Immune ToleranceNCT04525456
Immune Responses With Reduxium
A study testing Reduxium in people with Immune Tolerance and Viral Infection, run by Ogevity Therapeutics, Inc. at 3 sites in Singapore.
Trial summary
Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Tolerance, Viral Infection
- What is being tested?
- Reduxium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSingapore
- Study dates
- 7 Oct 2020to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of 21 - 50 years of age
- Normal blood pressure (BP <140/90 nnHg)
- Normal fasting glucose (<6mmol/L)
- Subjects must stop all supplement for 1 month prior to enrolment
Who cannot join
- Subjects with known history of lungs or cardiovascular disease
- History of previous pancreatitis
- Past or current history of malignancy
- Subjects with type 2 diabetes
- Past or current history of peptic ulcer disease
- Current pregnancy or breastfeeding
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
National University of Singapore - The N.1 Institute for Health
Singapore, 117456
National University of Singapore - Yong Loo Lin School of Medicine
Singapore, 117597
National University Hospital
Singapore, 119074
About this study
Official title: Changes in the Immune Responses With Reduxium in Healthy Adults
Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. There is not enough data on the mechanism associated with the action of Reduxium or the extent of the immune response increase it produces. In this study, the investigators propose treating a group of healthy volunteers with Reduxium and investigate the utility of this approach in boosting the native and adaptive immune responses that correlate with immune protection. This may form the basis for a future study employing the product in infectious disease patients.
Read the detailed description
With the global population increasingly exposed to pandemic crises, permanent and expedient solutions are needed at an affordable cost. Vaccination is less than ideal as the virus is prone to a mutation that renders the previous generation of vaccine less effective. Epidemic and pandemic of viruses infection has become more common and affects both developed and less developed communities. Overcrowding and poor hygiene have been cited to be the major factors in these epidemics, but the host immune system and the ability of the human system to ward off virus infection is a factor less mentioned.
Nutrition is a critical determinant of immune responses and malnutrition the most common cause of immunodeficiency worldwide. Protein-energy malnutrition is associated with a significant impairment of cell-mediated immunity, phagocyte function, complement system, secretory immunoglobulin A antibody concentrations, and cytokine production. Deficiency of single nutrients also results in altered immune responses: this is observed even when the deficiency state is relatively mild. Of the micronutrients, zinc; selenium; iron; copper; vitamins A, C, E, and B6; and folic acid have important influences on immune responses. Adequate intake of vitamins B6, folate, B12, C, E, and of selenium, zinc, copper, and iron supports a T helper cell (Th)1 cytokine-mediated immune response with sufficient production of proinflammatory cytokines, which maintains an effective immune response and avoids a shift to an anti-inflammatory Th2 cell-mediated immune response and an increased risk of extracellular infections. Supplementation with these micronutrients reverses the Th2 cell-mediated immune response to a proinflammatory Th1 cytokine-regulated response with enhanced innate immunity.
Reduxium, a dietary supplement that provides immune support, is a low-cost candidate to boost immune response. Reduxium is a natural compound commercialised in the USA that helps restore homeostasis and controls inflammation. As no toxins or allergens are used, but purely food grade compounds, it is classified as a dietary supplement. Its current purpose is not to treat, diagnose, prevent or cure any disease, but it has immunomodulatory properties. Reduxium is manufactured using a proprietary reactor - a "biochemical cavitation mixer" that allows to create a "smart small molecule". The principal device belongs to the cavitation technology family and is used for the intensification of technological processes in liquid media (liquid processing, splitting of complex molecules, "cold" pasteurization, destruction of solid inclusions). The usage of this process technology enables compression of a set of molecules to 1/12th their original size. Its components are: Phosphoric Acid (58%), Microelement Complex (33.6%) (Zinc, Copper, Iron Pyrophosphate, Potassium, Calcium, Silica, Glycyrrhizic Acid (8.4%). The Microelement Complex is made up of a homogenized complex with special indication, pH =0.0008-0.4, waterless in the final composition.The complex molecules generated scan at the cellular level for the presence of pathogenic (bacterial, viral, fungal) etiologies by reading the characteristics of the electron proton (KNa) pump on the membrane. If these characteristics are violated, the supplement "enters" the cell. At the intra-cellular level, the supplement scans the cell in search of pathology; this "scanning process" is made on the basis of selectivity (healthy - do not touch/ill - induce apoptosis) through the mechanism of mitochondria activity. Specifically, the complex molecules start a cascade of biochemical processes (switching to mitochondria aerobic oxidation, restarting the methyl group with the "epigenetic" effects on DNA, apoptosis). It is unclear how and to which extent this mechanism contributes to innate immune activation following cellular damage and stress, or how it contributes to the adaptive immune response of T and B cells. The primary objective is to analyse the changes in the immune responses after two weeks of Reduxium intake.The secondary objective is to analyse the safety and tolerability of Reduxium.
- Conditions
- Immune Tolerance, Viral Infection
- Being tested
- Reduxium
- Keywords
- Antibody, Immunophenotyping, Immune cells
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReduxiumDietary supplement
Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Reduxium | Experimental | 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Receives: Dietary Supplement: Reduxium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies
Measured: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies
Measured: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Blood tests of monocytes subsets utilising groups of labelled antibodies
Measured: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Blood tests of NK cell subsets utilising groups of labelled antibodies
Measured: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Sodium blood tests
Measured: Baseline and week 8 post-baseline
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Potassium blood tests
Measured: Baseline and week 8 post-baseline
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Urea blood tests
Measured: Baseline and week 8 post-baseline
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Creatinine blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
AST blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
ALT blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Albumin blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
ALP blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Bilirubin blood tests
Measured: Baseline and week 8 post-baseline
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
LDH blood tests
Measured: Baseline and week 8 post-baseline
Secondary outcomes (1)
Number of Adverse Events After Reduxium Intake
To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events
Measured: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start7 Oct 2020
- Primary completion15 Dec 2020
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immune ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-centre, one-arm, prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ogevity Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525456
- Sponsor's protocol ID
- 0101.2006.0101.0001
- Status last verified
- May 2022
- First submitted
- 29 Jun 2020
- Last updated
- 27 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available
Publications
Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S.
PubMed 9250133Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. doi: 10.1159/000107673. Epub 2007 Aug 28.
PubMed 17726308Cui W, Fan Y, Wu W, Zhang F, Wang JY, Ni AP. Expression of lymphocytes and lymphocyte subsets in patients with severe acute respiratory syndrome. Clin Infect Dis. 2003 Sep 15;37(6):857-9. doi: 10.1086/378587. Epub 2003 Aug 28.
PubMed 12955652Li T, Qiu Z, Zhang L, Han Y, He W, Liu Z, Ma X, Fan H, Lu W, Xie J, Wang H, Deng G, Wang A. Significant changes of peripheral T lymphocyte subsets in patients with severe acute respiratory syndrome. J Infect Dis. 2004 Feb 15;189(4):648-51. doi: 10.1086/381535. Epub 2004 Feb 4.
PubMed 14767818
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Immune Responses With Reduxium in Healthy Adults
- ClinicalTrials.gov ID
- NCT04525456
- Acronym / sponsor ID
- 0101.2006.0101.0001
- Conditions
- Immune Tolerance, Viral Infection
- Keywords
- Antibody, Immunophenotyping, Immune cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ogevity Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National University of Singapore
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Posted 27 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. There is not enough data on the mechanism associated with the action of Reduxium or the extent of the immune response increase it produces. In this study, the investigators propose treating a group of healthy volunteers with Reduxium and investigate the utility of this approach in boosting the native and adaptive immune responses that correlate with immune protection. This may form the basis for a future study employing the product in infectious disease patients.
Detailed description
With the global population increasingly exposed to pandemic crises, permanent and expedient solutions are needed at an affordable cost. Vaccination is less than ideal as the virus is prone to a mutation that renders the previous generation of vaccine less effective. Epidemic and pandemic of viruses infection has become more common and affects both developed and less developed communities. Overcrowding and poor hygiene have been cited to be the major factors in these epidemics, but the host immune system and the ability of the human system to ward off virus infection is a factor less mentioned.
Nutrition is a critical determinant of immune responses and malnutrition the most common cause of immunodeficiency worldwide. Protein-energy malnutrition is associated with a significant impairment of cell-mediated immunity, phagocyte function, complement system, secretory immunoglobulin A antibody concentrations, and cytokine production. Deficiency of single nutrients also results in altered immune responses: this is observed even when the deficiency state is relatively mild. Of the micronutrients, zinc; selenium; iron; copper; vitamins A, C, E, and B6; and folic acid have important influences on immune responses. Adequate intake of vitamins B6, folate, B12, C, E, and of selenium, zinc, copper, and iron supports a T helper cell (Th)1 cytokine-mediated immune response with sufficient production of proinflammatory cytokines, which maintains an effective immune response and avoids a shift to an anti-inflammatory Th2 cell-mediated immune response and an increased risk of extracellular infections. Supplementation with these micronutrients reverses the Th2 cell-mediated immune response to a proinflammatory Th1 cytokine-regulated response with enhanced innate immunity.
Reduxium, a dietary supplement that provides immune support, is a low-cost candidate to boost immune response. Reduxium is a natural compound commercialised in the USA that helps restore homeostasis and controls inflammation. As no toxins or allergens are used, but purely food grade compounds, it is classified as a dietary supplement. Its current purpose is not to treat, diagnose, prevent or cure any disease, but it has immunomodulatory properties. Reduxium is manufactured using a proprietary reactor - a "biochemical cavitation mixer" that allows to create a "smart small molecule". The principal device belongs to the cavitation technology family and is used for the intensification of technological processes in liquid media (liquid processing, splitting of complex molecules, "cold" pasteurization, destruction of solid inclusions). The usage of this process technology enables compression of a set of molecules to 1/12th their original size. Its components are: Phosphoric Acid (58%), Microelement Complex (33.6%) (Zinc, Copper, Iron Pyrophosphate, Potassium, Calcium, Silica, Glycyrrhizic Acid (8.4%). The Microelement Complex is made up of a homogenized complex with special indication, pH =0.0008-0.4, waterless in the final composition.The complex molecules generated scan at the cellular level for the presence of pathogenic (bacterial, viral, fungal) etiologies by reading the characteristics of the electron proton (KNa) pump on the membrane. If these characteristics are violated, the supplement "enters" the cell. At the intra-cellular level, the supplement scans the cell in search of pathology; this "scanning process" is made on the basis of selectivity (healthy - do not touch/ill - induce apoptosis) through the mechanism of mitochondria activity. Specifically, the complex molecules start a cascade of biochemical processes (switching to mitochondria aerobic oxidation, restarting the methyl group with the "epigenetic" effects on DNA, apoptosis). It is unclear how and to which extent this mechanism contributes to innate immune activation following cellular damage and stress, or how it contributes to the adaptive immune response of T and B cells. The primary objective is to analyse the changes in the immune responses after two weeks of Reduxium intake.The secondary objective is to analyse the safety and tolerability of Reduxium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-centre, one-arm, prospective study
| Arm | Type | Receives |
|---|---|---|
| Reduxium | Experimental | Dietary Supplement: Reduxium1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects of 21 - 50 years of age
- Normal blood pressure (BP <140/90 nnHg)
- Normal fasting glucose (<6mmol/L)
- Subjects must stop all supplement for 1 month prior to enrolment
Key exclusion criteria (6 listed)
- Subjects with known history of lungs or cardiovascular disease
- History of previous pancreatitis
- Past or current history of malignancy
- Subjects with type 2 diabetes
- Past or current history of peptic ulcer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReduxiumSingle-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days. | Dietary supplement | Reduxium |
Primary outcome
Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Blood tests of monocytes subsets utilising groups of labelled antibodies
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Blood tests of NK cell subsets utilising groups of labelled antibodies
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Sodium blood tests
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Potassium blood tests
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Urea blood tests
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Creatinine blood tests
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
AST blood tests
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
ALT blood tests
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Albumin blood tests
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
ALP blood tests
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
Bilirubin blood tests
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
Time frame: Baseline and week 8 post-baseline
LDH blood tests
1 secondary outcome
Number of Adverse Events After Reduxium Intake
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9250133Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S.
- Background: PubMed 17726308Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. doi: 10.1159/000107673. Epub 2007 Aug 28.
- Background: PubMed 12955652Cui W, Fan Y, Wu W, Zhang F, Wang JY, Ni AP. Expression of lymphocytes and lymphocyte subsets in patients with severe acute respiratory syndrome. Clin Infect Dis. 2003 Sep 15;37(6):857-9. doi: 10.1086/378587. Epub 2003 Aug 28.
- Background: PubMed 14767818Li T, Qiu Z, Zhang L, Han Y, He W, Liu Z, Ma X, Fan H, Lu W, Xie J, Wang H, Deng G, Wang A. Significant changes of peripheral T lymphocyte subsets in patients with severe acute respiratory syndrome. J Infect Dis. 2004 Feb 15;189(4):648-51. doi: 10.1086/381535. Epub 2004 Feb 4.
- Individual participant dataSharing planned: No. There is no plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduxium in people with Immune Tolerance and Viral Infection, run by Ogevity Therapeutics, Inc. at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake (time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525456, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.