Protocol summary
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Study aim
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The aim of this study is the enhancement of emotional regulation in children with cancer.
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Design
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Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45-minutes. Sessions were conducted 5 times weekly for 4 weeks.
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Settings and conduct
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The study was conducted at the Mahak Hospital and Rehabilitation Complex. located in Tehran, Iran.
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Participants/Inclusion and exclusion criteria
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Hospitalized patients were eligible to participate in the MBCT-C if they were 11 to 13 years of age Patients who were determined to be diagnosed with a terminal illness were excluded.
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Intervention groups
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The primary aim of MBCT-C is to improve effective self-regulation through the development of mindful attention and to decenter from thoughts and emotions. The main component of this therapy is awareness of the present moment, which helps them decide more wisely. Unlike cognitive therapy, no effort is made to restructure or change existing thoughts and emotions. Individuals in this program learn to be mindful in daily life.
The control group was 20 children with cancer hospitalized and were not under any psychological and psychiatric therapy.
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Main outcome variables
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Change in internalizing and attention problems.
General information
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Reason for update
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Mindfulness-Based Cognitive Therapy has been focused on the reduction in internalizing and attention problems as well as enhancement in emotional regulation. So, we decided to assess the variables which had more support in the literature review. We selected internalizing and attention problems because more studies examined them.
Moreover, we found out in hospitalized children who could stay in the hospital for one month, internalizing and attention problems are more evident than adjustment problems. Hence, we decided to change the independent variable from adjustment to attention and internalizing problems.
Besides, parents in the initial interviews reported that their children's internalizing and attention problems are more frequent than the adjustment problems. It became another reason to change the "adjustment" variable to the internalizing and attention issues.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2013120614338N1
Registration date:
2013-12-06, 1392/09/15
Registration timing:
registered_while_recruiting
Last update:
2021-01-02, 1399/10/13
Update count:
1
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Registration date
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2013-12-06, 1392/09/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Funded by researcher
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Expected recruitment start date
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2013-09-01, 1392/06/10
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Expected recruitment end date
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2014-03-11, 1392/12/20
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Actual recruitment start date
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2013-08-31, 1392/06/09
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Actual recruitment end date
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2014-03-10, 1392/12/19
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Trial completion date
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2014-03-10, 1392/12/19
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Scientific title
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The effectiveness of Modified Mindfulness-based Cognitive Therapy for hospitalized Children Hospitalized with Cancer compared to control group in attention problems and internalizing problems.
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Public title
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The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Children with Cancer
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Hospitalized patients were eligible to participate in the Mindfulness-Based Cognitive Therapy for Children (MBCT-C) program in addition to receiving TAU if they were (a) 11 to 13 years of age; (b) had at least average fluency in Persian; (c) had received the first diagnosis of any type of cancer except brain cancers; (d) were undergoing radiation therapy and/or chemotherapy through the hospital’s oncology division; and (e) had not received any psychological interventions or psychiatric medications in the six months preceding the study. Diagnostic inclusion criteria were: (f) a diagnosis of Autism spectrum disorder (ASD) (Diagnostic and Statistical Manual of Mental Disorders (IV) (DSM-IV (American Psychiatric Association, 2000); and (g) at least two comorbid diagnoses in any of four diagnostic categories (anxiety, depression, psychosomatic, or attention deficit disorders). Diagnoses were ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Persian version (K-SADS-PL-P). Additionally, patients needed to be: (h) in the borderline or clinical range for internalizing problems (T-score ≥ 60) and attention problems (T-score ≥ 57) on at least two of four subscales of the Child Behavior Checklist (CBCL) or Youth Self-Report (YSR )(depression/anxiety, withdrawal/depression, somatic complaints, and attention problems) at the screening assessment.
Exclusion criteria:
Patients who were determined to (i) have a major cognitive dysfunction or developmental disability, or (j) was diagnosed with a terminal illness (defined as having a prognosis of fewer than six months) were excluded. Moreover, Brain cancers were excluded based on research suggesting that these may affect attention (Raghubar et al., 2017), a key outcome variable.
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Age
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From 11 years old to 13 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We utilized simple randomization through the excel file of random numbers. The unit of randomization was individual.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-08-27, 1392/06/05
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Ethics committee reference number
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58/850/ص
Health conditions studied
1
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Description of health condition studied
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cancer
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ICD-10 code
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F06.30
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ICD-10 code description
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Mood disorder due to known physiological condition, unspecified
2
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Description of health condition studied
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anxiety
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ICD-10 code
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F06.4
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ICD-10 code description
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Anxiety disorder due to known physiological condition
3
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Description of health condition studied
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depression
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ICD-10 code
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F06.31
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ICD-10 code description
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Mood disorder due to known physiological condition with depressive features
4
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Description of health condition studied
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somatic complaints
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ICD-10 code
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F06.4
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ICD-10 code description
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Anxiety disorder due to known physiological condition
5
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Description of health condition studied
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attention problems
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ICD-10 code
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F90
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ICD-10 code description
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Attention-deficit hyperactivity disorders
Primary outcomes
1
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Description
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internalizing and attention problems
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Timepoint
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Before and 4 weeks after the treatment as well as 2-month follow-up
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Method of measurement
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CBCL and YSR
Secondary outcomes
1
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Description
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more cooperation in medical treatments in participants
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Timepoint
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Before and after the treatment as well as at follow-up point
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Method of measurement
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Interviews
Intervention groups
1
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Description
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Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment as usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45 min. Sessions were conducted 5 times weekly for 4 weeks. Primary outcome measures were the Child Behavior Checklist, Parent Report and its companion instrument, and the Youth Self-Report (YSR). Data were collected at pre-intervention, post-intervention, and at 2 months following the intervention.
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Category
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Treatment - Other
2
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Description
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Forty youth were age and gender-matched, and then randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). Mahak hospital provided some welfare services and social work services. Welfare services as well as social work services was equal for both experimental and control group. Social workers were assigned to accompany the child and help the family to become acquainted with the cancer, available services, hospital procedure and personnel, and disjunctive treatment. Moreover, they facilitated a shared playroom that every child welcomed to join. They could use from various toys there and made friend with others. Parents could accompany their children there. And the group was lead by social workers. The room was open 2 hours daily from 2 pm to 4 pm. Children could use from snacks there and remaining there was not mandatory.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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The main researcher (samaneh abedini)
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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to respect to confidentiality, we do not aim to share our participants' names or pictures, but we can share their general demographic features as well as the results of their assessments through our publications or presentations at conferences.
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When the data will become available and for how long
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The results of data analysis will be available for everyone in google scholar when we could publish them in one scientific journal. it seems that in February of 2021 the article derived from the results will be published.
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To whom data/document is available
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The results of data analysis will be available for the public.
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Under which criteria data/document could be used
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Persons who want to use the results of data analysis have to cite us and our research as a reference.
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From where data/document is obtainable
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The results of data analysis can be downloaded from google scholar. Individuals interested in reading the article derived from these data can contact the corresponding author to receive the full-text article. Other researchers can contact Samaneh Abedini through the following email to receive the main article:
samaneh.abedini88@gmail.com
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What processes are involved for a request to access data/document
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Academic persons who need the data can send an email to the researchers. If they contacted the corresponding author, they could receive the article within one week.
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Comments
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