Protocol summary
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Study aim
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The aim of this study is to determine the effects of combined probiotic and selenium supplementation on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Golabchi Welfare Organization (Kashan, Iran)
Madar, Shayestegan and Amin Welfare Organizations (Shahrekord, Iran).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Alzheimer's disease and aged 55 to 100 years will be included in this study. Exclusion criteria: Patients with metabolic syndrome, diabetes, cardiovascular disease, chronic infections, consuming probiotic and/or synbiotic supplements within 8 weeks prior to the study, taking other forms of probiotics including probiotic yogurt and other fermented foods, and taking antioxidants supplements will be excluded.
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Intervention groups
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Patients will be assigned to receive selenium supplements (n=30)and combined probiotic and selenium supplementation (n=30) and placebo (n=30).
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Main outcome variables
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Fasting blood samples will be taken at baseline and after 12-week intervention and insulin resistance, inflammatory factors and biomarkers of oxidative stress, and cognitive function will be measured at baseline and end-of-trial
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:
IRCT20170612034497N5
Registration date:
2018-04-02, 1397/01/13
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
2
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Registration date
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2018-04-02, 1397/01/13
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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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Expected recruitment start date
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2017-12-29, 1396/10/08
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Expected recruitment end date
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2018-01-29, 1396/11/09
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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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Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease
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Public title
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Effect of combined probiotic and selenium supplementation in treatment of patients with Alzheimer's disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Alzheimer's disease
Individuals aged 55 to 100 years
Exclusion criteria:
Patients with metabolic syndrome
Patients with diabetes
Patients with cardiovascular disease
Patients with chronic infections
Consuming probiotic and/or synbiotic supplements within 8 weeks prior to the study
Taking other forms of probiotics including probiotic yogurt and other fermented foods
Taking antioxidants supplements
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Age
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From 55 years old to 100 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age subjects will be randomly divided into three groups to take either selenium supplements + probiotic placebos (n = 30) or selenium and probiotic supplements (n = 30) or selenium and probiotic placebos (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2017-12-28, 1396/10/07
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Ethics committee reference number
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IR.Kaums.REC.1396.65
Health conditions studied
1
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Description of health condition studied
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Alzheimer's disease
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ICD-10 code
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G30
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ICD-10 code description
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Alzheimer's disease
Primary outcomes
1
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Description
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Cognitive function
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Mini Mental State Exam (MMSE)
Secondary outcomes
1
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA kit
3
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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ELISA kit
6
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
11
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Bifidobacterium lactis (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and bifidobacterium longum (2×109 CFU/g) and selenium (200 µg), daily, for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Oral capsule containing selenium (200 µg), daily, for 12 weeks.
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo oral capsule, daily, for 12 weeks.
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Category
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Placebo
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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Kashan 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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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be 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