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Reyataz

Last reviewed on RxList: 5/1/2018
Reyataz Side Effects Center

Last reviewed on RxList 5/1/2018

Reyataz (atazanavir sulfate) is an antiviral medication in a group of HIV medicines called protease inhibitors used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Reyataz is not a cure for HIV or AIDS. Common side effects of Reyataz include:

  • headache,
  • nausea,
  • vomiting,
  • diarrhea,
  • stomach pain,
  • fatigue,
  • fever,
  • trouble sleeping,
  • numbness or burning pain in your hands or feet,
  • dizziness,
  • depression, or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Tell your doctor if you have serious side effects of Reyataz including:

  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • severe tiredness,
  • vision changes,
  • severe or persistent headaches,
  • signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores),
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter),
  • signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech),
  • yellowing eyes or skin,
  • increased thirst or urination,
  • dizziness,
  • lightheadedness, or
  • signs of a kidney stone (such as pain in side/back/abdomen, painful urination, blood in the urine).

The recommended oral dosage of Reyataz depends on the treatment history of the patient and the use of other co-administered drugs. Reyataz should not be taken together with ritonavir if you are also using the steroid medicine fluticasone. Reyataz may interact with digoxin, antibiotics, antifungals, antidepressants, blood thinners, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, insulin or oral diabetes medication, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or stomach acid reducers. Many other medicines can interact with Reyataz. Tell your doctor all prescription and over-the-counter medications and supplements you use. Reyataz should be used only when prescribed during pregnancy. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Reyataz (atazanavir sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Reyataz Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

  • sudden dizziness (like you might pass out);
  • severe pain in your side or lower back, painful urination, blood in your urine;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision; or
  • liver or gallbladder problems--nausea, vomiting, upper stomach pain, itching, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Atazanavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement;
  • weakness or prickly feeling, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • fever;
  • nausea, vomiting, stomach pain, diarrhea;
  • headache, muscle pain;
  • depressed mood, sleep problems (insomnia);
  • numbness, tingling, or burning pain in your hands or feet; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Reyataz (Atazanavir Sulfate)

Reyataz Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions In Treatment-Naive Adult Patients

The safety profile of REYATAZ in treatment-naive adults is based on 1625 HIV-1 infected patients in clinical trials. 536 patients received REYATAZ 300 mg with ritonavir 100 mg and 1089 patients received REYATAZ 400 mg or higher (without ritonavir).

The most common adverse reactions were nausea, jaundice/scleral icterus, and rash.

Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-naive patients receiving combination therapy including REYATAZ 300 mg with ritonavir 100 mg and REYATAZ 400 mg (without ritonavir) are presented in Tables 7 and 8, respectively.

Table 7: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Study AI424138

  96 weeksc
REYATAZ 300 mg with ritonavir 100 mg (once daily) and tenofovir DF with emtricitabined
(n=441)
96 weeksc
lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir DF with emtricitabined
(n=437)
Digestive System
  Nausea 4% 8%
  Jaundice/scleral icterus 5% *
  Diarrhea 2% 12%
Skin and Appendages
  Rash 3% 2%
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on the regimen containing REYATAZ.
c Median time on therapy. d As a fixed-dose combination: 300 mg tenofovir DF, 200 mg emtricitabine once daily.

Table 8: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Studies AI424-034, AI424-007, and AI424-008

  Study AI424-034 Studies AI424-007, -008
64 weeksc
REYATAZ 400 mg once daily + lamivudine + zidovudinee
64 weeksc
efavirenz 600 mg once daily + lamivudine + zidovudinee
120 weeksc,d
REYATAZ 400 mg once daily + stavudine + lamivudine or didanosine
73 weeksc,d
nelfinavir750 mg TID or 1250 mg BID + stavudine + lamivudine or didanosine
(n=404) (n=401) (n=279) (n=191)
Body as a Whole
  Headache 6% 6% 1% 2%
Digestive System
  Nausea 14% 12% 6% 4%
  Jaundice/scleral icterus 7% * 7% *
  Vomiting 4% 7% 3% 3%
  Abdominal pain 4% 4% 4% 2%
  Diarrhea 1% 2% 3% 16%
Nervous System
  Insomnia 3% 3% <1% *
  Dizziness 2% 7% <1% *
  Peripheral neurologic symptoms <1% 1% 4% 3%
Skin and Appendages
  Rash 7% 10% 5% 1%
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on regimens containing REYATAZ.
c Median time on therapy.
d Includes long-term follow-up.
e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.

Adverse Reactions In Treatment-Experienced Adult Patients

The safety profile of REYATAZ in treatment-experienced adults is based on 119 HIV-1 infected patients in clinical trials.

The most common adverse reactions are jaundice/scleral icterus and myalgia.

Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-experienced patients receiving REYATAZ/ritonavir are presented in Table 9.

Table 9: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Experienced Patients,b Study AI424-045

  48 weeksc
REYATAZ/ritonavir 300/100 mg once daily + tenofovir DF + NRTI
(n=119)
48 weeksc
lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir DF + NRTI
(n=118)
Body as a Whole
  Fever 2% *
Digestive System
  Jaundice/scleral icterus 9% *
  Diarrhea 3% 11%
  Nausea 3% 2%
Nervous System
  Depression 2% <1%
Musculoskeletal System
  Myalgia 4% *
* None reported in this treatment arm.
a Includes events of possible, probable, certain, or unknown relationship to treatment regimen.
b Based on the regimen containing REYATAZ.
c Median time on therapy.
d As a fixed-dose combination.

Laboratory Abnormalities In Treatment-Naive Patients

The percentages of adult treatment-naive patients treated with combination therapy including REYATAZ 300 mg with ritonavir 100 mg and REYATAZ 400 mg (without ritonavir) with Grade 3-4 laboratory abnormalities are presented in Tables 10 and 11, respectively.

Table 10: Grade 3-4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Naive Patients,a Study AI424-138

Variable Limitd 96 weeksb
REYATAZ 300 mg with ritonavir 100 mg (once daily) and tenofovir DF with emtricitabinec
96 weeksb lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir DF with emtricitabinec
(n=441) (n=437)
Chemistry High    
  SGOT/AST ≥5.1 x ULN 3% 1%
  SGPT/ALT ≥5.1 x ULN 3% 2%
  Total Bilirubin ≥2.6 x ULN 44% <1%
  Lipase ≥2.1 x ULN 2% 2%
  Creatine Kinase ≥5.1 x ULN 8% 7%
  Total Cholesterolf ≥240 mg/dL 11% 25%
Hematology Low    
  Neutrophils <750 cells/mm3 5% 2%
a Based on the regimen containing REYATAZ.
b Median time on therapy.
c As a fixed-dose combination: 300 mg tenofovir DF, 200 mg emtricitabine once daily.
d ULN = upper limit of normal.

Table 11: Grade 3-4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Naive Patients, a Studies AI424-034, AI424-007, and AI424-008

Variable Limitd Study AI424-034 Studies AI424-007, -008
64 weeksb
REYATAZ 400 mg once daily + lamivudine + zidovudinee
64 weeksb
efavirenz 600 mg once daily + lamivudine + zidovudinee
120 weeksb,c
REYATAZ 400 mgonce daily + stavudine + lamivudine or + stavudine + didanosine
73 weeksb,c
nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine
Variable Limitd (n=404) (n=401) (n=279) (n=191)
Chemistry High        
  SGOT/AST ≥5.1 x ULN 2% 2% 2% 5%
  SGPT/ALT ≥5.1 x ULN 4% 3% 9% 7%
  Total Bilirubin ≥2.6 x ULN 35% <1% 47% 3%
  Amylase ≥2.1 x ULN * * 14% 10%
  Lipase ≥2.1 x ULN <1% 1% 4% 5%
  Creatine Kinase ≥5.1 x ULN 6% 6% 11% 9%
  Total Cholesterolf ≥240 mg/dL 6% 24% 19% 48%
  Triglycerides ≥751 mg/dL <1% <1% 4% 2%
Hematology Low        
  Hemoglobin <8.0 g/dL 5% 3% <1% 4%
  Neutrophils <750 cells/mm3 7% 9% 3% 7%
* None reported in this treatment arm.
a Based on regimen(s) containing REYATAZ.
b Median time on therapy.
c Includes long-term follow-up.
d ULN = upper limit of normal.
e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily

Change in Lipids from Baseline in Treatment-Naive Patients

For Study AI424-138 and Study AI424-034, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Tables 12 and 13, respectively.

Table 12: Lipid Values, Mean Change from Baseline, Study AI424-138

    REYATAZ/ritonavira,b opinavir/ritonavirb,c
Baseline Week 48 Week 96 Baseline Week 48 Week 96
mg/dL
(n=428e)
mg/dL
(n=372e)
Changed (n=372e) mg/dL
(n=342e)
Changed (n=342e) mg/dL
(n=424e)
mg/dL
(n=335e)
Changed
(n=335e)
mg/dL
(n=291e)
Changed
(n=291e)
LDL-Cholesterolf 92 105 +14% 105 +14% 93 111 +19% 110 +17%
HDL-Cholesterolf 37 46 +29% 44 +21% 36 48 +37% 46  
Total Cholesterolf 149 169 +13% 169 +13% 150 187 +25% 186 +25%
Triglyceridesf 126 145 +15% 140 +13% 129 194 +52% 184 +50%
a REYATAZ 300 mg with ritonavir 100 mg once daily with the fixed-dose combination: 300 mg tenofovir DF, 200 mg emtricitabine once daily.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 1% in the lopinavir/ritonavir treatment arm and 1% in the REYATAZ/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 8% in the lopinavir/ritonavir treatment arm and 2% in the REYATAZ/ritonavir arm. Through Week 96, serum lipid-reducing agents were used in 10% in the lopinavir/ritonavir treatment arm and 3% in the REYATAZ/ritonavir arm.
c Lopinavir 400 mg with ritonavir 100 mg twice daily with the fixed-dose combination 300 mg tenofovir DF, 200 mg emtricitabine once daily.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 or Week 96 values and is not a simple difference of the baseline and Week 48 or Week 96 mean values, respectively.
e Number of patients with LDL-cholesterol measured.
f Fasting.

Table 13: Lipid Values, Mean Change from Baseline, Study AI424-034

  REYATAZa,b favirenzb,c
Baseline mg/dL
(n=383e)
Week 48 mg/dL
(n=283e)
Week 48 Changed
(n=272e)
Baseline mg/dL
(n=378e)
Week 48 mg/dL
(n=264e)
Week 48 Changed
(n=253e)
LDL-Cholesterolf 98 98 +1% 98 114 +18%
HDL-Cholesterol 39 43 +13% 38 46 +24%
Total Cholesterol 164 168 +2% 162 195 +21%
Triglyceridesf 138 124 - 9% 129 168 +23%
a REYATAZ 400 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 0% in the efavirenz treatment arm and <1% in the REYATAZ arm. Through Week 48, serum lipid-reducing agents were used in 3% in the efavirenz treatment arm and 1% in the REYATAZ arm.
Efavirenz 600 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values.
e Number of patients with LDL-cholesterol measured.
f Fasting.

Laboratory Abnormalities In Treatment-Experienced Patients

The percentages of adult treatment-experienced patients treated with combination therapy including REYATAZ/ritonavir with Grade 3-4 laboratory abnormalities are presented in Table 14.

Table 14: Grade 3-4 Laboratory Abnormalities Reported in ≥2% of Adult Treatment-Experienced Patients, Study AI424-045a

Variable Limitc 48 weeksb
REYATAZ/ritonavir 300/100 mg once daily + tenofovir DF + NRTI
48 weeksb 400/100 mg twice dailyd +lopinavir/ritonavir tenofovir DF + NRTI
(n=119) (n=118)
Chemistry High    
  SGOT/AST ≥5.1 x ULN 3% 3%
  SGPT/ALT ≥5.1 x ULN 4% 3%
  Total Bilirubin ≥2.6 x ULN 49% <1%
  Lipase ≥2.1 x ULN 5% 6%
  Creatine Kinase ≥5.1 x ULN 8% 8%
  Total Cholesterolf ≥240 mg/dL 25% 26%
  Triglycerides ≥751 mg/dL 8% 12%
  Glucose ≥251 mg/dL 5% <1%
Hematology Low    
  Platelets <50,000 cells/mm3 2% 3%
  Neutrophils <750 cells/mm3 7% 8%
a Based on regimen(s) containing REYATAZ.
b Median time on therapy.
c ULN = upper limit of normal.
d As a fixed-dose combination.

Change in Lipids from Baseline in Treatment-Experienced Patients

For Study AI424-045, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Table 15. The observed magnitude of dyslipidemia was less with REYATAZ/ritonavir than with lopinavir/ritonavir. However, the clinical impact of such findings has not been demonstrated.

Table 15: Lipid Values, Mean Change from Baseline, Study AI424-045

  REYATAZ/ritonavira,b lopinavir/ritonavirb,c
Baseline mg/dL
(n=111e)
Week 48 mg/dL
(n=75e)
Week 48 Changed
(n=74e)
Baseline mg/dL
(n=108e)
Week 48 mg/dL
(n=76e)
Week 48 Changed
(n=73e)
LDL-Cholesterolf 108 98 - 10% 104 104 +1%
HDL-Cholesterol 40 39 39 39 41 39
Total Cholesterol 188 170 - 8% 181 187 +6%
Triglyceridesf 215 161 161 196 224 224
a REYATAZ 300 mg once daily + ritonavir + tenofovir DF + 1 NRTI.
b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 4% in the lopinavir/ritonavir treatment arm and 4% in the REYATAZ/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 19% in the lopinavir/ritonavir treatment arm and 8% in the REYATAZ/ritonavir arm.
c Lopinavir/ritonavir (400/100 mg) BID + tenofovir DF + 1 NRTI.
d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values.,br /> e Number of patients with LDL-cholesterol measured.
f Fasting.

Adverse Reactions In Pediatric Patients

REYATAZ Capsules

The safety and tolerability of REYATAZ Capsules with and without ritonavir have been established in pediatric patients at least 6 years of age from the open-label, multicenter clinical trial PACTG 1020A.

The safety profile of REYATAZ in pediatric patients (6 to less than 18 years of age) taking the capsule formulation was generally similar to that observed in clinical studies of REYATAZ in adults. The most common Grade 2-4 adverse events (≥ 5%, regardless of causality) reported in pediatric patients were cough (21%), fever (18%), jaundice/scleral icterus (15%), rash (14%), vomiting (12%), diarrhea (9%), headache (8%), peripheral edema (7%), extremity pain (6%), nasal congestion (6%), oropharyngeal pain (6%), wheezing (6%), and rhinorrhea (6%). Asymptomatic second-degree atrioventricular block was reported in <2% of patients. The most common Grade 3-4 laboratory abnormalities occurring in pediatric patients taking the capsule formulation were elevation of total bilirubin (≥3.2 mg/dL, 58%), neutropenia (9%), and hypoglycemia (4%). All other Grade 3-4 laboratory abnormalities occurred with a frequency of less than 3%.

Adverse Reactions In Pediatric Patients

REYATAZ Oral Powder

The data described below reflect exposure to REYATAZ oral powder in 155 subjects weighing at least 5 kg to less than 35 kg, including 134 patients exposed for 48 weeks. These data are from two pooled open-label, multi-center clinical trials in treatment-naive and treatment-experienced pediatric patients (AI424-397 [PRINCE I] and AI424-451 [PRINCE II]). Age ranged from 3 months to 10 years of age. In these studies 51% were female and 49% were male. All patients received ritonavir and 2 nucleoside reverse transcriptase inhibitors (NRTIs).

The safety profile of REYATAZ in pediatric patients taking REYATAZ oral powder was generally similar to that observed in clinical studies of REYATAZ in pediatric patients taking REYATAZ capsules. The most common Grade 3-4 laboratory abnormalities occurring in pediatric patients weighing 5 kg to less than 35 kg taking REYATAZ oral powder were increased amylase (33%), neutropenia (9%), increased SGPT/ALT (9%), elevation of total bilirubin (≥ 2.6 timesx ULN, 16%), and increased lipase (8%). All other Grade 3-4 laboratory abnormalities occurred with a frequency of less than 3%.

Adverse Reactions In Patients Co-Infected With Hepatitis B And/Or Hepatitis C Virus

In Study AI424-138, 60 patients treated with REYATAZ/ritonavir 300 mg/100 mg once daily, and 51 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, each with fixed dose tenofovir DF-emtricitabine, were seropositive for hepatitis B and/or C at study entry. ALT levels >5 timesx ULN developed in 10% (6/60) of the REYATAZ/ritonavir-treated patients and 8% (4/50) of the lopinavir/ritonavir-treated patients. AST levels >5 timesx ULN developed in 10% (6/60) of the REYATAZ/ritonavir-treated patients and none (0/50) of the lopinavir/ritonavir-treated patients.

In Study AI424-045, 20 patients treated with REYATAZ/ritonavir 300 mg/100 mg once daily, and 18 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, were seropositive for hepatitis B and/or C at study entry. ALT levels >5 timesx ULN developed in 25% (5/20) of the REYATAZ/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients. AST levels >5 timesx ULN developed in 10% (2/20) of the REYATAZ/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients.

In Studies AI424-008 and AI424-034, 74 patients treated with 400 mg of REYATAZ once daily, 58 who received efavirenz, and 12 who received nelfinavir were seropositive for hepatitis B and/or C at study entry. ALT levels >5 timesx ULN developed in 15% of the REYATAZ-treated patients, 14% of the efavirenz-treated patients, and 17% of the nelfinavir-treated patients. AST levels >5 timesx ULN developed in 9% of the REYATAZ-treated patients, 5% of the efavirenz-treated patients, and 17% of the nelfinavir-treated patients. Within REYATAZ and control regimens, no difference in frequency of bilirubin elevations was noted between seropositive and seronegative patients [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following events have been identified during postmarketing use of REYATAZ. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: edema

Cardiovascular System: second-degree AV block, third-degree AV block, left bundle branch block, QTc prolongation [see WARNINGS AND PRECAUTIONS]

Gastrointestinal System: pancreatitis

Hepatic System: hepatic function abnormalities

Hepatobiliary Disorders: cholelithiasis [see WARNINGS AND PRECAUTIONS], cholecystitis, cholestasis

Metabolic System and Nutrition Disorders: diabetes mellitus, hyperglycemia [see WARNINGS AND PRECAUTIONS]

Musculoskeletal System: arthralgia

Renal System: nephrolithiasis [see WARNINGS AND PRECAUTIONS], interstitial nephritis, granulomatous interstitial nephritis, chronic kidney disease [see WARNINGS AND PRECAUTIONS]

Skin and Appendages: alopecia, maculopapular rash [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], pruritus, angioedema

Read the entire FDA prescribing information for Reyataz (Atazanavir Sulfate)

Related Resources for Reyataz

Read the Reyataz User Reviews »

© Reyataz Patient Information is supplied by Cerner Multum, Inc. and Reyataz Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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