Approved Clinical Trials This page provides a searchable list of all clinical trial research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology (UNCST).
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Name Title Study Sites Nationality Approval Date Expiry Date Sample Size Target Population Sponsors Field of Science/Classification Trial Type Research Type  
PATRICK MUSINGUZI
ID: UNCST-2023-R007731
UTILITY, ACCEPTABILITY AND APPLICABILITY OF A NUCLEIC ACID AMPLIFICATION TEST (NAAT) IN COMPARISON WITH SYNDROMIC APPROACH IN THE MANAGEMENT OF SEXUALLY TRANSMITTED DISEASES AT MULAGO NATIONAL REFERRAL HOSPITAL IN UGANDA.
REFNo: HS3100ES

To estimate the actual relative prevalence of causative agents of STDs in our study setting.,To evaluate the acceptability of the NAAT.,To assess the degree of concordance between actual pathogens diagnosed through the molecular test and the presumed pathogens indicated by the syndromic approach.,To evaluate whether the use of NAAT for the management of STDs improves clinical outcome and microbiological cure compared with the syndromic approach.,To evaluate whether microbiological diagnosis using NAAT improves appropriateness of therapy of STDs (as a measure of clinical usefulness) in comparison with the syndromic approach without or with limited laboratory tests currently in use.,
Uganda 2024-01-05 9:01:56 2027-01-05 240 Adults aged 18 years and above presenting with signs and symptoms of STDs at the Mulago Hospital STDs clinic during the study period, who provide written consent to the participation to the study and are diagnosed with UDS, AVD and GUD. Italian Society of Infectious and Tropical Diseases (SIMIT) Medical and Health Sciences Clinical Trial Non-degree Award
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
Six weeks of daily Rifapentine vs. a comparator arm of 12-16 week Rifamycin-based treatment of latent M. tuberculosis infection: Assessment of safety, tolerability, and effectiveness
REFNo: HS3492ES

The main objective of this trial is to compare the safety and effectiveness of a six-week regimen of daily Rifapentine to that of a standard arm of 12weeks of HP or 12 weeks of H or 16 weeks of R for the treatment of LTBI
Kampala, Mulago
Uganda 2023-12-21 20:31:51 2026-12-21 The target total enrollment is 3400 participants from all participating sites and approximately 250 participants will be enrolled from the Ugandan site The target study population will include male and female (except pregnant or breast-feeding) participants aged 12 years or older with LTBI who do not have evidence of active disease and are at increased risk of progression to active TB. U.S. Centers for Disease Control and Prevention Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Ssesanga Ernest
ID: UNCST-2023-R008022
EFFECT OF MHEALTH COMMUNICATION ON STIGMA AND RETENTION IN CARE AMONG YOUTH LIVING WITH HIV AND LINKED TO CARE IN UGANDA.
REFNo: SS2215ES

1. To explore the effect of mhealth communication on stigma among youth living with HIV and linked to care in Uganda.
2. To systematically develop and evaluate an mHealth intervention on stigma and retention in care among youth living with HIV and linked to care in Uganda.
3. To investigate the determinants of stigma and retention in care among youth living with HIV and linked to care in Uganda.
4. To determine the effect of mhealth communication on retention in care among youth living with HIV and linked to care in Uganda.
Kampala, Nsambya
Kampala, Mulago
Jinja,
Jinja,
Uganda 2023-12-19 11:26:33 2026-12-19 142 Participants will include voluntary consented and assented HIV-positive patients aged 15-24 years, who communicate in English, Lusoga or Luganda. Clinical Uganda Virus Research Institute Social Science and Humanities Clinical Trial Degree Award
Cissy  Kityo
ID: UNCST-2021-R013663
Platform Assessing Regimens And Durations In a Global Multisite consortium for TB. A Seamless Phase 2B/2C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis
REFNo: HS3044ES

Phase 2C: Amongst regimens selected for progression from phase 2B, to further evaluate the safety profile and to identify the optimal treatment duration (between 8 and 16 weeks) based on unfavourable outcome to support advancement to future Phase 3 trials.,Phase 2B: To identify regimens with acceptable safety profile that have the greatest potential, based on assessment of quantitative sputum liquid culture and treatment failure/relapse to progress to investigation of optimal treatment duration in Phase 2C.,To identify novel drug regimen(s) with acceptable safety profile, non-inferior efficacy and shortened treatment duration compared to the standard-of-care 24-week HRZE regimen that could be used to treat people with rifampicin susceptible and rifampicin resistant TB.,
Kampala, Kampala
Wakiso, Kampala
Mukono, Kampala
Mpigi, Mpigi
Uganda 2023-12-01 17:56:07 2026-12-01 Up to 2500 overall will be enrolled, 700 in phase 2B and 1800 in phase 2C. An estimate of 165 patients in total for Uganda sites (60 in phase 2B and 105 in phase 2C) and about 30 patients for JCRC Lubowa in phase 2B and 55 patients in phase 2C. Adults ≥18 years with newly diagnosed pulmonary TB will be enrolled University College London Medical and Health Sciences Clinical Trial Non-degree Award
Jude Byansi Zziwa
ID:
DEVELOPING A FRAMEWORK FOR PROVIDING SUSTAINABLE SANITATION SERVICES IN URBAN SCHOOLS IN LOW- AND MIDDLE-INCOME COUNTRIES: A CASE OF TWO CITIES IN UGANDA
REFNo: SIR254ES

(iv) To establish the effect of the school centered sanitation service framework on human faecal exposure pathways in urban schools of LMICs.,To ascertain how the key factors in objective (ii) above, interact to provide sustainable sanitation services in city schools,To establish factors sustaining sanitation service provision in city schools,To determine the status of sanitation service provision in city schools ,The general objective of this study is to develop a sanitation management framework that will contribute to sustainable service provision in urban schools of Low- and Middle Income Countries (LMICs).,
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Arua, Pajuni, Adumi, Oluko, Todamu, Aroi, Manibe and Ayivuni
Arua, Arua Hill, River Oli
Uganda 2023-11-20 15:27:51 2026-11-20 2,434 participants The pupil population from age 9 to 25 years, Teacher population from age 23 to 60 years, Other stakeholders will be adults. Male and female participants will be balanced. Citywide Inclusive sanitation Program Engineering and Technology Clinical Trial Degree Award
sunday anziku oyeeson
ID:
Exploring the Teachers’ Feedback Practices and its Influence on Students’ Learning in CBC: A case of a selected secondary school in Central Division, Arua City.
REFNo: SS2007ES

To explore how teachers’ feedback influences students' learning in CBC in lower secondary schools in Arua City.
To find out how students perceive the influence of feedback on their own learning in CBC.
To examine the strategies used by teachers to administer feedback to students in CBC in lower secondary schools in Arua City.
To find out the challenges faced by teachers in administering feedback to students in CBC in lower secondary schools in Arua City.

Uganda 2023-11-16 13:34:21 2026-11-16 2 school administrators (Headteacher and Deputy), 3 Teachers of lower secondary or CBC classes (S.1, S.2, and S.3) and 9 Students in CBC classes (considering 3 students from each class) The study will be conducted in a secondary school involving CBC class students, teachers and the school administrators Self-Sponsored Social Science and Humanities Clinical Trial Degree Award
Esther Atukunda Cathyln
ID: UNCST-2019-R001701
Integration of a patient-centered mobile health intervention (Support-Moms) into routine antenatal care to improve maternal health in Uganda.
REFNo: HS3366ES

Evaluate the cost and cost-effectiveness of implementing Support-Moms intervention into routine care and implications for sustainability,Evaluate intervention implementation using the Proctor framework and plan for future scale-up per the Consolidated Framework for Implementation Research ,Test the effectiveness of the Support-Moms intervention in a randomized controlled trial,
Uganda 2023-11-13 12:57:49 2026-11-13 824 We will include individuals who: 1) are in the first trimester of pregnancy who have not yet presented for ANC, 2) reside in the catchment area of a study HC, 3) are emancipated minors and adults aged ≥ 18 years, 4) report access to a cell phone with reception in their home, 5) are able to identify at least two social supporters living within the study districts, and 6) are able to provide consent. National Institutes of Health Medical and Health Sciences Clinical Trial Non-degree Award
JOSAPHAT KAYOGOZA BYAMUGISHA
ID: UNCST-2019-R001680
A phase II/III, open-label, randomized clinical trial to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
REFNo: HS3240ES

To assess the time to insert the REBOA.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding ‘inevitable’ hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.,To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm,To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.,To assess if the number of participants with acute kidney injury is lower in the intervention arm compared to the comparator arm,To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.,To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm., To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.,To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using REBOA). ,
Kampala, Kawempe
Uganda 2023-11-13 12:15:41 2026-11-13 10 women in phase IIb and 212 women in Phase III (222 IN TOTAL) Women aged 18 and above years and emancipated minors with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg will be recruited Centre For International Health Medical and Health Sciences Clinical Trial Non-degree Award
Stephen Okoboi
ID: UNCST-2019-R001356
Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men who Have Sex with Men (MSM) in Uganda
REFNo: HS3021ES

Estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.,Conduct a pilot randomized trial to pilot test the preliminary effectiveness of peer delivered HIV/syphilis self-tests and partner services versus facility-based testing., Conduct formative research to inform implementation of peer delivered self-tests for HIV and syphilis with partner services for Ugandan MSM. ,
Uganda 2023-10-31 19:59:00 2026-10-31 200 Inclusion criteria: In both arms, peers will recruit network members who are 1) aged 18 years and older, 2) Self-report of anal sexual intercourse at least once in the prior quarter 3) self-identify as MSM, 4) not tested in past 3 months or never tested for HIV or syphilis before; 5) willing to provide informed consent; 6) willing to undergo study procedures National Institute of health Medical and Health Sciences Clinical Trial Non-degree Award
Prudence Beinamaryo
ID: UNCST-2023-R007239
Efficacy of the combination ivermectin and albendazole vs albendazole alone in school-aged children infected with Trichuris trichiura: a randomized controlled trial
REFNo: HS3160ES

To evaluate the safety and tolerability of the ,To determine the CRs and ERRs of the study drugs (i.e. albendazole alone, albendazole-ivermectin) against Ascaris lumbricoides and hookworm in co-infected participants.,To determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura,To demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of CRs against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.,
Kabale, Rukore
Kabale, Rukore
Uganda 2023-10-04 13:42:09 2026-10-04 750 School age children of from Age 6-12 both males and female of any tribe residing in area. Prof. Dr. Jennifer Keiser Medical and Health Sciences Clinical Trial Non-degree Award
Andrew Odur
ID: UNCST-2022-R009128
A RANDOMIZED CONTROL TRIAL TO DETERMINE THE EFFICACY OF MACHINE LEARNING MODELS TO PREDICT POSTPARTUM HEMORRHAGE
REFNo: HS3132ES

Determine whether earlier knowledge of the high-risk patient likelihood of morbidity can change clinical management to better outcomes,Demonstrate the efficacy of a mobile app prediction-based platform in informing clinical judgment,Determine the suitability of mobile app-based platform integration into the clinical workflow of African obstetricians,Determine the efficacy of ML models to predict the likelihood of pregnancy complications among African mothers,We aim to conduct a randomized control trial to determine the efficacy of machine learning models to predict postpartum hemorrhage to potentially establish a new gold standard way of screening patients in low-resource settings,
Lira, Cathedral
Uganda 2023-10-02 15:32:14 2026-10-02 RCT sample size will be 200 The study will enroll pregnant women 18 years and older attending ANC at Lira Regional Referral Hospital intending to deliver from the same facility residing within 10 km distance from the hospital. INFIUSS Health, Inc Medical and Health Sciences Clinical Trial Non-degree Award
Conrad Muzoora Kihembe
ID: UNCST-2019-R001432
REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE (REVIVE)
REFNo: HS2892ES

To determine whether azithromycin is effective in reducing the incidence of new infection compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is effective in reducing mortality and hospitalisation at early and late timepoints (4weeks and 24weeks) compared to placebo in adults with advanced HIV (CD4 ≤ 100 cells/mm3).,To determine whether azithromycin is an effective and safe intervention to reduce excess mortality in adults with advanced HIV (CD4 ≤ 100 cells/mm3). ,
All Districts, Not applicable
Uganda 2023-09-27 17:43:49 2026-09-27 8000 18 years and above, all sexes and all tribes Population Health Research Institute (PHRI) Canada Medical and Health Sciences Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria.
REFNo: HS2817ES

Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria.
Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated
P. falciparum malaria
Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
All parts:
To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria


Tororo, Tororo
Tororo, Tororo
Uganda 2023-09-26 11:55:15 2026-09-26 Part A 12,pART b18 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Dennis Buwembo Rogers
ID: UNCST-2021-R011765
QUALITY OF SELF-CARE FOR OLDER (AGED 60 YEARS AND ABOVE) PEOPLE WITH DEMENTIA IN WAKISO DISTRICT, UGANDA. CAREGIVER PERCEPTIONS, AND EFFECTS OF A PSYCHOEDUCATION INTERVENTION ON QUALITY OF SELF-CARE.
REFNo: HS2958ES

To determine the effect of a remotely delivered psychoeducation intervention for caregivers of older people with dementia on the quality of self-care.,To explore the perception, caregivers of older people with dementia have towards quality of self-care.,To measure the quality of self-care for older people with dementia in Wakiso district, Uganda.,To Improve quality of self-care provided to older people with dementia through use of a remotely delivered psychoeducation intervention of caregivers of older people with dementia in Wakiso, district Uganda.,
Wakiso, Kiwenda
Uganda 2023-09-19 7:51:22 2026-09-19 71 Caregivers of older people diagnosed with dementia, 18-70 years, both female and males, all tribes as applicable Brain Health Training Program Medical and Health Sciences Clinical Trial Degree Award
Edrisa Mutebi Ibrahim
ID:
Safety of JNK61 in Healthy Human Volunteers.
REFNo: HS2474ES

To determine the effect of JNK61 on the blood sugar levels in healthy human volunteers.,To determine the safety of JNK61 in healthy human volunteers,
Kampala, Makerere University
Uganda 2023-08-30 16:05:54 2026-08-30 50 Male and female adults of any tribe Government of Uganda through Makerere University Research and Innovations Fund Medical and Health Sciences Clinical Trial Non-degree Award
Joseph  Matovu KB
ID: UNCST-2020-R014654
Enhancing communication on relationship preservation, safer conception, and pre-exposure prophylaxis (PrEP) to promote HIV testing
REFNo: HS3025ES

Conduct a pilot trial of “PrEPing Healthy Families” with intervention sites implementing the novel communication,Conduct formative research to expand a communication strategy focused on relationship preservation and safer conception into a multi-component intervention with broader reach,To leverage the growing availability of PrEP to determine if and how a communication strategy focused on relationship preservation and safer conception can increase testing and entry into treatment (ART) or prevention (PrEP) among couples in Uganda,
Mukono, Ntaawo ward
Mityana, Central ward
Butambala, Gombe ward
Uganda 2023-08-25 8:26:15 2026-08-25 267 The proposed study will recruit up to 267 total participants. These participants include project advisory board members (up to 25) clients in assisted partner notification (APN) or antenatal care (ANC) programs (up to 36 for in-depth interviews [IDIs], up to 150 for exit surveys), their partners (up to 36 for IDIs), and ANC/APN providers at the intervention site (up to 20). Participants will all be aged 18 years and above and all sexes. Glenn Wagner Medical and Health Sciences Clinical Trial Non-degree Award
Mark Kaddumukasa
ID: UNCST-2020-R001798
SELF MANAGEMENT INTERVENTION FOR REDUCING EPILEPSY BURDEN AMONG UGANDANS WITH EPILEPSY
REFNo: HS2944ES

1. To assess the efficacy of SMART- U vs. eTAU via an RCT.
H1: Individuals randomized to SMART-U will have significantly improved QOL and fewer seizures compared to eTAU.
H2: Individuals randomized to SMART-U will have greater improvement in depression and functional status compared to eTAU.
2. To use short message service (SMS) delivered via mobile phone text to validate patient self-reported seizure occurrence and push epilepsy self-management messaging in a practical/accessible format.
3. To obtain input from stakeholders (patients, family and clinicians) guided by an Integrated Promotion Action on Research Implementation in Health Services (i-PARIHS) framework to help establish sustainable infrastructure that will facilitate future scale up of SMART in Uganda with epilepsy partners

Kampala, Mulago
Mbarara, Mbarara
Uganda 2023-08-25 8:11:10 2026-08-25 188 Target population: all adult patients attending the neurology clinic at Mulago and Mbarara hospitals. Accessible population: All adult patients with epilepsy on treatment attending the clinic during the study period. Study population: All adult patients with epilepsy on treatment who will meet the inclusion criteria from all tribes attuning the study clinics. All consecutive adult patients who came either for follow up or as new referrals with confirmed diagnosis of epilepsy were screened for the inclusion into the study. NIH/ USA Medical and Health Sciences Clinical Trial Non-degree Award
Sharon Pang Sze Lu
ID:
Transform Randomised Controlled Trial in Uganda
REFNo: SS1823ES

To evaluate the impact of the Transform program on the key indicators in values, health and livelihood in Uganda
Hong Kong 2023-08-25 8:07:30 2026-08-25 4800 The study population will include participants aged 18 to 90 years old. Both male and female participants are included in the study. ICM will first choose communities and identify 30 ultra-poor households for its Transform program (administered across control and treatment groups). Eligibility for Transform is determined using poverty assessment via an asset-based scoring and self-reported household income. Historically, there have been an average of 30 households per community. With a target sample size of 160 communities, we will have approximately 4,800 households in the study. ICM targets communities to receive a Transform program based on the proportion of community members living in ultra-poverty (less than USD $0.50/person/day).Participants who are above the threshold using the poverty assessment will be excluded from the study. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants. International Care Ministries Social Science and Humanities Clinical Trial Non-degree Award
Adoke Yeka
ID: UNCST-2021-R004300
An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria (KARISMA – KAE609’s Role In Severe Malaria)
REFNo: HS1980ES

Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.

Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin

Tororo, Masafu
Uganda 2023-08-18 9:05:14 2026-08-18 200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site The study population will consist of male and female participants, including pediatric participants aged ? 6 months or older. Approximately 252 participants (60 participants of ? 12 years and 192 participants < 12 years) will be randomized Novartis Medical and Health Sciences Clinical Trial Non-degree Award
Henry Mugerwa
ID: UNCST-2019-R000420
PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES

Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria

Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
Uganda 2023-08-10 13:49:44 2026-08-10 14 The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. Novartis Medical and Health Sciences Clinical Trial Non-degree Award
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