INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
C. I. DIRECT BLUE 218
NTP Experiment-Test: 05130-02 Report: PEIRPT05
Study Type: CHRONIC Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
Facility: Microbiological Associates
Chemical CAS #: 10401-500
Lock Date: 10/29/91
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 5 8 1 3
Natural Death 4 2 2 5
Moribund 3 2
Accidently Killed 1
Survivors
Terminal Sacrifice 37 40 46 38
Missing 1 1 1
Animals Examined Microscopically 49 50 49 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (47) (45) (46) (42)
Intestine Large, Cecum (47) (50) (48) (45)
Intestine Small, Duodenum (46) (50) (48) (46)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Intestine Small, Jejunum (47) (49) (48) (45)
Carcinoma 1 (2%)
Intestine Small, Ileum (48) (50) (48) (45)
Carcinoma 1 (2%)
Liver (49) (50) (49) (49)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 3 (6%) 1 (2%)
Hemangiosarcoma, Metastatic, Skin 1 (2%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 5 (10%) 5 (10%) 6 (12%) 12 (24%)
Hepatocellular Adenoma 6 (12%) 8 (16%) 9 (18%) 6 (12%)
Hepatocellular Adenoma, Multiple 1 (2%) 4 (8%) 8 (16%) 35 (71%)
Hepatocholangiocarcinoma 1 (2%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Osteosarcoma, Metastatic, Nose 1 (2%)
Sarcoma Stromal, Metastatic, Uterus 1 (2%)
Mesentery (6) (5) (3) (5)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (20%)
Histiocytic Sarcoma 1 (20%)
Pancreas (49) (50) (48) (49)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Salivary Glands (49) (50) (49) (48)
Stomach, Forestomach (49) (50) (48) (49)
Page 2
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (49) (50) (48) (49)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (50) (49) (49)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (48) (48)
Adenoma 1 (2%)
Adrenal Medulla (49) (49) (48) (47)
Pheochromocytoma Benign 1 (2%) 2 (4%)
Pituitary Gland (48) (50) (49) (45)
Pars Distalis, Adenoma 2 (4%) 6 (12%) 2 (4%)
Thyroid Gland (49) (50) (49) (49)
Follicular Cell, Adenoma 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2) (1)
Carcinoma, Metastatic, Thyroid Gland 1 (50%)
Sarcoma, Metastatic, Skeletal Muscle 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47) (50) (48) (49)
Choriocarcinoma 1 (2%)
Cystadenoma 2 (4%) 1 (2%) 1 (2%)
Granulosa Cell Tumor Benign 1 (2%) 2 (4%)
Hemangioma 1 (2%) 1 (2%)
Teratoma Benign 1 (2%) 1 (2%) 1 (2%)
Thecoma Benign 1 (2%)
Uterus (49) (50) (49) (49)
Deciduoma Benign 1 (2%)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%)
Hemangiosarcoma, Metastatic, Bone Marrow 1 (2%)
Histiocytic Sarcoma 1 (2%)
Page 3
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Leiomyoma 1 (2%) 1 (2%)
Polyp Stromal 1 (2%) 1 (2%)
Sarcoma Stromal 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (49) (49)
Vertebral, Hemangiosarcoma 1 (2%)
Lymph Node (9) (10) (8) (7)
Bronchial, Hepatocellular Carcinoma,
Metastatic, Liver 1 (10%)
Bronchial, Osteosarcoma, Metastatic, Bone 1 (10%)
Iliac, Sarcoma Stromal, Metastatic, Uterus 1 (11%)
Lumbar, Hepatocholangiocarcinoma, Metastatic,
Liver 1 (10%)
Mediastinal, Hepatocholangiocarcinoma,
Metastatic, Liver 1 (10%)
Renal, Hepatocholangiocarcinoma, Metastatic,
Liver 1 (10%)
Lymph Node, Mandibular (49) (48) (48) (47)
Lymph Node, Mesenteric (46) (48) (47) (46)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Spleen (48) (50) (49) (49)
Hemangiosarcoma 1 (2%)
Thymus (46) (48) (48) (46)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (49) (48)
Adenoma 1 (2%)
Skin (49) (50) (49) (49)
Squamous Cell Carcinoma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 2 (4%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (49) (49)
Dorsal, Osteosarcoma 1 (2%)
Vertebra, Hemangiosarcoma, Extension 1 (2%)
Skeletal Muscle (3) (1)
Back, Hemangiosarcoma, Extension 1 (33%)
Back, Sarcoma 1 (100%)
Page 4
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - cont
Diaphragm, Hepatocholangiocarcinoma,
Metastatic, Liver 1 (33%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (50) (49) (49)
Alveolar/Bronchiolar Adenoma 5 (10%) 5 (10%) 4 (8%) 1 (2%)
Alveolar/Bronchiolar Adenoma, Multiple 2 (4%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Osteosarcoma, Metastatic, Nose 1 (2%)
Sarcoma Stromal, Metastatic, Uterus 1 (2%)
Nose (49) (50) (49) (49)
Osteosarcoma 1 (2%)
Trachea (49) (50) (49) (49)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (3) (2)
Adenoma 3 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (49) (49)
Bilateral, Osteosarcoma, Metastatic, Bone 1 (2%)
Urinary Bladder (48) (50) (48) (49)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(49) *(50) *(49) *(49)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant Histiocytic 1 (2%) 2 (4%) 1 (2%)
Lymphoma Malignant Lymphocytic 4 (8%) 7 (14%) 5 (10%) 2 (4%)
Lymphoma Malignant Mixed 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Lymphoma Malignant Undifferentiated Cell 1 (2%) 1 (2%)
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(49) *(50) *(49) *(49)
____________________________________________________________________________________________________________________________________
Page 6
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM
FEMALE LOW FEM MID FEM HIGH FEM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 29 35 34 46
Total Primary Neoplasms 37 59 52 78
Total Animals with Benign Neoplasms 20 21 26 42
Total Benign Neoplasms 23 29 33 53
Total Animals with Malignant Neoplasms 14 24 17 24
Total Malignant Neoplasms 14 30 19 25
Total Animals with Metastatic Neoplasms 2 6 3 2
Total Metastatic Neoplasm 4 20 4 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 7
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 9 10 10 10
Early Deaths
Accidently Killed 1
Natural Death 3 2 5 4
Moribund Sacrifice 2 2 3 1
Survivors
Terminal Sacrifice 44 46 42 45
Missing 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (47) (46) (47)
Intestine Large, Colon (48) (50) (50) (49)
Intestine Large, Cecum (48) (49) (48) (48)
Intestine Small, Duodenum (48) (48) (47) (49)
Adenoma 1 (2%)
Intestine Small, Jejunum (49) (49) (49) (49)
Carcinoma 1 (2%) 3 (6%)
Intestine Small, Ileum (49) (49) (47) (48)
Liver (50) (50) (50) (50)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%) 1 (2%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 7 (14%) 3 (6%) 8 (16%) 17 (34%)
Hepatocellular Adenoma 12 (24%) 9 (18%) 7 (14%) 9 (18%)
Hepatocellular Adenoma, Multiple 4 (8%) 10 (20%) 10 (20%) 31 (62%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Mast Cell Tumor Malignant, Metastatic, Spleen 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Mesentery (3) (1)
Sarcoma, Metastatic, Uncertain Primary Site 1 (100%)
Pancreas (49) (50) (50) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Salivary Glands (49) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (50)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Hemangiosarcoma 1 (2%)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Adenoma 3 (6%) 1 (2%)
Capsule, Adenoma 1 (2%)
Pituitary Gland (49) (48) (48) (48)
Thyroid Gland (50) (50) (50) (50)
Follicular Cell, Adenoma 2 (4%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (2) (1)
Sarcoma, Metastatic, Uncertain Primary Site 1 (50%)
Abdominal, Hemangiosarcoma, Metastatic,
Spleen 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ductus Deferens (1)
Epididymis (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Sarcoma 1 (2%) 1 (2%)
Preputial Gland (29) (23) (23) (21)
Prostate (50) (49) (50) (50)
Histiocytic Sarcoma 1 (2%)
Seminal Vesicle (50) (50) (50) (50)
Testes (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Interstitial Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant, Metastatic, Spleen 1 (2%)
Lymph Node (4) (1) (2) (3)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (50%)
Page 9
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Bronchial, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (50%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (50%)
Lymph Node, Mandibular (46) (49) (49) (48)
Lymph Node, Mesenteric (48) (49) (50) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Spleen (49) (50) (50) (50)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Thymus (49) (45) (46) (42)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Subcutaneous Tissue, Fibroma 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Lipoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 12 (24%) 8 (16%) 7 (14%) 3 (6%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 3 (6%) 2 (4%) 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (6%) 3 (6%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Sarcoma, Metastatic, Skeletal Muscle 1 (2%)
Nose (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
Page 10
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Pinna, Sarcoma 1 (50%)
Harderian Gland (3) (4) (4)
Adenoma 3 (100%) 3 (75%) 4 (100%)
Bilateral, Adenoma 1 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Renal Tubule, Adenoma 2 (4%) 1 (2%) 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymphoma Malignant Lymphocytic 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Lymphoma Malignant Mixed 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94
Route: DOSED FEED Time: 23:49:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM
MALE LOW MALE MID MALE HIGHMALE
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 31 37 28 46
Total Primary Neoplasms 51 59 46 78
Total Animals with Benign Neoplasms 25 31 21 42
Total Benign Neoplasms 35 45 31 51
Total Animals with Malignant Neoplasms 14 14 12 24
Total Malignant Neoplasms 16 14 15 27
Total Animals with Metastatic Neoplasms 2 3 4 4
Total Metastatic Neoplasm 3 10 6 4
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 12
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