Protocol summary
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Study aim
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the effects of Iranian Traditional Medicine diet on invitro fertilization outcomes
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Design
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A Randomized Controlled Trial
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Settings and conduct
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The study was designed as a randomized clinical trial. Participants in the study were referred to Hazrat Zahra infertility treatment center affiliated to Shahrekord University of Medical Sciences. At the beginning of the study, the volunteers were examined by a practitioner to qualify for the study.
The control group received routine healthcare and modern dietary recommendations and the intervention group was advised to observe health principles and nutritional recommendations based on ITM sources. Each individual in the intervention group was trained on traditional dietary advices , foods preparation, nutritionally-prohibited foods and essential health recommendations by the researcher. They also received a training guidance text on the above- mentioned points for further self-learning.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria: infertile women with ovulatory problems or endometriosis or ideophatic infertility, age 20 to 40 years, giving written consent to participate in the study. Women who had infertility with anatomical causes, infertility of their husbands, having uterine myoma or hydrosalpinx, smoking, drinking alcohol, and diabetes mellitus were not included. Exclusion criteria were as follow: lack of interest or cooperation during the study, refusal to go through IVF / ICSI.
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Intervention groups
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Each individual in the intervention group was trained on traditional dietary advices ,prohibited foods and essential health recommendations.
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Main outcome variables
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The primary outcomes of the study were the rate of sponteneous pregnancy and clinical pregnancy, and the secondary outcomes included ovum number, mature ovum number, embryo number, embryo quality, fertilization rate, implantation rate, and chemical pregnancy.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017013032245N2
Registration date:
2017-03-08, 1395/12/18
Registration timing:
prospective
Last update:
2019-01-14, 1397/10/24
Update count:
1
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Registration date
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2017-03-08, 1395/12/18
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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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Vice chancellor for research, Iran University of Medical Sciences
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Expected recruitment start date
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2017-02-03, 1395/11/15
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Expected recruitment end date
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2017-07-06, 1396/04/15
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Actual recruitment start date
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2017-04-10, 1396/01/21
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Actual recruitment end date
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2017-11-20, 1396/08/29
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Trial completion date
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2018-03-11, 1396/12/20
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Scientific title
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Clinical trial comparing the effects of diet based on traditional medicine and usual diet on the results of in vitro fertilization for infertile women
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Public title
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The impact of diet based on Iranian Traditional Medicine on IVF/ICSI outcomes of infertile women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
infertile women with ovulatory problems or endometriosis or idiopathic infertility and endometriosis
age 20 to 40 years
giving written consent to participate in the study
no infertility with anatomical causes
no infertility of their husbands
not having uterine myoma or hydrosalpinx
no smoking
no alcohol drinking
not diabetic
Exclusion criteria:
lack of interest or cooperation during the study,
refusal to go through IVF / ICSI.
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Age
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From 20 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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3
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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:
124
Actual sample size reached:
180
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the order of entry to study based on a permuted blocks of size four, the patients in each four age groups of under 30, 30-34, 35-37, and 38-40 years were randomly assigned to the intervention and control groups. The random allocation sequence was generated by an investigator who was not involved in eliciting data or conducting the study.
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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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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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2017-01-15, 1395/10/26
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Ethics committee reference number
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IR.IUMS.REC1395.9221309206
Health conditions studied
1
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Description of health condition studied
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infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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clinical pregnancy
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Timepoint
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3 mounts after intervention
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Method of measurement
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sonography
Secondary outcomes
1
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Description
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Oocyt quality
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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Oocyt quality evaluation criteria
2
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Description
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Embryo quality
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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Embryo quality evaluation criteria
3
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Description
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Endometrium tickness
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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Sonography
4
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Description
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Implantation rate
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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The number of gestational sac divided by the number of transferred embryos
5
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Description
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Fertility rate
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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the number of oocytes fertilized divided by the number of oocytes inseminated
6
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Description
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Chemical pregnancy
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Timepoint
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2-3 mounts after intervention
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Method of measurement
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Serum Β-hCG meausurment
Intervention groups
1
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Description
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Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).
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Category
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Treatment - Other
2
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Description
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Control group: The usual daily diet in the control group for 2 to 3 months before IVF/ICSI.
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Category
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Treatment - 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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Yes
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Title of funding source
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Research Institute for Islamic and Complementary Medicine (RICM)
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Proportion provided by this source
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50
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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
2
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Sponsor
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Grant name
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Grant code / Reference number
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-
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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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Vice Chancellor for research of Iran University of Medical Sciences
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Proportion provided by this source
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50
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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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data will be sent to researchers upon request.
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When the data will become available and for how long
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After publication the results of study
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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for systematic or meta-analysis study
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From where data/document is obtainable
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ِDr Mojgan Tansaz
tansaz_mojgan@yahoo.com
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What processes are involved for a request to access data/document
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E-mail correspondence with the principle researcher
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Comments
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There are no patient names in the data file and numerical codes are used to identify them.