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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/NCT03948477
Registration number
NCT03948477
Ethics application status
Date submitted
28/03/2019
Date registered
14/05/2019
Date last updated
25/05/2022
Titles & IDs
Public title
Pantoprazole Prophylaxis Against Delayed CINV for Patients Receiving Breast Cancer Chemotherapy
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Scientific title
Phase II, Randomised, Double-blinded, Placebo Controlled, Crossover Trial to Assess Pantoprazole's Effectiveness as Prophylaxis Against Delayed CINV in Patients Receiving Adjuvant or Neoadjuvant Breast Cancer Chemotherapy
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Secondary ID [1]
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CTNZ-2017-01
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Universal Trial Number (UTN)
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Trial acronym
PantoCIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Oncology
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Breast Cancer
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Chemotherapy-induced Nausea and Vomiting
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Condition category
Condition code
Cancer
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Breast
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pantoprazole 40mg
Treatment: Drugs - Placebo
Other: Pantoprazole/Placebo - Participants will take one 40 mg capsule of Pantoprazole daily for 5 days at the beginning of cycle 1 then they will take one capsule of matched Placebo daily for 5 days at the beginning of cycle 2
Other: Placebo/Pantoprazole - Participants will take one capsule of matched Placebo daily for 5 days at the beginning of cycle 1 then they will take one 40 mg capsule of Pantoprazole daily for 5 days at the beginning of cycle 2
Treatment: Drugs: Pantoprazole 40mg
Proton pump inhibitor, drug action is to irreversibly block the hydrogen-potassium adenosine triphosphatase enzyme system (the 'proton pump') of the gastric parietal cell. This reduces basal and stimulated gastric acid secretion therefore raising gastric pH.
Treatment: Drugs: Placebo
Matched placebo
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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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Reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy
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Assessment method [1]
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To determine whether Pantoprazole can reduce the incidence of delayed CINV in patients receiving adjuvant or neoadjuvant breast cancer chemotherapy (as measured on day 5 using the MASCC Antiemesis Tool (MAT) to assess nausea over days 2-5 of each chemotherapy cycle) as compared to placebo. Specifically, the primary endpoint will be the complete absence of both nausea and vomiting during days 2-5.
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Timepoint [1]
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Measured on day 5, after chemotherapy
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Secondary outcome [1]
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Nausea MAT scores
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Assessment method [1]
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Whether Pantoprazole improves nausea MAT scores over days 2-5
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Timepoint [1]
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Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
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Secondary outcome [2]
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Vomiting MAT scores
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Assessment method [2]
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Whether Pantoprazole reduces the number of episodes of vomiting (MAT) over days 2-5
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Timepoint [2]
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Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
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Secondary outcome [3]
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Heartburn improvement
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Assessment method [3]
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Whether Pantoprazole improves heartburn score (measured using the FSSG for reflux and/or dyspepsia) as self-reported on day 5 regarding days 2-5.
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Timepoint [3]
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Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
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Secondary outcome [4]
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Heartburn and Nausea scores
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Assessment method [4]
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Whether FSSG scores (heartburn) are associated with the MAT nausea scores reported by the patient over days 2-5.
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Timepoint [4]
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Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days), using a regression model, with allowance for a possible non-linear relationship.
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Secondary outcome [5]
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Use of breakthrough medications
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Assessment method [5]
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Whether Pantoprazole lowers the requirement for breakthrough medications (as self-recorded by the patients on days 2-5).
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Timepoint [5]
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Days 2-5 following chemotherapy for cycle 1 and 2 (each cycle is either 14 or 21 days)
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Secondary outcome [6]
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Patient preference
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Assessment method [6]
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Whether Pantoprazole is preferred by patients over Placebo (by using a patient preference survey at the end of cycle 2).
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Timepoint [6]
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end of chemotherapy cycle 2 (cycle 2 is either 14 or 21 days)
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Secondary outcome [7]
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Adverse events
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Assessment method [7]
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To assess whether adverse events (including hypomagnesemia, diarrhoea, abdominal pain and headache as defined by CT CAE version 4.03) are more common on Pantoprazole than on Placebo.
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Timepoint [7]
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From date of consent to 28 days after the last study treatment
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Eligibility
Key inclusion criteria
1. Men or women who are being considered for adjuvant or neoadjuvant chemotherapy with
either FEC or AC or TC chemotherapy and have been deemed by their treating Oncologist
as being fit for treatment. The scheduled length of each chemotherapy cycle must be
14-21 days.
2. Age =18 years.
3. Willing to comply with all study requirements, including treatment (being able to
swallow tablets), timing and nature of required assessments.
4. All patients must be able to speak and read in English to ensure consent is informed
and documentation of patient-reported outcome measures can be adhered to.
5. Signed, written informed consent.
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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?
No
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Key exclusion criteria
1. Patients who are receiving therapy to reduce gastric acid (including proton pump
Inhibitors (e.g. Omeprazole, Pantoprazole, Lansoprazole, Esomeprazole or Histamine
type-2 receptor antagonists e.g. Ranitidine)) at the time of enrolment will be
excluded from the trial.
2. Patients with pre-existing hypomagnesemia as defined by the reference range at the
investigating sites laboratory.
3. Patients with a history of cardiac arrhythmias including atrial fibrillation or
paroxysmal tachycardias.
4. Patients with known metastatic disease.
5. The presence of any serious medical or psychiatric conditions, which might limit the
ability of the patient to comply with follow up.
6. The presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow up schedule,
including alcohol dependence or drug abuse.
7. Pregnancy, lactation or inadequate contraception. Women must be postmenopausal,
infertile, or use a reliable means of contraception. Women of childbearing potential
must have a negative pregnancy test done within 7 days prior to registration.
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Study design
Purpose of the study
Prevention
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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 administering the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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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
10/06/2019
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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
15/10/2021
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Dunedin
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Country [4]
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New Zealand
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State/province [4]
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Hamilton
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Country [5]
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New Zealand
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State/province [5]
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New Plymouth
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Country [6]
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New Zealand
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State/province [6]
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Palmerston North
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Country [7]
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New Zealand
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State/province [7]
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Rotorua
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Country [8]
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New Zealand
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State/province [8]
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Tauranga
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Country [9]
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New Zealand
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State/province [9]
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Wellington
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Country [10]
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New Zealand
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State/province [10]
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Whangarei
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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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 study explores whether a commonly used medication called Pantoprazole can help prevent
delayed nausea and vomiting from chemotherapy for early breast cancer.
Delayed nausea, and occasionally vomiting, can occur after breast cancer chemotherapy,
affecting quality of life. A potential cause of these delayed side effects is that the
chemotherapy may cause stomach irritation. Pantoprazole is commonly used to treat stomach
irritation by reducing stomach acid, which may in turn improve nausea and/or vomiting.
Patients undergoing breast cancer chemotherapy before or after primary surgery will be
invited to participate in the study. They will be asked how much nausea or vomiting they have
with and without Pantoprazole from Day 2 until 5 after they receive chemotherapy. All
participants will still receive all of the usual anti-sickness medications, which are very
effective in preventing sickness in the first 24 hours after treatment, but not for delayed
symptoms.
Information from the study may lead to a change in practice with patients using Pantoprazole
to reduce the risks of delayed nausea and vomiting.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03948477
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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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Ricard Isaacs, MBChB FRACP
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Address
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Midcentral Regional Cancer Centre Services
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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/NCT03948477
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