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Study Detail

Study ID 1009
Name Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia
Contact Email biolincc@imsweb.com
Acronym MSH
Period 1992-2008
Design Clinical Trial
Study PI Samuel Charache, Michael Terrin
Institution Multiple institutes
URL https://biolincc.nhlbi.nih.gov/studies/MSH/
CTGovID https://clinicaltrials.gov/ct2/show/NCT00000586
Funding Agency NHLBI
Grant Number UO1-HL45692, UO1-HL45696
Overview The primary objective of MSH was to determine whether or not treatment with hydroxyurea titrated to maximum tolerated doses would reduce the frequency of vaso-occlusive (painful) crises by at least 50%. The principal end point was the occurrence of a vaso-occlusive (painful) crisis, defined as pain not due to another cause, lasting at least four hours and requiring parenteral (or equivalent doses of oral narcotics)) narcotics or non-steroidal anti-inflammatory drugs for relief. Occurrences of chest syndrome were counted as crises. Pain due to chronic conditions such as ankle ulcers, osteomyelitis or aseptic necrosis of bone was not counted as crises. The secondary objectives investigated the correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises, and the effect of treatment on the quality of life.
Focus Areas 1. Correlations of fetal hemoglobin (HbF) levels and other patient or treatment characteristics with the occurrence of vaso-occlusive (painful) crises,
2. Effect of treatment on the quality of life
3. Crises which occur between two years after study entry and theend of follow-up for each patient.
4. In-patient crises.
5. The duration of hospitalization for each in-patient crisis.Records will also be kept of the occurrence of events which areclearly-defined, sickle-related and not painful crises including a. Death;
6. b. Stroke;
7. c. Development of any indication resulting in treatment withchronic transfusion therapy, such as stroke or pulmonaryfailure;
8. d. New osteomyelitis, proved by culture, with consistent abnormalitieson x-ray and/or bone scan;
9. e. Development of a new ankle ulcer or recurrence of a previouslyhealed ankle ulcer;
10. f.Infections;
11. g.Aseptic necrosis of bone.
Outcomes Occurrence of vaso-occlusive (painful) crisis [ Time Frame: Measured during the first 2 years a patient was enrolled in the study ]
Data Location BioLINCC, BioData Catalyst
Biospecimen Available Blood; DNA; Plasma; Serum;
Data Consent Data sharing via BioLINCC; By signing the consent, the patient gives the MSH investigators permission to get records from any medical facility attended during the study. Data may be shared with the National Heart, Lung, and Blood Institute, the manufacturer of hydroxyurea, or the U.S. Food and Drug Administration (FDA).
Biospecimen Consent Sample sharing via BIOLINCC; Genetic Use of Specimens Allowed
Contact Consent NA
Genomic Data No
Age Range 18-50
No. Participants 299
Inclusion Criteria 1. Men and women, ages 18 to 50, who had at least three emergency room visits or hospitalizations for sickle cell anemia during the year prior to recruitment.
2. Patients with greater than 20 crises per year were included.
3. Diagnosis of sickle cell anemia by gel electrophoresis conducted by a Core Laboratory.
4. Patients were required to successfully complete a 2 week “run-in” period comprised of two visits with baseline blood sample collections, completion of a two week diary and daily ingestion of a folic acid tablet.
Exclusion Criteria 1. They are unwilling to use contraception unless tubal ligation, hysterectomy or vasectomy has been performed (in the patient or partner(s)).
2. They are receiving prescriptions for more than 30 oxycodone capsules (or equivalent-see section 6.2) at a time from clinic personnel.
3. Creatinine is >1.7 mg/dL;
4. Transfusions have been received within 2 months of enrollment, or the patient is on a chronic transfusion program; or the patient is likely to begin chronic transfusion therapy in the next two years;
5. Active liver disease is present, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>300 units or abnormal and increasing on serial samples;
6. There is a contraindication for potentially immunosuppressive therapy (HIV antibody testing is required for eligibility and a positive test will result in patient ineligibility);
7. Serum B12, ferritin or folate is abnormally low (patients are acceptable after treatment of deficiency states);
8. Hydroxyurea therapy has been or is currently being administered;
9. The patient is pregnant (tested for in all women before randomization) or breast-feeding;
10. S/ß0 thalassemia is known to be present;
11. The patient is receiving theophylline, androgen, estrogen, progestin (except for birth control), calcium channel blockers, danazol, or any other drug suspected to have an anti-sickling effect
12. The patient has a history of cerebrovascular accident (stroke) and has been on a chronic transfusion program
13. The patient has a history of congestive heart failure and has been on a chronic transfusion program
14. There has been failure to obtain informed consent
15. Hemoglobin-A greater than 15%.
Study Documentation
  Select All
   1. Clinical_Protocol
   2. EXT-1_Protocol
   3. PFU_Protocol
Forms
  Select All
   1. Form 01-Eligibility Screening Form I
   2. Form 02-Eligibility Screening Form II
   3. Form 03-Demographics
   4. Form 04-Medical Examination and History
   5. Form 05-Patient Diary
   6. Form 07-Gel Electrophoresis Report
   7. Form 08-Request for Enrollment
   8. Form 09-Treatment Initiation
   9. Form 11-Health Status Survey
   10. Form 12-Profile of Mood States and Ladder of Life
   11. Form 14-Patients Usual Residence
   12. Form 20-Follow-Up Visit
   13. Form 22-Missed Visit
   14. Form 23-Six-Month Medical Review and Examination
   15. Form 25-Medical Contact
   16. Form 30-Toxicity Review
   17. Form 31-Study Treatment Inventory
   18. Form 32-Initiation of Treatment Stop Order
   19. Form 33-Patient Contact for Treatment Stop Order Office
   20. Form 34-Patient Contact for Treatment Stop Order Clinic
   21. Form 35-Restart Treatment Order
   22. Form 37-Resume Tratement Order
   23. Form 39-Four-Week Telephone Follow-Up
   24. Form 44-Crisis Review Committee Event Classification Form
   25. Form 45-Death Notification
   26. Form 70 Study Close-Out for Investigators
   27. Form 73 Study Close-Out for Clinic Director
   28. Form 74-Study Close-Out for MSH Assistant Coordinator
   29. Form 75-Study Close-Out for Participant
   30. FU-Y1-5-Form 40-Patient Enrollment
   31. FU-Y1-5-Form 41-Demographics
   32. FU-Y1-5-Form 42-Health Status Questionnaire
   33. FU-Y1-5-Form 43-Medical Review and Examination
   34. FU-Y1-5-Form 44 Rev4-Hydroxyurea Review
   35. FU-Y1-5-Form 45-Protocol Review and Collection of Samples
   36. FU-Y1-5-Form 47-Chest X-Ray Summary
   37. FU-Y1-5-Form 48-ECG Summary
   38. FU-Y1-5-Form 49-Local Laboratory Report
   39. FU-Y1-5-Form 50-Patient Event
   40. FU-Y1-5-Form 55-Event Classification
   41. FU-Y6-9-Form 41-Demographics (1)
   42. FU-Y6-9-Form 42-Health Status Questionnaire
   43. FU-Y6-9-Form 43-Medical Review and Examination
   44. FU-Y6-9-Form 44-Hydroxyurea Review
   45. FU-Y6-9-Form 45-Protocol Review and Collection of Samples
   46. FU-Y6-9-Form 46-Offspring Review
   47. FU-Y6-9-Form 47-Chest X-Ray Summary
   48. FU-Y6-9-Form 48-ECG Summary
   49. FU-Y6-9-Form 49-Local Laboratory Report
   50. FU-Y6-9-Form 50-Patient Event
   51. FU-Y6-9-Form 66-Status of Patients Not Enrolled
   52. FU-Y6-9-Form 67-Arterial Blood Gases Analysis
   53. FU-Y6-9-Form 68-Spirometry Data Form
   54. FU-Y6-9-Form 69-HRCT of the Chest
   55. FU-Y6-9-Form 70-Patient Enrollment

Data ElementVariables
Substance Use ALC_CUR
ALC_HIGH
ALC_YRS
CHEWTOB
CIGARS
CIGRTS
LASTSMOK
PACK_YRS
PIPES
SIXWEEKS
SMOKE
TOB_AGE
TOBACCO
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis APLAS_HX
Bleeding BLEED_HX
BLEED_HX
BLEED_HX
Other Blood Problem HEMATO
Sickle Cell Disease SC_DIAG
SCD_DIAG
Data ElementVariables
Cancer CALEU_HX
CANCER
NEOP_HX
NEOP_HX
Data ElementVariables
Aneurysm
Cardiac Failure CHF_HX
CHF_HX
CHF_HX
Cardiovascular Problem CARD_SYS
Heart Problem
Data ElementVariables
Gastrointestinal Problem GI_SYS
GIDIS_HX
GIDIS_HX
GIDIS_HX
INDIG_HX
INDIG_HX
Hepatitis HEPAT_HX
Liver Problem HEP_FAIL
HEPSEQ
Data ElementVariables
Family MedHx FAMCA_HX
Data ElementVariables
Genitourinary Problem HEMAT_HX
HEMAT_HX
HEMAT_HX
HEMATUR
IMPOT_HX
URIN_SYS
Kidney Problem REN_FAIL
Priapism PRIAP
PRIAP_HX
PRIAP_HX
PRIAP_HX
Renal Dialysis History
Data ElementVariables
Fever FEVER
HIV Infection
Immune Problem IMMUNO
IMMUNO
Infection CHPOX_HX
CHPOX_HX
HERPS_HX
HERPS_HX
HERPZ_HX
HERPZ_HX
INFECT
INFECT
SEPS_INF
Vaccination
Data ElementVariables
Adverse event ADV_STP
ALT_STP
BTOX_STP
CREA_STP
GI_STP
HAIR_STP
OTH_RMK1
OTH_STP
SKIN_STP
Death AUTOPSY
DEAD
DTH_LOC
EVT_CODE
FATAL
LOC_RMK
VIS_DT
VSTAT66
Disability Status ACTIVITY
Hospitalization
Medical Event DISPOSTN
HAIR_L
NAUSEA
O_SX
S_SX
Serious Adverse Event
Data ElementVariables
Anxiety
Depression
Emotional Health DISTRES
PSYCH
SF_5A
SF_5B
SF_5C
SF_9A
SF_9B
SF_9C
SF_9D
SF_9E
SF_9F
SF_9G
SF_9H
SF_9I
SF_9J
UNDSTD
Mental status
Psychiatric Disorder
Data ElementVariables
Musculoskeletal Problem EDEMA
FISTULA
MUSKEL
NECF_HX
NECH_HX
Osteomyelitis OSTEO_HX
OSTEO_HX
Osteonecrosis NECF_HX
NECH_HX
Rheumatic Diseases
Data ElementVariables
Meningitis
Neurologic Event DIZ_HEAD
FAINT
NAUSEA
NEUR_SYS
Seizure
Stroke SKIN_HX
STRK_HX
STROK_HX
STROK_HX
STROKE
STROKE
Transient Ischemic Attack
Data ElementVariables
Ocular Problem SCLERAL
Sickle Retinopathy
Data ElementVariables
Abdominal Pain LIV_LLQ
LIV_LLQ
LIV_LUQ
LIV_LUQ
LIV_RLQ
LIV_RLQ
LIV_RUQ
LIV_RUQ
General Pain PAIN_NSC
PAIN01
SF_7
SF_8
Headache
Management MDVIS01
Pain Attack ADD_INFO
CRISIS
DIAG_A
PAIN
PAIN_EVT
PAIN_SC
UNCERT
Skeletal and Joint Pain
Data ElementVariables
Birth Outcome LIVE_BTH
PREG_TRM
Gestational Age
Menstruation
Pregnancy CUR_PREG
GRAVID
P4_MOYR
PREG
PREG_STP
PREG_STP
PREGNT
PREGNT
PROTEC
Reproductive Behavior ANDROG
BIRTHCON
DEPOPRO
ESTROG
IMPOT_HX
IMPOT_HX
NORPLANT
PROTEC
Data ElementVariables
Acute Chest Syndrome CHEST_SY
CHST_HX
CHST_HX
Asthma
Lung Disease CHST_HX
CPF_HX
CPF_HX
CPF_HX
ENT_SYS
PULM_SYS
Other Respiratory Problem
Data ElementVariables
Skin Problem HRLOS_HX
HRLOS_HX
HRLOS_HX
NAIL_HX
OLDULCRS
OTH_HX
SKIN_HX
SKIN_HX
SKIN_R
SKIN_SYS
SKINULCR
SKINULCR
SKINULCR
ULCR_HX
Data ElementVariables
Cardiovascular
Digestive CHOL_HX
CHOL_HX
CHOL_HX
Genitourinary
Lymphatic
Musculoskeletal
Ocular
Respiratory
Surgery History
Data ElementVariables
Address
Age
Ethnic Group RACE
Gender GENDER
GENDER
Language
National Origin
Nuclear Family
Race
Data ElementVariables
Community HOUSE
HOUSE_FU
ROOMS
ROOMS_FU
URBSUBRU
Individual
Data ElementVariables
Annual Income INCOME_H
INCOME_H
INCOME_P
INCOME_P_FU
Education EDUCATN
EDUCATN_FU
Employment Status EMP_5YRS
EMP_5YRS_FU
EMPLYMNT
EMPLYMNT_FU
INDUSTRY
INDUSTRY
OCCUPATN
OCCUPATN_FU
UNEMP_MO
UNEMP_YR
UNEMP_YR_FU
YRS_WRKD
YRS_WRKD
Household PERSONS
PERSONS
Insurance MEDICAID
MEDICAID_FU
MEDICARE
MEDICARE_FU
PRIVINS
PRIVINS_FU
STATEINS
STATINS
Marital Status MARITAL
MARITAL_FU
Data ElementVariables
Exposure CAEXPRSK
RADEXP
Lead Poisoning
Data ElementVariables
Facility Type EMER_F
IN_PAT
MSHCL
SC_FACIL
Provider Type
Quality of Care
Visit DR_VIS
SCH_CONT
VIS_39
Data ElementVariables
Country of Care
Facility Type
Quality of Care TRIPTIME
DISTANCE
MODE_TRS
Data ElementVariables
Abdomen
Bone
Brain
Chest AB_BONTH
AB_HEART
AB_HILUM
AB_PLEUR
AB_PULPA
ARTENLAR
BONEINFA
BONYABSP
BONYEROS
DIFEMPHY
DIFFUSEP
DIFPLEUR
EMPHYSEM
LOCALPF
LOCCONSO
LOCEMPHY
LULOBE
LULOBEPC
OTHERABG
OTHERBON
OTHERCAR
OTHERPLE
OTHERPUL
PLEURABS
PLEURALE
PULABSPE
PULFIBRO
PULINFAR
RLLOBE
RLLOBEPC
RMLOBE
RMLOBEPC
RULOBE
RULOBEPC
CARDABSP
CARDIOME
FOCPLEUR
GVABSPEC
HILUMABS
LLOBE
LLOBE_
LMLOBE
LMLOBEPC
Data ElementVariables
Echocardiogram ATR_FIB
ATR_FLU
ATR_PMB
C_LBBB
C_RBBB
ECG_NORM
ECG_RECM
ECGOLDMI
ECGOT_SP
ECGOTHR
ECGOTHR
I_RBBB
LVH
LVQSR
OT_ARRHY
P_PULM
PVB
Q_WVS
RVH
SIN_RHY
SINUS_RT
ST_DEP
ST_ELEV
TWV_INV
Data ElementVariables
Abdomen
Biliary Tract
Chest LUNGCLR
LUNGCLR
CXRAY_ST
CXRAYINT
Extremities
Gallbladder
Liver
Skull
Data ElementVariables
Cognitive Functioning
Emotional Functioning ACTV_15V
ANXI_41T
BLUE_18D
BUSH_65F
CHEE_38V
DISC_32D
EDGE_16T
ENER_19V
EXHA_40F
FATG_29F
HELP_48D
HPLS_21D
LIVE_07V
LOL5YA
LOL5YH
LOLNOW
MISR_36D
NERV_34T
PEP    56V
REST_27T
SAD    14D
SF_4B
TENS_02T
UNEA_26T
UNHA_05D
VIGO_63V
WEAR_49F
WORN_04F
WRTH_58D
Physical Functioning SF_1
SF_10A
SF_10B
SF_10C
SF_10D
SF_2
SF_3A
SF_3B
SF_3C
SF_3D
SF_3E
SF_3F
SF_3G
SF_3H
SF_3I
SF_3J
School Functioning
Social Functioning SF_4A
SF_4C
SF_4D
SF_6
Data ElementVariables
Blood Differential Test BASOS
EOS
LYMPHS
MONOS
NEUTS
Blood Gases ACUTELTI
BLOODGAS
CARBOXYH
COOXIMET
EXPLAIN
METHEM
OXYHEM
OXYSAT
PACO2
PAO2
PERCTO2
PH
ROOMAIR
Blood Smear SLIDE
Blood Typing
Coagulation Test
Complete Blood Count HGB
MCH
MCHC
MCV
PCV
PLATELET
RBC
RBC_MYEL
RDW
RETIC_CT
WBC
Comprehensive Metabolic Panel (CMP) ALBUMIN
ALK_PHOS
ALT
AST
CALCIUM
CREAT
DIR_BILI
GLUCOSE
PHOSPH
TOT_BILI
TOT_PROT
UREA_NIT
URIC_A
Enzyme
General BLOODS
CENTR
DIFVEN
DNA
B_HEM
R_HEM
S_HEM
S_PROB
SERUM
NOVENA
O_PROB
Hemoglobin Electrophoresis AHGB
HB_PATRN
SC
Iron FERRITIN
Data ElementVariables
Cardiovascular Test MURMTYPE
MURMURS
S3GALLOP
SINUS
Data ElementVariables
Genitourinary Test
Urine Test URI_RBC
URI_WBC
Data ElementVariables
Eye exam SCL_ICT
SCLERAL
SCLERAL
Data ElementVariables
Abdomen
Anthropometrics bmi
bmi
bmi
HEIGHT
HEIGHT
HGT
WEIGHT
WEIGHT
WEIGHT
WEIGHT
WGT
Cardiovascular S3GALLOP
S3GALLOP
SINUS
SINUS
MURMTYPE
MURMTYPE
MURMURS
MURMURS
Extremities ULCR_HX
FISTULA
OLDULCRS
EDEMA
General SKINRSH
SWEAT
FEVER
HAIRLOS
BLEED
INFECT
LYMP_ANC
LYMP_ANC
LYMP_ANC
LYMP_CER
LYMP_CER
LYMP_CER
LYMP_GRN
LYMP_GRN
LYMP_GRN
LYMP_OTH
LYMP_OTH
LYMP_OTH
Liver LIV_LLQ
LIV_LUQ
LIV_RLQ
LIV_RUQ
LIVER
LIVER
LIVER
Reproductive
Respiratory RESP
RESPRATE
RESPRATE
COUGH
LUNGCLR
Spleen
Vital signs CEL_FAR
DBP
DBP
DBP
DBP
PULSE
PULSE
PULSE
PULSE
RESPRATE
RESPRATE
SBP
SBP
SBP
SBP
TEMP
TEMP
TEMP2
Data ElementVariables
Pulmonary Function Test BREATHCA
CAPMEAS
HEDILUTI
LUNGCAP
LUNGVOL
OTHER
PLETHYSM
POSTFE25
POSTFE50
POSTFEV
POSTFVC
POSTPEF
POSTSPIR
PREFEF25
PREFEF50
PREFEV
PREFVC
PREPEF
PRESPIRO
RESIDCAP
RESIDVOL
SPECIFY
Respiratory Test
Data ElementVariables
Antibiotics ANTBIOT
Asthma THEOPH
THEOPHYL
Blood Medication History ANTIHYP
CBLK
DIURETIC
Cardiovascular
Compliance
Current Medication
Depression Medication History ANTIDEPR
FLUOXET
Hydroxyurea CAPS_200
CAPS_500
HUCOM85
HUDOS85
HUTYP85
MISS_STP
OTH_RMK2
OTHR_STP
PLBO_STP
RX_DOSE
STOP_F33
TK_TIM
TXINTC
TXINTD
TXINTR
UNBL_STP
Medication ACETAMIN
ACETAMIN
ANDROG
ANTICONV
ANTIDEPR
ANTIHYP
ASPIRIN
ASPIRIN
BENZOD
BIRTHCON
CBLK
COD
COD_DO
COD_NA
DEM
DEM_DO
DEM_NA
DEPOPRO
DIURETIC
ESTROG
FEN
FEN_DO
FLUOXET
HISTAM
HISTAM
HYD
HYD_DO
HYD_NA
IRON
MOR
MOR_DO
MOR_NA
NEUROLEP
NORPLANT
NSAID
O_NARC
OR1
OR1_DO
OR1_NA
OR2
OR2_DO
OR2_NA
OTHR_MED
OTHR_MED
OXY
OXY_DO
OXY_NA
THEOPHYL
Neurologic Medication History ANTICONV
BENZOD
NEUROLEP
Pain COD_DAO
COD_DOSO
COD_O_NA
COD_ORL
DEM_DAO
DEM_DAP
DEM_DOSO
DEM_DOSP
DEM_O_NA
DEM_ORL
DEM_P_NA
DEM_PAR
DIL_DAO
DIL_DAP
DIL_DOSO
DIL_DOSP
DIL_O_NA
DIL_ORL
DIL_P_NA
DIL_PAR
FEN_DA
FEN_DOS
FEN_NA
FENPAT
KET_DA
KET_NA
KETDOS
KETOR
MEDS01
MOR_DAO
MOR_DAP
MOR_DOSO
MOR_DOSP
MOR_O_NA
MOR_ORL
MOR_P_NA
MOR_PAR
NS1_DA
NS1_DOS
NS1_NA
NS1_RMK
NSAID
NSAID
PA1_DAP
PA1_DOSP
PA1_NA
PA1_PAR
PA1_RMK
PAR_NAR
OR1_DAO
OR1_DOSO
OR1_NA
OR1_RMK
ORAL_NAR
OXY_30
OXY_DAO
OXY_DOSO
OXY_O_NA
OXY_ORL
SCD Medication ANTSC
Sildenafil
Supplements IRON
Data ElementVariables
Blood Transfusion FVTRAN
TRAN_STP
TRANSF
TRANSFUS
UNTBL
Chronic Transfusion CHR_TO
CHR_TR
CHTRAN
Transfusion Complications
Data ElementVariables
Oxygen
Treatment RADTHE
TH_PHL
TREATED
Data ElementVariables
ASCQ-Me Emotional Impact
ASCQ-Me Social Functioning
Brief Resiliency Scale
NeuroQOL Fatigue
NIH Toolbox Loneliness
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS) ACTV_15V
ANXI_41T
BLUE_18D
BUSH_65F
CHEE_38V
DISC_32D
EDGE_16T
ENER_19V
EXHA_40F
FATG_29F
HELP_48D
HPLS_21D
LIVE_07V
MISR_36D
NERV_34T
PEP    56V
REST_27T
SAD    14D
TENS_02T
UNEA_26T
UNHA_05D
VIGO_63V
WEAR_49F
WORN_04F
WRTH_58D
PROMIS Anxiety
PROMIS Emotional Distress- Depression
PROMIS Emotional Support
PROMIS Fatigue
PROMIS Global Mental Health
Data ElementVariables
Child Health Questionnaire (CHQ)
Ladder of Life LOL5YA
LOL5YH
LOLNOW
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey SF_1
SF_10A
SF_10B
SF_10C
SF_10D
SF_2
SF_3A
SF_3B
SF_3C
SF_3D
SF_3E
SF_3F
SF_3G
SF_3H
SF_3I
SF_3J
SF_4A
SF_4B
SF_4C
SF_4D
SF_5A
SF_5B
SF_5C
SF_6
SF_7
SF_8
SF_9A
SF_9B
SF_9C
SF_9D
SF_9E
SF_9F
SF_9G
SF_9H
SF_9I
SF_9J
UNDSTD
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