNOWN INDICATION ENCEPHALOPATHY 123
C PRODUCT USED FOR UNKNOWN INDICATION ENDOTRACHEAL INTUBATION 123
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL HAEMORRHAGE 123
C PRODUCT USED FOR UNKNOWN INDICATION HAEMATOMA 123
C PRODUCT USED FOR UNKNOWN INDICATION HAEMOLYSIS 123
C PRODUCT USED FOR UNKNOWN INDICATION HEPATIC FAILURE 123
C PRODUCT USED FOR UNKNOWN INDICATION LIVER DISORDER 123
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 123
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY HYPERTENSION 123
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 123
C PRODUCT USED FOR UNKNOWN INDICATION SEPTIC SHOCK 123
C PRODUCT USED FOR UNKNOWN INDICATION SERRATIA BACTERAEMIA 123
C PRODUCT USED FOR UNKNOWN INDICATION STAPHYLOCOCCAL BACTERAEMIA 123
C PRODUCT USED FOR UNKNOWN INDICATION SURGERY 7
C PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOPENIA 123
C THYROID DISORDER MUSCULOSKELETAL PAIN 1
C THYROID DISORDER MYALGIA 1
C THYROID DISORDER NECK PAIN 1
C THYROID DISORDER PLATELET COUNT DECREASED 1
C TYPE 2 DIABETES MELLITUS CARDIOVASCULAR DISORDER 1
C TYPE 2 DIABETES MELLITUS CORONARY ARTERY OCCLUSION 1
C TYPE 2 DIABETES MELLITUS HEART INJURY 1
C TYPE 2 DIABETES MELLITUS LEG AMPUTATION 1
C TYPE 2 DIABETES MELLITUS LOBAR PNEUMONIA 1
C TYPE 2 DIABETES MELLITUS MYOCARDIAL INFARCTION 1
C TYPE 2 DIABETES MELLITUS POST PROCEDURAL COMPLICATION 1
C UTERINE LEIOMYOMA DECREASED APPETITE 1
C UTERINE LEIOMYOMA HEADACHE 1
C UTERINE LEIOMYOMA HOT FLUSH 1
C UTERINE LEIOMYOMA HYPOAESTHESIA 1
C UTERINE LEIOMYOMA OEDEMA PERIPHERAL 1
C UTERINE LEIOMYOMA PARAESTHESIA 1
C UTERINE LEIOMYOMA SKIN TIGHTNESS 1
C WEIGHT DECREASED DECREASED APPETITE 1
C WEIGHT DECREASED HEADACHE 1
C WEIGHT DECREASED HOT FLUSH 1
C WEIGHT DECREASED HYPOAESTHESIA 1
C WEIGHT DECREASED OEDEMA PERIPHERAL 1
C WEIGHT DECREASED PARAESTHESIA 1
C WEIGHT DECREASED SKIN TIGHTNESS 1
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