| Changes to trial information |
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| Trial Information |
Trial description |
11/09/2025 |
As requested per PACTR Response |
Primary Objective:
To evaluate the effectiveness of Continuity Genome Restorer (CGR) in restoring genomic continuity resonance and reversing multi-system health failures, including blood disorders, bone infections, kidney failure, diabetes, and chronic wound healing.
Secondary Objectives:
To assess the safety and tolerability of CGR resonance restoration.
To measure improvements in quality of life, reduction of chronic pain, and avoidance of invasive procedures (amputation, transplantation).
To establish continuity resonance mapping as a clinical biomarker for disease reversal. |
Background
Despite decades of progress in global medicine, Africa and the world continue to face high burdens of chronic and terminal illnesses — including diabetes, blood disorders, kidney failure, HIV/AIDS, bone infections, neurodegenerative conditions, and psychosis. Conventional medicine remains limited to chemical drugs, invasive surgeries, or lifelong organ transplantation, which often prolong suffering without restoring true health.
The Human Genome Project provided a genetic map but did not solve the underlying challenge of restoring life when DNA resonance is broken. To address this gap, the Continuity Genome Restorer (CGR) has been developed. CGR is a non-invasive, resonance-based technology built on the Fourth Law of Logic (Continuity), designed to restore genomic resonance and enable natural regeneration of blood, tissues, bones, organs, and neural circuits.
Summary
The CGR-AFRICA Trial is a multi-country, multi-disease pilot clinical study aimed at evaluating the safety and effectiveness of CGR in reversing chronic and life-threatening conditions. The trial will enroll 5,000 participants across 11 African countries, with each participant receiving three CGR sessions over six months, followed by 18 months of monthly monitoring.
Primary outcomes include genomic continuity restoration (via resonance mapping), blood regeneration, wound/bone healing, organ function recovery, and disease reversal in diabetes, HIV/AIDS, and kidney failure. Secondary outcomes include improvements in quality of life, avoidance of amputations/transplants, telomere lengthening (aging reversal), and immune system restoration.
This will be Africa’s first large-scale trial in Continuity Medicine, positioning the continent as the global leader in resonance-based healthcare innovation. |
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Inclusion criteria |
11/09/2025 |
The minimum age of eligibility has been lowered from 18 years to 13 years.
Reason for Change:
Disease Burden in Adolescents: Many of the target conditions — such as sickle cell disease, Type 1 diabetes, and HIV/AIDS — disproportionately affect adolescents in Africa, with onset often occurring between 13–17 years. Excluding this age group would deny early access to potentially life-saving intervention.
Ethical Safeguards: Adolescents will only be enrolled with assent from the participant and written consent from a parent or legal guardian, in line with international ethical guidelines.
Continuity Medicine Applicability: CGR is non-invasive and does not involve chemical drugs or surgery, making it safer for adolescents compared to high-risk pharmaceutical interventions.
Pilot Inclusivity: Expanding eligibility ensures that the trial reflects the real health demographics of Africa, where a large portion of the population is under 18.
Upper Age Limit Unchanged: Participants above 80 years remain excluded due to frailty, multiple comorbidities, and increased trial safety risks. |
Participants must meet all of the following:
Age: 18–80 years old.
Residence: Must reside in one of the participating African countries during the trial period.
Diagnosis: Clinically diagnosed with at least one of the following conditions:
Blood disorders (e.g., anemia, sickle cell disease, rare bone marrow failure).
Diabetes (Type 1 or Type 2).
Chronic kidney disease or history of kidney failure.
Chronic wound infections (non-healing wounds, risk of amputation).
Bone infections or degeneration (osteomyelitis, post-fracture non-healing, arthritis-related degeneration).
HIV/AIDS with ongoing immune compromise despite antiretroviral therapy.
Organ failure (early to moderate stage heart, liver, or lung dysfunction).
Neurodegenerative diseases (e.g., early-stage Parkinson’s, Alzheimer’s, multiple sclerosis).
Autoimmune conditions (e.g., lupus, rheumatoid arthritis).
Disease Stage: Conditions considered non-responsive or poorly responsive to conventional treatments, or where invasive/life-threatening interventions (amputation, transplant, lifelong drug dependency) are being considered.
Consent: Able and willing to provide written informed consent.
Commitment: Willing to attend all CGR sessions and follow-up visits for the full 24-month trial. |
Participants must meet all of the following:
Age: 13–80 years old.
Residence: Must reside in one of the participating African countries during the trial period.
Diagnosis: Clinically diagnosed with at least one of the following conditions:
Blood disorders (e.g., sickle cell disease, anemia, rare bone marrow failure).
Diabetes (Type 1 or Type 2).
Chronic kidney disease or history of kidney failure.
Chronic wound infections (non-healing wounds, risk of amputation).
Bone infections or degeneration (osteomyelitis, fracture non-healing, arthritis-related degeneration).
HIV/AIDS with ongoing immune compromise despite treatment.
Organ failure (early-to-moderate stage heart, liver, or lung dysfunction).
Neurodegenerative diseases (early-stage Parkinson’s, Alzheimer’s, multiple sclerosis).
Autoimmune conditions (e.g., lupus, rheumatoid arthritis).
Psychosis or severe psychiatric disorders not responding to conventional therapy.
Disease Stage: Must have conditions considered non-responsive or poorly responsive to conventional treatments, or where invasive/life-threatening interventions (amputation, transplant, lifelong drug dependency) are being considered.
Consent/Assent:
Adults (≥18 years): Able and willing to provide written informed consent.
Adolescents (13–17 years): Able to provide assent, with parental/guardian consent required.
Commitment: Willing to attend all CGR sessions and follow-up visits for the full 24-month trial duration. |
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| Eligibility |
Exclusion criteria |
11/09/2025 |
Exclusion Criteria – Reason for Change
The exclusion criteria were updated to reflect the inclusion of adolescents (13–17 years), which required additional ethical and safety safeguards.
Reason for Change:
Adolescent Participation: Since adolescents (13–17 years) are now eligible, exclusions were added for:
Guardian refusal (when a parent/legal guardian does not provide consent).
Pregnant adolescents (to avoid risks to unborn or breastfeeding infants).
Enhanced Ethical Safeguards: The criteria were adjusted to ensure full protection of minors, aligning with international clinical trial standards.
Risk Management: By clarifying exclusions (guardian refusal, pregnancy in adolescents, device interference), the study minimizes risks while safely expanding eligibility to younger participants.
Consistency with Inclusion Change: The shift from 18+ only to 13–80 years necessitated parallel updates in exclusion to ensure that vulnerable adolescents are not exposed to risks without safeguards. |
Participants will not be eligible if they meet any of the following:
Age: Below 18 years or above 80 years.
Pregnancy and Breastfeeding: Pregnant or breastfeeding women (due to unknown resonance effects on fetal/infant development).
Active Cancer: Currently undergoing chemotherapy, radiotherapy, or other aggressive cancer treatments.
Severe Psychiatric Illness: Individuals with uncontrolled psychiatric or cognitive conditions (e.g., schizophrenia, severe dementia) that impair the ability to consent or comply with study requirements.
Substance Abuse: Active alcohol or substance abuse likely to interfere with adherence.
Medical Instability: Patients with advanced, unstable, or end-stage organ failure (e.g., requiring mechanical ventilation, dialysis dependence without residual function, end-stage liver failure).
Concurrent Experimental Therapy: Participation in another interventional clinical trial within the last 6 months.
Non-Adherence Risk: Inability or unwillingness to attend the 3 core CGR sessions and monthly follow-ups for 24 months.
Contraindication to Resonance Monitoring: Any implanted electronic medical devices (e.g., certain pacemakers, defibrillators) that could interfere with resonance mapping. |
Participants will not be eligible if they meet any of the following:
Age: Younger than 13 years or older than 80 years.
Pregnancy and Breastfeeding:
Pregnant or breastfeeding women.
Pregnant adolescents (13–17 years) are excluded due to unknown resonance effects on fetal/infant development.
Guardian Refusal: Adolescents (13–17 years) whose parent/guardian does not provide written consent.
Active Cancer: Currently undergoing chemotherapy, radiotherapy, or other aggressive cancer treatments.
Severe Psychiatric Illness: Individuals with uncontrolled psychiatric or cognitive conditions (e.g., schizophrenia with acute crisis, severe dementia) that impair ability to consent/assent or comply with study requirements.
Substance Abuse: Active alcohol or substance abuse likely to interfere with adherence.
Medical Instability: Patients with advanced, unstable, or end-stage organ failure (e.g., requiring mechanical ventilation, dialysis dependence without residual function, end-stage liver failure).
Concurrent Experimental Therapy: Participation in another interventional clinical trial within the last 6 months.
Non-Adherence Risk: Inability or unwillingness to attend the 3 core CGR sessions and monthly follow-ups for 24 months.
Contraindication to Resonance Monitoring: Presence of implanted electronic medical devices (e.g., certain pacemakers, defibrillators) that could interfere with resonance mapping. |
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| Eligibility |
Age group |
11/09/2025 |
The eligible age group was changed from 18–80 years to 13–80 years.
Reason for Change:
Disease Burden in Adolescents: Many of the target diseases for CGR — such as sickle cell disease, Type 1 diabetes, and HIV/AIDS — often begin in adolescence. Excluding 13–17 year-olds would deny them access to a potentially life-saving intervention.
Ethical Balance: Adolescents (13–17 years) can now be safely included with dual safeguards: their own assent and written guardian/parental consent.
Non-Invasive Nature of CGR: Since CGR is non-chemical and non-surgical, it poses minimal risk compared to conventional drug or surgical trials, making it suitable for adolescents.
African Demographics: Africa has a very young population, and including adolescents ensures the trial reflects the continent’s real health needs.
Upper Limit (80+): Remains unchanged — participants above 80 are excluded due to frailty and comorbidities that may confound results. |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, National Health Research Centre, New Referral Hospital Bots Abelo Lepereng, Maseri, 0000, Lesotho, 01 Nov 2025, , +26622220000, qmmhHRrecruitment@gmail.com, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Mbabane Government Hospital Health Research Unit, Mbabane Eswatini, Mbabane, 0000, Swaziland, 01 Nov 2025, , +26824042113, secretary@ehls.org.sz, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Chris Hani Baragwanath Academic Hospital, Old Potchefstroom Road, Soweto, South Africa, Johannesburg, 1864, South Africa, 01 Nov 2025, , 00270119330967, Nita.Soma@gauteng.gov.za, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Kenyatta National Hospital , Hospital Rd Nairobi Kenya, Nairobi, 0000, Kenya, 01 Nov 2025, , +254202726300, knhadmin@knh.or.ke, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Lagos University Teaching Hospital, Idi-Araba, Surulere, Lagos State, Nigeria, Lagos, 0000, Nigeria, 01 Nov 2025, , +2348070591395, enquiry@lasuth.org.ng, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Cairo University Medical Research Centre, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, 0000, Egypt, 01 Nov 2025, , +2025729584, kasralainyrec@kasralainy.edu.eg, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Mulago National Referral Hospital , Haji Musa Kasule Road Kampala Uganda, Kampala, 0000, Uganda, 01 Nov 2025, , +256414554008, admin@mulagohospital.go.ug, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Windhoek Central Hospital, Ooievaar Street,Windhoek Namibia Windhoek North, Namibia, Windhoek , 0000, Namibia, 01 Nov 2025, , +264612039111, enquiry@wch.gov.na, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, Korle Bu Teaching Hospital Accra, Guggisberg Ave Accra Ghana, Accra, 0000, Ghana, 01 Nov 2025, , +233302739510, dma.sec@kbth.gov.gh, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Ethics |
Ethics List |
11/09/2025 |
Required for submission |
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FALSE, King Faisal Hospital Kigali, KG 544 Street 10 Kacyiru Gasabo Kigali, Kigali, 0000, Rwanda, 01 Nov 2025, , +250788123200, info@kfhkigali.com, |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Ishaga Rd Idi-Araba Lagos 102215 Lagos Nigeria, Lagos, 0000, Nigeria, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone , Gaborone , Botswana, Principal Investigator |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone , 0000, Botswana, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, Gaborone, Botswana, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, 0000, Botswana, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, Gaborone, Botswana, Principal Investigator |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, 0000, Botswana, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
|
Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Gaborone, 0000, Lesotho, Principal Investigator |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
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Date
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Reason
|
Old Value
|
Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, New Referral Hospital Bots Abelo Lepereng, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, New Referral Hospital Bots Abelo Lepereng, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
|
Date
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Reason
|
Old Value
|
Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Maseru, 0000, Lesotho, Principal Investigator |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, New Referral Hospital Bots Abelo Lepereng, Maseru, 0000, Lesotho, Principal Investigator |
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Section Name
|
Field Name
|
Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Johannesburg, 0000, South Africa, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Johannesburg, 0000, South Africa, Principal Investigator |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Old Potchefstroom Road, Soweto, South Africa, Johannesburg, 0000, South Africa, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Johannesburg, 0000, South Africa, Principal Investigator |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Plot No 11683 End of Block 5 Gaborone Botswana, Johannesburg, 0000, South Africa, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Old Potchefstroom Road, Soweto, South Africa, Johannesburg, 0000, South Africa, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Old Potchefstroom Road, Soweto, South Africa, Johannesburg, 0000, South Africa, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Ishaga Rd Idi-Araba Lagos 102215 Lagos Nigeria, Lagos, 0000, Nigeria, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
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Old Value
|
Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Hospital Rd Nairobi Kenya, Nairobi, 0000, Kenya, Principal Investigator |
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Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
|
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Hospital Rd Nairobi Kenya, Nairobi, 0000, Kenya, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Mbabane Eswatini, Mbabane, 0000, Swaziland, Principal Investigator |
Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Hospital Rd Nairobi Kenya, Nairobi, 0000, Kenya, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Ishaga Rd Idi-Araba Lagos 102215 Lagos Nigeria, Lagos, 0000, Nigeria, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Ishaga Rd Idi-Araba Lagos 102215 Lagos Nigeria, Lagos, 0000, Nigeria, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Ishaga Rd Idi-Araba Lagos 102215 Lagos Nigeria, Lagos, 0000, Nigeria, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, 0000, Egypt, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, , Egypt, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, , Egypt, Principal Investigator |
Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, 0000, Egypt, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Al-Saray Street El Manial Cairo 11956 Egypt, Cairo, 0000, Egypt, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Haji Musa Kasule Road Kampala Uganda, Kampala, 0000, Uganda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Haji Musa Kasule Road Kampala Uganda, Kampala, 0000, Uganda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Haji Musa Kasule Road Kampala Uganda, Kampala, 0000, Uganda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, KG 544 Street 10 Kacyiru Gasabo Kigali, Kigali, 0000, Rwanda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, KG 544 Street 10 Kacyiru Gasabo Kigali, Kigali, 0000, Rwanda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, KG 544 Street 10 Kacyiru Gasabo Kigali, Kigali, 0000, Rwanda, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, C3WC GF3 Windhoek Namibia, Windhoek, 0000, Namibia, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, C3WC GF3 Windhoek Namibia, Windhoek, 0000, Namibia, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, C3WC GF3 Windhoek Namibia, Windhoek, 0000, Namibia, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Principal Investigator, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Guggisberg Ave Accra Ghana, Accra, 0000, Ghana, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Public Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Guggisberg Ave Accra Ghana, Accra, 0000, Ghana, Principal Investigator |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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| Contact People |
Contacs List |
11/09/2025 |
Submission required |
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Scientific Enquiries, Ssemakula, Luyima, Mr., ceo@scvxafrica.co.site, , 26669532985, Guggisberg Ave Accra Ghana, Accra, 0000, Ghana, Principal Investigator |
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| Eligibility |
Minimum age |
11/09/2025 |
The eligible age group was changed from 18–80 years to 13–80 years.
Reason for Change:
Disease Burden in Adolescents: Many of the target diseases for CGR — such as sickle cell disease, Type 1 diabetes, and HIV/AIDS — often begin in adolescence. Excluding 13–17 year-olds would deny them access to a potentially life-saving intervention.
Ethical Balance: Adolescents (13–17 years) can now be safely included with dual safeguards: their own assent and written guardian/parental consent.
Non-Invasive Nature of CGR: Since CGR is non-chemical and non-surgical, it poses minimal risk compared to conventional drug or surgical trials, making it suitable for adolescents.
African Demographics: Africa has a very young population, and including adolescents ensures the trial reflects the continent’s real health needs.
Upper Limit (80+): Remains unchanged — participants above 80 are excluded due to frailty and comorbidities that may confound results. |
18 Year(s) |
13 Year(s) |