Zero risk for central line-associated bloodstream

Zero risk for central line-associated bloodstream infection: Are we there yet?* Mary-Louise McLaws, MPH, PhD; Anthony R. Burrell, MB, BS Objective: Identify the longest period a central line remains free from central line-associated bloodstream infection during an 18-month insertion-bundle project. Design: Prospective cohort. Setting: New South Wales adult intensive care units at university teaching hospitals between July 2007 and December 2008. Patients: Intensive care unit adult patients whose central line was inserted in the intensive care unit. Intervention: Compliance with the insertion bundle for central lines during the first 12-month roll-out period and the last 6 months. Main Outcomes: The cumulative line days that remained close to infection-free before the lowest probability of central lineassociated bloodstream infection, 1 in 100 chances, was identified using conditional probability modeling. An adjusted central line-associated bloodstream infection rate was calculated for these cumulated line days and thereafter where the probability for infection increased with additional dwell time. Results: The lowest probability identified for central line-associated bloodstream infection was 1 in 100 chances regardless of the phase of the project or central line type. During the first 12 months of the project, the close to infection-free period finished by the end of day 7 giving an adjusted central line-associated

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entral line-associated bloodstream infections (CLABSIs) are among the top four sites for healthcare-associated infections and the most costly (1). High CLABSI rates are not uncommon in Australia: 3.7 (95% confidence interval [CI] 2.5–5.3)/1,000 line days from pooled data from seven teaching intensive care units

*See also p. 657. From the School of Public Health and Community Medicine (MLM), the University of New South Wales, Sydney, and the Clinical Excellence Commission (MLM, ARB), Intensive Care Coordination and Monitoring Unit, New South Wales Department of Health, New South Wales, Australia. Supported, in part, by the New South Wales Health Department. The authors have not disclosed any potential conflicts of interest. For information regarding this article, E-mail: [email protected] Copyright © 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins DOI: 10.1097/CCM.0b013e318232e4f3

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bloodstream infection rate of 1.8 (95% confidence interval 0.9 – 3.3)/1000 line days. By the last 6 months of the project the close to infection-free period was extended by 2 additional line days to the end of day 9, giving an adjusted central line-associated bloodstream infection rate of 0.9 (95% confidence interval 0.5– 1.5)/1,000 line days. For dialysis and unspecified central line types, the close to infection-free period was extended by 5 additional line days, from day 2 with a rate of 4.3 (95% confidence interval 0.9 –12.5)/1,000 line days to day 7, giving a rate of 0.6 (95% confidence interval 0.2–2.4)/1,000 line days. Conclusion: The success of the insertion bundle was identified by improved analysis that identified that the safest dwell time was extended to the first 9 days for centrally inserted lines and up to day 7 for dialysis, peripherally inserted central catheters, and unspecified central line types. Given that three quarters of intensive care unit patients have their central line removed by day 7, zero risk for central line-associated bloodstream infection should be achievable in the majority of patients where clinicians comply with the clinician and patient insertion bundles. (Crit Care Med 2012; 40:388 –393) KEY WORDS: bloodstream infection rate; central line dwell time; patient safety; risk free

(ICUs) for the period 1998 –2000 (2), and 6.4 (95% CI 5.6 –7.2)/1,000 line days from pooled data from 13 teaching hospitals during 2002–2004 (3). The most recent mean rates in adult teaching ICUs in the United States that contribute to the National Healthcare Safety Network Report system range from 1.2 to 5.6/1,000 line days, and median rates range from 1.2 to 3.8/1,000 line days (4). Surveillance systems were in place in these ICUs (1– 4) but surveillance alone does not necessarily result in sustained, low CLABSI rates. As such, CLABSI has gained international attention, with stakeholders agreeing that with judicious clinical practice the risk for CLABSI should be zero (5). Multiple prevention strategies have been successful in reducing CLABSI (6), ranging from improved technology of the device (7–10), which are expensive but appropriate for extended exposure to central venous lines (CVLs) (6), to inexpensive aseptic insertion (11–13), early removal

of lines (14, 15), and postinsertion care (16). Strategies that have included the insertion bundle have resulted in CLABSI rates coming close to but not entirely achieving or sustaining zero risk (11–13, 17, 18). Similarly, our statewide intervention of insertion bundles in 34 Australian public teaching ICUs achieved a significant reduction in the aggregated CLABSI rate, from 3.0 to 1.2 per 1000 line days, but did not reach zero risk at anytime during the 18-month project (19). Guidelines (14, 15) include the importance of a short catheter dwell time based on two studies (20, 21), although neither illustrated a direct link between judicious removal of lines and reduced CLABSI. Yet the advice is logical – the shorter the dwell time the lower the risk for CLABSI. Previously, surveillance data (2) were analyzed for risk of CLABSI by dwell time and found the longest dwell time associated with the closest zero risk for CLABSI was the first 5 line days, when the probCrit Care Med 2012 Vol. 40, No. 2

ability of infection was ⬍1 in 100 (22). Additional dwell time of up 15 days increased the probability of CLABSI to 6 in 100 (22). Based on the logic that a longer dwell time is associated with CLABSI (14, 15), and evidence that the first 5 line days has the closest zero risk for infection (22) without intervention, time to CLABSI should therefore be the end point when examining the impact of the prevention strategies. In this paper we report the impact of an insertion bundle on the “infection-free” dwell time. Details of our statewide insertion-bundle intervention are reported elsewhere (19).

METHODS Thirty-seven public ICUs in New South Wales (NSW) public hospitals (ten tertiary university teaching and 25 nontertiary units that included 12 metropolitan, 13 rural, and two pediatric) were invited to participate in the statewide intervention between July 2007 and December 2008. The intervention was a collaborative between the Clinical Excellence Commission (an independent government organization promoting safety and quality in health care) and the NSW Intensive Care Coordination and Monitoring Unit. The Clinical Ethics Branch of the NSW Health Department considered the intervention to be a quality improvement activity that did not require ethics approval. Only university teaching (tertiary) ICUs in accordance with the NSW Department of Health role delineation classification (23) of health facilities are reported in this paper.

Intervention Senior intensive care clinicians in collaboration with the Clinical Excellence Commission and Intensive Care Coordination and Monitoring Unit developed a guideline for the aseptic insertion of CVLs in public hospital ICUs. The guideline was based on supporting evidence that CLABSI is causally related to insertion technique, and that compliance with hand hygiene, skin preparation, and full barrier precautions is essential (11–15). There was no other focus on CVLs in any of the ICUs in NSW during the collaborative intervention, such as rapid removal of CVLs or a specific focus on postinsertion CVL management. Detailed methodology of the intervention is available at: http://www.cec.health.nsw.gov.au/ files/clab-icu/publications/final-report.pdf, and elsewhere (19). A checklist (24) was developed to support compliance behavior with the guideline and was divided into patient and clinician bundles: Patient Bundle 1) Prepare procedure site with 2% alcoholic chlorhexidine

Crit Care Med 2012 Vol. 40, No. 2

2) Fully drape patient with sterile sheet 3) Check central line position by radiograph and/or transducer Clinician Bundle 4) 5) 6) 7)

Scrub hands at least 2 mins Wear hat, mask, and eyewear Don sterile gloves and gown Maintain sterile technique

Before the intervention there was no uniform requirement across NSW ICUs to practice any other bundle item or a postinsertion management protocol, resulting in a wide variation in practice. The intervention required standardized preparation and practice: physicians were to prepare for CVL insertion in accordance with the clinician and patient bundles, use a pre-prepared trolley outfitted with equipment required for aseptic insertion, and where possible, have an assistant. Compliance with each element of the clinician and patient bundles was recorded by clinicians or assistants on completion of CVL insertion. The checklist was completed for CVLs inserted in patients who had been admitted to the ICU for ⱖ24 hrs. To be considered compliant with a bundle, each element of the bundle was to be checked at the time of insertion as having been complied. If one or more element of a bundle was not checked, then clinician was categorized as noncompliant. A detailed analysis of compliance with every element of the two bundles is reported elsewhere (19). The checklist also included: insertion and removal date of each CVL to calculate total number of catheter line days; insertion site (jugular, subclavian, femoral, cubital fossa); type of line classified into centrally inserted lines and other (peripherally inserted central catheters and dialysis); a standardized surveillance definition of CLABSI (Appendix); complications (multiple passes, hematoma, and pneumothorax); and ICU discharge date. Only central lines that terminated at or close to the heart or in one of the great vessels (for full description see the Centers for Disease Control and Prevention definitions [4]) were included in this study. It is usual practice in NSW ICUs that noncoated catheters are routinely inserted. The intervention continued for 18 months.

Outcome Measurements Only CVLs inserted in the ICU were included in the analysis. Data were collected to calculate: 1) the distribution of catheter dwell time; 2) a conventional rate of CLABSI for centrally inserted lines and other central lines; and 3) identification of the line day where the reduction of risk of CLABSI was significant. Data collected for the first 12 months were compared with data collected for the last 6 months of the intervention. The definition of

central line days was the catheter dwell time from insertion to removal while in the ICU, or date of discharge from the ICU, whichever came first. Any CLABSI manifesting within 24 hrs after discharge from ICU was included in the dataset. While this follow-up period fell short of the 48-hr definition (4), a 24-hr follow-up period was chosen as the cut point due to lack of human resources to follow all patients discharged to the ward. Where the catheter dwell time was ⬎30 days, the ICU was contacted to check the data for accuracy. There were insufficient peripherally inserted central catheters to establish reliable CLABSI rates or perform probability estimates for infection-free days for peripherally inserted central catheters alone. Lines were classified as “centrally inserted” and “other” (dialysis, peripherally inserted central catheter, and unknown).

Conventional CLABSI Rate Calculations The distribution of CLABSI data, referred to statistically as “count data,” will always be overdispersed due to CLABSI being statistically uncommon. Therefore, a priori to the intervention, the distribution was expected not to provide a reliable estimation of infection rates. The first 12-month period of the intervention was considered a roll-out period for individual ICUs, leaving the last 6-month period as the comparison period to establish effect of the intervention. The first 12 months, July 2007 to June 2008, was required to allow the guideline, checklist, and required resources to be accepted and adhered to during this run-in period. Central and “other” line types were examined for catheter dwell time by quartiles. The data for type of lines inserted and dwell time by quartiles did not differ (with the exception of the 75th quartile for “other” lines), supporting the rationale that these important confounders in the first 12-month run-in period did not alter during the last 6-month comparative period.

Adjusted CLABSI Rate Calculations Analysis for infection-free days using probability estimates was stratified for centrally inserted and other central line types. Single line days were entered and the cumulative infected proportion where a change in the probability for infection was reported as percentage chance of a CLABSI. Because the change in the risk probability for CLABSI occurs after several catheter days, the risk is presented by a stratum of catheter days. The dwell time in catheter days that would contribute to a stratum was identified as the dwell time with the greatest increase in the proba-

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Table 1. Distribution of line days and conventional central line-associated bloodstream infection rates

Intervention Period by Line Type Central lines 1–12 months 13–18 months Other lines 1–12 months 13–18 months

Total Lines Inserted 关CLABSI/Total Line Days兴

Range Line Days

Removal Day Adjusted for Catheter Dwell Time, 25th, 50th, 75th Percentiles

Conventional CLABSI Rate/1000 Line Days (95% Confidence Interval) 关CLABSI/Total Line Days兴

1316 关27/7, 176兴 2850 关26/16, 100兴

1–58 1–96

2, 4, 7 2, 4, 7

3.8 (2.5–5.5) 1.6 (1.0–2.4)

.002

466 关7/1, 805兴 1035 关5/4, 126兴

1–96 1–248

2, 4, 7 2, 5, 29

3.9 (1.6–8.0) 1.2 (0.4–2.8)

.05

Difference Over Time p (␹2)

CLABSI, central line-associated bloodstream infection.

ply by the last quarter compared with the first quarter of the project. Compliance with the patient bundle improved by 17.7 percentage points between the first quarter and the last quarter, from 74.1% to 91.8% (p ⬍ .0001, chi-squared ⫽ 252.68), by which time clinicians being 3.94 times more likely to comply.

Conventional CLABSI Rate

Figure 1. Quarterly compliance rates.

bility for CLABSI. Each catheter dwell-time stratum includes only those catheter days that contributed to that stratum. This censoring allows calculation of an adjusted rate for each catheter dwell-time stratum. For example, catheters inserted for 12–13 days will not contribute 13 days to the 12–13 line-day stratum. Rather, 9 days will be contributed to the 1–9 line-day stratum, 2 days to the 10 –11 line-day stratum, and 2 line days to the 12–13 line-day stratum, thereby correctly contributing a total 13 line days to the intervention. The usual format for presenting probability estimates for an event in a curve does not inform readers of the correctly adjusted line day rates for each stratum where the risk of CLABSI increases. Therefore, in addition to the curve, analysis of infection-free risk of CLABSI by dwell-time strata and adjusted CLABSI rates per 1000 catheter days by strata are presented in table format. For full methodology of adjusted line days see (22). Exact test was used for estimating 95% CI around the rate since CLABSI is a statistically rare outcome. Fisher’s exact test was used to estimate significance with ␣ set at the 5% level. SPSS (version 15; SPSS, Chicago, IL) was used to establish infection-free days by Kaplan-Meier probability estimates and Bernoulli trials. The model examining conditional probabilities for the occurrence of CLABSI and

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adjusted CLABSI rates are presented in tabular format rather than the traditional graphic format to illustrate the frequent change in risk of CLABSI and assist readers to identify the lineday stratum that has the smallest probability of CLABSI and observe the adjusted line day rate. EpiInfo (version 6.04b; Centers for Disease Control and Prevention, Atlanta, GA) software was used to determine the distribution of line days and relative risk estimates.

RESULTS Distribution of Line Days One quarter of all centrally inserted lines had a dwell time of up to 2 days, half were removed by the end of day 4, and the majority, 75%, were removed by day 7 (Table 1).

Compliance With Bundles Compliance with the clinician bundle improved by 28.9 percentage points, from 61% to 90% (p ⬍ .0001, chi-squared ⫽ 354.38) between the first quarter of the first roll-out period to the last quarter of the intervention period (Fig. 1). Clinicians were 1.5 times more likely to com-

CLABSI was significantly reduced (relative risk ⫽ 0.43, 95% CI 0.25– 0.74; p ⫽ .002, chi-squared ⫽ 10.08) in centrally inserted lines, from 3.8 (95% CI 2.5–5.5)/ 1000 unadjusted line days in the first 12 months to 1.6 (95% CI 1.0 –2.4)/1000 line days by the last 6 months of the intervention (Table 1). CLABSI associated with other central line types were also significantly less likely (relative risk ⫽ 0.31, 95% CI 0.10 – 0.98; p ⫽ .05) by the last 6 months of the intervention, where the CLABSI rate was 1.2 (95% CI 0.4 –2.8)/ 1000 unadjusted line days.

Dwell Time From Insertion to CLABSI Centrally Inserted Lines. Evidence of an increased probability for CLABSI is illustrated in the adjusted rates from estimated probabilities model (Table 2, Fig. 2), which unlike conventional calculations, adjusts rates for catheters that are removed. Even after the intervention, there was no catheter dwell time identified as being entirely zero risk for CLABSI (i.e., 0% or 0 in 100 chance). The safest dwell time was the lowest cumulative probability of CLABSI, 1 in 100 chance, for a cumulative catheter dwell time of 7 days during the first 12 months, giving an adjusted CLABSI rate of 1.8/1000 line days. By the last 6 months of the intervention, the lowest probability of 1 in 100 for CLABSI occurred after a cumulative Crit Care Med 2012 Vol. 40, No. 2

Table 2. Analysis for the probability of infection-free line-days and adjusted risk rate for centrally inserted central line associated bloodstream infection First 12-Months Intervention Period

Last 6-Months Intervention Period

Cumulative Proportion for Catheter Adjusted Rate CLABSI/1000 Cumulative Proportion for Catheter Adjusted Rate CLABSI/1000 Infection-Free Days at Dwell-Time Line-Days (95% CI) Infection-Free Days at Dwell-Time Line-Days (95% CI) End of Each Line-Day Stratum Strata [CLABSI/Adjusted Line-Days] End of Each Line-Day Stratum Strata [CLABSI/Adjusted Line-Days] 0.99 0.98 0.97 0.96 0.94 0.93 0.92 0.89 0.86 0.68 0.68 Total unadjusted CLABSI rate (95% CI)

1–7 8 9 10 11 12 13 14–15 16–20 21–28 ⱖ29

1.8 (0.9–3.3) [10/5487] 2.8 (0.0–15.7) [1/352] 15.1 (4.1–38.3) [4/264] 5.1 (0.0–27.5) [1/197] 24.5 (6.7–61.6) [4/163] 7.5 (0.2–41.2) [1/133] 18.3 (2.2–64.7) [2/109] 9.1 (1.1–32.4) [2/220] 3.0 (0.0–16.5) [1/336] 2.7 (0.0–15.2) [1/363] 0.0 (0.0–75.5) [0/47] 3.8 (2.5–5.5) [27/7176]

0.99 0.98 0.97 0.96 0.95 0.94 0.93 0.92 0.89 0.87 0.87 Total unadjusted CLABSI rate

Figure 2. Probability of infection-free days for central venous lines (CVLs) inserted in teaching hospital intensive care units. CLABSI, central line-associated bloodstream infection.

dwell time of 9 days. This dwell time had a 50% reduction (relative risk ⫽ 0.50) in the CLABSI rate (0.9/1000 line days) compared with the rate calculated for the 1 in 100 chance dwell-time stratum during the first 12 months (Table 2). A probability of 3 in 100 chances of CLABSI occurred for a catheter dwell time of 9 days in the first 12 months while this probability occurred after a dwell time of 13 days in the last 6 months, giving 4 additional days before this probability occurred. Other Central Line Types. During the first 12 months, the lowest probability for CLABSI, 1 in 100, occurred for a dwell time of 2 days, and by the last 6 months of the intervention the safest dwell time occurred at day 5 (Table 3, Fig. 3). During Crit Care Med 2012 Vol. 40, No. 2

the first 12 months, a cumulative probability of 6 in 100 for CLABSI occurred by the end of day 9 and remained steady for the remaining dwell time. During the last 6 months, the same level of probability for CLABSI, 6 in 100, was extended by 9 line days to day 18.

DISCUSSION The rate of CLABSI in centrally inserted central lines in ICUs across NSW in the 12 months before the insertion bundle intervention was 3.8 (95% CI2.5– 5.5)/1,000 line days, which was similar to the rates in the previous decade (19). By the end of our 18-month project, the mean CLABSI rate reduced to 1.6 (95% CI 1.0 –2.4)/1,000 line days, which was

1–9 10–11 12–13 — 14 15–16 — 17–20 — 21–30 ⱖ31

0.9 (0.5–1.5) [12/13551] 5.9 (1.9–13.7) [5/845] 4.1 (0.5–14.6) [2/491] — 22.3 (6.1–56.2) [4/179] 3.9 (0.0–21.5) [1/257] — 3.3 (0.0–18.2) [1/304] — 3.2 (0.0–17.7) [1/312] 0.0 (0.0–22.6) [0/161] 1.6 (1.0–2.4) [26/16100]

similar to that achieved by Pronovost et al (12). Our rate may be underestimated given that we only followed-up patients discharged from the ICU for the first 24 hrs. However, given that the 50th and 75th percentiles for dwell times were the same or similar in the pre- and postintervention periods, both periods should be comparable. More notable than the impact on the aggregate rate is the close to zero-risk dwell time; the insertion bundle extended the dwell time closest to zero risk to the first 9 days. The insertion bundle has achieved markedly reduced CLABSI in other ICUs, but none have reported a zero risk for infection (11–13, 17, 18, 25–28). The difference between our results and those who believed they were unable to obtain an infection-free dwell time was in the different analytical approach. We used estimated probabilities for CLABSI at different dwell times to identify the dwell time that was closest to being infection-free, ⬍1 in 100 chance of infection, thereby revealing the full impact of aseptic insertion technique. A study undertaken outside the ICU using the insertion bundle strategy that did not reduce CLABSI had a median catheter dwell time of 14 days (28). One reason for their inability to reduce CLABSI may be that their dwell time was double the dwell time of the majority of our CVLs and is 50% longer than our safest near infection-free dwell time of up to 9 days. The nature of the short, acute stay in the ICU suits the basic preventive premise of the insertion bundle: that aseptic insertion will have an enduring effect for up to 9 days but not for a protracted period. 391

Table 3 Analysis for the probability of infection-free line-days and adjusted risk rate for other line types associated bloodstream infection First 12-Months Intervention Period

Last 6-Months Intervention Period

Cumulative Proportion for Catheter Adjusted Rate CLABSI/1000 Cumulative Proportion for Catheter Adjusted Rate CLABSI/1000 Infection-Free Days at Dwell-Time Line-Days (95% CI) Infection-Free days at Dwell-Time Line-Days (95% CI) End of Each Line-Day Stratum Strata [CLABSI/Adjusted Line-Days] End of Each Line-Day Stratum Strata [CLABSI/Adjusted Line-Days] 0.998 0.98 0.94 0.94

1–2 3–8 9 ⱖ10

Total Unadjusted CLABSI rate (95% CI)

4.3 (0.9–12.5) [3/697] 3.7 (0.8–10.8) [3/805] 17.2 (0.4–92.4) [1/58] 0.0 (0.0–14.9) [0/245] 3.9 (1.6–8.0) [7/1805]

0.998 0.98 0.94 0.94 0.47 0.47 Total Unadjusted CLABSI rate (95% CI)

1–7 8–10 11–18

0.6 (0.0–2.4) [2/3063] 2.8 (0.0–15.6) [1/355] 3.0 (0.0–16.6) [1/334]

19–43 ⱖ44

5.9 (0.0–32.5) [1/169] 0.0 (0.0–17.8) [0/205] 1.2 (0.4–2.8) [5/4126]

infection remain with noninsertion factors, principally postinsertion line care.

REFERENCES

Figure 3. Probability of infection-free days for other line types inserted in teaching hospital intensive care units.

Our analysis for the safest dwell time has implications for analysis of surveillance data. Our probability estimates identified that conventional aggregation of different dwell times used to establish CLABSI/1000 line days is simplistic. Short dwell times do not carry the same risk of CLABSI as prolonged dwell times. Hence, aggregating dwell times will not discriminate low-risk from high-risk lines; 75% of our patients had a catheter dwell time of ⱕ7 days and had the lowest risk of CLABSI, while the minority of our patients had longer dwell times and the highest risk of CLABSI. In the future, a threshold rate for CLABSI should be set at zero for the 75% of catheters with a dwell time of 1–9 days. This would require removing data (for the minority of patients who provide an excessive dwell time of ⬎8 days) from surveillance or examining this high-risk group separately. Essentially, our study has shown that the first 8 –9 catheter days post insertion have the closest to zero risk for CLABSI, suggesting aseptic insertion has effectively made CLABSI a rare event for the majority of centrally inserted lines that 392

are removed by day 9. Clinicians should, however, be mindful that by extending the catheter dwell time past day 12, the probability of CLABSI will rise to 3 in 100. Coated lines, such as chlorhexidine gluconate-silver sulfadiazine (7, 8), are costly but appropriate for acute healthcare settings having difficulty achieving a zero rate for CLABSI in the first 9 days despite institutionalizing preventive practices, and antibiotic locks (9) and novel locks for hemodialysis catheters (10) are appropriate for patients who are expected to have an extended CVL exposure (11). It is rare for NSW ICUs to use antimicrobial-coated lines but prevention strategies that include technology may potentially be cost effective for patients expected to have a catheter dwell time past day 13.

ACKNOWLEDGMENTS We thank all those staff in ICUs in NSW who participated willingly in this project and congratulate them on the results. This achievement has made it easier to identify that the residual risks for

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APPENDIX The standardized definition of CLABSI was as follows: ● The cultured organism is not related to infection at another site and ● The presence of a recognized pathogen cultured from one or more blood cultures; or ● The presence of fever (⬎38°C), chills, or rigors; or hypotension within 24 hrs of a positive blood culture being collected and at least one of the following: ● Isolation of the same potential contaminant from two or more blood cultures drawn on separate occasions within a 48-hr period (isolates identified by suitable microbiological techniques); ● Isolation of a potential contaminant from a single blood culture drawn from a patient with an intravascular line (within 48 hrs of the episode) and appropriate antimicrobial therapy against that isolate is commenced.

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