Abstract

The term vaccination inequity generally reflects disparities in vaccination coverage within a community. It has been described as “avoidable differences in immunization coverage between population groups,” arising “because barriers to immunization among disadvantaged groups are not addressed through policies, structures, governance or program implementation.”1World Health Organization Regional Office for EuropeEuropean vaccine action plan 2015–2020. World Health Organization Regional Office for Europe, Copenhagen, DenmarkPublished 2014http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-immunization/publications/2014/european-vaccine-action-plan-20152020-2014Date accessed: October 16, 2020Google Scholar,2Sodha SV Dietz V Strengthening routine immunization systems to improve global vaccination coverage.Br Med Bull. 2015; 113: 5-14https://doi.org/10.1093/bmb/ldv001Crossref PubMed Scopus (38) Google Scholar Thus, inequity exists when some infants, children, or adults do not receive vaccination, despite being eligible. This could broadly be related to insufficient pull (i.e., demand) by eligible individuals or inadequate push (i.e., supply) by the healthcare system. Insufficient pull exists when vaccines are made available and accessible by the healthcare system, but eligible individuals fail to get vaccinated. This may be related to insufficient education, sociodemographic biases, inadequate community empowerment, lack of access, and disinterest. Inadequate push results from healthcare system issues affecting vaccine availability, affordability, and delivery. This supplement issue reports inequities related to pull and push factors in different countries and regions around the world. However, vaccination inequity can be a much broader issue, especially because the dictionary definition of inequity is linked to the lack of fairness or justice.3Inequity. Merriam-Webster.https://www.merriam-webster.com/dictionary/inequity. Accessed October 2, 2020.Google Scholar, 4Inequity. Cambridge dictionary.https://dictionary.cambridge.org/dictionary/english/inequity. Accessed October 2, 2020.Google Scholar, 5Inequity. Collins.https://www.collinsdictionary.com/dictionary/english/inequity. Accessed October 2, 2020.Google Scholar, 6Inequity. Oxford Lexico.https://www.lexico.com/definition/inequity. Accessed October 2, 2020.Google Scholar, 7Inequity. Dictionary.com.https://www.dictionary.com/browse/inequity. Accessed October 2, 2020.Google Scholar In that context, vaccination inequity should focus on the unfairness/injustice(s) associated with vaccination (beyond the aforementioned pull and push factors). This commentary explores some of the inequities in policies and practices associated with newer vaccines in India. The Government of India launched the Expanded Program on Immunization (EPI) in 1978. This was changed to the Universal Immunization Program in 1985, providing vaccines against 6 diseases free of charge to all infants across the country. The Universal Immunization Program schedule was aligned to the vaccination strategy prevalent in most developing countries. A limited number of additional vaccines were available through private sector providers in return for out-of-pocket payment. This situation changed dramatically in the early 1990s, when India witnessed a wave of economic reforms and liberalization. This led to greater purchasing power among individuals and institutions, including World Trade Organization membership, and also eased the importation of many hitherto unavailable products, including vaccines. This combination made India an attractive market for international vaccine manufacturers. Developed healthcare systems make public health vaccination decisions on the basis of infectious disease epidemiology, community burden, risks and consequences (such as complications, sequelae) of the disease to individuals and society, and significance of the disease vis-à-vis other pressing health issues. In short, need drives vaccine development, deployment, and decisions, with the healthcare system attempting to find solutions to meet the need. In India, the reverse is often true. The solution (generally an imported vaccine) is licensed for sale in the open market, and a need is then identified to justify its use. This need is often artificially created and supported by vaccine manufacturers, who use 2 broad approaches.8Mathew JL Pneumococcal vaccination in developing countries: where does science end and commerce begin?.Vaccine. 2009; 27: 4247-4251https://doi.org/10.1016/j.vaccine.2009.04.031Crossref PubMed Scopus (15) Google Scholar One is the academic channel, by organizing and sponsoring educational activities (e.g., Continuing Professional Development programs, lavish conferences) and motivating key opinion leaders (often on a paid basis) to highlight the need. The other is the commercial channel, through extensive marketing, direct-to-consumer advertising, and providing vaccines to physicians at prices lower than retail. These measures create a clamor for the introduction of newer vaccines, even without scientific justification.9Mathew JL Global access to vaccines: vaccine science and commerce: never the twain shall meet.BMJ. 2008; 336: 974https://doi.org/10.1136/bmj.39563.553715.BECrossref PubMed Google Scholar Assessment of disease burden and epidemiological characterization are hampered by nonexistent or inadequate surveillance/reporting systems. In such situations, indirect estimates, extrapolations from other settings, guesswork, and inaccurate calculations are used to quantify the need. Notable examples are the 10-fold inflation of poliomyelitis cases (compared with the available data),10Sathyamala C Mittal O Dasgupta R Priya R Polio eradication initiative in India: deconstructing the GPEI.Int J Health Serv. 2005; 35: 361-383https://doi.org/10.2190/K882-9792-3QYX-JKTDCrossref PubMed Scopus (37) Google Scholar inaccurate estimation of hepatitis B prevalence,11Thyagarajan SP Jayaram S Mohanavalli B Prevalence of HBV in general population of India.in: Sarin SK Singal AK Hepatitis B in India: Problems and Prevention. CBS Publishers and Distributors, New Delhi, India1996: 5-16Google Scholar and various modeling estimates used to calculate the burden of childhood pneumonia (and the proportion with pneumococcal disease).12Rudan I Boschi-Pinto C Biloglav Z Mulholland K Campbell H Epidemiology and etiology of childhood pneumonia.Bull World Health Organ. 2008; 86: 408-416https://doi.org/10.2471/blt.07.048769Crossref PubMed Scopus (909) Google Scholar,13Wahl B Knoll MD Shet A et al.National, regional, and state-level pneumonia and severe pneumonia morbidity in children in India: modelled estimates for 2000 and 2015.Lancet Child Adolesc Health. 2020; 4: 678-687https://doi.org/10.1016/S2352-4642(20)30129-2Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar The paucity of data on the twin issues of local disease burden and potential vaccine effectiveness suits the vaccine industry and the for-profit healthcare sector in the country. Data and vaccine recommendations of developed countries are transplanted to India. Guidance provided by global bodies, such as WHO and the United Nations Children's Fund, and prestigious universities, international public health institutions, and research foundations, among others, further bolster this approach. Indian stakeholders, including policymakers and healthcare professionals, generally accept this. Dissenting voices challenging the dependence on external data are ignored. This leads to the inequity wherein a country like India with immense intellectual expertise, robust technical know-how, a strong indigenous vaccine industry, and a powerful economy (currently ranked fifth worldwide) ends up bowing to intellectual imperialism disguised as external assistance/guidance to address its own public health problems. Additional pertinent issues like vaccine effectiveness, cost effectiveness, alternate strategies, and sustainability are obviously never considered.14Mathew JL KNOW ESSENTIALS: a tool for informed decisions in the absence of formal HTA systems.Int J Technol Assess Health Care. 2011; 27: 139-150https://doi.org/10.1017/S0266462311000109Crossref PubMed Scopus (11) Google Scholar,15Mathew JL KNOW ESSENTIALS – a novel algorithm for informed vaccine-related decision-making in developing countries.Int J Infect Dis. 2010; 14: e447https://doi.org/10.1016/j.ijid.2010.02.612Abstract Full Text Full Text PDF Google Scholar Similarly, the short-term and long-term consequences of including a vaccine in the immunization program, and the impact on other healthcare needs, are also not taken into account. 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However, a similar pattern is apparent for all newer (non-EPI) vaccines, including those for hepatitis A, human papillomavirus, rotavirus, influenza, varicella, acellular pertussis vaccine, and typhoid conjugate vaccine.Table 1Profile of Indian States Where PCV Was Launched in the First PhaseVariableIndiaUttar PradeshBiharMadhya PradeshRajasthanHimachal PradeshUnder 5 mortality rateaPer 1,000 live births.49.778.158.164.650.737.6 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.132618Child mortality rateaPer 1,000 live births.9.415.610.514.29.73.5 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.162928Infant mortality rateaPer 1,000 live births.40.763.548.151.241.334.3 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.143714Neonatal mortality rateaPer 1,000 live births.29.545.136.736.929.825.5 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.143813Percentage with ARI in preceding 2 weeks2.74.72.52.12.11.6 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.112202024Percentage for whom ARI treatment was sought78.176.568.072.387.889.0 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.2216203033Percentage with full vaccination62.051.161.753.654.869.5 RankbRanking is in the order of worst to best among 36 states and union territories of India. ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine.71481023a Per 1,000 live births.b Ranking is in the order of worst to best among 36 states and union territories of India.ARI, acute respiratory infection; PCV, pneumococcal conjugate vaccine. Open table in a new tab India has had a robust vaccine (development and production) industry for many decades.59Lahariya C A brief history of vaccines & vaccination in India.Indian J Med Res. 2014; 139: 491-511https://www.ijmr.org.in/showBackIssue.asp?issn=0971-5916;year=2014;volume=139;issue=4;month=AprilDate accessed: October 6, 2020PubMed Google Scholar In fact, a significant proportion of the EPI vaccines used globally are produced in India. In addition, the local biotechnology industry is able to produce many new vaccines very quickly. Unfortunately, this technological expertise has not been harnessed to make the country completely self-sufficient with respect to its own vaccine requirements. Some years back, manufacturing plants for some vaccines were even shutdown. This vacuum and the open market policy allow multinational manufacturers to sell vaccines designed and developed for entirely different settings, at prices set by them. This inequity is particularly relevant because India has a large annual birth cohort exceeding 27 million and, hence, should be in a position to demand the development, manufacture, and marketing of vaccines, tailored to the country's needs (in terms of diseases targeted and serotypes included).26JL Mathew Universal pneumococcal vaccination for India.Indian Pediatr. 2008; 45: 160-161https://www.indianpediatrics.net/feb2008/160.pdfDate accessed: October 6, 2020PubMed Google Scholar,60Mittal SK Mathew JL IPV revisited… yet again.Indian Pediatr. 2008; 45: 390-395https://www.indianpediatrics.net/may2008/390.pdfDate accessed: October 6, 2020PubMed Google Scholar An assured market for several million annual doses, for several years, could also have been leveraged to negotiate acceptable prices with indigenous and foreign manufacturers.26JL Mathew Universal pneumococcal vaccination for India.Indian Pediatr. 2008; 45: 160-161https://www.indianpediatrics.net/feb2008/160.pdfDate accessed: October 6, 2020PubMed Google Scholar,60Mittal SK Mathew JL IPV revisited… yet again.Indian Pediatr. 2008; 45: 390-395https://www.indianpediatrics.net/may2008/390.pdfDate accessed: October 6, 2020PubMed Google Scholar There is no single agency in India tasked with monitoring communicable disease epidemiology (akin to the U.S. Centers for Disease Control and Prevention); however, recently the country's National Institute of Communicable Disease in New Delhi was redesignated as the National Centre for Disease Control.61National Centre for Disease Control. https://ncdc.gov.in/index.php. Accessed October 13, 2020.Google Scholar Unfortunately, its public health component, especially regarding prevention of diseases, is limited and it functions more as an advanced microbiology laboratory providing diagnostic facilities rather than proactively defining disease burden in India. This institution could be repurposed to collate available data from hospital and community sentinel sites in the country, sustain and upgrade the surveillance system built up for polio eradication, monitor vaccine adverse events, and scientifically guide the country toward rational vaccination decisions. The Indian Academy of Pediatrics (IAP)—the national society of child health professionals—is a major voice advocating for newer vaccines. The Advisory Committee on Vaccines and Immunization Practices (formerly Committee on Immunization) of this august body periodically issues consensus statements, position papers, and recommendations favoring various new vaccines. These documents have several common features. First, they are always issued after the appearance of the new vaccine in the domestic market.28Indian Academy of Pediatrics Committee on Immunization (IAPCOI)Consensus recommendations on immunization, 2008.Indian Pediatr. 2008; 45: 635-648https://www.indianpediatrics.net/aug2008/635.pdfDate accessed: October 6, 2020PubMed Google Scholar, 62Balasubramanian S Shah A Pemde HK et al.Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP) recommended immunization schedule (2018–19) and update on immunization for children aged 0 through 18 years.Indian Pediatr. 2018; 55: 1066-1074https://doi.org/10.1007/s13312-018-1444-8Crossref PubMed Scopus (40) Google Scholar, 63Vashishtha VM Choudhury P Kalra A et al.Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years–India, 2014 and updates on immunization.Indian Pediatr. 2014; 51: 785-800https://doi.org/10.1007/s13312-014-0504-yCrossref PubMed Scopus (83) Google Scholar, 64Vashishtha VM Kalra A et al.Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (acvip)Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years, India, 2013 and updates on immunization.Indian Pediatr. 2013; 50: 1095-1108https://doi.org/10.1007/s13312-013-0292-9Crossref PubMed Scopus (36) Google Scholar, 65Vashishtha VM Yewale VN Bansal CP Mehta PJ Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP). 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IAP Committee on Immunization.Indian Pediatr. 2007; 44: 390-392https://www.indianpediatrics.net/may2007/390.pdfDate accessed: October 6, 2020PubMed Google Scholar Second, they are issued despite a paucity of local data on disease burden, epidemiology, and vaccine effectiveness.28Indian Academy of Pediatrics Committee on Immunization (IAPCOI)Consensus recommendations on immunization, 2008.Indian Pediatr. 2008; 45: 635-648https://www.indianpediatrics.net/aug2008/635.pdfDate accessed: October 6, 2020PubMed Google Scholar,62Balasubramanian S Shah A Pemde HK et al.Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP) recommended immunization schedule (2018–19) and update on immunization for children aged 0 through 18 years.Indian Pediatr. 2018; 55: 1066-1074https://doi.org/10.1007/s13312-018-1444-8Crossref PubMed Scopus (40) Google Scholar, 63Vashishtha VM Choudhury P Kalra A et al.Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years–India, 2014 and updates on immunization.Indian Pediatr. 2014; 51: 785-800https://doi.org/10.1007/s13312-014-0504-yCrossref PubMed Scopus (83) Google Scholar, 64Vashishtha VM Kalra A et al.Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (acvip)Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years, India, 2013 and updates on immunization.Indian Pediatr. 2013; 50: 1095-1108https://doi.org/10.1007/s13312-013-0292-9Crossref PubMed Scopus (36) Google Scholar, 65Vashishtha VM Yewale VN Bansal CP Mehta PJ Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP). IAP perspectives on measles and rubella elimination strategies.Indian Pediatr. 2014; 51: 719-722https://doi.org/10.1007/s13312-014-0488-7Crossref PubMed Scopus (17) Google Scholar, 66Vashishtha VM Kalra A Choudhury P Influenza vaccination in India: position paper of Indian Academy of Pediatrics, 2013.Indian Pediatr. 2013; 50: 867-874https://doi.org/10.1007/s13312-013-0230-xCrossref PubMed Scopus (19) Google Scholar, 67Vashishtha VM Bansal CP Gupta SG Pertussis vaccines: position paper of Indian Academy of Pediatrics (IAP).Indian Pediatr. 2013; 50: 1001-1009https://doi.org/10.1007/s13312-013-0274-yCrossref PubMed Scopus (27) Google Scholar, 68Singhal T Amdekar YK Thacker N Indian Academy of Pediatrics. IAP Committee on Immunization.Indian Pediatr. 2007; 44: 390-392https://www.indianpediatrics.net/may2007/390.pdfDate accessed: October 6, 2020PubMed Google Scholar In some instances, statements such as “there is no reason to believe that the disease burden of pertussis is low in adolescents in India” have been used to justify a vaccine.28Indian Academy of Pediatrics Committee on Immunization (IAPCOI)Consensus recommendations on immunization, 2008.Indian Pediatr. 2008; 45: 635-648https://www.indianpediatrics.net/aug2008/635.pdfDate accessed: October 6, 2020PubMed Google Scholar In short, a problem is identified to fit the solution, rather than the other way around. Third, the recommendations are framed to apparently guide pediatricians “in office practice” (pseudonym for the for-profit private sector) to use newer vaccines for children's families who can pay for them.28Indian Academy of Pediatrics Committee on Immunization (IAPCOI)Consensus recommendations on immunization, 2008.Indian Pediatr. 2008; 45: 635-648https://www.indianpediatrics.net/aug2008/635.pdfDate accessed: October 6, 2020PubMed Google Scholar,63Vashishtha VM Choudhury P Kalra A et al.Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years–India, 2014 and updates on immunization.Indian Pediatr. 2014; 51: 785-800https://doi.org/10.1007/s13312-014-0504-yCrossref PubMed Scopus (83) Google Scholar,64Vashishtha VM Kalra A et al.Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (acvip)Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years, India, 2013 and updates on immunization.Indian Pediatr. 2013; 50: 1095-1108https://doi.org/10.1007/s13312-013-0292-9Crossref PubMed Scopus (36) Google Scholar,69Vashishtha VM IAP-ACVIP immunization recommendations: focus on an ‘individual’ child in ‘office practice’ setting.Indian Pediatr. 2019; 56: 510-511https://www.indianpediatrics.net/june2019/510.pdfDate accessed: October 6, 2020PubMed Google Scholar This could have been reasonable, if parents are engaged in a free and fair discussion highlighting the available data (or lack thereof). But in practice, parents are often nudged to purchase expensive vaccines. Innovative terms such as “optional vaccine,” “desirable vaccine,” and “administration with a one-to-one discussion” were coined to promote the use of vaccines for commercial rather than scientific reasons. All this leads to the inequity wherein those who most require a vaccine (because they are at higher risk) do not receive it, whereas those who get a vaccine (because they can afford it) perhaps least require it.70Paul Y Some issues arising from 2018–19 IAP immunization recommendations.Indian Pediatr. 2019; 56: 338https://www.indianpediatrics.net/apr2019/338.pdfDate accessed: October 6, 2020PubMed Google Scholar The other major consequence is that instead of being proactive (demanding vaccines to meet the country's needs based on local evidence), this academic body remains reactive (identifying means to use vaccines available in the market). Of course, the IAP will justify its position in various ways, including guidance to its members, protection of individual children, and advocacy for child health. Fourth, the reactive approach results in diverting focus from relevant issues. For example, instead of studying whether current infant measles epidemiology still necessitates 2 doses of measles vaccine early in life rather than a single dose later in infancy as in developed countries (which can reduce programmatic cost), the focus is on using multiple doses of measles–mumps–rubella vaccine.68Singhal T Amdekar YK Thacker N Indian Academy of Pediatrics. IAP Committee on Immunization.Indian Pediatr. 2007; 44: 390-392https://www.indianpediatrics.net/may2007/390.pdfDate accessed: October 6, 2020PubMed Google Scholar Similarly, the measles–rubella vaccine used in the EPI program is not available to private sector providers, whereas the measles–mumps–rubella vaccine is. Therefore, the IAP has been at pains to suggest that mumps is also a disease of great public health significance and, hence, the measles–mumps–rubella vaccine should be used in place of the measles–rubella vaccine.62Balasubramanian S Shah A Pemde HK et al.Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP) recommended immunization schedule (2018–19) and update on immunization for children aged 0 through 18 years.Indian Pediatr. 2018; 55: 1066-1074https://doi.org/10.1007/s13312-018-1444-8Crossref PubMed Scopus (40) Google Scholar The commercial emphasis on newer vaccines has led the IAP to develop its own vaccination schedule, designed to be used by the for-profit healthcare sector. Unfortunately, this is pitched as a national schedule and the IAP recommends this as an alternative to the EPI schedule. Naturally, the IAP schedule includes several more vaccines and many more doses of some vaccines than the EPI. In the absence of an official agency to develop country-specific guidelines based on Indian epidemiology and public health considerations, the IAP freely advises the Government about EPI decisions as well. In principle, Indian citizens have complete freedom to make vaccination choices and decisions for their children. Vaccination is not compulsory in the sense of eliciting punitive action (or forfeiture of privileges) as happens in some other settings. In fact, the Government makes extensive efforts in the EPI program to track unvaccinated children and ensure completion of vaccination through motivation, education, community participation, and social mobilization. The Mission Indradhanush initiative and its avatars, Intensified Mission Indradhanush and Intensified Mission Indradhanush 2.0, are steps in this direction.71Gurnani V Haldar P Aggarwal MK et al.Improving vaccination coverage in India: lessons from Intensified Mission Indradhanush, a cross-sectoral systems strengthening strategy.BMJ. 2018; 363: k4782https://doi.org/10.1136/bmj.k4782Crossref PubMed Scopus (55) Google Scholar By contrast, newer (more expensive) non-EPI vaccines are often forced onto families, without empowering them to make informed choices or decisions. This is done overtly as well as subtly, often by healthcare providers offering for-profit services. The vaccine industry supports this by supplying vaccines to healthcare providers at rates much cheaper than the market price (as an incentive to prescribe them at market prices). Unempowered families often leave the decision to their healthcare providers, who make decisions based on their personal biases, rather than assisting families to make informed choices. Many healthcare providers disingenuously argue that even if disease epidemiology does not warrant a vaccine, “What harm can it do?” Sometimes, families declining non-EPI vaccines for financial reasons develop a sense of guilt. Such families often opt for 1 or 2 doses of expensive vaccines, rather than the whole series. This creates the inequity where partially vaccinated children may remain susceptible to the disease. •Communicable disease epidemiology should be the main driver for vaccination policy and practice decisions.•Robust disease surveillance systems are essential before vaccines are introduced. This will help establish the need for vaccines and later assess vaccine effectiveness (or otherwise).•The newly designated National Centre for Disease Control can be repurposed as the nodal agency for monitoring communicable disease epidemiology, establishing need for vaccines, and guiding stakeholders toward decisions based on scientific rather than commercial considerations.•The desire to protect individual children and willingness to pay for vaccines (rather than waiting for them to become available through the EPI) can be addressed by empowering families (to make informed decisions) through public health education campaigns rather than individual healthcare providers. The authors acknowledge and thank the Global Institute for Vaccine Equity at the University of Michigan School of Public Health for financial support of this supplement. The findings and conclusions of articles in this supplement are those of the authors and do not necessarily represent the official position of the University of Michigan. The authors received no financial support for the research, authorship, or publication. None of the authors has any commercial associations, current and over the past 5 years, that might pose a conflict of interest. JLM conceptualized the study, searched literature, interpreted data, drafted the manuscript, and finalized the manuscript. SKM reviewed the draft manuscript and provided intellectual input. IRB/Ethics committee approval was not sought because no identifiable data of individual subjects were accessed, analyzed, or presented. No financial disclosures were reported by the authors of this paper. Download .pdf (.39 MB) Help with pdf files

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