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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05825209
Registration number
NCT05825209
Ethics application status
Date submitted
27/03/2023
Date registered
24/04/2023
Date last updated
24/10/2023
Titles & IDs
Public title
Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity
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Scientific title
Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
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Secondary ID [1]
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MAGSLE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Food-Grown Magnesium
Treatment: Drugs - Microcrystalline cellulose
Active Comparator: Food-Grown Magnesium - Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
Placebo Comparator: Microcrystalline cellulose - Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.
Treatment: Drugs: Food-Grown Magnesium
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)
Treatment: Drugs: Microcrystalline cellulose
1 daily dose of 2 capsules containing microcrystalline cellulose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
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Assessment method [1]
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Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M). Sleep quality is assessed by a 5 category rating from 'Very poor' to 'Very good'. Sleep quality is also assessed by a 5 category rating of the degree of rested state from 'Not at all rested' to "Very well-rested'
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Timepoint [1]
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Baseline, week 1, week 4 and week 8
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Primary outcome [2]
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Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
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Assessment method [2]
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Change in sleep quantity, as defined as the collective amount of sleep obtained in a given period, by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
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Timepoint [2]
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Baseline, week 1, week 4 and week 8
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Secondary outcome [1]
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Change in quality of life
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Assessment method [1]
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Change in quality of life as assessed by the Short Form 36 Health Survey Questionnaire (SF36) which consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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Timepoint [1]
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Baseline and week 8
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Secondary outcome [2]
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Change in height in anthropometry measurements
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Assessment method [2]
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Height as measured by stadiometer in centimeters
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Timepoint [2]
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Baseline and week 8
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Secondary outcome [3]
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Change in weight in anthropometry measurements
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Assessment method [3]
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Weight as measured by digital scales in kilograms
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Timepoint [3]
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Baseline and week 8
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Secondary outcome [4]
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Change in BMI in anthropometry measurements
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Assessment method [4]
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Height and will be combined to report BMI in kg/m2
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Timepoint [4]
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Baseline and week 8
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Secondary outcome [5]
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Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [5]
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Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
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Timepoint [5]
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Baseline, week 4 and week 8
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Secondary outcome [6]
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Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
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Assessment method [6]
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Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M). Participants are asked "How long did it take you to fall asleep?"
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Timepoint [6]
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Baseline, week 1, week 4 and week 8
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Secondary outcome [7]
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Change in sleep onset time as assessed by wrist actigraphy
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Assessment method [7]
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Change in sleep onset time as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
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Timepoint [7]
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Baseline, week 1, week 4 and week 8
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Secondary outcome [8]
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Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [8]
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Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
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Timepoint [8]
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Baseline, week 4 and week 8.
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Secondary outcome [9]
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Change in sleep pattern disturbance as assessed by wrist actigraphy
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Assessment method [9]
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Change in sleep pattern disturbance as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
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Timepoint [9]
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Baseline, week 1, week 4 and week 8
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Secondary outcome [10]
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Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
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Assessment method [10]
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Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) which is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. The ESS score (the sum of 8 item scores) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity or their 'daytime sleepiness'.
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Timepoint [10]
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Baseline, week 4 and week 8
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Secondary outcome [11]
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Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
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Assessment method [11]
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Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire. Ten component scores are derived, each scored 0 (none) to 4 (very severe). The component scores are summed to produce a global score (range 0 to 40). Higher scores indicate more severe symptoms.
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Timepoint [11]
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Baseline, week 4 and week 8
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Secondary outcome [12]
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Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
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Assessment method [12]
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Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21) comprising 21 questions all with a rating scale from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms.
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Timepoint [12]
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Baseline and week 8
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Eligibility
Key inclusion criteria
- Adults 18 years or older
- Otherwise healthy
- Disturbed sleeping pattern (defined as difficulty falling asleep, waking up during the
sleep cycle or waking up too early and being unable to fall back to sleep)
- Able to provide informed consent
- Agree not to change current diet/exercise or not to use other medicines or supplements
for sleep or anxiety other than the test product during entire study period.
- Agree not to participate in another clinical trial while enrolled in this trial
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Minimum age
18
Years
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Maximum age
No limit
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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
- Unstable or serious illness (e.g. serious mood disorders such as depression or bipolar
disorder, neurological disorders such as MS, kidney disease, liver disease, GIT
conditions, heart conditions, diabetes, thyroid gland function) (1)
- History of renal function impairment
- Regular sleeping pattern
- Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for
malignancy within the previous 2 years
- Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other
anticoagulation therapy
- Receiving/prescribed sleep or anxiety medication/aid
- Sleep apnea
- Diagnosed or consistent gastrointestinal issues that disrupt sleep
- Active smokers, nicotine use, drug abuse
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- People with serious mood disorders (such as depression, anxiety and bipolar disorder)
will be excluded
- Those suffering from insomnia or have night-shift employment and unable to have a
normal night's sleep (2)
- People suffering any neurological disorders such as MS
- Pregnant or lactating woman
- Any condition which in the opinion of the investigator makes the participant
unsuitable for inclusion
- Participants who have participated in any other clinical trial during the past 6
months
- Clinically significant acute or chronic inflammation, or connective tissue disease or
arthritis
- History of infection in the month prior to the study
- Regularly taking stimulants (e.g., coffee, caffeine supplements, caffeine containing
beverages) 2 hours before bed
- Disturbed sleeping pattern caused by external factors (e.g., children, partner,
noises)
1. An unstable illness is any illness that is currently not being treated with a
stable dose of medication or is fluctuating in severity. A serious illness is a
condition that carries a risk of mortality, negatively impacts quality of life
and daily function and/or is burdensome in symptoms and/or treatments.
2. Insomnia has been excluded as it is a significant health condition, and we are
testing on otherwise healthy participants (as per TGA complementary medicine
requirements)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/07/2023
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Sample size
Target
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Global Pty Ltd - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a double-blind randomised placebo-controlled trial to evaluate orally-dosed
food-grown magnesium compared to placebo on improvement in sleep quality and quantity as well
as quality of life in otherwise healthy participants aged 18 years and older.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05825209
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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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Amanda Rao, PhD
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Address
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RDC Clinical Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05825209
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