Osteoporosis and Sarcopenia Prevention in Middle-Aged Population (FORTIFY)
This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies.
The study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs).
After baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level.
All participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis/sarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year [QALY] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Christian FANG
- Número de telefone: +852 22554581
- E-mail: cfang@hku.hk
Locais de estudo
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Hong Kong, Hong Kong
- Queen Mary Hospital, The University of Hong Kong, Hong Kong,
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Investigador principal:
- Christian FANG
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Contato:
- Christian FANG
- Número de telefone: +852 22554581
- E-mail: cfang@hku.hk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- General Population: Women and men aged 40-60 years, defined as age groups where the rate of injuries were still relatively lower, thus considered as a low to moderate risk cohort for osteoporosis.
- Risk profile: Targets a low to moderate risk cohort for osteoporosis (e.g., as defined by no prior fragility fracture and questionnaire). This aligns with the study's primary prevention objective.
- Individuals with well-controlled comorbidities like hypertension, diabetes, or pre-diabetes can be included in the study program. Exercise and healthy nutritional diets can also help treat their existing health conditions.
Exclusion Criteria:
- Significant comorbidities: Individuals with existing (e.g., severe or uncontrolled) medical illness, due to risk to aerobic exercise. This includes, but is not limited to, active ischemic heart disease, unstable angina, uncontrolled hypertension, or other conditions as determined by study physicians.
- High baseline activity: Individuals who have engaged in >4 hours intensive sports per week will be excluded. This population is deemed to be at very low risk, thus would likely derive minimal additional benefit from the intervention, and their inclusion could represent inefficient use of finite resources (e.g., DEXA scanning services).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention Group
The intervention group will receive active, dynamic, and sustained support designed to build habits and maintain long-term healthy habits.
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The interventions include FUN Day, reinforcement FUN Day (2 months), nine mandatory structured exercise touchpoints, active chatbot with reminders/feedback/gamification, start and end DEXA scans (co-payment), 3-month assessment, ongoing incentives, and souvenirs at multiple points.
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Comparador Ativo: Control Group
The control group will receive passive and static support.
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The control group serves to establish baseline comparison with the intervention group to determine whether this new and intensive program is significantly better than the current standard of advice and basic tools.
These include FUN Day, exercise videos, passive chatbot for data reporting, start and end DEXA scans (co-payment), 3-month assessment, and souvenirs at study start and end.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fracture risk
Prazo: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
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It measures the incidence of fracture or adverse events, which is the ultimate clinical endpoint for osteoporosis prevention. Unit of measure: Count of fractures (per participant) Source: Electronic report/questionnaire and medical records for verification |
To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Quality-Adjusted Life Years ("QALYs")
Prazo: Questionnaire to be taken at baseline (first FUN Day), post-intervention assessment day at 3-month, and annually during the study period (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
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It assesses cost-effectiveness compared to pharmacological treatment, using the EQ-5D-5L questionnaire to calculate Quality-Adjusted Life Years (QALYs), which measure both the quality and length of life. This calculation also incorporates cost data derived from both the program itself and overall healthcare utilization. Unit of measure: 0.0 to 1.0 (the higher the better), though the scale can technically go below zero. A score of 1.0 represents perfect, full, or optimal health, while a score of 0.0 is equivalent to a health state of death. Scores between 0.01 and 0.99 reflect living with varying degrees of disability. Source: participant self-administered questionnaire |
Questionnaire to be taken at baseline (first FUN Day), post-intervention assessment day at 3-month, and annually during the study period (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
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Health literacy
Prazo: Questionnaire to be taken at baseline (during first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
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Knowledge of osteoporosis, sarcopenia, exercise, and healthy diet tested. Unit of measure: total source (higher = better understanding) reflects the participants' capacity to manage their own risk and to reject harmful misconception. Unit of Measure: Summary score, higher indicates better knowledge (exact range to be specified). Source: Short, self-administered electronic questionnaire. |
Questionnaire to be taken at baseline (during first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after study ends, years 4-10).
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Change in bone mineral density (BMD)
Prazo: Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.
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Participants' BMD measurements done by DEXA scans (e.g., Z-score or T-score at lumbar spine and hip). It is a gold-standard indicator of osteoporosis risk and primary prevention target. Unit of measure: T-score or Z-score (unitless). T-score compares to healthy young adult (normal ≥ -1.0; osteopenia -2.5 to -1.0; osteoporosis ≤ -2.5). Z-score compares to age-matched population (normal > -2.0; below expected ≤ -2.0). Source: DEXA scan |
Scans to be done twice, once at baseline (after first FUN Day) and another scan between years 2-3 of the study.
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Fall risk
Prazo: To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
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Measures the participants' use of specialist and inpatient services (e.g., Accident & Emergency Department visits). Unit of Measure: Count of such events during the observation period. Source: Electronic questionnaire/report and medical record verification |
To be reported monthly throughout study period (years 0-3) and annually after the study ends with long-term follow up (years 4-10).
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Upper body musculoskeletal strength
Prazo: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Assessed based on grip strength value using digital dynamometer. The participant squeezes the device with maximum effort and force is recorded. It is a strong predictor of overall muscle strength and fracture risk. It is low cost and scalable. Unit of measure: Force in kilogram (kg). ≥24 kg target, which aligns with Asian fracture risk thresholds Source: Physical assessment with dynamometer |
Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Lower body musculoskeletal strength
Prazo: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Assessed by using the 30-second chair stand test and it reflects functional mobility, including fall risk, endurance, and daily function. Participants are asked to stand up fully and sit down again as many times as possible in 30 seconds. Unit of Measure: Number of completed stands. Higher counts indicate better lower-body strength and functional mobility Source: Physical assessment |
Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Balance
Prazo: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Assessed using the single leg stance test. The participant stands on one leg at a time with eyes open and arms positioned at the sides. The time they can maintain the position without the raised foot touching the ground is recorded, with a maximum of 30 seconds per trial. Each leg is tested separately. Longer standing times indicate better balance, which reflects functional mobility, fall risk, endurance, and daily function. Unit of Measure: The time in seconds from when the raised foot leaves the floor until it touches the ground, recorded as a value less than 30 seconds. If the participant maintains the position for 30 seconds or longer, the score is recorded as ">30 seconds" (maximum). Source: Physical assessment. |
Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Cardiovascular fitness
Prazo: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Assessed by using the three-minute step test and it reflects functional mobility, including fall risk, endurance, and daily function. Unit of Measure: Heart rate measured for 60 seconds or 1 minute in beats per minute (bpm) Source: Physical Assessment with the heart rate monitor |
Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Lean muscle mass distribution
Prazo: Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Assessed by using the InBody composition analysis. It serves as a proxy for sarcopenia risk and early marker of physical decline. Unit of Measure: Estimated lean mass in kilograms (kg) Source: InBody machine |
Assessment to be taken at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Intervention group has additional measurements during reinforcement FUN Day before the 3-month assessment day.
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Exercise adherence
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured by using the Exercise Adherence Rating Scale (EARS) is a self-administered questionnaire delivered by the chatbot. It contains 6 items (e.g., "I do my exercise as prescribed") rated on a 5-point Likert scale (0 = never, 4 = always). Unit of Measure: Total scores range from 0 to 24, with higher scores indicating better adherence. Source: Electronic self-reported questionnaire. |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Exercise frequency
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured as the number of exercise sessions logged by the participant via chatbot. Unit of measure: Number of sessions. Source: Electronic questionnaire and records |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Physical activity level
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured using the Physical Activity Rating Scale-3 (PARS-3). This self-report questionnaire assesses the frequency, duration, and intensity of physical activity. Each criterion is scored on a 5-point scale. Unit of Measure: Responses are converted into a continuous score. Generally to find the total score, the scores from three different categories are multiplied together, resulting in a final score between 0 and 100. Higher scores represent higher overall physical activity levels beyond the structured program sessions. This total categorizes a person's physical activity into low (lower or equivalent to 19 points), moderate (20 to 42 points), or high (higher or equivalent to 43 points) levels. Exact range to be specified) Source: Electronic self-reported questionnaire |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Dietary habits (e.g. calcium and vitamin D)
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured based on self-reported nutrition survey. It is essential for bone formation and muscle health. Unit of measure: Score, with higher score showing better adherence to dietary guidelines (exact range to be specified) Source: Chatbot questionnaire |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Self-efficacy for exercise
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured based on self-reported questionnaire using Self-Efficacy for Exercise Scale - Chinese (SEE-C). It predicts long-term maintenance of physical activity together with the PRETIE-Q questionnaire. Unit of Measure: Total score (exact range to be determined), with higher score indicates greater self-efficacy. Source: Electronic questionnaire. |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Exercise tolerance
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured by using PRETIE-Q questionnaire to measure preference for and tolerance of high-intensity exercise. It predicts long-term maintenance of physical activity together with the Self-Efficacy for Exercise Scale - Chinese (SEE-C) questionnaire. Unit of Measure: Score (exact range to be specified), with higher score means greater preference or tolerance. Source: Electronic self-reported questionnaire |
To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Chatbot engagement
Prazo: To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.
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Measured based on chatbot usage data captured (with backend digital analytics) throughout the 4-year study. It is a proxy for sustained participant engagement. Unit of measure: number of interactions (count) or response rate (%), to be determined later. Continuous with range determined later and higher engagement means better outcome measure. Source: Digital usage data with backend digital analytics. |
To be reported monthly throughout the 4-year study (years 0-4). Long-term follow up if possible.
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Satisfaction on the program
Prazo: To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Measured based on short, self-administered questionnaire by chatbot.
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To be reported at baseline (first FUN Day), post-intervention assessment day at 3 months, and annual year assessments (years 1-3). Long-term follow up if possible (annually after the study ends, years 4-10).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christian FANG, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças ósseas
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Manifestações Neuromusculares
- Condições Patológicas, Anatômicas
- Doenças Metabólicas
- Doenças Ósseas Metabólicas
- Atrofia Muscular
- Atrofia
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Osteoporose
- Sarcopenia
- Técnicas de investigação
- Design de pesquisa epidemiológica
- Métodos epidemiológicos
- Design de pesquisa
- Métodos
- Grupos de controle
Outros números de identificação do estudo
- UW 26
- 2026-0026-002 (Número de outro subsídio/financiamento: The Hong Kong Jockey Club Charities Trust)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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