AzTrials
AzTrials

Acquisition of Literacy Skills for All Children, Including Those With SLDs, Appropriateness of Referrals for SLD Assessment for Accurate Early Detection of SLDsALFABETONCT07510126

Literacy Skills Improvement and Early Diagnosis of Specific Learning Disorders (SLD) Using a New Phono Syllabic Program

A study testing Alfabeto program and Other literacy teaching methods in people with Acquisition of Literacy Skills for All Children, Including Those With SLDs, Appropriateness of Referrals for SLD Assessment for Accurate Early Detection of SLDs, run by IRCCS Burlo Garofolo at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Scientific evidence shows that systematic phonological approaches are more effective than other methods in teaching children to read and should therefore be adopted in schools. Neuropsychological and neuroscientific research confirms that reading acquisition requires activation of the phonological route because… Read more about this study

Who is it for?
Ages 5 to 6 years
What is being tested?
Alfabeto program and Other literacy teaching methods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,407 participants
Where
1 siteItaly
Study dates
5 Sep 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written Informed consent for screening tests signed by parents

Who cannot join

  • Children who need differentiated teaching programming with a dedicated teacher (L.104 Comma 1 e 3)

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Clinical Epidemilogy and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo Garofolo

    Trieste, Trieste, 34137

Other trials in Italy

About this study

Official title: Improvement of Reading and Writing Skills and Early Identification and Diagnosis of Specific Learning Disorders (SLD) Using a Structured Phonic-syllabic Program for First and Second Grade Primary School Children: a Randomized Controlled Trial

Scientific evidence shows that systematic phonological approaches are more effective than other methods in teaching children to read and should therefore be adopted in schools. Neuropsychological and neuroscientific research confirms that reading acquisition requires activation of the phonological route because engages appropriate neural circuits. Conversely, an early focus on whole word recognition hinders acquisition of the alphabetic code activating inefficient brain pathways. The aim of the randomized controlled trial is to demonstrate that the ALFABETO program, rigorous and structured phono-syllabic approach, is superior to other literacy instruction methods in promoting reading and writing skills in all children, including those with difficulties or at risk of Specific Learning Disorders (SLD). The study will recruit first-grade classes from Comprehensive Institutes in the Friuli Venezia Giulia Region that volunteer to participate to the project. Classes will be randomly assigned to an Experimental Group (ALFABETO program) or a Control Group (literacy method chosen by the class teacher). At least 902 children will be enrolled. The intervention will start in first grade and continue throughout second grade, with classes following the assigned method for both school years. Teachers in the Experimental Group will receive online training session and supervision throughout both school years. They will be provided with ALFABETO teacher manuals and student books for first and second grade. Assessments will be conducted at three time points: T0 (September 2025, prerequisite skills), T1 (May 2026, end of first grade), and T2 (May 2027, end of second grade). Standardized measures will assess reading speed, lexical decision, spelling, phonological processing, and writing speed (second grade only). Questionnaires will also be administered to schools, teachers and families. Children identified as at risk of SLD at T2 will be referred for free diagnostic evaluation at IRCCS Burlo Garofolo. Confirmed diagnoses will follow standard care pathways within the National Health Service. Inclusion criteria include parental informed consent; exclusion criteria include children receiving individualized instruction with a dedicated support teacher (Law 104). Schools must provide instruction in Italian and include first-grade classes with different teachers. Montessori, Waldorf, adult education, and multi-grade classes are excluded.

Read the detailed description

Specific learning disorders (SLDs) are neurodevelopmental disorders characterized by deficits in specific domains of reading (dyslexia), writing (dysorthographia/dysgraphia), or calculation (dyscalculia), in a relevant but defined way that leaves general intellectual functions intact. They have a neurobiological and genetic basis but are not related to neurological damage nor to significant socio-cultural disadvantages. However, SLDs can compromise personality development, social adaptation, and be associated with psychopathological disorders, both externalizing, i.e., oppositional, or defiant behaviour, and internalizing, i.e., anxious, and/or depressive traits, which can further impair a student's adaptation. In Italy, SLDs affect 3.5% of the school population; in Friuli Venezia Giulia (FVG), 3.1% of students are diagnosed with SLDs. Screening and early diagnosis play an important positive role in determining the evolution of the disorder and the overall emotional and cognitive development of children with SLDs. Diagnosis of disorders in reading and writing skills can only be made from the end of second grade in primary school. Italian and regional FVG regulations promote early identification of children with SLDs at school where, however, SLDs are often confused with learning difficulties, which affect approximately 20% of children and for which adequate reinforcement and targeted teaching methods are considered sufficient to improve reading and writing skills. This results in a high percentage of inappropriate referrals to the National Health Service (SSN) for SLD evaluation (40% false positives in 2023), leading to a lengthening of waiting times for a definitive SLD diagnosis.

The Guidelines of the Istituto Superiore di Sanità (ISS) recommend, as priority actions in first-grade primary school, phonological-metaphonological interventions to explicitly promote grapheme-phoneme association strategies for reading and writing. The literature supports these recommendations. Numerous studies have highlighted the essential role of Phonological Skills, demonstrating how systematic phonological methods are more helpful for children learning to read than all other methods and should therefore be implemented in schools. Furthermore, phonological skills also improve writing skills. This is further supported by evidence from the field of neuropsychology and from neuroscience using neuroimaging techniques. Dehaene has shown that a child learning to read needs to use the phonological pathway, which allows them to read a word by transcoding individual graphemes into their corresponding phonemes, thereby highlighting the neural circuits involved in grapheme-phoneme correspondence. On the contrary, having to pay attention to the overall shape of the word hinders the acquisition of the alphabetic code by directing brain activity towards an inadequate circuit.

The Alfabeto program is a rigorous, structured phono-syllabic approach that has been shown to be sustainable and effective in improving the reading and writing skills of all children in a quasi-experimental before-and-after study with a control group, conducted in first-grade classes during the 2019/2020 school year.

This randomized controlled trial aims to demonstrate that the Alfabeto program is superior for the acquisition of both reading and writing skills for all children, including those with learning difficulties or SLDs, compared to other teaching methods. If, as we expect, the program benefits all children, not only those with SLDs, the implementation of this method in a primary school setting should guarantee a reduction in inappropriate referrals for psychological evaluation and, consequently, in assessment waiting lists, thereby enabling true, accurate early detection of children with SLDs.

All FVG schools will be asked by the Regional School Office (USR) to join the project. School representatives will be invited to participate in a webinar to present the study and receive SLD training from specialized personnel. During the same period, family paediatricians will also be informed of the study's contents and objectives.

First-grade classes of schools that have accepted to take part in the project will be recruited. The randomization will be by class; therefore, all the children of the enrolled class, who do not have any of the exclusion criteria, will be assigned to a reading and writing learning method specified as follows:

  • control group (CG) will comply with any of the standard methods used in Italian schools to teach reading and writing in first grade (synthetic: alphabetic method, focused on the single sound; phono-syllabic, starting from the single sounds to arrive to syllables; analytical: starting from the whole word; analytical-synthetic: starting from the entire word and then moving to the single letter or vice versa). In second grade, they will follow the teacher-chosen standard program.
  • Experimental group (EG) will follow the Alfabeto reading and writing method in first grade, and will continue with the same method also in second grade.

Alfabeto is a structured phono-syllabic program, developed by SApIE Association (Society for Learning and Education informed by Evidence) starting from the working material of Dr. Ventriglia. It is:

  • Phonological: based on the phonological and meta-phonological dimensions;
  • Syllabic: open syllables [i.e., Consonant-Vowel groups (CV)] are central to the methodology;
  • Generative: Once the ability to read CVs has been acquired, reading is extended to all types of compound forms.
  • Structured: it progresses according to a precise order of phonological difficulty, and full words or parts of them are never presented to children before they can decode them analytically; therefore, children master the mechanics of reading gradually.
  • Explicit: the program is composed of 5 units, each divided into 2-hour work sessions with clear didactic objectives, exercises, and games. The program is carried out in compliance with the principles of cognitive load theory, which require that no distracting stimuli, particularly graphic ones, be used. (19)
  • Playful: the program requires teachers to convey a sense of play, fun, and passion for the pronunciation of sounds to make children feel that phono-syllabic learning can be fun. Mistakes are part of the process; teachers themselves will play making mistakes, asking children to correct them.

Block randomization to either CG or EG will be performed by the SCR of Clinical Epidemiology and Public Health Research Unit using a computerized electronic random number generator.

Blocks will be single schools or school areas, so that first-grade classes within the same school or area will be paired and balanced by demographic and socio-cultural background. Given the experimental nature of the intervention, it will not be possible to ensure blindness.

Before the start of the school year, participating schools will be notified of the class assignment to EG or GC, and EG teachers will complete a 2-hour online synchronous training course on the Alfabeto program led by Dr. Ventriglia. She will also support EG teachers throughout the school year, both in the first and second grades, through monthly 2-hour synchronous online meetings.

EG teachers will receive the Teacher's Book to guide them step by step in applying the Alfabeto program, and EG children will receive the Child's Book, both in the first and second grades.

Parents of enrolled children will be adequately informed about the study at the beginning of the school year. They will be asked to sign informed consent for the administration of the validated tests used in the study, and a specific consent to privacy for the acquisition and storage of data collected through the study. Parents will also be asked to complete a questionnaire about the child and family (language spoken at home, age, parents' work and education, child's health problems, disability certification).

EG or CG teaching will start in September 2025 (start of first grade: T0) and will end in June 2027 (end of second grade: T2). At T0:

  1. A progressive ID number will be assigned to each child to ensure maximum confidentiality of data collected and analysed;
  2. Scores will be collected from the prerequisite tests administered to each child who meets the inclusion criteria, regardless of the allocation group. The tests administered online or on-site by research fellows or university students assigned to the project will be: the PRCR-2 Battery Quick Colour Naming and Letter recognition test and the Spontaneous writing test;
  3. Schools will be asked to fill in a questionnaire on the economic and social characteristics of the area in which the school is situated and of the families of the pupils who attend it, as well as on the procedures implemented for the identification and management of SLD children. Teachers will be asked to describe the methods they have used to teach reading and writing over the years, as well as their knowledge of SLDs, including the support they provide and the actions they take. Information will be collected on which textbook has been chosen for the first three years of primary school.

At T1:

  1. Scores for the following tests will be collected for each child, regardless of the allocation group: New Reading Tests MT for school - speed of reading, Lexical decision test (DLC), Integrated Stella - Apolito word dictation, and the METAFONO test. The DLC, METAFONO test and the word dictation will be administered collectively by the teachers while the MT test will be administered individually online or on-site by research fellows or university students assigned to the project. Children with scores that classify them as at risk for SLDs in at least one of the above tests will be considered 'T1 presumed SLD'.
  2. Scores for the following questionnaire will be collected for each child, regardless of the allocation group: SDQ-I (Strengths and Difficulties Questionnaire) filled in by the class teacher/s.

At T2:

  1. The same tests performed at T1, with the same parameters but specific for the second grade, plus the collective BVSCO writing speed test, will be administered. Children with a score that classifies them as at risk for SLDs ' in at least one of the above tests will be considered 'T2 presumed SLD'.
  2. The same SDQ-I, filled in by the class teacher/s, will also be collected. 'T2 presumed SLD' children will be sent to IRCCS Burlo Garofolo for SLD evaluation, as per the ISS Guideline. The evaluation visit, booked through the hospital's booking centre (CUP) with a specific research code and free of charge for participating families, will consist of a first psychological visit carried out by qualified research fellows assigned to the project online or in person at the Child Neurology and Psychiatry Department of IRCCS Burlo Garofolo. This set-up will ensure that SLD evaluation is delivered to 'T2 presumed SLD' children in a timely and manageable manner.

All SLD diagnoses will be documented and registered in a medical report inserted into the regional clinical system (G2). The medical report, including the functional profile and the impaired abilities, will be delivered to families and, through them to schools, after confirmation and countersignature by the authorized neuropsychiatrist/psychologist of the Child Neurology and Psychiatry Department.

Non-SLD children will be provided with tools to improve their reading and writing skills. SLD-confirmed children will enter the standard of care pathway, and all subsequent visits will be managed and paid through the (SSN) according to standard practices, including the payment of the 'ticket' by families that are not entitled to specific exemptions.

Inclusion criteria include parental informed consent; exclusion criteria include children receiving individualized instruction with a dedicated support teacher (Law 104). Schools must provide instruction in Italian and include first-grade classes with different teachers. Montessori, Waldorf, adult education, and multi-grade classes are excluded.

Being tested
Alfabeto program, Other literacy teaching methods
Keywords
Alfabeto program, Early SLD intervention and diagnosis, Waiting list reduction, Improvement of reading and writing skills
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alfabeto programOther

    Alfabeto is a structured phono-syllabic program developed by the SApIE Association from Dr. Ventriglia's materials. The method focuses on phono-syllabic and meta-phonological skills, with open CV syllables at the core. The method is generative: once CV decoding is mastered, reading extends to more complex forms. It is structured and explicit, progressing according to increasing phonological difficulty and preventing exposure to whole words before analytic decoding skills are acquired. The program includes five units with 2-hour sessions, clear objectives, exercises and games, and follows cognitive load theory by avoiding distracting stimuli. It adopts a playful approach, encouraging enjoyment of sound pronunciation and treating errors as part of learning.

  • Other literacy teaching methodsOther

    The other literacy teaching methods will be those used in Italian schools to teach reading and writing in first grade (synthetic: alphabetic method, focused on the single sound; phono-syllabic, starting from the single sounds to arrive to syllables; analytical: starting from the whole word; analytical-synthetic: starting from the whole word and then moving to the single letter or vice versa). In second-grade, they will follow the standard program chosen by the teacher.

Study groups in NCT07510126
Study groupRoleWhat they receive
Experimental Group (EG)ExperimentalThe Experimental Group (EG) will follow the Alfabeto reading and writing method in first and second grade.
Receives: Other: Alfabeto program
Control Group (CG)Active comparatorThe control group (CG) will comply with any of the standard literacy teaching methods used in Italian schools to teach reading and writing to first graders.
Receives: Other: Other literacy teaching methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in mean DLC score between EG and GC groups

    DLC is made up of a list of 60 words and 60 non-words (i.e. nonsense). The task required is to recognize and mark the non-words. The evaluation of the performance is given by the score obtained by adding 1 point for each recognized non-word and subtracting 1 point for each word (i.e. with a complete meaning) marked incorrectly. Outcome variable is continuous and can get to a maximum of 60 points.

    Measured: 8 months from enrolment

Secondary outcomes (13)
  1. Difference in mean MT score between EG and GC groups

    Outcome variable is the reading time. It is a continuous variable and can get to a maximum of 4 minutes

    Measured: 8 months from enrolment

  2. Difference in mean word dictation score between EG and GC groups

    Collective integrated dictation test requires children to write 16 words of increasing phonological complexity with the addition of 2 trisyllable and 2 quadrisyllable words with complex consonant groups. The score will be given by assigning 1 point for each correct word and 0 points for each incorrect word. Both the word with errors within the graphemic structure (omissions, substitutions) and the word omitted or only partially transcribed will be considered incorrect. Only in the first grade, double letter errors and mirror writing are not considered. The outcome variable is continuous and can get to a maximum of 20.

    Measured: 8 months from enrolment

  3. Difference in mean DLC score between EG and GC groups

    DLC is made up of a list of 60 words and 60 non-words (i.e. nonsense). The task required is to recognize and mark the non-words. The evaluation of the performance is given by the score obtained by adding 1 point for each recognized non-word and subtracting 1 point for each word (i.e. with a complete meaning) marked incorrectly. Outcome variable is continuous and can get to a maximum of 60 points.

    Measured: 20 months from enrolment

  4. Difference in 'presumed SLD' prevalence between EG and GC groups

    Percentage

    Measured: 8 months from enrolment

  5. Difference in mean word dictation score between EG and GC groups

    Collective integrated dictation test requires children to write 16 words of increasing phonological complexity with the addition of 2 trisyllable and 2 quadrisyllable words with complex consonant groups. The score will be given by assigning 1 point for each correct word and 0 points for each incorrect word. Both the word with errors within the graphemic structure (omissions, substitutions) and the word omitted or only partially transcribed will be considered incorrect. Only in the first grade, double letter errors and mirror writing are not considered. The outcome variable is continuous and can get to a maximum of 20.

    Measured: 20 months from enrolment

  6. Difference in mean MT score between EG and GC groups

    Outcome variable is the reading time. It is a continuous variable and can get to a maximum of 4 minutes

    Measured: 20 months from enrolment

  7. Difference in mean writing BVSCO score between EG and GC groups

    The test is structured in three parts: a. Write continuously, without lifting the pen from the paper, in cursive, the syllable "le" for one minute. In the evaluation, the number of correct pairs, in which both graphemes are recognizable, is counted and multiplied by 2; b. Write the word "uno", in cursive, for one minute. The evaluation considers the number of recognizable graphemes; c. Write the numbers in the word in order, starting from one, for one minute. The evaluation considers the number of recognizable graphemes. Total score is obtained summing the three sub-score and the outcome variable is continuous.

    Measured: 20 months from enrolment

  8. Difference in prevalence of 'presumed SLD' (sent for clinical evaluation) between EG and GC groups

    Percentage

    Measured: 20 months from enrolment

  9. Difference in diagnosed SLD prevalence between EG and GC groups

    Percentage

    Measured: 30 months from enrolment

  10. Difference in diagnosed SLD/'presumed SLD' percentage between EG and GC groups

    Percentage

    Measured: 30 months from enrolment

  11. Difference in mean T2-T1 scores, for all standardized tests, between EG and GC groups

    Outcome variable is continuous and can be a negative number

    Measured: 20 months from enrolment

  12. Difference in mean meta-phonological (METAFONO) score between the EG and GC groups

    The MeTaFono is a phonological awareness test consisting of 16 closed-ended items. Each item is designed to evaluate the identification of phonological units across increasing levels of complexity, including initial phonemes (4 items), final phonemes (4 items), initial syllables (4 items), and final syllables (4 items).

    Items are scored dichotomously: one point for each correct response and zero for each incorrect response. No partial credit is given, and incorrect responses are not penalized. The total score is computed by summing the number of correct responses, yielding a score range from 0 to 16, with higher scores indicating a more advanced level of phonological awareness. The outcome variable is continuous and can get to a maximum of 16.

    Measured: 8 months from enrolment

  13. Difference in mean meta-phonological (METAFONO) score between the EG and GC groups

    The MeTaFono is a phonological awareness test consisting of 16 closed-ended items. Each item is designed to evaluate the identification of phonological units across increasing levels of complexity, including initial phonemes (4 items), final phonemes (4 items), initial syllables (4 items), and final syllables (4 items).

    Items are scored dichotomously: one point for each correct response and zero for each incorrect response. No partial credit is given, and incorrect responses are not penalized. The total score is computed by summing the number of correct responses, yielding a score range from 0 to 16, with higher scores indicating a more advanced level of phonological awareness. The outcome variable is continuous and can get to a maximum of 16.

    Measured: 20 months from enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start5 Sep 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled open-label superiority trial
Masking
None (open label)
Enrolment
1,407 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510126
Sponsor's protocol ID
RC 04/25
Acronym
ALFABETO
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be shared only upon motivated request to the PI of the study

Publications

  • Tressoldi PE, et al.; BVSCO-2 Batteria per la valutazione della scrittura e della competenza ortografica - 2; 2012; Giunti OS Editore

  • Marotta L, et al.; Test CMF Valutazione delle competenze metafonologiche; 2004; Erickson Editore.

  • Stella G, Apolito A.; Lo screening precoce nella scuola elementare. Può una prova di 16 parole prevedere i disturbi specifici di apprendimento?; Dislessia; 2004; 1(1); 111-118.

  • Caldarola N, et al.; DLC. Una prova di decisione lessicale per la valutazione collettiva delle abilità di lettura; Dislessia; 2012; 9; 89-104.

  • Cornoldi C, Colpo G.; Prove di lettura MT-2 per la scuola primaria; 2012; Giunti OS Editore.

  • Frith U.; Beneath the surface of developmental dyslexia, in Patterson KE et al, Surface Dislexia; 1985; London Routledge & Kegan Paul.

  • Cornoldi C, et al.; PRCR. Prove di Prerequisito per la Diagnosi delle Difficoltà di Lettura e Scrittura; 2009; Giunti OS Editore.

  • Calvani A, Ventriglia L.; Libro del bambino per la classe seconda; presumed publication year 2026; Carocci Editore.

  • Calvani A, Ventriglia L.; Libro dell'insegnante per la classe seconda; presumed publication year 2026; Carocci Editore.

  • Calvani A, Ventriglia L.; Libro del bambino per la classe prima; 2023; Carocci Editore.

  • Calvani A, Ventriglia L.; Libro dell'insegnante per la classe prima; 2023; Carocci Editore.

  • Calvani A.; Teorie dell'istruzione e carico cognitivo, modelli per una scuola efficace; 2009; Erickson Editore.

  • Ventriglia L.; Come insegnare a leggere ai bambini. Presentazione di una metodologia; Form@re; 2016; 2(16); 374-384.

  • Calvani A, et al.; Teaching to read: an interesting interface between neuroscience and education; Italian journal of educational technology; 2022; doi:10.17471/2499-4324/1265

  • Dehaene S.; I neuroni della lettura; 2009; Raffaello Cortina Editore

Questions about this trial

What is this clinical trial studying?

A study testing Alfabeto program and Other literacy teaching methods in people with Acquisition of Literacy Skills for All Children, Including Those With SLDs, Appropriateness of Referrals for SLD Assessment for Accurate Early Detection of SLDs, run by IRCCS Burlo Garofolo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in mean DLC score between EG and GC groups (time frame: 8 months from enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510126, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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