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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acquisition of Literacy Skills for All Children, Including Those With SLDs, Appropriateness of Referrals for SLD Assessment for Accurate Early Detection of SLDs
• Intervention / Treatment: Other: Alfabeto program; Other: Other literacy teaching methods

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.

• Study Type: Interventional
• Enrollment (Estimated): 1407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste
    • Trieste, Trieste, Italy, 34137
      • Clinical Epidemilogy and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Children who will attend, starting in September 2025, first-grade classes of schools in the FVG region:

• who have accepted the participation in the project
• with Italian as the primary language
• with at least two first-grade (non-multigrade) classes in which Italian is taught as the primary language by different teachers, following curricula that do not include Montessori, Waldorf, Pizzigoni, or Agazzi.

Inclusion Criteria:

Written Informed consent for screening tests signed by parents

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (EG); The Experimental Group (EG) will follow the Alfabeto reading and writing method in first and second grade.	Other: Alfabeto program; 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.
Active Comparator: Control Group (CG); The 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.	Other: Other literacy teaching methods; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 months from enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months from enrolment
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.	8 months from enrolment
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.	20 months from enrolment
Difference in 'presumed SLD' prevalence between EG and GC groups	Percentage	8 months from enrolment
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.	20 months from enrolment
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	20 months from enrolment
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.	20 months from enrolment
Difference in prevalence of 'presumed SLD' (sent for clinical evaluation) between EG and GC groups	Percentage	20 months from enrolment
Difference in diagnosed SLD prevalence between EG and GC groups	Percentage	30 months from enrolment
Difference in diagnosed SLD/'presumed SLD' percentage between EG and GC groups	Percentage	30 months from enrolment
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	20 months from enrolment
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.	8 months from enrolment
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.	20 months from enrolment

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Collaborators: University of Trieste; University of Udine; Regione Friuli Venezia Giulia; Ufficio Scolastico Regionale Friuli Venezia Giulia

Publications and helpful links

General 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
• Padovani R, et al.; Sperimentazione del metodo sillabico per insegnare a leggere e scrivere nella scuola primaria; Dislessia; 2018; 15(2); 161-172.
• Franceschi S, et al.; Identificazione precoce dei soggetti a rischio DSA ed efficacia di un intervento abilitativo meta fonologico; Dislessia; 2011; 8(3); 247-266.
• Pinto G.; Il suono, il segno, il significato. Psicologia dei processi di alfabetizzazione; 2003; Carocci Editore
• Melby-Lervag M, Lyster SA, Hulme C. Phonological skills and their role in learning to read: a meta-analytic review. Psychol Bull. 2012 Mar;138(2):322-52. doi: 10.1037/a0026744. Epub 2012 Jan 16.
• Ehri LC, et al.; Phonemic awareness instruction helps children learn to read: evidence from the national reading panel's meta-analysis; Reading Research Quarterly; 2001; 36; 250-287.
• Melon C, et al.; Response to intervention model for the prevention of learning difficulties and early identification of learning disabilities: a pilot study; Gior Neuropsich Età Evol; 2014; 34; 191-198.
• Delibera regionale Friuli Venezia Giulia n.933; Protocollo d'intesa per le attività di identificazione precoce dei casi sospetti di disturbo specifico dell'apprendimento; 2014.
• Ministero dell'Istruzione, dell'Università e della Ricerca; Linee guida per la predisposizione di protocolli regionali per l'individuazione precoce dei casi sospetti di DSA; 2013.
• Ministero dell'Istruzione, dell'Università e della Ricerca; Legge 8 ottobre 2010, n 170; Nuove norme in materia di disturbi specifici di apprendimento in ambito scolastico.
• Ministero dell'Istruzione, dell'Università e della Ricerca; Linee guida per il diritto allo studio degli alunni e degli studenti con DSA; 2011
• Byrne J, et al.; Effects of preschool phoneme identity training after six years; Journal of Educational Psychology; 2000; 92; 659-667.
• Barbiero C, Montico M, Lonciari I, Monasta L, Penge R, Vio C, Tressoldi PE, Carrozzi M, De Petris A, De Cagno AG, Crescenzi F, Tinarelli G, Leccese A, Pinton A, Belacchi C, Tucci R, Musinu M, Tossali ML, Antonucci AM, Perrone A, Lentini Graziano M, Ronfani L; of behalf of the EpiDIt (Epidemiology of Dyslexia in Italy) working group. The lost children: The underdiagnosis of dyslexia in Italy. A cross-sectional national study. PLoS One. 2019 Jan 23;14(1):e0210448. doi: 10.1371/journal.pone.0210448. eCollection 2019.
• Livingston EM, et al.; Developmental dyslexia: Emotional impact and consequences; Learning Difficulties Australia; 2018; 23(2); 107-35.
• Istituto Superiore di Sanità; Linee guida: Gestione dei Disturbi Specifici dell'Apprendimento (DSA); 2018
• American Psychiatric Association; Diagnostic and statistical manual of mental disorders (5th ed.); Arlington, VA; American Psychiatric Publishing; 2013

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Alfabeto program; Early SLD intervention and diagnosis; Waiting list reduction; Improvement of reading and writing skills
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease
• Other Study ID Numbers: RC 04/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared only upon motivated request to the PI of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No