ID

37318

Descrição

Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02089126

Link

https://clinicaltrials.gov/show/NCT02089126

Palavras-chave

Versões (1)
  1. 16/07/2019 16/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02089126

Inglês

Eligibility Type 2 Diabetes Mellitus NCT02089126

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with type 2 diabetes
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
2. adults who are at least 19 years old
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
3. patients who have taken glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before visit 1 (screening) as monotherapy or patients who have taken glimepiride at a stable dose (≥4mg/day) and metformin for 8 weeks or more before visit 1 (screening) as combination therapy
Descrição

Glimepiride Dose Stable U/day | Metformin | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0061323
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0009429
4. patients who satisfy the following hba1c (%) criteria: 7 ≤ hba1c ≤ 11
Descrição

Criteria Fulfill | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2]
C0474680
5. patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
Descrição

Informed Consent | Informed Consent Patient Representative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
6. patients who fall under one of the following 3 cases
Descrição

Case Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1265611
1. patients who are surgically sterile
Descrição

Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038288
2. post-menopausal females who are above 45 years of age and 2 years after the last menstruation
Descrição

Postmenopausal state | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
3. fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.
Descrição

Childbearing Potential Premenopausal Contraceptive methods Quantity | Gender Contraceptive methods Quantity | Sterilization Absent | Contraception, Barrier

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0279752
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0038288
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0004764
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | Diabetes with coma | Precoma Diabetic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
UMLS CUI [3]
C1263960
UMLS CUI [4,1]
C1142529
UMLS CUI [4,2]
C0241863
2. patients with gestational diabetes or secondary diabetes
Descrição

Gestational Diabetes | Secondary diabetes mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C0271640
3. patients with nyha class iii, iv congestive heart failure or arrhythmias requiring treatment
Descrição

Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0332121
4. patients with thyroid gland dysfunction and tsh that is out of normal range
Descrição

Thyroid dysfunction | Serum TSH level abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0348024
UMLS CUI [2]
C0580434
5. patients with pituitary insufficiency or adrenal insufficiency
Descrição

Hypopituitarism | Adrenal gland hypofunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020635
UMLS CUI [2]
C0001623
6. patients with hereditary problems, such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption
Descrição

Problem Hereditary | Galactose intolerance | Lapps Lactase deficiency | Glucose-galactose malabsorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033213
UMLS CUI [1,2]
C0439660
UMLS CUI [2]
C0016952
UMLS CUI [3,1]
C0337904
UMLS CUI [3,2]
C0302813
UMLS CUI [4]
C0268186
7. female patients who are pregnant or breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patients whose bmi exceeds 40 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
9. patients whose creatinine clearance is below 30ml/min/1.73m2
Descrição

Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
10. patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose alt/ast level exceeds 2.5 times the upper limit of the normal range
Descrição

Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
11. patients who are continuously taking the following drugs for 2 weeks or more at visit 1 (screening), or need to take them continuously and repeatedly
Descrição

Taking medication Continuous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C0549178
cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
Descrição

Cyclosporine | Sirolimus | Tacrolimus | Nicotinic Acid U/day | Isotretinoin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0072980
UMLS CUI [3]
C0085149
UMLS CUI [4,1]
C0028049
UMLS CUI [4,2]
C0456683
UMLS CUI [5]
C0022265
strong cyp3a4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
Descrição

CYP3A4 Inducers Strong | Rifampin | Phenytoin | Carbamazepine | Rifabutin | Phenobarbital

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3850041
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0035608
UMLS CUI [3]
C0031507
UMLS CUI [4]
C0006949
UMLS CUI [5]
C0140575
UMLS CUI [6]
C0031412
warfarin, dicoumarin, digoxin
Descrição

Warfarin | Dicoumarin | Digoxin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0733631
UMLS CUI [3]
C0012265
systemic glucocorticoids
Descrição

Glucocorticoids, Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3540777
12. patients who have taken anti-obesity drugs or had a surgery related to obesity within 12 weeks before visit 1 (screening)
Descrição

Anti-Obesity Agents | Obesity surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2]
C1167841
13. patients who have received insulin and glp-1 analogue treatment within 8 weeks prior to visit 1 (screening)
Descrição

Insulin | GLP-1 Analogue

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C3273809
14. patients who have received a treatment due to malignant tumor within 5years before visit 1 (screening) however, patients whose basal cell or squamous cell skin cancer or in situ cervical cancer has been treated can be enrolled.
Descrição

Cancer treatment | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
15. patients with a history of myocardial infarction, unstable angina and coronary artery bypass surgery within 6 months prior to visit 1 (screening)
Descrição

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
16. patients with a history of alcohol or drug addiction within 1 year prior to visit 1 (screening)
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
17. patients who have a medical history of hypersensitivity to the same class as gemigliptin or dipeptidyl peptidase 4 (dpp 4) inhibitor drugs
Descrição

Hypersensitivity Pharmaceutical Preparations Gemigliptin Class | Hypersensitivity Pharmaceutical Preparations Dipeptidyl-Peptidase IV Inhibitors Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3501981
UMLS CUI [1,4]
C0456387
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1827106
UMLS CUI [2,4]
C0456387
18. patients with a history of hypersensitivity to the drugs belonging to the same class as glimepiride or sulfonylureas and sulfonamide
Descrição

Hypersensitivity Pharmaceutical Preparations Glimepiride Class | Hypersensitivity Pharmaceutical Preparations Sulfonylureas Class | Hypersensitivity Pharmaceutical Preparations Sulfonamide Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0061323
UMLS CUI [1,4]
C0456387
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0038766
UMLS CUI [2,4]
C0456387
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0038760
UMLS CUI [3,4]
C0456387
19. patients who have participated in another clinical trial within 3 months prior to visit 1 (screening)
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
20. patients deemed unsuitable for this trial based on the judgment of the investigator
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02089126

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. patients with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Adult | Age
Item
2. adults who are at least 19 years old
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Glimepiride Dose Stable U/day | Metformin | Combined Modality Therapy
Item
3. patients who have taken glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before visit 1 (screening) as monotherapy or patients who have taken glimepiride at a stable dose (≥4mg/day) and metformin for 8 weeks or more before visit 1 (screening) as combination therapy
boolean
C0061323 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Criteria Fulfill | Hemoglobin A1c measurement
Item
4. patients who satisfy the following hba1c (%) criteria: 7 ≤ hba1c ≤ 11
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative
Item
5. patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Case Quantity
Item
6. patients who fall under one of the following 3 cases
boolean
C1706256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Sterilization
Item
1. patients who are surgically sterile
boolean
C0038288 (UMLS CUI [1])
Postmenopausal state | Age
Item
2. post-menopausal females who are above 45 years of age and 2 years after the last menstruation
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential Premenopausal Contraceptive methods Quantity | Gender Contraceptive methods Quantity | Sterilization Absent | Contraception, Barrier
Item
3. fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0279752 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0038288 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | Diabetes with coma | Precoma Diabetic
Item
1. patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C1263960 (UMLS CUI [3])
C1142529 (UMLS CUI [4,1])
C0241863 (UMLS CUI [4,2])
Gestational Diabetes | Secondary diabetes mellitus
Item
2. patients with gestational diabetes or secondary diabetes
boolean
C0085207 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Treatment required for
Item
3. patients with nyha class iii, iv congestive heart failure or arrhythmias requiring treatment
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Thyroid dysfunction | Serum TSH level abnormal
Item
4. patients with thyroid gland dysfunction and tsh that is out of normal range
boolean
C0348024 (UMLS CUI [1])
C0580434 (UMLS CUI [2])
Hypopituitarism | Adrenal gland hypofunction
Item
5. patients with pituitary insufficiency or adrenal insufficiency
boolean
C0020635 (UMLS CUI [1])
C0001623 (UMLS CUI [2])
Problem Hereditary | Galactose intolerance | Lapps Lactase deficiency | Glucose-galactose malabsorption
Item
6. patients with hereditary problems, such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption
boolean
C0033213 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0016952 (UMLS CUI [2])
C0337904 (UMLS CUI [3,1])
C0302813 (UMLS CUI [3,2])
C0268186 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
7. female patients who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Body mass index
Item
8. patients whose bmi exceeds 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Creatinine clearance measurement
Item
9. patients whose creatinine clearance is below 30ml/min/1.73m2
boolean
C0373595 (UMLS CUI [1])
Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
10. patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose alt/ast level exceeds 2.5 times the upper limit of the normal range
boolean
C0741494 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Taking medication Continuous
Item
11. patients who are continuously taking the following drugs for 2 weeks or more at visit 1 (screening), or need to take them continuously and repeatedly
boolean
C1290952 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Cyclosporine | Sirolimus | Tacrolimus | Nicotinic Acid U/day | Isotretinoin
Item
cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
boolean
C0010592 (UMLS CUI [1])
C0072980 (UMLS CUI [2])
C0085149 (UMLS CUI [3])
C0028049 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0022265 (UMLS CUI [5])
CYP3A4 Inducers Strong | Rifampin | Phenytoin | Carbamazepine | Rifabutin | Phenobarbital
Item
strong cyp3a4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0035608 (UMLS CUI [2])
C0031507 (UMLS CUI [3])
C0006949 (UMLS CUI [4])
C0140575 (UMLS CUI [5])
C0031412 (UMLS CUI [6])
Warfarin | Dicoumarin | Digoxin
Item
warfarin, dicoumarin, digoxin
boolean
C0043031 (UMLS CUI [1])
C0733631 (UMLS CUI [2])
C0012265 (UMLS CUI [3])
Glucocorticoids, Systemic
Item
systemic glucocorticoids
boolean
C3540777 (UMLS CUI [1])
Anti-Obesity Agents | Obesity surgery
Item
12. patients who have taken anti-obesity drugs or had a surgery related to obesity within 12 weeks before visit 1 (screening)
boolean
C0376607 (UMLS CUI [1])
C1167841 (UMLS CUI [2])
Insulin | GLP-1 Analogue
Item
13. patients who have received insulin and glp-1 analogue treatment within 8 weeks prior to visit 1 (screening)
boolean
C0021641 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Cancer treatment | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
14. patients who have received a treatment due to malignant tumor within 5years before visit 1 (screening) however, patients whose basal cell or squamous cell skin cancer or in situ cervical cancer has been treated can be enrolled.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
15. patients with a history of myocardial infarction, unstable angina and coronary artery bypass surgery within 6 months prior to visit 1 (screening)
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Substance Dependence
Item
16. patients with a history of alcohol or drug addiction within 1 year prior to visit 1 (screening)
boolean
C0038580 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparations Gemigliptin Class | Hypersensitivity Pharmaceutical Preparations Dipeptidyl-Peptidase IV Inhibitors Class
Item
17. patients who have a medical history of hypersensitivity to the same class as gemigliptin or dipeptidyl peptidase 4 (dpp 4) inhibitor drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3501981 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1827106 (UMLS CUI [2,3])
C0456387 (UMLS CUI [2,4])
Hypersensitivity Pharmaceutical Preparations Glimepiride Class | Hypersensitivity Pharmaceutical Preparations Sulfonylureas Class | Hypersensitivity Pharmaceutical Preparations Sulfonamide Class
Item
18. patients with a history of hypersensitivity to the drugs belonging to the same class as glimepiride or sulfonylureas and sulfonamide
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0061323 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0038766 (UMLS CUI [2,3])
C0456387 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0038760 (UMLS CUI [3,3])
C0456387 (UMLS CUI [3,4])
Study Subject Participation Status
Item
19. patients who have participated in another clinical trial within 3 months prior to visit 1 (screening)
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
20. patients deemed unsuitable for this trial based on the judgment of the investigator
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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