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JUPITER. J ustification for the U se of statins in P rimary prevention: an I ntervention T rial E valuating R osuvastatin. Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).

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jupiter

JUPITER

Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin

Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter2
JUPITER
  • JUPITER is the first large-scale, prospective study to examine the role of statin therapy in individuals with low to normal LDL-C levels, but with increased cardiovascular risk identified by elevated CRP
  • It assessed the long-term impact of rosuvastatin (CRESTOR™) in individuals potentially at increased cardiovascular (CV) risk due to elevated CRP levels who do not qualify for lipid-lowering treatment according to current guidelines

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter rationale
JUPITER - Rationale
  • Nearly half of all cardiovascular events occur in patients who are apparently healthy and who have low or normal levels of LDL-C
  • hsCRP predicts cardiovascular disease independent of LDL-C levels
  • Along with improved screening there is a need to examine the use of lipid-lowering agents as a method of reducing the risk of cardiovascular events

Ridker PM. New Engl J Med 2002; 347: 1557–1565

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

prevalence of conventional risk factors in male patients with chd
Prevalence of conventional risk factors† in male patients with CHD

Four (0.9%)

Three

None

8.9%

19.4%

Two

27.8%

43.0%

One

Total male patients=87 869CHD=coronary heart disease

†smoking, hypertension, hypercholesterolaemia and diabetes mellitus

Khot UN et al. JAMA 2003; 290: 898–904.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

slide5

8

7

6

5

4

3

2

1

0

CRP Epidemiology

CRP levels in the US, NHANES 1999-2000

Men

Women

33.3

Percentile

50

66.7

CRP, mg/L

30-39

40-49

50-59

60-69

70-79

80+

30-39

40-49

50-59

60-69

70+

Age (yrs)

Age (yrs)

Ford ES, Giles WH, Myers GL, Mannino DM. Clin Chem 2003; 49(4):686-90.

Ford ES, Giles WH, Mokdad AH, Myers GL. Clin Chem 2004; 50(3):574-81.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

crp contributes to all stages of atherosclerosis
CRP contributes to all stages of atherosclerosis

Roles

of CRP

  • Endothelial
  • Dysfunction
  •  Vasodilation
  • NO
  • Endothelial
  • activation
  • Monocyte

adhesion

  • Endothelial

progenitor cells

  • Plaque
  • progression
  • Monocyte

migration

  • VSMC

proliferation

  • Plaque Rupture
  • /Thrombosis
  • Capthinning
  • TF secretion

 Fibrinolysis

Progression of atherosclerosis

NO: Nitric oxide, VSMC: Vascular Smooth Muscle Cell, TF: Tissue factor

Bisoendial RJ, Kastelein JJP, Stroes ESG. Atherosclerosis 2007; 195:e10-18

Packard RRS, Libby P. Clin Chem 2008; 54:24-38

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

crp is a stronger predictor of future events compared with other markers in women

Lp(a)

Homocysteine

IL-6

TC

LDL-C

sICAM-1

SAA

ApoB

TC/HDL-C

CRP

CRP + TC/HDL-C

1.0

2.0

4.0

6.0

0

Relative risk of future cardiovascular events

CRP is a stronger predictor of future events compared with other markers in women

CRP=C-reactive protein; Lp(a)=lipoprotein (a); IL=interleukin; TC=total cholesterol; LDL-C=low-density lipoprotein cholesterol; sICAM-1=soluble intercellular adhesion molecule 1; SAA=serum amyloid A; Apo=apolipoprotein; HDL-C=high-density lipoprotein cholesterol

Blake GJ, Ridker PM. Circ Res 2001; 89: 763–771.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

crp predicts risk of mi and stroke in apparently healthy men
CRP predicts risk of MI and stroke in apparently healthy men

*

3.5

2.0

***

3.0

1.5

2.5

Relativerisk of ischaemicstroke

Relative risk of MI

2.0

1.0

1.5

1.0

0.5

0.5

0

0

1

2

3

4

1

2

3

4

Quartile of CRP

Quartile of CRP

CRP=C-reactive protein; MI=myocardial infarction*p=0.03 vs quartile 1; ***p<0.001 vs quartile 1

Ridker PM et al. N Engl J Med 1997; 336: 973–979.

Quartile 1: ≤ 0.55 ; Quartile 2: ≤ 0.56-1.14;

Quartile 3: 1.15-2.10 ; Quartile 4:  2.11.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

rate of cardiovascular events in women in relation to ldl c and crp
Rate of cardiovascular events in women in relation to LDL-C and CRP

100

10

CRP (mg/L)

1

0.1

1.3

2.6

3.9

5.2

6.5

LDL-C (mmol/L)

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive proteinRidker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

cardiovascular event free survival in women using combined ldl c and crp measurements
Cardiovascular event-free survival in women using combined LDL-C and CRP measurements

1.00

Low LDL-C, low CRP

0.99

Probability of event-free survival

High LDL-C, low CRP

0.98

Low LDL-C, high CRP

0.97

High LDL-C, high CRP

0.96

0

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive proteinMedian LDL-C=3.2 mmol/L (124 mg/dL)

Median CRP=1.5 mg/LRidker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

ldl c and crp as markers of cardiovascular events the afcaps texcaps study
LDL-C and CRP as markers of cardiovascular events – the AFCAPS/TexCAPS study

Median LDL-C=3.9 mmol/L (149 mg/dL). Median CRP=1.6 mg/L

LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; NNT=number needed to treat to prevent one coronary event; na=not applicable.

Ridker PM et al. N Engl J Med 2001; 344: 1959–1965.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

crp is a strong independent predictor of future cv events
CRP is a strong independent predictor of future CV events
  • CRP is a strong independent predictor of cardiovascular events1
  • Addition of CRP to the Framingham algorithm improves global cardiovascular risk prediction2
  • CRP and LDL-C are complementary biomarkers for identifying at-risk individuals3

1. Ridker PM. JACC 2007;49:2129-38.

2. Ridker PM. JAMA 2007;297:611-9.

3. Ridker PM et al. N Engl J Med 2002; 347: 1557–1565.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter objective
JUPITER - Objective
  • The primary objective was to investigate whether long-term treatment with rosuvastatin 20 mg decreases the rate of first major cardiovascular events compared with placebo in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated CRP levels

Ridker PM. Circulation 2003; 108: 2292–2297

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter study design
JUPITER – study design

No history of CAD

men ≥50 yrs

women ≥60 yrs

LDL-C <3.36 mmol/L

CRP ≥2.0 mg/L

Rosuvastatin 20 mg (n~8900)

Placebo

run-in

Placebo (n~8900)

Visit:Week:

1–6

2–4

30

413

Final3–4 y

6-month

intervals

Lead-in/eligibility

Randomisation

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

HbA1C

CAD=coronary artery disease; LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; HbA1c=glycated haemoglobin

Ridker PM. Circulation 2003; 108: 2292–2297. Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter study endpoints
JUPITER - Study Endpoints
  • Primary Endpoint
    • Time to the first occurrence of a major cardiovascular event, composite of:
      • cardiovascular death
      • Stroke
      • MI
      • unstable angina
      • arterial revascularisation
  • Secondary Endpoints:
    • total mortality
    • non-cardiovascular mortality
    • development of diabetes mellitus
    • development of venous thromboembolic events
    • bone fractures
    • discontinuation of study medication due to adverse effects.

Ridker PM. Circulation 2003; 108: 2292–2297

jupiter study design16
JUPITER – study design

No history of CAD

men ≥50 yrs

women ≥60 yrs

LDL-C <3.36 mmol/L

CRP ≥2.0 mg/L

Rosuvastatin 20 mg (n~8900)

Placebo

run-in

Placebo (n~8900)

Visit:Week:

1–6

2–4

30

413

Final3–4 y

6-month

intervals

Lead-in/eligibility

Randomisation

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

Lipids

CRP

Tolerability

HbA1C

CAD=coronary artery disease; LDL-C=low-density lipoprotein cholesterol; CRP=C-reactive protein; HbA1c=glycated haemoglobin

Ridker PM. Circulation 2003; 108: 2292–2297. Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter study endpoints17
JUPITER – study endpoints
  • Primary
    • time to the first occurrence of a major cardiovascular event (cardiovascular death, stroke, MI, unstable angina or arterial revascularisation)
  • Secondary
    • Efficacy (incident diabetes mellitus, venous thromboembolic events, bone fractures)
    • Safety (total mortality noncardiovascular mortality, adverse events)

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

major inclusion criteria
Major inclusion criteria
  • Men aged ≥50 years; women aged ≥60 years
  • Fasting LDL-C levels 3.36 mmol/L, CRP levels ≥2.0 mg/L and TG levels 5.65 mmol/L on initial screening

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

major exclusion criteria
Major exclusion criteria
  • Current use of statinsor other lipid-lowering therapies
  • Prior history of cardiovascular or cerebrovascular events, such as MI, unstable angina, prior arterial revascularisation or stroke, or CHD-risk equivalents
  • Chronic inflammatory condition, such as severe arthritis, lupus or inflammatory bowel disease
  • CK 3 x ULN

MI=myocardial infarction; CHD=coronary heart disease; ULN=upper limit of normal

Ridker PM. Circulation 2003; 108: 2292–2297.

Ridker PM. Am J Cardiol 2007; 100: 1659–1664.

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter major exclusion criteria
JUPITER - Major exclusion criteria
  • Current use of statinsor other lipid-lowering therapies
  • Current use of hormone replacement therapy
  • Prior history of cardiovascular or cerebrovascular events, such as MI, unstable angina, prior arterial revascularisation or stroke, or CHD-risk equivalents
  • Chronic inflammatory condition, such as severe arthritis, lupus or inflammatory bowel disease and/or treatment with immunosuppressants
  • Uncontrolled:
    • hypertension: SBP > 190 mmHg or DBP > 100 mmHg
    • hypothyroidism: TSH > 1.5 x ULN
  • CK 3 x ULN
  • Serum creatinine > 2.0 mg/dL
  • Evidence of hepatic dysfunction (ALT > 2 x ULN)
  • History of prior malignancy, alcohol or drug abuse

Ridker PM. Circulation 2003; 108: 2292–2297

CHD = coronary heart disease; CK = creatinine kinase; ULN = upper limit of normal; SBP = systolic blood pressure; DBP = diastolic blood pressure

Ridker P et al. N Eng J Med 2008;359: 2195-2207

jupiter patient flow
JUPITER - PatientFlow

89,890 subjects screened

17,802 randomized

Rosuvastatin 20mg

n=8,901

Placebo

n=8,901

Lost to follow up

n=44

Lost to follow up

n=37

Completed study

n=8,857

Completed study

n=8,864

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

slide22

JUPITER - Baseline characteristics*

Rosuvastatin Placebo n=8901 n=8901

Age (years) 66 (60-71) 66 (60-71)

Male sex (%) 61.5 62.1

Race (%)

White 71.4 71.1

Black 12.4 12.6

Hispanic 12.6 12.8

Other 3.6 3.5

BMI (kg/m2)28.3 (25.3-32.0) 28.4 (25.3-32.0)

Systolic BP (mmHg) 134 (124-145) 134 (124-145)

Diastolic BP (mmHg) 80 (75-87) 80 (75-87)

*All values are median (interquartile range) or N (%).

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

slide23

JUPITER - Baseline laboratory parameters*

Rosuvastatin Placebo n=8901 n=8901

Total cholesterol (mg/dL) 4.81 (4.34-5.17) 4.78 (4.37-5.15)

LDL cholesterol (mg/dL) 2.69 (2.43-3.08) 2.69 (2.43-3.08)

HDL cholesterol (mg/dL) 1.27 (1.03-1.55) 1.27 (1.03-1.55)

Triglycerides (mg/dL) 1.33 (0.96-1.91) 1.33 (0.97-1.90)

hsCRP (mg/L) 4.2 (2.8-7.1) 4.3 (2.8-7.2)

Glucose(mg/dL)94 (87-102) 94 (88-102)

HbA1c(%) 5.7 (5.4-5.9) 5.7 (5.5-5.9)

Glomerular filtration rate,

(ml/min/1.73m2) 73.3 (64.6-83.7) 73.6 (64.6-84.1)

For hsCRP, values are the average of the values obtained at two screening and visits

*All values are median (interquartile range) or N (%).

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

slide24

JUPITER - Medical History

Medical HistoryRosuvastatin Placebo n=8901 n=8901

Current smoker (%) 15.7 16.0

Family history CHD†(%) 11.2 11.8

Metabolic syndrome‡(%) 41.0 41.8

Aspirin use (%) 16.6 16.6

†Family history of premature CHD defined as first degree relative with CHD at age < 55 yrs (male), < 65 yrs (female); ‡ Metabolic syndrome defined according to consensus criteria of AHA/NHLBI

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter population compared with previous trials in patients without established chd
JUPITER population compared with previous trials in patients without established CHD

CVD=cardiovascular disease; CHD=coronary heart disease; LDL-C=low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; hsCRP=high sensitivity C-reactive protein; *Baseline lipid levels are mean values.

Ridker PM et al. Am J Cardiol 2007; 100: 1659–1664

Ridker PM et al. N Engl J Med. 2001 344: 1959-65

slide26

JUPITER - Primary EndpointTime to first occurrence of a CV death, non-fatal stroke, non-fatalMI, unstable angina or arterial revascularization

9

Hazard Ratio 0.56

(95% CI 0.46-0.69)

P<0.00001

Placebo

8

7

6

5

Rosuvastatin 20 mg

Percent of patients with

primary endpoint

4

3

NNT for 2y = 95

5y* = 25

2

1

0

0

1

2

3

4

5

Years

Number at risk

RSV 8901 8412 3893 1353 538 157

Placebo 8901 8353 3872 1333 531 174

Ridker P et al. N Eng J Med 2008;359: 2195-2207

*Extrapolated figure based on Altman and Andersen method

jupiter primary endpoint components
JUPITER - Primary Endpoint Components
          • Placebo Rosuvastatin HR 95% CI p-value [n=8901][n=8901]
  • n (rate**) n (rate**)

Primary Endpoint 251 (1.36) 142 (0.77) 0.56 0.46-0.69 <0.001*

(Time to first occurrence of CV death, MI, stroke, unstable angina, arterial revascularisation)

Non-fatal MI 62 (0.33) 22 (0.12) 0.35 0.22-0.58 <0.001*

Fatal or non-fatal MI 68 (0.37) 31 (0.17) 0.46 0.30-0.70 0.0002

Non-fatal stroke 58 (0.31) 30 (0.16) 0.52 0.33-0.80 0.003

Fatal or non-fatal stroke 64 (0.34) 33 (0.18) 0.52 0.34-0.79 0.002

Arterial Revascularization 131 (0.71) 71 (0.38) 0.54 0.41-0.72 <0.0001

Unstable angina† 27 (0.14) 16 (0.09) 0.59 0.32-1.10 0.09

CV death, stroke, MI 157 (0.85) 83 (0.45) 0.53 0.40-0.69 <0.001*

Revascularization

or unstable angina 143 (0.77) 76 (0.41) 0.53 0.40-0.70 <0.001*

** Rates are per 100 person years;† Hospitalisation due to unstable angina; *Actual p-value was < 0.00001

HR – Hazard Ratio; CI – Confidence Limit

Ridker P et al. N Eng J Med 2008;359: 2195-2207

jupiter subgroup analysis
JUPITER – Subgroup analysis

Placebo better

Rosuvastatin better

0.8

0.4

0.2

1.2

0.6

0

1

Hazard ratio (95% CI)

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter total mortality death from any cause
JUPITER - Total MortalityDeath from any cause

Hazard Ratio 0.80

(95% CI 0.67-0.97)

p=0.02

7

Placebo

6

5

Rosuvastatin 20mg

Percent total mortality

4

3

2

1

0

0

1

2

3

4

5

Years

Number at risk

RSV 8901 8787 4312 1602 676 227

Placebo 8901 8775 4319 1614 681 246

Ridker P et al. N Eng J Med 2008;359: 2195-2207

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

slide30
JUPITER Effects on LDL-C, HDL-C, TG and hsCRP at 12 months;Percentage change between rosuvastatin and placebo

10

LDL-C

HDL-C

TG

hsCRP

4%

0

p<0.001*

-10

17%

-20

Percentage change from baseline (%)

p<0.001

-30

37%

-40

p<0.001

50%

-50

p<0.001

-60

Ridker P et al. N Eng J Med 2008;359: 2195-2207

*P-value at study completion (48 months) = 0.34

For complete therapeutic and safety information please consult the CRESTOR® Product Monograph.

jupiter tolerability and safety data
JUPITERTolerability and safety data

Placebo Rosuvastatin p-value [n=8901][n=8901]

  • Adverse Events, (%)
  • Any serious adverse event 15.5 15.2 0.60
  • Muscle weakness, stiffness, pain 15.4 16.0 0.34
  • Myopathy 0.1 0.1 0.82
  • Rhabdomyolysis 0.0 <0.1* ----
    • Newly diagnosed cancer 3.5 3.4 0.51
    • Death from cancer 0.7 0.4 0.02
    • Gastrointestinal disorders 19.2 19.7 0.43
    • Renal disorders 5.4 6.0 0.08
    • Bleeding 3.1 2.9 0.45
    • Hepatic disorders 2.1 2.4 0.13
  • Other events, (%)
    • Newly diagnosed diabetes** 2.4 3.0 0.01
    • Haemorrhagic stroke 0.1 0.1 0.44

*Occurred after trial completion; **physician reported newly diagnosed diabetes

Ridker P et al. N Eng J Med 2008;359: 2195-2207

jupiter laboratory safety data
JUPITERLaboratory Safety Data

Placebo Rosuvastatin p-value [n=8901][n=8901]

  • Laboratory Values, N (%)
  • Serum creatinine‡ 10 (0.10) 16 (0.20) 0.24
    • ALT > 3 x ULN# 17 (0.20) 23 (0.30) 0.34
  • Glycosuria† 32 (0.40) 36 (0.50) 0.64
  • Laboratory Values, median values (IQR)
  • GFR*, (mL/min/1.73m2) 66.6 (58.8-76.2) 66.8 (59.1-76.5) 0.02
  • % HbA1c** 5.8 (5.6-6.1) 5.9 (5.7-6.1) 0.001
  • Fasting plasma glucose**, (mg/dL) 98 (90-106) 98 (91-107) 0.12

GFR = Glomerular filtration rate, HbA1c = Haemoglobin A1c

# on consecutive visits, ‡ >100% increase from baseline,*at 12 months, **at 24 months, †>trace at 12 months

Ridker P et al. N Eng J Med 2008;359: 2195-2207

jupiter summary and perspectives
JUPITER – summary and perspectives
  • The JUPITER study included patients with low to normal LDL-C who were at increased CV risk as identified by elevated CRP levels and who did not require statin treatment based on current treatment guidelines
  • A 44% reduction in the primary endpoint of major cardiovascular events (composite of: CV death, MI, stroke, unstable angina, arterial revascularisation) was observed in patients who received rosuvastatin 20 mg compared with placebo (p< 0.00001)
  • A 20% reduction in total mortality was observed in patients who received rosuvastatin 20 mg compared with placebo (p=0.02), a unique finding for statins in a population without established CHD
  • In JUPITER, long-term treatment with rosuvastatin 20 mg was well tolerated in nearly 9000 study participants
  • There was no difference between treatment groups for muscle weakness, cancer, haematological disorders, gastrointestinal, hepatic or renal systems
  • The results from JUPITER highlight the importance of highly effective statin treatment for these patients with an increased risk of CV disease

Ridker P et al. N Eng J Med 2008;359: 2195-2207

acknowledgements
Acknowledgements
  • The JUPITER Steering Committee
    • P Ridker (Chairman), Boston, MA, USA
    • A Gotto, New York, NY, USA
    • P Libby, Boston, MA, USA
    • J Willerson, Houston, TX, USA
    • J Genest, Montreal, Canada
  • The JUPITER Independent Data Monitoring Board
  • The JUPITER investigators and participating patients
  • This study is supported by AstraZeneca
slide35

DISCLAIMER

  • This slide presentation may include evolving scientific information that has not been reviewed and approved by Health Canada. These slides are intended for educational purposes only.
  • AstraZeneca Canada Inc. does not recommend the use of CRESTOR® in any other indication than as described in the Canadian Product Monograph.
  • INDICATIONS AND CLINICAL USES
  • CRESTOR® (rosuvastatin calcium) is indicated as an adjunct to diet, at least equivalent to the Adult Treatment Panel III (ATP III TLC diet), for the reduction of elevated total cholesterol (Total-C), LDL-C, Apo-B, Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL-C; in hyperlipidemic and dyslipidemic conditions, when response to diet and exercise alone has been inadequate including:
    • Primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia and severe non-familial hypercholesterolemia)
    • Combined (mixed) dyslipidemia (Type IIb)
    • Homozygous familial hypercholesterolemia where CRESTOR ® is used either alone or as an adjunct to diet and other lipid lowering treatment such as apheresis
  • Rosuvastatin is not indicated for the treatment of patients with high C-Reactive Protein (CRP).
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