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Assuring Adequate Treatment for Persons Diagnosed With Gonorrhea in New York State

Currenti, Salvatore MPH∗,†; Muse, Alison MPH; Qian, Feng MD, PhD, MBA; Bomma, Srikanth MS; Peravali, Sushma MS

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doi: 10.1097/OLQ.0000000000001241
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Neisseria gonorrhoeae is the bacterium responsible for gonorrhea that remains a major public health concern worldwide. National data published by the Centers for Disease Control and Prevention (CDC) stated that there were greater than 555,000 gonorrhea diagnoses reported in 2017, representing an 18.6% increase from the previous year and up 75.2% since an unprecedented low in 2009.1 In New York State (NYS) excluding New York City (NYC), the number of laboratory-confirmed gonorrhea diagnoses reported in 2017 was 10,620 representing a 6.0% increase from 2016 (unpublished data from the NYS Department of Health). Over time, N. gonorrhoeae has adapted and exhibited resistance to a wide range of antibiotics,2,3 which may lead to increased gonorrhea transmission due to persistent infection, increased risk of HIV acquisition, and hundreds of millions of dollars in direct medical care costs.4 The CDC continuously modifies recommendations for the treatment of gonorrhea to mitigate antibiotic resistance, with guidance that has evolved from the recommendation of select monotherapies, to increased dosages, and most recently in 2015, dual therapy with differing antibiotic classes.5–13 Prevention of the emergence of antibiotic resistance depends on a comprehensive approach including secondary public health prevention efforts. Effective treatment for those diagnosed with gonorrhea per the most current CDC treatment guidelines is crucial.

New York State Public Health Law §602(b) mandates that county-run local health departments (LHDs) assure treatment for persons diagnosed with sexually transmitted diseases (STDs),14 and LHDs work closely with health care providers (HCPs) to ensure adequate treatment for persons diagnosed with gonorrhea. In NYS, the Department of Health (NYSDOH) General Public Health Work program allows the Commissioner of Health to establish standards for the delivery of core public health services and to provide additional funding to LHDs that meet or exceed performance standards. A financially based performance incentive (PI) was developed for LHDs in NYS to improve adherence to federally recommended gonorrhea treatment guidelines. Studies have evaluated the effect of economic incentives on health care delivery, and the main findings showed that primary motivations are often dictated by professional norms; however, financial incentives may serve as a motivating factor.15–17 In this study, our objectives are 3-fold: (1) to detail how the PI program was implemented in NYS, (2) to report and evaluate the real-world effectiveness of the PI program, and (3) to explain our findings based on empirical data and our previous experiences and knowledge.

MATERIALS AND METHODS

In this study, we conducted a nonrandomized pre/post design observational study to describe, evaluate, and investigate an LHD-level intervention that included financial incentives, supplemented by education, data monitoring, and technical assistance (TA) to improve adherence to CDC guidelines for the treatment of uncomplicated gonorrhea in NYS. All LHDs in NYC were included in the study except for those in New York City because the city has its own surveillance system. The study therefore included 57 county-run LHDs. All data were collected from November 2013 to May 2017, and LHDs were offered financial incentives during 2 phases.

Surveillance

In NYS, reporting of suspected or confirmed communicable diseases by all testing HCPs and laboratories is mandated under the Sanitary Code (10NYCRR 2.10). The Electronic Clinical Laboratory Reporting System provides laboratories that serve NYS with a single electronic system for secure transmission of reportable disease information to the NYSDOH and LHDs. Laboratories that confirm gonorrhea diagnoses, most often by nucleic acid amplification test and/or culture, report electronically through Electronic Clinical Laboratory Reporting System and clinical results are routed to LHDs based on the county of patient residence. Each electronic report consists of patient identifiers, locating information, ordering provider, reporting laboratory, test type, and result, and triggers automatic generation of a gonorrhea case report in the NYS Communicable Disease Electronic Surveillance System (CDESS), a web-based secure surveillance system. Determination of uncomplicated gonorrhea infection was made by the LHD through provider follow-up and assessment of the electronic report. The CDESS reports were deduplicated by NYSDOH to ensure there was only one per patient when multiple positive test results were reported within 30 days from initial diagnosis. Multiple reports for the same patient outside the 30-day window were therefore included as separate events. For this analysis, CDESS served as the source of data, and only uncomplicated gonorrhea diagnoses among persons 12 years or older were included. Presumptive diagnoses without laboratory confirmation were excluded.

Treatment Verification

Treatment details are not submitted through electronic reporting; however, HCPs may contact LHDs directly to report a diagnosis of gonorrhea and to communicate treatment information. When a patient is presumed to be untreated, LHDs work to assure treatment through 3 methods: (1) contacting the HCP listed on the laboratory report and requesting treatment information, (2) determining a plan for adequate treatment with the HCP when the patient is to return to the provider’s office, and (3) coordinating with the patient directly to seek treatment at the LHD clinic or subcontracted HCP. If patients are treated with a nonrecommended regimen, LHDs will try to coordinate retreatment through the HCP, and when not possible, LHDs will recommend a future test-of-cure to detect therapeutic failure. When patients are not expected to return to the diagnosing HCP, the LHD will attempt to coordinate with the patient directly for re-treatment at the LHD clinic or subcontracted facility. Although not required in NYS, LHDs may follow-up with the patient’s pharmacy or access medical record systems to ensure medication was received by the patient.

Implementation and PI Details

LHDs were invited to attend a web conference that detailed the upcoming PI measure, and all expectations were explained. Local health departments were expected to complete gonorrhea case reports in CDESS and asked to record all treatment information, and if inadequately treated or untreated, the primary reason (see Table 1 for a description of all accepted reasons). The NYSDOH project coordinator explained to LHDs that on a monthly basis, cumulative summary reports would be generated, comparing LHD performance across the state. Summary reports contained the total number of diagnoses and the percentages of adequate, inadequate, and missing treatment.

TABLE 1 - Definition of the Primary Reasons for Inadequate or Missing Treatment for Persons Diagnosed With Gonorrhea
Reasons Definition
Patient lost to follow-up Unable to locate patient to assure treatment
Patient refused Refusal of treatment or retreatment per CDC recommendations
Patient allergy Allergic to any recommended regimen
Non-NYS or NYC provider LHD unable to confirm treatment or facilitate retreatment
HCP education and treatment unchanged* LHD was unable to facilitate retreatment for inadequately treated patients and subsequently the LHD educated the provider’s office using the most current CDC recommendations
No same-day treatment Recommended regimen was provided but not administered on the same day
Negative test-of-cure LHD obtained a negative test result after initial diagnosis and treatment with a nonrecommended regimen
Clinical trial Patient participating in a clinical trial
Regimen not recommended Patient treated with a nonrecommended regimen and no evidence of HCP education
Not treated Patient untreated at the time of surveillance report closure
*A reason for inadequate or missing treatment to be selected on the electronic case report form used in NYS. This reason accounted for the practical complexities encountered by both LHDs and HCPs when LHDs were striving to achieve effective patient treatment for gonorrhea based on the newest CDC recommendations at the time of treatment.

The Pre-PI, November 2013 through May 2014, served as the control. During this phase, we measured adherence to any recommended treatment regimen per the 2012 CDC guidance. During PI One, November 2014 through May 2015, the goal was 90% adherence to any recommended treatment regimen per the 2012 CDC guidance. Adequate treatment for the Pre-PI and PI One was defined as follows: a single intramuscular (IM) dose of ceftriaxone 250 mg or a single oral dose of cefixime 400 mg plus a single oral dose of azithromycin 1 g or doxycycline 100 mg twice daily for 7 days; or if the patient had a cephalosporin allergy, then a single oral dose of azithromycin 2 g. We required dual therapy with recommended antibiotics to be administered at a maximum of 2 days apart from each other. Performance measurements for PI Two (November 2015 through May 2016) and Post-PI (November 2016 through May 2017) were based on the updated CDC treatment guidelines published in June 2015.8 For PI Two, we set a primary goal of 90% adherence to any recommended regimen and a secondary goal of 85% adherence first-line therapy. Adequate treatment for PI Two and Post-PI was defined as follows: a single oral dose of azithromycin 1 g plus either a single IM dose of ceftriaxone 250 mg or a single oral dose of cefixime 400 mg plus; or if the patient had a cephalosporin allergy, then a single oral dose of azithromycin 2 g plus either a single oral dose of gemifloxacin 320 mg or a single IM dose of gentamicin 240 mg. Adequate first-line therapy was defined as a single IM dose of ceftriaxone 250 mg and a single oral dose of azithromycin 1 g administered on the same day. Performance incentive phases were conducted in 7-month blocks for administrative reasons.

During each PI phase, the NYSDOH project coordinator, an epidemiologist, reviewed all performance reports and routinely provided TA to LHDs that did not meet performance measures on monthly review. This included sending a line list of persons who were inadequately treated or untreated to LHDs privately. The TA included encouraging LHDs to follow-up with HCPs to promote retreatment and/or education of the CDC guidelines, improving data accuracy and completeness, and documenting the primary reason for inadequate or missing treatment. After the end of each PI phase, LHDs were allowed a 3-month follow-up period to address surveillance data and assure patient treatment per guidelines. Review and follow-up with LHDs continued to occur during the Post-PI.

Financial Structure

The financial incentives received for this program was designated for LHDs only and not HCPs. For LHDs with a county population of ≥300,000 (10 counties), $300,000 was available. For LHDs with a population between ≥75,000 and <300,000 (22 counties), $450,000 was available. Lastly, for LHDs with a county population of <75,000 (25 counties), $250,000 was available. The amount of each performance award was based on the number of LHDs within each population size category that met the treatment adherence goal. When the minimum treatment adherence goal was not met, the LHD did not receive an award. New York State DOH required LHDs to use awarded funds in one or more of the following ways: to increase their annual base funding for NYS-mandated core public health activities, for new initiatives, or for needed equipment. Presentation of results and notification of awards was conducted at a statewide conference attended by public health leaders from all NYS LHDs 2 months after the follow-up period ended.

Statistical Analyses

We applied a descriptive analysis to report the treatment adequacy according to CDC guidelines across all time frames (Pre-PI, PI One, PI Two, and Post-PI). Then we conducted a subgroup descriptive analysis by county population size (≥300,000, >75,000–<300,000, and ≤75,000) and by volume of diagnoses during the study period (≥1000, ≥100–<1000, and <100). We conducted χ2 tests using SAS 9.4 (SAS Institute Inc., Cary, NC) to evaluate the association between treatment adequacy and all 4 time frames (Pre-PI, PI One, PI Two, Post-PI). Missing treatment accounted for a small proportion (≤4%) of all observations and were excluded from analyses. We used a 2-sided α level of 0.05 for statistical tests.

RESULTS

Financial Awards

A total of 53 (93.0%) of 57 counties received a financial award. The breakdown by county population size was as follows: 90.0% (9/10) of counties with ≥300,000 persons received a $30,000 award; 91.0% (20/22) of counties with ≥75,000–<300,000 persons received a $20,900 award; and 96.0% (24/25) of counties with <75,000 persons received a $13,000 award.

Principle Findings

As shown in Table 2, we observed an upward trend in treatment adequacy over time (Pre-PI: 82%; PI One 92.1%; PI Two 90.4%; Post-PI 90.5%). For PI Two, we conducted a subanalysis to evaluate the secondary goal, adherence to first-line therapy, and 85.0% (4289/5045) of all persons diagnosed with gonorrhea received same-day therapy. The association between treatment adequacy and time frame was significant (P < 0.0001). We also detected a significant association between treatment adequacy and county population size (≥300,000, >75,000–<300,000, and ≤75,000) and the findings are summarized in Table 3. A statistically significant association was also found between treatment adequacy and the total number of gonorrhea diagnoses (≥1000, ≥100–<1000, <100) reported by LHDs during the study period and is summarized in Table 4.

TABLE 2 - Treatment and Data Summary During Each PI Time Frame for All LHDs
Treatment Pre-PI, % PI One, % PI Two, % Post-PI, %
Adequate 2732 (82.0) 4216 (92.1) 4563 (90.4) 5285 (90.5)
Inadequate 476 (14.3) 261 (5.7) 380 (7.5) 412 (7.1)
Missing 125 (3.5) 103 (2.2) 102 (2.0) 141 (2.4)
Total 3333 4580 5045 5838
Number (and percentage) of persons diagnosed with uncomplicated gonorrhea infection that were treated per CDC guidelines during 4 separate time frames. Adequate treatment for the Pre-PI and PI One is based on the 2012 CDC guidelines. For PI Two and Post-PI, adequate treatment is based on the 2015 CDC guidelines. A statistically significant association was found (χ2 (3, N = 18326) = 226.36, P < 0.0001).

TABLE 3 - Treatment and Data Summary During Each PI Time Frame, by LHD County Population Size
Treatment County Population ≥300,000 County Population >75,000–<300,000 County Population ≤75,000
Pre-PI PI One PI Two Post-PI Pre-PI PI One PI Two Post-PI Pre-PI PI One PI Two Post-PI
Adequate, % 2230 (82.2) 3268 (91.9) 3609 (90.5) 3963 (91.0) 426 (82.1) 811 (92.6) 814 (90.8) 1138 (89.5) 76 (76.0) 137 (91.3) 140 (88.0) 186 (86.9)
Inadequate, % 376 (13.8) 195 (5.5) 303 (7.6) 281 (6.5) 78 (15.0) 53 (6.0) 61 (6.8) 104 (8.2) 22 (22.0) 13 (8.7) 16 (10.1) 26 (12.2)
Missing, % 108 (4.0) 91 (2.6) 77 (1.9) 109 (2.5) 15 (2.9) 12 (1.4) 22 (2.4) 29 (2.3) 2 (2.0) 0 (0.0) 3 (1.9) 2 (0.9)
Total 2714 3554 3989 4353 519 876 897 1271 100 150 159 214
Number (and percentage) of persons diagnosed with uncomplicated gonorrhea infection that were treated per CDC guidelines during 4 separate time frames, categorized by county population size. Adequate treatment for the Pre-PI and PI One is based on the 2012 CDC guidelines. For PI Two and Post-PI, adequate treatment is based on the 2015 CDC guidelines. Statistical analyses were significant for all county population subgroups (≥300,000: χ2 [3, n = 14,225] = 181.28, P < 0.0001; >75,000–<300,000: χ2 [3, n = 3485] = 40.44, P < 0.0001; ≤75,000: χ2 [3, n = 616] = 11.61, P = 0.0088).

TABLE 4 - Treatment and Data Summary During Each PI Phase, by Total Number of LHD Reported Gonorrhea Diagnoses
Treatment LHD Diagnoses ≥1000 LHD Diagnoses ≥100–999 LHD Diagnoses <100
Pre-PI PI One PI Two Post-PI Pre-PI PI One PI Two Post-PI Pre-PI PI One PI Two Post-PI
Adequate, % 1941 (82.9) 2798 (92.0) 3303 (91.0) 3371 (91.5) 654 (79.9) 1207 (92.5) 1021 (88.9) 1608 (89.3) 137 (79.2) 211 (89.8) 239 (89.5) 308 (87.3)
Inadequate, % 316 (13.5) 163 (5.4) 266 (7.3) 233 (6.3) 127 (15.5) 77 (5.9) 90 (7.8) 138 (7.7) 33 (19.1) 21 (8.9) 24 (9.0) 40 (11.3)
Missing, % 84 (3.6) 79 (2.6) 60 (1.7) 81 (2.2) 38 (4.6) 21 (1.6) 38 (3.3) 54 (3.0) 3 (1.7) 3 (1.3) 4 (1.5) 5 (1.4)
Total 2341 3040 3629 3685 819 1305 1149 1800 173 235 267 353
Number (and percentage) of persons diagnosed with uncomplicated gonorrhea infection that were treated per CDC guidelines during 4 separate time frames, categorized by the total number of gonorrhea diagnoses reported by LHDs during all 4 PI periods. Adequate treatment for the Pre-PI and PI One is based on the 2012 CDC guidelines. For PI Two and Post-PI, adequate treatment is based on the 2015 CDC guidelines. Statistical analyses were significant for all diagnoses subgroups (≥1000: χ2 [3, n = 12,391] = 150.11, P < 0.0001; ≥100–<1000: χ2 [3, n = 4922] = 69.33, P < 0.0001; <100: χ2 [3, n = 1013] = 13.11, P = 0.0044).

Reason(s) for Inadequate or Missing Treatment Information

In PI One, a primary reason for inadequate or missing treatment was documented for 62.1% (226/364) of diagnosed persons. The most common reason was patient was lost to follow-up, selected in 53.5% (121/226), followed by HCP education and treatment unchanged at 15.1% (34/226), and patient refusal at 12.4% (28/226). In PI Two, a primary reason was selected for 53.0% (401/756) of diagnosed persons. The most common reason was HCP education and treatment unchanged at 38.2% (153/401), and then patient lost to follow-up at 21.5% (86/401). During the Post-PI period, a primary reason was selected for 63.1% (361/572) of diagnosed persons. The top reason was patient was lost to follow-up at 22.2% (80/361), and then HCP education and treatment unchanged at 19.9% (72/361). All reasons selected for inadequately or untreated diagnosed persons during PI One, PI Two, and Post-PI are presented in Table 5.

TABLE 5 - Primary Reasons for Inadequate or Missing Treatment Among Persons Diagnosed With Gonorrhea During Each PI Time Frame*
Reasons PI One, % PI Two, % Post-PI, %
Patient lost to follow-up 121 (53.5) 86 (21.5) 80 (22.2)
Patient refused 28 (12.4) 21 (5.2) 19 (5.3)
Patient allergy 15 (6.6) 51 (12.7) 18 (5.0)
Non-NYS or NYC provider 6 (2.7) 17 (4.2) 11 (3.0)
HCP education and treatment unchanged 34 (15.1) 153 (38.2) 72 (19.9)
No same-day treatment 1 (0.4) 17 (4.2) 50 (13.8)
Negative test-of-cure 1 (0.4) 12 (3.0) 25 (6.9)
Regimen not recommended 20 (8.9) 34 (8.5) 50 (13.8)
Not treated 0 (0.0) 10 (2.5) 36 (10.0)
Clinical trial 0 (0.0) 0 (0.0) 0 (0.0)
Total 226 401 361
Number (and percentage) of persons diagnosed with uncomplicated gonorrhea infection that were inadequately treated per CDC guidelines or untreated and the primary reasons selected by LHDs during 3 separate time frames.
*Primary reasons were not collected during the Pre-PI.

DISCUSSION

During the PI, public health intervention by NYSDOH improved LHD adherence to federally recommended gonorrhea treatment guidelines. Overall, the implementation of the PI led to an initial increase in treatment adequacy, from the Pre-PI (82.0%) to PI One (92.1%) and PI Two (90.4%) and was sustained after the incentive period ended (Post-PI; 90.5%). We consistently found a statistically significant association between treatment adequacy and time frame based on our overall and 2 subgroup (by population size and diagnoses volume) analyses. The top 3 reasons for inadequate or missing treatment were patient lost to follow-up, HCP education and treatment unchanged, and regimen not recommended.

With a narrow range of CDC-recommended antibiotics to effectively treat gonorrhea, combined with concerns of antibiotic resistance, it is important to understand and monitor treatment practices. In response, we decided to use existing organizational frameworks to incentivize and promote adherence to federal recommendations for gonorrhea treatment. The PI program was multifaceted and interdisciplinary, including patients, county LHDs, HCPs, and NYSDOH staffs. Financial thresholds were determined using a combination of gonorrhea burden (i.e., amount of gonorrhea diagnoses) and county population size.

Overall, the PI program was well received by LHDs and evidenced by the improvement in treatment adherence after implementation. In 2018, the CDC conducted a weighted analysis of STD Surveillance Network with documented treatment information for ≥80% of cases, and 85.8% of reported patients with uncomplicated gonorrhea received the recommended treatment.18 The PI program served to improve treatment adequacy, and by comparison to STD Surveillance Network sites, NYS is one of the leaders for adequate treatment of uncomplicated gonorrhea nationally. Although treatment adherence was overall high, there is still room for improvement. Through NYSDOH reviews with LHDs, we learned of challenges in assuring simultaneous or same-day dual therapy, especially in rural areas or counties with small populations. The most common hypotheses were HCP unfamiliarity with the most current CDC treatment guidelines and, possibly more likely, travel difficulties on behalf of the patient, specifically, encountering barriers to filling an oral antibiotic(s) because of inconvenience of travel or inability to locate a nearby pharmacy. Furthermore, considering the difficulties with assuring same-day or simultaneous dual therapy, some HCPs did not feel that retreatment was necessary when patients did not receive dual therapy on the same day, citing overtreatment.

After the PI program and removal of financial incentive to LHDs, the proportion of diagnosed persons receiving adequate treatment remained high. Our hypotheses include the following: (1) the impact of enhanced surveillance and follow-up; (2) repeated education and exposure to the CDC recommendations presented by NYSDOH, clinical education initiatives, and other public health conferences and workshops (i.e., cointerventions); and (3) a potential carryover effect from the incentive time frame. In this study, we detected statistically significant associations suggesting the incentive program was effective across all county population sizes and volume of reported diagnoses. We remain cautious, although we identified statistical significance because results may not be entirely applicable to the PI program owing to the cointerventions previously mentioned. Other research studies have investigated and found positive associations between financially based incentive programs and health care services.19,20 Financial incentives may be an effective motivational tool for improving the outcomes of health care and public health services. Before the implementation of the PI program in NYS to promote adherence to CDC guidelines for the treatment of gonorrhea by LHDs, there was a separate incentive program for LHDs to improve the timeliness and completeness of case reports entered into the statewide surveillance system (CDESS). This program was a large success, and every county LHD exceeded expectations and were awarded funding, based on county population size (unpublished data from the NYSDOH).

Continuous improvement of treatment adherence in NYS would require addressing the main barriers (i.e., top reasons for inadequate or missing treatment). Patient lost to follow-up was the most frequent reason listed by LHDs. This was expected given experiences with engaging priority populations in STD prevention behaviors. Although difficult to make these decisions without laboratory confirmation, this may indicate a need for an enhanced patient assessment to determine the likelihood of reengagement to care for treatment and, when doubtful, to opt for presumptive treatment. In NYS, public health investigators employed by both the state and LHDs are responsible for interviewing those diagnosed with STD to assure treatment, elicit partners, and notify partners of potential exposure. When presumptive treatment is not preferred in these situations, it is important to use these investigators to reengage diagnosed persons to care. Second, HCP education and treatment unchanged represents a somewhat positive outcome from inadequate treatment in the form of education of the treatment guidelines. As mentioned previously, this reason may be used by LHDs to explain when diagnosed persons are treated with the recommended antibiotics but not on the same day. In the future, it may be helpful to provide scientific evidence to HCPs showing that either retreatment should not be viewed as overtreatment or, when not treated on the same day with recommended antibiotics, a test-of-cure for treatment failure is needed.

There were many strengths identified throughout the PI program. Most evident, there were great collaborations and routine feedback between the NYSDOH and LHDs, which led to greater confidence in quality and completeness of surveillance data. Second, the CDC treatment recommendations were educated frequently, both to LHDs and through LHD contacts with HCPs. To further increase exposure to the CDC treatment guidelines, the NYSDOH developed and disseminated HCP education materials, by creating pocket-size treatment cards designed to be worn by HCPs, which document approved CDC regimens for gonorrhea and other STDs. Third, the successes seen among LHDs with larger county populations point to the importance of staffing size and specialized personnel for gonorrhea follow-up, evidenced by the maintenance of treatment adherence rates after program implementation.

There were some limitations to this study. First, we excluded the missing treatment data in our final analysis, but the data missingness was consistently extremely low (<4%) and likely did not impact the conclusions of this study. Second, although it is a common practice for LHDs to conduct treatment verification through a mix of HCP contacts, patient report during interview, and patient-specific electronic searches using health information systems, in some instances, the date of treatment may correspond to the date of prescription and not physical intake or administration of antibiotic(s). We believe this occurred infrequently and did not lead to an overestimation of treatment adherence. Third, as previously mentioned, we cannot rule out the possibility of cointerventions that may have occurred outside the PI program. Lastly, the results of this study may not be generalizable to other states or other conditions because the organizational public health structure that exists in NYS may not be applicable in other jurisdictions.

In conclusion, in NYS, the PI program worked to improve and maintain adequacy of treatment for gonorrhea. The PI program was a multifaceted intervention that included, but was not limited to, money, education, enhanced surveillance, TA, and quality assurance. Financial incentives may serve as a powerful motivator; however, there are other mechanisms that we suggest in addition to monetary incentives. Future studies including longer follow-up and better tools to adjust for other interventions or policies are still needed.

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