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Trial registered on ANZCTR
Registration number
ACTRN12620000701921p
Ethics application status
Submitted, not yet approved
Date submitted
18/05/2020
Date registered
26/06/2020
Date last updated
25/10/2021
Date data sharing statement initially provided
26/06/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and tolerance of manuka honey for use as a nebulizer solution
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Scientific title
Safety and tolerance of manuka honey for use as a nebulizer solution in a group of healthy volunteers
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Secondary ID [1]
301275
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None
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Universal Trial Number (UTN)
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Trial acronym
MANFFT-02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory diseases
317453
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Infectious diseases
317651
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Condition category
Condition code
Respiratory
315551
315551
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0
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Other respiratory disorders / diseases
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Infection
315736
315736
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Up to 15 subjects will be recruited and each will be required to sequentially take sterile saline (control), 3.13, 6.25, 12.5, 25 and 50% v/v medical grade manuka honey in a nebuliser solution for 10 min.
Subjects will be tested at either the Ruakura Research Centre (Hamilton), or at the ManukaMed facility (Masterton). Participants will self-administer the doses under the supervision of the principle investigator. One of each of the doses will be administered on successive days for a total of 6 days.
The nebulizer is a jet (compressor) type that delivers 0.3 mL per min with a mean particle diameter of 3 uM (model C801, Omron Healthcare Ltd, Kyoto, Japan). Therefore, subjects will breath 3 mL over the 10 min period. The volume administered during the 10 min period will be the product of the volume added minus the volume remaining after 10 min.
The nebulizer has not been approved for this use, nor has approval been sought by either the manufacturer, or the New Zealand Medicines and Medical Devices Safety Authority.
During the 10 min treatment period, subjects will wear a silicone face mask provided with the nebulizer.
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Intervention code [1]
317581
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Treatment: Other
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Intervention code [2]
317582
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Treatment: Drugs
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Intervention code [3]
317583
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Treatment: Devices
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Comparator / control treatment
sterile saline 0.9% w/v
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Any change in SpO2 between baseline and post-treatment time-point measurements using a pulse oximeter for 30 seconds.
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Assessment method [1]
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Timepoint [1]
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0 (baseline), 1, 3, 6 and 24 h post-dose administration on each test day.
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Primary outcome [2]
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Any change in lung performance (Forced Vital Capacity (FVC), Forced Expiratory Volume (FEV1), FEV1/FVC x 100 (FEV1%), Average Forced Expiratory Flow between 25 and 75% (FEF2575) and Peak Expiratory Flow (PEF)) as measured using a spirometer between baseline and post-treatment time-point measurements. This is a composite primary outcome.
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Assessment method [2]
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Timepoint [2]
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0 (baseline), 1, 3, 6 and 24 h post-dose administration on each test day.
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Primary outcome [3]
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Any change in vital signs (heart rate, respiratory rate, temperature and blood pressure) between baseline and post-treatment time-point measurements.
Heart rate will be measured using a pulse oximeter for 30 seconds at each time-point, respiratory rate will be measured by countered the breaths for 15 seconds and multiplying by 4, temperature will be measured using an infrared contactless thermometer and blood pressure will be measured using a sphygmomanometer (Omron Healthcare Ltd). This is a composite primary outcome
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Assessment method [3]
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Timepoint [3]
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0 (baseline), 1, 3, 6 and 24 h post-dose administration on each test day.
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Secondary outcome [1]
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Participant preference/tolerability of each dosage will be assessed daily after administration of the intervention using a study-specific questionnaire that will evaluate stickiness, flavour and odour on a n-point scale. This is a composite secondary outcome.
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Assessment method [1]
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Timepoint [1]
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At 6h post-dose administration on each test day.
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Secondary outcome [2]
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Any Adverse and/or Serious Adverse Events reported by the subject, or observed by the investigator will be recorded. This is a composite secondary outcome.
A list of potential adverse events is included in the protocol and the CI will prompt the subject at each visit time-point if they are feeling unwell, or have noticed any of those potential AE or SAEs. Every AE, or SAE will be assessed by the CI or Co-CI for severity and relatedness to study products.
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Assessment method [2]
383717
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Timepoint [2]
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O, 3, 6 and 24 h after nebulization. Subjects will be able to contact the investigator at any time up to 7 d post-study. The investigator will also follow-up with each subject 7 d after the study.
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Eligibility
Key inclusion criteria
1. Be able and willing to give written informed consent,
2. Understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator,
3. Male and female subjects who are 18 to 80 years of age,
4. Subjects are not currently ill, or have a history of respiratory or cardiac disease,
5. Have vital signs that are within the normal range at time of screening (blood pressure 90/60 to 120/80 mm Hg; pulse 60-100 beats per min; breathing 12-20 breaths per min; temperature 36.5 to 37.3 °C),
6. Have lung performance parameters that are within the predicted range for their age and sex at time of screening (European Respiratory Society (ERS), European Community for Coal and Steel (ECCS)/Knudson) provided by the spirometer software (WinspiroPRO).
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Subjects who are hypersensitive, or have an allergic reaction to honey, or bee products.
2. Subjects who are on medication that may influence pulmonary measurements.
3. Subjects who are asthmatics.
4. Subjects who are ill (including common cold) on the day, or for the previous week(s).
5. Subject has a history or presence of significant cardiovascular disease, including having a cardiac pacemaker,
6. Subject has a significant acute or chronic coexisting illness which in the opinion of the investigator, could affect the outcome of the study, including kidney, liver or renal disease/dysfunction, uncontrolled metabolic disease,
7. Subject has a history of hypertension or elevated blood pressure (systolic, >140 mmHg or a diastolic, >90 mmHg), unless on stable anti-hypertensive medication for at least 3 months prior to and for the duration of the study,
8. Subject has a history of drug and / or alcohol abuse,
9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
Dose-escalating safety study with subjects offered six different concentrations of manuka honey mixed in sterile saline at 0, 3.13, 6.25, 12.5, 25 and 50% v/v with one treatment offered each test day from lowest to highest dose.
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
Sample size was determined by requiring a detectable difference of 15% with a coefficient of variation of 10% at a power of 80% and with a probability of 0.05% for each parameter. The sample size required for the study is 8. At a probability of 0.01% the sample size increases to 15. However, with the possibility of subjects not completing the study, or dropping out before the study commences, we have increased the number of subjects to 15 with an equal number of males and females to be recruited.
Analysis of variance will be used to analyse the data in the software package Prism v8.4 (Graphpad Software LLC).
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
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Other reasons
Did not gain ethical approval
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Date of first participant enrolment
Anticipated
13/07/2020
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Actual
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Date of last participant enrolment
Anticipated
31/08/2020
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Actual
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Date of last data collection
Anticipated
28/09/2020
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
22560
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Waikato, Auckland, Wairarapa
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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ManukaMed LP
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Address [1]
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3 Edwin Feist Place, Solway, Masterton, 5810
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Country [1]
305722
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
ManukaMed LP
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Address
3 Edwin Feist Place, Solway, Masterton, 5810
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
306144
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Other collaborator category [1]
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University
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Name [1]
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Waikato University
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Address [1]
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Private Bag 3105
Hamilton 3240
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Country [1]
281311
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New Zealand
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
305997
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
305997
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
305997
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New Zealand
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Date submitted for ethics approval [1]
305997
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21/05/2020
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Approval date [1]
305997
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Ethics approval number [1]
305997
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Summary
Brief summary
We have shown that medical grade manuka honey inhibits SARS-CoV-2, the virus responsible for Covid-19. Medical grade manuka honey has a high concentration of methylglyoxal (>550 mg/kg) that has known antibacterial properties and may also now have antiviral properties. SARS-CoV-2 enters the respiratory track and concentrates in the lungs. Therefore, manuka honey might provide a simple and cost-effective means to control the viral burden at the source of entry into the body.
We believe that medical grade manuka honey may be used to treat subjects with Covid-19 through administration into the lungs as an atomised mist generated via a nebulizer. Before offering manuka honey as a treatment to patients with Covid-19, we need to establish that administration via nebulization is safe, tolerable and has no side-effects. To date, we only have anecdotal evidence from dozens of people whom have taken manuka honey in nebulizers at 50% v/v in sterile saline to help combat the common cold. Those individuals claimed that it helped them to recover faster and that there were no side-effects or difficulties in taking manuka honey in this way. The present study seeks to determine the safety and optimal dose of medical grade manuka honey for use in a nebulizer solution.
We will examine the effect of doses up to 50% v/v on saturated oxygen, heart rate, breathing rate, temperature, lung performance measurements and evaluate subject feedback by way of a questionnaire.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Chris McMahon
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Address
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ManukaMed LP
Ruakura Research Centre
10 Bisley Rd,
Hamilton 3214
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Country
102358
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New Zealand
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Phone
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+64 0210795110
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Chris McMahon
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Address
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ManukaMed LP
Ruakura Research Centre
10 Bisley Rd,
Hamilton 3214
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Country
102359
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New Zealand
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Phone
102359
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+64 0210795110
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Fax
102359
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Chris McMahon
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Address
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ManukaMed LP
Ruakura Research Centre
10 Bisley Rd,
Hamilton 3214
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Country
102360
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New Zealand
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Phone
102360
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+64 0210795110
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Fax
102360
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Email
102360
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data will remain confidential until and Patent Cooperation Treaty (PCT) has been filed.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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