Abstract
Introduction
Disease-modifying therapies (DMTs) for Alzheimer's disease, such as Lecanemab, represent a shift from symptomatic treatment toward disease modification. Their implementation raises broader societal, ethical, and systemic challenges related to early diagnosis, healthcare preparedness, long-term care adaptation, and equitable access to treatment.
Aim
This study explored expert perspectives on the societal, ethical, and systemic implications of introducing disease-modifying Alzheimer's therapies within Central European healthcare and long-term care contexts.
Methods
A three-round modified Delphi study combining qualitative and quantitative elements was conducted with ten multidisciplinary experts from Slovenia, Austria, and Bosnia and Herzegovina. Data were collected through anonymised online questionnaires and analysed using thematic analysis, descriptive statistics, and Kendall's coefficient of concordance (W).
Results
The Delphi process identified six highly prioritised themes: (1) public and professional awareness and education (M = 9.71), (2) development of tailored long-term care models (M = 9.71), (3) faster access to innovative therapies (M = 9.43), (4) reduction of dementia-related stigma through public dialogue (M = 8.57), (5) consideration of cultural beliefs and healthcare funding (M = 8.29), and (6) accessibility of medications despite pricing strategies (M = 8.29). Kendall's coefficient indicated low statistical agreement among expert rankings (W =.084), suggesting partial alignment regarding thematic priorities rather than strong consensus.
Conclusion
The findings suggest that implementing disease-modifying Alzheimer's therapies represents not only a biomedical innovation but also a broader socio-gerontological and health system challenge.
1. Introduction
Alzheimer's disease (AD) represents one of the most significant health and social care challenges associated with population ageing. The increasing prevalence of dementia places growing pressure not only on healthcare systems but also on long-term care structures, informal caregiving networks, and wider social support systems (Maestre et al., 2023). Beyond its clinical manifestations, dementia is increasingly recognised as a complex social and ethical phenomenon associated with stigma, dependency, loss of autonomy, and broader societal attitudes toward ageing and cognitive decline (Zimmermann, 2017). In recent years, the emergence of disease-modifying therapies (DMTs) for Alzheimer's disease, particularly anti-amyloid monoclonal antibodies such as Lecanemab, has introduced a significant shift in the therapeutic paradigm of dementia care. Unlike traditional symptomatic therapies, disease-modifying treatments aim to slow disease progression by targeting underlying neuropathological mechanisms, particularly amyloid-β accumulation. Clinical evidence from the CLARITY-AD trial demonstrated that Lecanemab may slow cognitive and functional decline in individuals with early Alzheimer's disease (van Dyck et al., 2023). However, the introduction of disease-modifying therapies also raises broader ethical, organisational, and socioeconomic challenges that extend beyond pharmacological efficacy alone. Unlike conventional symptomatic treatments, DMTs require early diagnosis, biomarker confirmation, longitudinal monitoring, and specialised healthcare infrastructure, including amyloid PET imaging, cerebrospinal fluid analysis, MRI monitoring, infusion services, and genetic testing (Walsh et al., 2024; Cummings et al., 2024). Consequently, implementation of these therapies may place substantial pressure on already strained healthcare systems and intensify inequalities in access to diagnostics and treatment. Several authors have emphasised that the implementation of new Alzheimer's therapies raises important ethical concerns regarding informed consent, prioritisation of treatment eligibility, reimbursement policies, and healthcare equity (Karneboge et al., 2025; Yeo-Teh & Tang, 2023). Furthermore, concerns remain regarding the psychological and social implications of early diagnosis, particularly in environments where dementia continues to be highly stigmatised (Clement et al., 2015; Zimmermann, 2017). Previous research has shown that stigma may negatively influence help-seeking behaviour and delay diagnostic processes, thereby limiting opportunities for timely intervention (Clement et al., 2015). In this context, public awareness and destigmatisation become increasingly important components of successful therapeutic implementation. The anticipated impact of disease-modifying Alzheimer's therapies is also closely connected to the future organisation of long-term care systems. Earlier diagnosis and prolonged management of mild stages of dementia may require a gradual transition from institution-centred models of care toward more flexible, community-based, and person-centred approaches. Previous studies suggest that implementation of DMTs will likely increase demand for specialised consultations, diagnostic pathways, interdisciplinary coordination, caregiver support, and adapted long-term care services (Aye et al., 2025). Consequently, the introduction of these therapies represents not only a biomedical innovation but also a broader socio-gerontological challenge affecting healthcare systems, workforce structures, caregiving models, and social policy. These challenges may be particularly relevant within Central European healthcare and long-term care systems, where considerable differences exist regarding financing models, service organisation, dementia care infrastructure, and cultural attitudes toward ageing and family caregiving. Austria, Slovenia, and Bosnia and Herzegovina represent distinct healthcare and social care contexts characterised by varying levels of preparedness for the implementation of innovative Alzheimer's therapies. While Austria has already initiated certain implementation processes for anti-amyloid therapies (Kunz, 2025), Slovenia and Bosnia and Herzegovina continue to face broader systemic and financial barriers to diagnostic capacity, reimbursement structures, and long-term care adaptation. Despite rapidly growing clinical literature on disease-modifying Alzheimer's therapies, their societal, ethical, and systemic implications within Central European healthcare and long-term care contexts remain insufficiently explored. This study addresses this gap by examining expert perspectives on the anticipated challenges associated with introducing Lecanemab into these care systems. Development and Mechanism of Action of Beta-Amyloid Antagonists such as Lecanemab The development of anti-amyloid monoclonal antibodies such as Lecanemab represents a shift from symptomatic Alzheimer's disease treatment toward disease modification. By targeting soluble amyloid-β protofibrils, Lecanemab aims to slow cognitive and functional decline in the early stages of the disease (van Dyck et al., 2023). Compared with earlier anti-amyloid therapies such as Aducanumab, (sold under the brand name Aduhelm) Lecanemab has been associated with a more favourable balance between efficacy and safety, although concerns regarding implementation, monitoring requirements, and long-term clinical benefit remain under discussion (Cummings et al., 2024; Yeo-Teh & Tang, 2023). Risks and Patient Eligibility Criteria for Lecanemab Treatment Clinical evidence from the CLARITY-AD Phase III trial indicates that Lecanemab may slow cognitive decline in patients with early Alzheimer's disease; however, treatment is associated with potentially serious adverse events, primarily amyloid-related imaging abnormalities (ARIA), which are detected through magnetic resonance imaging and may be symptomatic or asymptomatic (van Dyck et al., 2023). The risk of ARIA is higher among ApoE ε4 carriers, particularly homozygotes, which necessitates genetic testing before treatment initiation to inform risk stratification (Ritchie et al., 2024). Consequently, regulatory recommendations restrict Lecanemab therapy to patients with mild cognitive impairment or mild dementia due to Alzheimer's disease, confirmed through PET imaging or cerebrospinal fluid analysis. Baseline and periodic MRI monitoring are required to detect ARIA and guide treatment decisions (U.S. Food and Drug Administration, 2023). Jönsson et al. (2023) estimate that approximately 5.4 million individuals in the 27 EU countries could potentially be eligible for Lecanemab treatment, with annual treatment costs exceeding 133 billion EUR if priced similarly to the United States. Table 1 provides an overview of estimated annual per-patient costs of Lecanemab across selected healthcare systems.
Table 1. Annual Per-Patient Cost of Lecanemab
| Country | Cost (EUR, approx.) | Included Elements | Source |
|---|---|---|---|
| United States | 24,766 | Drug only | Eisai Co., Ltd. (2023) |
| Sweden | 2,947 | Drug only (cost-effective estimate) | Xia et al. (2025) |
| Japan | 19,000-20,000 | Drug only | Sagehashi (2023) |
| Europe (estimate) | 24,766 | Drug only (reference price) | Jönsson et al. (2023) |
Note. Costs are approximate and based on publicly available estimates. EUR = Euro.
This study used a modified Delphi design combining qualitative and quantitative elements to systematically collect, refine, and prioritise expert perspectives on the anticipated social, ethical, and systemic implications of introducing disease-modifying therapies for Alzheimer's disease. The Delphi method is a structured, iterative research technique designed to collect and refine expert opinion through multiple rounds of questionnaires and controlled feedback (Hasson et al., 2000; Keeney et al., 2011). Based on the methodological literature, the Delphi approach was selected because it is particularly suitable for research areas in which empirical evidence remains limited, future implementation pathways are uncertain, and multidisciplinary expert judgement is required to inform healthcare policy, clinical practice, and system development (Jorm, 2015). In addition, Delphi methods are widely used in gerontology, nursing, and palliative care research to support the development of operational, organisational, and ethical recommendations (Jünger et al., 2017).
1.1. Overview and definitions
The methodological design was based on a modified Delphi approach, allowing expert perspectives to be gathered, refined, and prioritised across several iterative rounds. The modified Delphi approach was considered particularly appropriate for this study because the broader societal, ethical, and systemic implications of disease-modifying Alzheimer's therapies remain insufficiently explored, and empirical evidence regarding their long-term implementation is still emerging. In contrast to a classical Delphi design based exclusively on predefined items, the present study employed a modified Delphi approach combining qualitative open-ended exploration in the first round with iterative quantitative prioritisation and ranking in subsequent rounds. This design enabled the identification of emerging themes while simultaneously refining and prioritising expert perspectives through controlled feedback between rounds.
1.2. Study setting
A three-round modified Delphi process was applied to collect and refine expert perspectives on the anticipated social, ethical, and systemic implications of introducing disease-modifying therapies for Alzheimer's disease within European health and social care systems. All Delphi rounds were conducted online using anonymised questionnaires to minimise dominance effects and encourage independent expert evaluation. After each round, aggregated findings were returned to participants as controlled feedback, allowing them to reconsider and refine their responses in subsequent rounds. Methodological rigour was supported through anonymisation, iterative feedback, and the integration of qualitative thematic analysis with descriptive statistical analysis.
1.3. Participants
The expert panel consisted of ten professionals representing a wide range of academic and clinical disciplines. Participants were selected through purposive sampling based on their professional expertise, publication record, and experience in dementia care, public health, or health policy. The panel included three full professors (PhD) specialising in sociology, law, and psychology; three medical doctors (MD) with specialisations in psychiatry, gerontology, and geriatrics; two associate professors (PhD) in social gerontology; and one professor of public health (PhD), as presented in Table 2.
Table 2. Profile of experts involved in the Delphi study according to academic rank, expertise and nationality
| No. | Academic Rank | Field of Expertise | Country |
|---|---|---|---|
| 1 | Prof. PhD | Sociology | Slovenia |
| 2 | Prof. PhD | Law | Slovenia |
| 3 | Prof. PhD | Psychology | Slovenia |
| 4 | Dr. MD | Specialist in Psychiatry | Slovenia |
| 5 | Dr. MD | Specialist in Gerontology | Austria |
| 6 | Ass. Prof. PhD | Social Gerontology | Slovenia |
| 7 | Dr. MD | Geriatrician | BIH |
| 8 | Prof. PhD | Public Health | BIH |
| 9 | Ass. Prof. PhD | Social Gerontology | Austria |
| 10 | PhD, MD | Specialist in Psychiatry | Slovenia |
1.4. Data processing methods
All qualitative data collected during the three Delphi rounds were analysed using the qualitative analysis software ATLAS.ti (Version 23), which enabled systematic coding, categorisation, and thematic synthesis. The software supported the organisation of expert statements, identification of recurrent patterns, and visualisation of thematic relationships. In the first round, open-ended expert responses were subjected to inductive content analysis to identify recurring concepts and thematic patterns related to the anticipated effects of disease-modifying Alzheimer's therapies. These themes were iteratively reviewed and merged into broader categories that capture the ethical, social, and systemic dimensions of implementation. In the second round, statements derived from the qualitative analysis were transformed into a structured questionnaire rated on a five-point Likert scale (1 = strongly disagree; 5 = strongly agree). Quantitative data were analysed using descriptive statistics, including mean scores, standard deviations, and variance measures, to assess the relative importance and variability of expert ratings. The stability of expert opinions was evaluated by comparing mean ratings and dispersion values between rounds. In the third round, the ten highest-rated statements were re-evaluated and ranked according to perceived importance using a 10-point scale. Items achieving higher mean scores and lower variability were interpreted as highly prioritised themes within the expert panel rather than indicators of statistical consensus. Agreement among experts in the final ranking round was assessed using Kendall's coefficient of concordance (W). Kendall's W is a non-parametric measure used to evaluate the degree of concordance among multiple raters ranking the same set of items (Schmidt, 1997; Legendre, 2005). In this study, Kendall's W was used to distinguish statistical agreement from thematic prioritisation.
2. Results
Across the three Delphi rounds, experts identified several recurring themes related to the anticipated societal, ethical, and systemic implications of introducing disease-modifying therapies for Alzheimer's disease. The findings demonstrated partial thematic alignment across key priorities, particularly in public awareness, long-term care adaptation, equitable access to treatment, and healthcare system preparedness.
3. Results delphi first round: identification of key themes
In the first Delphi round, experts provided open-ended responses regarding the potential societal, ethical, and systemic implications of introducing new disease-modifying therapies for Alzheimer's disease. The responses addressed three broad areas: societal impacts of new therapies, public awareness and attitudes toward early signs of Alzheimer's disease, and potential effects on long-term care systems. Qualitative analysis of the collected expert statements yielded twenty-nine thematic codes representing the most recurrent concepts identified across responses. These themes were grouped into positive, negative, and neutral categories, as presented in Tables 3-5.
Table 3. Semantic analysis of expert opinions on new Alzheimer's medications: Positive statements
| Category | Main Thematic Elements | Representative Statements |
|---|---|---|
| Positive Statements | • Increased public awareness and improved societal understanding of Alzheimer’s disease | “Public awareness has significantly improved.” |
| • Greater patient independence and support for community-based care | “New therapies allow for better long-term care models.” | |
| • Expectation that scientific advances will reduce costs and expand access | “Scientific progress will drive improvements in treatment and access.” | |
| • Reduced need for hospital visits due to self-administered biological therapies |
Table 4. Semantic analysis of expert opinions on new Alzheimer's medications: Negative statements
| Category | Main Thematic Elements | Representative Statements |
|---|---|---|
| Negative Statements | • High medication costs and risk of serious side effects | “Drugs are expensive and have serious side effects.” |
| • Limited access for older adults, raising age-discrimination concerns | “Diagnosis and monitoring are too costly and complex.” | |
| • Health systems unprepared for complex diagnostics and monitoring | “Institutional care is not adapted to dementia needs.” | |
| • Therapies offer only modest slowing of progression |
Table 5. Semantic analysis of expert opinions on new Alzheimer's medications: Neutral statements
| Category | Main Thematic Elements | Representative Statements |
|---|---|---|
| Neutral Statements | • Ethical dilemmas related to eligibility and prioritisation | “More training and education are required for caregivers.” |
| • Need for adapted and updated care models | “New therapies will extend the early phase of the disease.” | |
| • Dementia stigma remains a major barrier to early diagnosis and treatment | “Stigma is still a major barrier to early diagnosis.” |
Tables 3-5 summarise the semantic analysis of expert responses. Positive statements emphasised increased public awareness, greater patient autonomy, expectations that scientific progress may improve access to treatment, and the potential for new care models. Negative statements primarily reflected concerns about high medication costs, possible side effects, limited accessibility, and insufficient preparedness of existing health systems. Neutral statements focused on ethical dilemmas, the need for adapted care models, and the continuing role of stigma in delaying early diagnosis and treatment. Among the identified themes, public awareness and destigmatisation emerged as among the most prominent themes. Experts emphasised that early diagnosis and treatment uptake depend strongly on reducing stigma and improving public and professional understanding of Alzheimer's disease. Other recurrent themes included limited accessibility, the need for systematic change, financial barriers, diagnostic complexity, and the adaptation of long-term care services to earlier stages of the disease. Overall, the first Delphi round established a framework of interconnected social, ethical, and systemic issues that informed the subsequent prioritisation process.
4. Results delphi second round: rating and refinement of themes
In the second Delphi round, experts further evaluated the themes identified in the first round. The highest-rated areas were related to public awareness and destigmatisation, long-term care adaptation, and equitable access to innovative Alzheimer's therapies. Statements addressing public and professional education, reducing dementia-related stigma, and preparing care systems for earlier-stage disease management received consistently high ratings. Themes related to diagnostic complexity, financial burden, reimbursement, and organisational preparedness also received high evaluations. These findings indicate that experts viewed the implementation of disease-modifying therapies not only as a clinical innovation but also as a broader health system challenge requiring coordinated diagnostic pathways, professional training, and sustainable financing mechanisms. The second round, therefore, refined the initial qualitative findings into three central thematic clusters: public awareness and destigmatisation; long-term care and system adaptation; and access, equity, and the ethical allocation of medications. These clusters informed the selection of the ten highest-rated statements for final prioritisation in the third Delphi round.
5. Results delphi third round: final prioritisation of themes
In the third Delphi round, the ten highest-rated statements from the previous phase were ranked according to their perceived overall importance for the implementation of disease-modifying therapies for Alzheimer's disease. Table 6 presents the final ranking of statements based on expert evaluations.
Table 6. Final Ranking of Statements
| No. | Statement | M |
|---|---|---|
| 1 | Raise awareness and educate the public and healthcare professionals. | 9.71 |
| 2 | Develop new long-term care tailored to AD patients. | 9.71 |
| 3 | Faster access to new drugs should be ensured. | 9.43 |
| 4 | It is important to speak as much as possible about the disease to reduce stigma. | 8.57 |
| 5 | Consider awareness, healthcare funding, and cultural beliefs. | 8.29 |
| 6 | Medications should be accessible despite pricing strategies. | 8.29 |
| 7 | There is still a great deal of stigma associated with dementia and Alzheimer’s. | 7.86 |
| 8 | Public awareness should be at the highest level. | 7.43 |
| 9 | It is necessary to consider awareness, diagnosis and treatment options. | 7.29 |
| 10 | Adequate knowledge is critical in Alzheimer’s. | 7.14 |
As shown in Table 6, the final ranking identified several highly prioritised themes, with mean importance scores ranging from 7.14 to 9.71 on a 10-point scale. Two statements shared the highest rank: ``Raise awareness and educate the public and healthcare professionals'' (M = 9.71) and ``Develop new long-term care tailored to AD patients'' (M = 9.71). These findings indicate the importance that experts attribute to both public and professional education, as well as to the adaptation of long-term care systems to emerging therapeutic developments. The third-ranked statement, ``Faster access to new drugs should be ensured'' (M = 9.43), reflected concerns regarding timely and equitable availability of disease-modifying therapies. Other highly ranked statements emphasised the need to reduce stigma, consider cultural beliefs and healthcare funding, and ensure accessibility despite pricing strategies. Overall, the ranking results suggest three closely interconnected priority areas: increasing awareness and education, adapting care systems to new treatment paradigms, and ensuring equitable access to innovative Alzheimer's therapies.
5.1. Level of agreement across expert rankings
Kendall's coefficient of concordance was calculated to assess statistical agreement among experts in the final ranking round. The analysis yielded W =.084, indicating low concordance among expert rankings. This finding suggests that, although several themes received high mean importance scores, experts did not rank all priorities in the same order. High mean scores, therefore, indicate perceived importance, whereas Kendall's W reflects the degree of agreement in ranking patterns across the expert panel. Accordingly, the results should be interpreted as shared thematic priorities and partial alignment rather than strong statistical consensus.
6. Discussion
The findings of this Delphi study provide insight into how experts perceive the broader societal and systemic implications of introducing disease-modifying therapies for Alzheimer's disease. The results highlight several interconnected themes: public awareness, ethical and structural challenges, and the need to adapt long-term care systems. The following discussion interprets these findings within the context of existing research and considers their implications for health and social care systems in Central Europe.
6.1. Public awareness and destigmatisation
The findings of this Delphi study highlight that the successful introduction of disease-modifying therapies for AD, such as Lecanemab, depends strongly on raising public and professional awareness and reducing the stigma associated with dementia. Experts consistently emphasised that earlier diagnosis and treatment uptake require broader public understanding of Alzheimer's disease and greater openness in discussing cognitive decline. Similar findings have been reported in previous research showing that stigma can negatively influence help-seeking behaviour and delay diagnosis (Clement et al., 2015). However, early detection also raises ethical concerns. Karneboge et al. (2025) note that identifying AD in early symptomatic stages may cause psychological distress and contribute to stigma, while also creating uncertainty regarding reimbursement for biomarker testing. These tensions highlight the need for balanced communication strategies that encourage early diagnosis while minimising potential social and psychological burdens for patients and families.
6.2. Ethical and structural challenges of introducing therapies
The introduction of new AD therapies has also raised broader ethical and structural concerns. Scholars have emphasised that the approval of innovative treatments such as Aducanumab or GV-971 has generated complex scientific and regulatory debates, highlighting tensions between clinical evidence, pharmaceutical innovation, and patient welfare (Yeo-Teh & Tang, 2023). Several studies also point to significant logistical barriers. The implementation of anti-amyloid therapies requires specialised diagnostic procedures and monitoring infrastructure, including amyloid biomarker testing, MRI imaging, and specialised infusion services (Cummings et al., 2024). Similarly, Walsh et al. highlight that expanded diagnostic requirements may place additional pressure on healthcare systems, particularly if primary care physicians are expected to refer large numbers of patients with suspected mild cognitive impairment for specialist evaluation (Walsh et al., 2024). These findings suggest that the clinical availability of disease-modifying therapies alone will not guarantee equitable access. Instead, health systems must address organisational capacity, diagnostic infrastructure, and reimbursement frameworks to ensure fair and sustainable implementation.
6.3. Adaptation of long-term care systems and community-based models
Another important theme emerging from this study concerns the transformation of long-term care systems. Experts highlighted the need to adapt care structures to accommodate earlier diagnosis and longer periods of disease management. This may require a gradual shift from institution-centred care models toward more community-based and person-centred approaches. Previous research also emphasises that early detection and treatment will increase demand for specialist consultations, diagnostic services, and patient counselling (Aye et al., 2025). As a result, healthcare systems may need to redesign care pathways and strengthen coordination between primary care, specialist services, and long-term care providers. More broadly, global policy discussions emphasise the need to improve dementia care systems, particularly in low- and middle-income countries that face growing demographic and resource challenges (Maestre et al., 2023). Sustainable implementation of new therapies will therefore require not only medical innovation but also investment in care infrastructure and workforce development.
6.4. Cultural and regional differences in dementia care
Although Slovenia, Austria, and Bosnia and Herzegovina are geographically close, they differ significantly in the organisation of dementia care, financial capacity, and cultural attitudes toward ageing and family caregiving. These contextual factors shape how new Alzheimer's therapies may be integrated into national healthcare systems. In Austria, where treatment implementation has already begun, discussions focus primarily on clinical monitoring capacity and service organisation (Kunz, 2025). In contrast, experts from Slovenia and Bosnia and Herzegovina expressed stronger concerns regarding financing, regulatory frameworks, and broader health system preparedness. Despite these contextual differences, experts across all three countries emphasised the importance of expanding community-based care models and addressing the persistent stigma associated with dementia. Alzheimer's disease, therefore, remains not only a medical condition but also a deeply social phenomenon shaped by cultural attitudes, healthcare systems, and societal expectations. The relatively low Kendall's W value may also reflect the complexity and multidimensional nature of implementing disease-modifying therapies across heterogeneous healthcare and long-term care contexts, where experts may prioritise similar themes but differ in how they rank their relative importance.
7. Conclusion
This study suggests that the emergence of disease-modifying therapies for Alzheimer's disease represents both a therapeutic opportunity and a systemic challenge. Rather than demonstrating strong consensus, the findings indicate that three key priority areas emerged from the Delphi process: increasing public and professional awareness, ensuring equitable access to diagnostics and treatment, and adapting long-term care systems to new therapeutic realities. Although these innovations offer potential to delay disease progression and improve quality of life, their integration into practice will require coordinated health system reforms, strengthened diagnostic capacity, and sustained public engagement to reduce stigma. The findings should therefore be understood as shared thematic priorities rather than definitive expert consensus. Ultimately, the promise of new Alzheimer's therapies extends beyond pharmacological advances and calls for a broader societal commitment to transforming dementia care. This study has several limitations. The expert panel was relatively small and geographically limited to Central Europe, which may restrict the generalisability of the findings. Additionally, the Delphi method reflects expert opinion rather than empirical clinical outcomes. The authors declare that they have no known competing financial or non-financial interests that could have influenced the work reported in this paper. This study involved a Delphi survey conducted among expert participants and did not include patients or personal health data. According to applicable institutional and national research regulations, ethical approval was not required. Participation was voluntary, and all experts were informed of the study's purpose. This study was conducted without any financial support or sponsorship. This study did not involve patients or clinical subjects. Explicit written consent was not required for this study. Participation was voluntary, and informed consent was implied by completing and submitting the questionnaires.
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