Protocol summary
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Study aim
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The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on the health-related quality of life questionnaire for women with PCOS (PCOSQ), hirsutism, frequency of menstrual cycles and to compare the effects of energy restricted diet on anthropometric and general Health related quality of life, depression and anexiety, Rosenberg's Self-Esteem Scale , Body Image, Binge eating scale, female sexual disorder between women with or without PCOS.
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Design
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A clinical trial with parallel groups in 101 women with polycystic ovary syndrome and 101 healthy control who were matched for body mass index and age and were selected by convenience sampling.
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Settings and conduct
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The case group will be recruited from PCOS women , attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls recruited from women attending for their annual visit to the health care center affiliated to Shahid Beheshti University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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1-Diagnosis of PCOS according to Rotterdam criteria
2- Age between 18-40 years old
3- BMI > 25 kg / m² and < 38 kg / m²
Exclusion criteria
1-Chronic disease
2- Using any hormonal drugs
3-Being pregnant and Lactation
4- Mental disorders
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Intervention groups
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The intervention includes a restricted energy low glycemic
index diet of 500 kcal per day for 6 months to reduce weight by 5 - 10% in women with polycystic ovary syndrome and healthy control.
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Main outcome variables
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General Health related quality of life, depression, Rosenberg's Self-Esteem Scale , Body Image, Binge eating scale, female sexual disorder, hirsutism, frequency of menstrual cycles, Health-related quality of life questionnaire for women with PCOS (PCOSQ), Anthropometric variables.
General information
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Reason for update
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Due to executive problems, the start of sampling was postponed and ethical approval was acquired from the ethics committee of the Research Institute of Endocrine Sciences.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016092129909N1
Registration date:
2016-12-08, 1395/09/18
Registration timing:
prospective
Last update:
2023-06-13, 1402/03/23
Update count:
2
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Registration date
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2016-12-08, 1395/09/18
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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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Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2019-01-04, 1397/10/14
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Expected recruitment end date
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2020-02-16, 1398/11/27
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation the effectiveness of interventions based on life style modification in women with polycystic ovarian syndrom
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Public title
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interventions based on lifestyle modification
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of PCOS according to Rotterdam criteria
All participants are Iranian speakers and have the ability to read and write
Age between 18-40 years old
BMI > 25 kg / m² and < 38 kg / m²
Exclusion criteria:
chronic disease
Using insulin-sensitizing drugs;
Using contraceptive drugs
Using antihypertensive drugs
Using lipid lowering drugs
Using any hormonal drugs
Using any antidepressants
Special diets or exercise for weight loss in past 6 months
Participating in previous similar studies
Ovulation induction in the past year
Smoking or using alcohol
Mental disorders
History of any type of malignancy
Being pregnant
Lactation in the past year
Bleeding of unknown cause
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Age
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From 18 years old to 40 years old
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Gender
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Female
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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:
220
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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2016-11-15, 1395/08/25
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Ethics committee reference number
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IR.SBMU.ENDOCRINE.REC.1395.276
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E20-E35
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ICD-10 code description
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Disorders of other endocrine glands
Primary outcomes
1
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Description
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Quality of Life Score in the Health Short Form Questionnaire (SF-36)
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Timepoint
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0-24 weeks
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Method of measurement
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The Short Form Health Survey(SF-36)
2
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Description
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Quality of Life Score in Polycystic Ovary Syndrome Questionnaire (PCOSQ)
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Timepoint
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0--24 weeks
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Method of measurement
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Polycystic Ovary Syndrome Questionnaire (PCOSQ)
Secondary outcomes
1
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Description
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Hirsutism
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Timepoint
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0-12-24 weeks
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Method of measurement
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Ferriman-Gallwey scoring
2
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Description
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Menstural Cyclicity
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Timepoint
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0-12-24 weeks
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Method of measurement
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Questionnare
3
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Description
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Waist Circumference
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Timepoint
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0-12-24 weeks
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Method of measurement
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non flexible tape measure
4
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Description
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Hip circumference
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Timepoint
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0-12-24 weeks
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Method of measurement
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non flexible tape measure
5
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Description
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Weight
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Timepoint
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0-12-24 weeks
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Method of measurement
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digital scale
6
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Description
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Hospital Depression and Anxiety Scale
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Timepoint
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0-24 weeks
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Method of measurement
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Hospital Depression and Anxiety Scale
7
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Description
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Self-esteem
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Timepoint
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0-24 weeks
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Method of measurement
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Rosenberg Self-esteem Scale (RSES)
8
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Description
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ُSexual function
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Timepoint
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Female Sexual Function Index (FSFI)
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Method of measurement
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0-24 weeks
9
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Description
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Body Shape Questionnaire
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Timepoint
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0-24 weeks
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Method of measurement
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Body Shape Questionnaire
10
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Description
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Multidimensional Body-self Relations Questionnaire (MBSRQ)
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Timepoint
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0-24 weeks
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Method of measurement
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Multidimensional Body-self Relations Questionnaire (MBSRQ)
11
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Description
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Binge Eating Scale (BES)
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Timepoint
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0-24 weeks
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Method of measurement
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Binge Eating Scale (BES)
Intervention groups
1
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Description
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energy restricted low glycemic اindex diet
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Category
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Lifestyle
1
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Sponsor
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Grant name
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not applicable
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Grant code / Reference number
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ندارد
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is 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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Main consequences, statistical analysis
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When the data will become available and for how long
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The access period will start 6 months after the results are published.
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Use of statistical tests in the present research in similar studies, Use the main results of current research by citing references to the main authors to compare the results of the current research with the studies of others.
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From where data/document is obtainable
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Email address
shishehgarf@yahoo.com
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What processes are involved for a request to access data/document
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6 months after the publication of the current research results, the information requested by the academic persons will be sent to their e-mail.
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Comments
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