Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000789561
Ethics application status
Approved
Date submitted
30/05/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression
Scientific title
Ketamine for Adults with Bipolar Depression (the Kite Trial): A Randomised, Double-blind, Midazolam-controlled, Multicentre Clinical Trial
Secondary ID [1] 311707 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 333178 0
Condition category
Condition code
Mental Health 329869 329869 0 0
Depression
Mental Health 330697 330697 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised Controlled Trial (RCT) Phase:
The intervention in the Kite trial during the 3-week RCT treatment phase is low-dose subcutaneous ketamine, administered twice a week. The starting dose for ketamine will be 0.6 mg/kg, or 0.025 mg/kg of midazolam (Level 1). Dose levels may be titrated at subsequent treatment visits in a step-wise manner, with the maximum dose level being Level 4 and the lowest level being Level 0. Between dose levels 1 and 3, there are 0.25 mg/kg increments in ketamine and 0.0075 mg/kg in midazolam. The final dose level increment from level 3 to level 4 is 0.2 mg/kg of ketamine and 0.010 mg/kg of midazolam. Treatments will be administered twice per week, with sessions separated by a minimum of two days. The total duration of the RCT phase is 3 weeks, with a maximum of 6 treatments received in this period. The study drug will be administered via subcutaneous injection which will be performed by a research team member, specifically a trained nurse or study doctor, with confirmed proficiency in subcutaneous administration and controlled drug management, adhering to Australian clinical trial and local state regulations and Good Clinical Practice (GCP). The Montgomery-Asberg Depression Rating Scale (MADRS) will be administered immediately before RCT treatments 2, 3, 4, 5, and 6, or within 24 hours prior to the planned administration of these treatments. Participants with inadequate treatment response – defined as less than a 50% reduction in baseline scores on the MADRS) – will receive an increased dose at that treatment session if the previous dose was well-tolerated. Tolerability of the acute response to treatment post-administration will also be assessed using the standardised Ketamine Side-Effects Tool (KSET), the Brief Psychiatric Rating Scale (BPRS), and the Clinician Administered Dissociative Symptoms Scale-6 Item (CADSS-6) questionnaire. Those who are unable to tolerate dose levels 1 - 4 may be down-titrated to lower levels.
Participants who are unable to tolerate the starting dose will have their dosage reduced for subsequent treatments to the minimum dose of 0.5 mg/kg.
All treatments are administered in person by a member of the study team. Adherence to treatments will be monitored by the study team through regular checks at the study site. Each treatment will be entered into the study-specific database to ensure adherence.

Open Label Extension (OLE) Phase:
Participants who continue into the OLE phase may receive an additional three weeks of twice-weekly open-label ketamine. Entry into the OLE phase will occur within three-to-four days after completion of the last RCT phase treatment. Dose titration will follow the same methodologies outlined during the RCT phase. However, participants who were randomised to receive ketamine during the RCT phase will start their OLE treatment at the last dose level of the RCT phase and may be titrated according to response and tolerability at subsequent treatment visits.
Intervention code [1] 328169 0
Treatment: Drugs
Comparator / control treatment
Randomised Controlled Trial (RCT) Phase:

The active placebo control treatment being tested in this study is low- dose midazolam, administered subcutaneously via injection into the abdomen. The active placebo control treatment will only be administered during the RCT phase of the trial.

The control treatment during the 3-week Randomised Controlled Trial (RCT) treatment phase is low-dose subcutaneous midazolam, administered twice a week. The starting dose for midazolam will be 0.025 mg/kg (Level 1). Dose levels may be titrated at subsequent treatment visits in a step-wise manner, with the maximum dose level being Level 4 and the lowest level being Level 0. Between dose levels 1 and 3, there are 0.0075 mg/kg increments in midazolam. The final dose level increment from level 3 to level 4 is 0.010 mg/kg of midazolam. Treatments will be administered twice per week, with sessions separated by a minimum of two days. The total duration of the RCT phase is 3 weeks, with a maximum of 6 treatments received in this period. The study control treatment will be administered via subcutaneous injection which will be performed by a research team member, specifically a trained nurse or study doctor, with confirmed proficiency in subcutaneous administration and controlled drug management, adhering to Australian clinical trial and local state regulations and Good Clinical Practice (GCP). The Montgomery-Asberg Depression Rating Scale (MADRS) will be administered immediately before RCT treatments 2, 3, 4, 5, and 6, or within 24 hours prior to the planned administration of these treatments. Participants with inadequate treatment response – defined as less than a 50% reduction in baseline scores on the MADRS) – will receive an increased dose at that treatment session if the previous dose was well-tolerated. Tolerability of the acute response to the control treatment post-administration will also be assessed using the standardised Ketamine Side-Effects Tool (KSET), the Brief Psychiatric Rating Scale (BPRS), and the Clinician Administered Dissociative Symptoms Scale-6 Item (CADSS-6) questionnaire. Those who are unable to tolerate dose levels 1 - 4 may be down-titrated to lower levels. Participants who are unable to tolerate the starting dose will have their dosage reduced for subsequent treatments to the minimum dose of 0.025 mg/kg of midazolam.

All control treatments are administered in person by a member of the study team. Adherence to treatments will be monitored by the study team through regular checks at the study site. Each treatment will be entered into the study-specific database to ensure adherence.

Open Label Extension (OLE) Phase:
Participants who were randomised to the active placebo control condition in the RCT Phase and who continue into the OLE phase may receive three weeks of twice-weekly open-label ketamine treatment. Entry into the OLE phase will occur within three-to-four days after completion of the last RCT phase treatment. Dose titration will follow the same methodologies outlined during the RCT phase. Participants who were randomised to the active placebo control condition during the RCT phase will begin at ketamine dose level 1 (0.6 mg/kg) at the first treatment in the OLE phase. The dosage may be titrated according to response and tolerability at subsequent OLE treatments, as per the methodology outlined in the RCT phase.
Control group
Active

Outcomes
Primary outcome [1] 337643 0
Effect of low-dose subcutaneous ketamine in comparison to midazolam control on depression symptoms in adults with bipolar depression.
Timepoint [1] 337643 0
Baseline, Day4, Day 8, Day 11, Day 15, Day 18, Day 19 (primary timepoint; 19 days post commencement of treatment).
Secondary outcome [1] 432674 0
Binary endpoint: Depression remission achieved or not achieved in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [1] 432674 0
Day 19 post-commencement of treatment.
Secondary outcome [2] 432675 0
Binary endpoint: Depression symptom extended response achieved or not achieved in adults with bipolar depression following treatment with subcutaneous ketamine compared to midazolam control.
Timepoint [2] 432675 0
Baseline and Day 39 post-commencement of treatment.
Secondary outcome [3] 432676 0
Change in participant reported depression symptoms in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [3] 432676 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [4] 432677 0
Change in atypical symptoms of depression in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [4] 432677 0
Baseline and Day 19 post-commencement of treatment
Secondary outcome [5] 434323 0
Patient reported global impression of improvement from baseline in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [5] 434323 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [6] 434324 0
Change in anxiety symptoms in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [6] 434324 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [7] 434325 0
Change in suicidal ideation in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [7] 434325 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [8] 434326 0
Change in quality of life in adults with bipolar depression, measured by the Assessment of Quality of Life-8 Dimensions (AQoL-8D) following treatment with subcutaneous ketamine compared to midazolam control.
Timepoint [8] 434326 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [9] 434327 0
Cost-effectiveness of subcutaneous ketamine in comparison to midazolam control in adults with bipolar depression, assessed from health sector and societal perspectives.
Timepoint [9] 434327 0
Day 19 post-commencement of treatment.
Secondary outcome [10] 434491 0
To evaluate differences in cardiorespiratory response following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [10] 434491 0
Day 1, Day 4, Day 8, Day 11, Day 15 and Day 18 post-commencement of treatment.
Secondary outcome [11] 434492 0
To evaluate differences in psychotomimetic symptoms, specifically hallucinations, delusions, and other thought disturbances, following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression. This will be assessed as a composite outcome using the positive symptoms subscale of the Brief Psychiatric Rating Scale (BPRS).
Timepoint [11] 434492 0
60- and 120-minutes post-dose on Day 1, Day 4, Day 8, Day 11, Day 15, and Day 18 post-commencement of treatment.
Secondary outcome [12] 434493 0
To evaluate differences in dissociative symptoms following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [12] 434493 0
60- and 120-minutes post-dose on Day 1, Day 4, Day 8, Day 11, Day 15, and Day 18 post-commencement of treatment.
Secondary outcome [13] 434494 0
To evaluate differences in side effects following treatment with low-dose subcutaneous ketamine versus midazolam placebo control in adults with bipolar depression.
Timepoint [13] 434494 0
Day 1, Day 4, Day 8, Day 11, Day 15 and Day 18 post-commencement of treatment.
Secondary outcome [14] 434495 0
To evaluate differences in manic symptoms following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [14] 434495 0
Day 1, Day 8, Day 15 and Day 19, Day 22, Day 29, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [15] 434753 0
To evaluate differences in suicidal ideation following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [15] 434753 0
Baseline, Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 19, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [16] 434798 0
To evaluate differences in the severity of ketamine craving following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [16] 434798 0
Day 1, Day 8, Day 15, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [17] 434799 0
To evaluate differences in cognitive function on the Identification Task following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [17] 434799 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [18] 434800 0
To evaluate differences in the tolerability of low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [18] 434800 0
Baseline, Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [19] 436107 0
Change in quality of life in adults with bipolar depression, measured by the Recovering Quality of Life-10 Dimensions (ReQoL-10) following treatment with subcutaneous ketamine compared to midazolam control.
Timepoint [19] 436107 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [20] 436202 0
Clinician reported global impression of improvement from baseline in adults with bipolar depression following treatment with subcutaneous ketamine in comparison to midazolam control.
Timepoint [20] 436202 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [21] 436554 0
To evaluate differences in suicidal behaviours following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [21] 436554 0
Baseline, Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 19, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [22] 436555 0
To evaluate differences in suicidal acts following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [22] 436555 0
Baseline, Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 19, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [23] 436556 0
To evaluate differences in non-suicidal self-injury following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [23] 436556 0
Baseline, Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 19, Day 22, Day 25, Day 29, Day 32, Day 36, Day 39, Day 39 (Follow-Up 1), Day 81 (Follow-Up 2) post-commencement of treatment.
Secondary outcome [24] 436557 0
To evaluate differences in cognitive function on the Two Back Test following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [24] 436557 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [25] 436558 0
To evaluate differences in cognitive function on the International Shopping List following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [25] 436558 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [26] 436559 0
To evaluate differences in cognitive function on the Set Shifting Task following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [26] 436559 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [27] 436560 0
To evaluate differences in cognitive function, as assessed by a composite score of the Trail Making Test A and B, following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [27] 436560 0
Baseline and Day 19 post-commencement of treatment.
Secondary outcome [28] 436561 0
To evaluate differences in cognitive function on the Verbal Fluency test following treatment with low-dose subcutaneous ketamine versus midazolam control in adults with bipolar depression.
Timepoint [28] 436561 0
Baseline and Day 19 post-commencement of treatment.

Eligibility
Key inclusion criteria
Consent and Capacity: Eligible participants must be able to provide written informed consent, demonstrating adequate intellectual capacity and fluency in English.
Age Requirement: Participants must be aged 18 years or older at the time of informed consent. Diagnosis: Participants must meet the DSM-5 criteria for either bipolar I or bipolar II disorder, currently experiencing a Major Depressive Episode, confirmed using the Structured Clinical Interview for DSM-5 (SCID-5).
Depression Severity: Participants must present with moderate-to-severe depression (as indicated by MADRS score greater than or equal to 20).
Stable Pharmacotherapy: Participants must be receiving stable pharmacotherapy treatment with one or more mood stabilising medications, which can include lithium, anti-convulsants, and atypical antipsychotics, for at least 28 days prior to the first treatment visit (Day 1) and must remain stable throughout the trial (unless changes are clinically indicated);
Reproductive Health Requirements: People of Childbearing Potential (POCBP) must have a negative pregnancy test, not be breastfeeding, and use effective contraception throughout the study. Additionally, abstention from egg or sperm donation during and following the study is required, with specific time frames set for each.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded Diagnoses: Participants should not meet DSM-5 criteria for current major depressive episodes with mixed features, rapid cycling bipolar disorder, schizoaffective disorder, or schizophrenia.
Compliance Issues: Participants with severe disturbances that prevent compliance with the study requirements or informed consent are excluded.
Medical Contradictions: Those with unstable medical conditions or contraindications to ketamine or midazolam use, according to product information forms, are not eligible.
Substance Use: Any history of ketamine use disorder or substance use disorder of at least moderate severity within the past 6 months excludes participation.
Concurrent Trial Participation: Participation in another clinical trial from the first day of this trial until the first follow-up visit (Day 39) disqualifies prospective participants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is assured using a secure, trial-specific REDCap database, with randomisation only occurring centrally by the randomisation coordinator (who is also blinded to treatment group allocation). This system uses a randomisation module with a sequence developed by an independent statistician, ensuring that the allocation remains undisclosed until the necessary point in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be developed by a statistician independent of the trial. Randomisation will be stratified by trial site, using random permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical methods/analysis:
Reporting of research findings will be in accordance with CONSORT and ICH guidelines. Independent statisticians will be responsible for randomisation and the final analysis. The statistician responsible for the final analysis will be blinded to treatment arm allocation and the identity of groups A and B until all analyses have been completed.

Demographic and clinical characteristics at baseline will be presented for all participants. Variables demonstrating significant differences between treatment arms, and any significant predictors of attrition, will be added to the primary and secondary analysis models as covariates.

Planned sensitivity analyses will be conducted to examine the effect of different proportions of missing data. Data will be assumed to be missing not at random and will be imputed using an appropriate imputation method.

The primary outcome of treatment efficacy will be evaluated using a linear mixed effects for repeated measures (MMRM) model with random intercept and fixed effects for treatment group, assessment timepoint, study site, and treatment group by assessment timepoint interaction, and a random effect for participant. Appropriate contrasts will be used at Day 19, to evaluate the superiority of ketamine in comparison to midazolam.

All secondary continuous outcome measures and tests of moderation will be analysed using the same approach as with the primary outcome variable. Where the objective involves a dichotomous outcome variable (e.g., remission versus remission-not-achieved), the same primary MMRM analysis model will be used, but with the outcome variable modelled using a binary logistic distributional family instead.

For the safety outcome analysis, treatment emergent adverse events (TEAE) will be summarised by treatment group, severity and MedDRA classification. Separate summaries of TEAE that are at the highest severity rating, and any that result in fatalities, will be summarised separately. Any AE that occurs prior to, or following conclusion of the study will not be included in the summary data.

Intercurrent events will be treated using both treatment policy and composite strategies as relevant.
- Treatment policy approach implies that the intercurrent event is considered irrelevant in defining the treatment effects of interest. Thus all data regardless of intercurrent event in included in the analysis.
- Composite approach implies that the intercurrent event is informative of treatment progression and should be incorporated into the outcome variable.

All tests will be conducted using a type I error = 0.05 (two-sided). All outcome measures will be evaluated using the full analysis and per protocol datasets with 95% confidence intervals reported throughout. Effects sizes will be calculated using Cohen’s guidelines.

Sample size estimation
Power analysis was performed via simulation using meta-analysis derived effect sizes, Cohen’s d=0.67 consistent with comparison between low-dose Ketamine and active control. The simulations were also informed by the following assumptions; power = 80%, Type I error = 0.05 (two-sided), correlation between timepoints = 0.5, intra-cluster correlation coefficient = 0.01 (variation between study sites), and attrition = 20%. Initial sample size estimations were inflated by a modest design effect to account for study site = 1.17, resulted in a target sample size = 98 (n=49 per treatment arm).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2024
Actual
Date of last participant enrolment
Anticipated
28/06/2027
Actual
Date of last data collection
Anticipated
17/09/2027
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 26515 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 26516 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 26517 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 42554 0
3050 - Parkville
Recruitment postcode(s) [2] 42555 0
2050 - Camperdown
Recruitment postcode(s) [3] 42556 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 316037 0
Government body
Name [1] 316037 0
NHMRC 2020 MRFF Million Minds Mission
Country [1] 316037 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318617 0
None
Name [1] 318617 0
None
Address [1] 318617 0
Country [1] 318617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314858 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314858 0
Ethics committee country [1] 314858 0
Australia
Date submitted for ethics approval [1] 314858 0
29/11/2023
Approval date [1] 314858 0
05/03/2024
Ethics approval number [1] 314858 0
HREC/103063/MH-2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132954 0
Prof Chris Davey
Address 132954 0
Department of Psychiatry, The University of Melbourne, Level 3, Alan Gilbert Building, 161 Barry Street, Carlton, Victoria, 3053
Country 132954 0
Australia
Phone 132954 0
+61 3 8344 5509
Fax 132954 0
Email 132954 0
c.davey@unimelb.edu.au
Contact person for public queries
Name 132955 0
Chris Davey
Address 132955 0
Department of Psychiatry, The University of Melbourne, Level 3, Alan Gilbert Building, 161 Barry Street, Carlton, Victoria, 3053
Country 132955 0
Australia
Phone 132955 0
+61 3 8344 5509
Fax 132955 0
Email 132955 0
c.davey@unimelb.edu.au
Contact person for scientific queries
Name 132956 0
Chris Davey
Address 132956 0
Department of Psychiatry, The University of Melbourne, Level 3, Alan Gilbert Building, 161 Barry Street, Carlton, Victoria, 3053
Country 132956 0
Australia
Phone 132956 0
+61 3 8344 5509
Fax 132956 0
Email 132956 0
c.davey@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after deidentification.
When will data be available (start and end dates)?
Data will be available Immediately following publication of the primary outcome paper, for an indefinite time.
Available to whom?
Available to research staff with appropriate Human Research and Ethics Approval.
Available for what types of analyses?
All types, both individual-level analyses as well as meta-analyses.
How or where can data be obtained?
Data can be requested directly from the investigators via email (c.davey@unimelb.edu.au) and will be approved on a case-by-case basis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22337Study protocol    Intention to publish the study protocol.



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