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Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses (BISTRO)

1. června 2026 aktualizováno: Montefiore Medical Center

Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial

This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.

The study compares two ways of connecting people to treatment:

Referral to a community treatment provider (usual care before the new program begins).

Onsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.

Participants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.

The study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.

The overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This is a Type 1 hybrid effectiveness-implementation study designed to evaluate the impact and feasibility of implementing low-threshold buprenorphine (BUP) treatment at syringe service programs (SSPs) in order to improve access to and retention in medications for opioid use disorder (MOUD) treatment among people with moderate to severe opioid use disorder (OUD). The study seeks to understand whether the low-threshold approach improves participant-level outcomes and how SSPs can successfully implement and sustain this model.

Study Design

The study uses a cluster randomized stepped wedge design, in which eight SSPs will be randomly and sequentially assigned to begin implementing the low-threshold BUP program until all sites have transitioned from the referral condition to the intervention condition. This design allows each site to serve as its own control and ensures equitable access to the intervention over time. The stepped wedge design also facilitates examination of temporal effects, while accounting for differences in local environments and SSP readiness for implementation.

Participants will be recruited across the eight SSPs in different geographic regions of the United States. SSPs will be selected to represent a range of community types (urban, suburban, and rural) and to reflect varying policy environments related to MOUD access.

Study Rationale and Background

Despite robust evidence that buprenorphine reduces overdose deaths and improves recovery outcomes, access to this medication remains limited, especially among people who use drugs and have difficulty navigating the healthcare system. Low-threshold buprenorphine models aim to reduce barriers by emphasizing same-day access, flexibility, and a treatment orientation that meets participants "where they are."

SSPs provide a trusted, nonjudgmental environment and are uniquely positioned to engage individuals who are at highest risk for overdose and least likely to access formal treatment. Integrating buprenorphine prescribing directly within SSPs could substantially expand access to life-saving treatment in community settings.

Study Objectives

Primary Objective:

To evaluate the effectiveness of low-threshold BUP treatment at SSPs compared to treatment as usual (TAU) for increasing 3-month retention in buprenorphine treatment.

Secondary Objectives:

Assess buprenorphine adherence, additional OUD treatment outcomes, and health-related quality of life.

Examine the cost-effectiveness of implementing low-threshold BUP at SSPs from both payer and societal perspectives.

Characterize implementation outcomes-adoption, acceptability, appropriateness, feasibility, reach, fidelity, and sustainability-across diverse SSP settings.

Exploratory Objectives:

Explore participant-level moderators (e.g., polysubstance use, co-occurring mental health conditions, housing status, rurality) that may predict outcomes or differential intervention effects.

Identify contextual determinants (organizational capacity, policy environment, leadership engagement) associated with successful SSP implementation.

Study Procedures

Participants will complete study assessments at baseline, 1 month, 3 months, and 6 months post-enrollment. Measures will include substance use patterns, treatment engagement, overdose events, hospitalizations, and self-reported recovery activities. Laboratory-confirmed urine drug screens will be used to verify buprenorphine adherence.

Pre-implementation (Treatment-as-Usual) Prior to implementing the low-threshold BUP model, SSPs will provide standard care, which includes referral to community MOUD providers for BUP treatment.

Post-implementation (Low-Threshold BUP Program) Once implementation begins, SSPs will offer onsite BUP treatment directly through trained prescribers and peer outreach workers. Clients identified as eligible and interested will receive a medical evaluation from a study clinician (SC), including assessment for contraindications, education on BUP use, and initiation via home induction or observed dosing as appropriate.

Follow-up visits will occur approximately every 4 weeks for 6 months and include focused psychosocial counseling, urine drug screening (when requested by the study clinician), and continued prescription management. Both in-person and telehealth models may be used to enhance accessibility. Participants may use any FDA-approved formulation of buprenorphine, including injectable long-acting formulations, based on shared decision-making between study clinician and participant.

Implementation Facilitation Strategy

To support successful and sustainable adoption of the low-threshold BUP model, the study's Lead Node (LN) will develop and deliver an Implementation Facilitation Package. This package will include:

Structured training for SSP staff and clinicians on low-threshold buprenorphine principles and program logistics.

Coaching on identifying a site champion, hiring or engaging a prescriber, and establishing clear protocols for medication management.

Ongoing facilitation meetings between the LN and SSP implementation teams (champion, prescriber, peer outreach worker) to troubleshoot challenges, monitor fidelity, and adapt workflows.

Tools for tracking and sustaining reach, fidelity, and acceptability over time.

Hypotheses and Analytical Approach

The central hypothesis is that embedding low-threshold buprenorphine treatment within SSPs will improve engagement and retention in MOUD compared to standard referral pathways. Analyses will use mixed-effects regression models accounting for site-level clustering and time effects. Effectiveness analyses will focus on 3-month retention as the primary outcome, with sensitivity analyses at 6 months. Cost-effectiveness analyses will use quality-adjusted life years (QALYs) as the main effectiveness measure.

Implementation analyses will use the Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) frameworks to identify determinants, measure outcomes, and map facilitation processes. Qualitative interviews with staff and participants will complement quantitative metrics, offering a comprehensive understanding of how and why the intervention succeeds or encounters barriers.

Expected Impact

This study addresses a critical public health need by testing a scalable, community-driven model of OUD treatment. If the low-threshold SSP-based buprenorphine program is found to be effective and cost-efficient, the Implementation Facilitation Package developed through this study will serve as a replicable framework for dissemination to SSPs or other community-based settings nationwide. The findings have the potential to directly inform national strategies for expanding access to evidence-based treatment, reducing overdose deaths, and promoting patient-centered care.

Typ studie

Intervenční

Zápis (Odhadovaný)

512

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy, 90029
        • Community Health Project Los Angeles (CHPLA)
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Amanda Cowan, MSc
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20002
        • HIPS
        • Kontakt:
    • Louisiana
      • Baton Rouge, Louisiana, Spojené státy, 70806
        • CARPBR/Be Safe Syringe Program
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Gjvar Payne
    • Minnesota
      • Duluth, Minnesota, Spojené státy, 55805
        • Harm Reduction Sisters
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Sue Purchase
    • New Mexico
      • Roswell, New Mexico, Spojené státy, 88203
        • Alianza of New Mexico
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ryan Nix
    • Oregon
      • Grants Pass, Oregon, Spojené státy, 97526
        • HIV Alliance
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Harmony Beckett
        • Dílčí vyšetřovatel:
          • Michaela Starr O'Leary
    • South Carolina
      • Greenville, South Carolina, Spojené státy, 29605
        • Challenges, Inc/Prisma Health
        • Vrchní vyšetřovatel:
          • Alain Litwin, MD
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Marc Burrows, MSW, LMSW, CPSS
    • Wisconsin
      • Milwaukee, Wisconsin, Spojené státy, 53212

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  1. ≥ 18 years old;
  2. Meet DSM-5 criteria for moderate or severe OUD;
  3. Interest in receiving buprenorphine treatment;
  4. Speaks English or Spanish;
  5. Currently an SSP client at the time of enrollment;
  6. Ability to provide informed consent.

Exclusion Criteria:

  1. Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;
  2. Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;
  3. Allergy to buprenorphine;
  4. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Treatment As Usual (TAU)
Participants enrolled before the intervention is implemented at each syringe service program (SSP) will receive standard of care, consisting of referral to community-based buprenorphine treatment providers. SSP staff will offer information and referral support but will not provide on-site buprenorphine treatment or prescribing.
Jiný: Standard of Care Referral
During the pre-implementation phase, SSP staff will refer participants with opioid use disorder to external community providers for buprenorphine treatment. Services offered include information, referral assistance, and linkage to care, but buprenorphine will not be initiated or managed at the SSP site.
Ostatní jména:
  • TAU
Experimentální: Low-threshold Buprenorphine (LTB)
After implementation at each SSP site, participants will have access to on-site, low-threshold buprenorphine treatment integrated into SSP services. This model focuses on minimizing barriers to treatment initiation and retention and includes , flexible policies and procedures and collaboration with a peer outreach worker.
Behaviorální: Low Threshold Buprenorphine

During the post-implementation phase, SSPs will implement a low-threshold model of care for buprenorphine treatment. This model includes:

Low barrier to entry

Flexible scheduling and follow-up procedures

Risk reduction counseling

Collaboration with a peer outreach worker

Training and technical assistance for SSP staff and clinicians to deliver care in non-traditional, low-barrier settings

This intervention focuses on implementing and evaluating a service delivery model to expand access to medication for opioid use disorder within SSPs.

Ostatní jména:
  • LTB

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
3-month Buprenorphine treatment retention (3-month retention)
Časové okno: Between baseline and 1-month following intervention, and between baseline and 3-months following intervention

Buprenorphine (BUP) treatment retention will be defined as having an active buprenorphine prescription between baseline and 1-month and between the 1-month (days 1-30) and 3-month (days 31-90) time points. Participants will be asked to provide evidence of BUP prescriptions at study visits (i.e., confirmed prescriptions). If a participant receives a second BUP prescription before the 1-month follow-up and the number of days dispensed covers dates after day 30 (i.e., carries over into the 31-90 days interval), this participant will have met the primary outcome. The primary outcome will require at least one day of an active BUP prescription based on confirmed prescriptions within the 2 time-points.

BUP treatment retention will be summarized as a binary ("Yes/No") variable. The number/percentage of participants who are retained at each timepoint will be summarized by arm. BUP treatment retention is the primary measure of effectiveness.
Between baseline and 1-month following intervention, and between baseline and 3-months following intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Buprenorphine Adherence
Časové okno: Baseline to 3-months following intervention
Adherence to buprenorphine is a composite measure and will be defined as participants meeting the primary outcome AND having a urine drug screen (UDS) that is positive for BUP at the 3-month timepoint. The number/percentage of participants who demonstrate BUP adherence will be summarized by arm.
Baseline to 3-months following intervention
6-month Buprenorphine Treatment Retention (6-month retention)
Časové okno: From baseline to 6-months following intervention
Buprenorphine (BUP) treatment retention at 6-months is a composite measure and will be defined as participants meeting the primary outcome AND having an active BUP prescription at the 1-month, 3-month, and 6-month timepoints.
From baseline to 6-months following intervention
Treatment and Recovery Activities
Časové okno: 6-months following intervention
Treatment and Recovery activities will be measured using the Treatment Effectiveness Assessment (TEA). The TEA is a patient-centered instrument for evaluating progress in recovery from addiction. The TEA consists of 4 items used to measure recovery progress in substance use, health, lifestyle, and community domains. Participants rate progress on a scale from 1 ("not better") to 10 ("very much better"), yielding a total score from 4-40, wherein higher scores indicate greater improvement. Results will be summarized by study arm using descriptive statistics.
6-months following intervention
Non-prescribed Opioid Use
Časové okno: 1-month, 3-months, and 6-months following intervention
Non-prescribed opioid use will be determined by the number of self-reported days of use of heroin, fentanyl, methadone, or opioid analgesics in the prior 30 days at each study visit (1-month, 3-months, and 6-months). Results will be summarized by study arm.
1-month, 3-months, and 6-months following intervention
Overdose (non-fatal and fatal)
Časové okno: 6-months following intervention
Non-fatal overdoses will be determined based on participant self-reporting during the 6 months of study participation. Fatal overdoses will be based on data collected from available administrative records or other reliable sources. This a continuous measure and the number/percentage of both fatal and non-fatal overdoses will be summarized by study arm.
6-months following intervention
Mean Intervention Costs
Časové okno: 6 months
Mean cost (in US dollars) of buprenorphine treatment will be reported for participants in each study arm. The resource utilization and resulting cost of implementing and administering the intervention will be estimated using micro-costing analysis and participant self-report. Mean costs (in US dollars) will be summarized by study arm.
6 months
Health-related Quality of Life - PROPr
Časové okno: 1-month, 3-months, and 6-months following intervention
Health-related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr) questionnaire. PROPr is a comprehensive, multi-attribute health utility measure that consolidates 7 PROMIS domains-Cognitive Function, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Social Roles-into a single score, the health utility index value. A single-attribute scoring function for each PROMIS domain is calculated, with 1 = "the utility of full health" and 0 = "the utility of that domain's disutility state. The 7 single-attribute functions are combined to produce a multi-attribute summary scoring function, where 0 = "the utility of dead" and 1 = "the utility of full health," with scores less than 0 corresponding to states judged worse than dead. Results will be summarized by study arm.
1-month, 3-months, and 6-months following intervention
Change in Health-related Quality of Life - QALYs
Časové okno: From Baseline to 6-months following intervention
Change in Health-related Quality of Life will be used to calculate quality-adjusted life-years (QALYs). QALYs is a measure that incorporates both duration and health-related quality-of-life into a single assessment and is used to assess cost-effectiveness. The health utility index value from the PROPr is converted into QALYs. Mean years gained from baseline to 6 months intervention will be summarized by study arm.
From Baseline to 6-months following intervention
Cost effectiveness - incremental cost-effectiveness ratio (ICER)
Časové okno: 6-months following intervention
The outcome of the cost-effectiveness analysis will be the incremental cost-effectiveness ratio (ICER), calculated as the adjusted-difference in costs (i.e., mean intervention costs per arm) divided by the adjusted-difference in effectiveness (i.e., mean change in Health-related Quality of Life per arm). The outcome is reported as a ratio of the two numbers.
6-months following intervention
Satisfaction with BUP treatment
Časové okno: 6-months following intervention
Satisfaction with BUP treatment will be measured by an adapted version of the Primary Care Buprenorphine Satisfaction Scale. The adapted version will use 5 (out of 19) items, covering satisfaction with the following three domains: overall and specific service components; staff expertise, concern and responsiveness; and helpfulness of overall and specific treatment components. Items are rated on a 5-point scale with 1 indicated low satisfaction and 5 indicating high satisfaction. The mean score from the 5 items will be reported.
6-months following intervention
Initiation of BUP treatment
Časové okno: Up to 6-months following intervention
Initiation of BUP treatment will be defined as having any self-report of taking prescribed BUP over 6 months of follow-up. Initiation of BUP treatment will be assessed as a binary ("Yes/No") variable. The number/percentage of participants who initiate BUP treatment over the 6 months of follow up will be summarized by arm.
Up to 6-months following intervention
Retention in any MOUD treatment
Časové okno: 6-months following intervention
Retention in any MOUD treatment will be measured based on participant self-reporting of having been engaged in an approved MOUD treatment service at 6 months. Retention in any MOUD treatment will be assessed as a binary ("Yes/No") variable. The number/percentage of participants who demonstrate retention in any MOUD treatment at the 6 months timepoint will be summarized by arm.
6-months following intervention
OUD severity
Časové okno: 6-months following intervention
OUD severity will be measured using the Diagnostic and Statistical Manual for Opioid Use Disorder, 5th Edition (DSM-5 OUD) checklist. The DSM-5 OUD checklist consists of 11 criteria, with diagnosis and severity based on the number of symptoms met within a specified period, in this case 6 months. Scoring is calculated by counting the number of "yes" responses for the 11 criteria: mild (2-3 symptoms), moderate (4-5 symptoms), and severe (6 or more symptoms). The number participants with mild, moderate, and severe symptoms will be summarized by study arm.
6-months following intervention
Number of days of other substance use
Časové okno: 1-month, 3-months, and 6-months following intervention
The number of days of other substance use will be measured based on participant self-reporting, using a modified version of the Addiction Severity Index. Assessments will ask separately about past-30 day use of heroin, fentanyl, methadone, buprenorphine, other opioids, benzodiazepines, other sedatives, cocaine, amphetamines, methamphetamine, cannabis, alcohol, and more than one substance. A composite measure that represents the number of days (0-30) using benzodiazepines, other sedatives, cocaine, amphetamines, methamphetamine, or alcohol will be reported as "days of other substance use".
1-month, 3-months, and 6-months following intervention
Depression
Časové okno: 6-months following intervention
Depression will be assessed using the individual Depression domain subscale from the PROMIS-PROPr instrument. The PROMIS-PROPr Depression domain subscale consists of 4 items asking participants to rate their levels of depression over the prior 7-day period. Scores are rated on a scale ranging from 1 "Never" to 5 "Always" for an overall possible raw score ranging from 4-20, such that higher scores are indicative of higher depression severity. Scores will be summarized by study arm using descriptive statistics.
6-months following intervention
Anxiety
Časové okno: 6-months following the intervention
Anxiety will be assessed using the individual Anxiety domain subscale from the PROMIS-PROPr instrument. The PROMIS-PROPr Anxiety domain subscale consists of 4 items asking participants to rate their levels of anxiety over the prior 7-day period. Scores are rated on a scale ranging from 1 "Never" to 5 "Always" for an overall possible raw score ranging from 4-20, such that higher scores are indicative of higher anxiety severity. Scores will be summarized by study arm using descriptive statistics.
6-months following the intervention
Pain Intensity
Časové okno: 6-months following intervention
Pain Intensity will be assessed using the individual Pain Intensity item from the PROMIS-PROPr. The PROMIS-PROPr Pain Intensity item asks participants to rate their average intensity of pain over the prior 7-day period. Scores are rated on a scale ranging from 1 "No Pain" to 10 "Worst Pain Imaginable" for an overall possible raw score ranging from 1-10, such that higher scores are indicative of higher pain intensity. Scores will be summarized by study arm using descriptive statistics.
6-months following intervention
Safety Outcomes
Časové okno: 6-months following intervention
A composite measure of experiencing one or more Targeted Safety Event (dichotomous, yes/no), which includes opioid overdoses (non-fatal and fatal), any hospitalization, or death, will be reported as an outcome measure.
6-months following intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Montefiore Medical Center

Spolupracovníci

National Institute on Drug Abuse (NIDA)
New York University
The Emmes Company, LLC

Vyšetřovatelé

  • Vrchní vyšetřovatel: Aaron D Fox, MD, MS, Albert Einstein College of Medicine

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. srpna 2026

Primární dokončení (Odhadovaný)

1. února 2028

Dokončení studie (Odhadovaný)

1. června 2028

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025-17318
  • 3UG1DA013035-24S1 (Grant/smlouva NIH USA)
  • 25-08-529 (Jiný identifikátor: Biomedical Research Alliance of New York (BRANY))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified demographic, clinical, laboratory, survey, qualitative data collected from case report forms (CRFs) will be preserved and shared.

The following data will be preserved but not shared as they may contain a large volume of personally identifiable information (PII): data derived from qualitative interviews, participant locator and other administrative forms. Likewise, data from all free-text and/or comments fields will not be shared due to the nature of the data and risk of exposing PI.

Scientific data will be processed and analyzed with Statistical Analysis System (SAS) software and shared in SAS and ASCII formats.

Časový rámec sdílení IPD

Datasets will be available when either (1) the primary outcome paper has been accepted for publication, (2) the data has been locked for more than 18 months, or (3) the grant concludes; whichever comes first. Datasets will remain accessible via the National Institute on Drug Abuse (NIDA) Data Share contingent on NIDA's continued support of the archive. To date, NIDA Data Share has not deleted any deposited data.

Kritéria přístupu pro sdílení IPD

Access to the scientific data will be controlled via a registration agreement for data use on the NIDA Data Share Website. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Standard of Care Referral

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Drogové intervence

CROs by country

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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