Protocol summary
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Study aim
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The aim of this study is to determine the effects of Q10 supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress among type 2 diabetes patients with coronary heart disease (CVD).
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Design
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Study design: 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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Population and sample size: 60 subjects with CVD eligible and referred to Outpatient Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Overweight patients aged 40-85 years old and diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Intake of CoQ10 or antioxidant supplements within the last 3 months, acute myocardial infarction within the past 3 months, cardiac surgery within the past 3 months and renal or liver failure.
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Intervention groups
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Intervention: Patients will be assigned to receive either 100 mg Q10 supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks
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Main outcome variables
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Outcomes: Glucose homeostasis parameters and hs-CRP (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201502245623N35
Registration date:
2015-03-06, 1393/12/15
Registration timing:
retrospective
Last update:
2019-10-18, 1398/07/26
Update count:
1
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Registration date
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2015-03-06, 1393/12/15
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-03-01, 1393/12/10
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Expected recruitment end date
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2015-03-04, 1393/12/13
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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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Effects of Q10 supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in type 2 diabetes with Coronary Heart Disease
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Public title
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Effect of supplementation in treatment of type 2 diabetes with Coronary Heart Disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Subjects aged 45-75 years
Diagnosed with type 2 diabetes and CVD
Exclusion criteria:
Intake of CoQ10 or antioxidant supplements within the last 3 months
Acute myocardial infarction within the past 3 months
Cardiac surgery within the past 3 months
Renal or liver failure
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Age
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From 40 years old to 85 years old
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Gender
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Both
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Phase
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3
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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:
60
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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 two groups to receive Q10 (n = 30) or placebo (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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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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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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2015-02-28, 1393/12/09
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Ethics committee reference number
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93193
Health conditions studied
1
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Description of health condition studied
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بیماری کرونر قلبی
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ICD-10 code
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I25.9
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ICD-10 code description
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Ischaemic heart disease (chronic)
Primary outcomes
1
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Description
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Fasting plasma glucose
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
2
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
3
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
4
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Description
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Insulin resistance
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
Secondary outcomes
1
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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 8 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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Total cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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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 8 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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Total antioxidant
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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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 8 weeks of intervention
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Method of measurement
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Spectrophotometry
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 8 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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VLDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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Description
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LDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
9
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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 8 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: Q10 tablet, 100 mg, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo tablet, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
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