Protocol summary
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Study aim
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Determining the effect of curcumin and vitamin D supplementation on inflammatory biomarkers and nutritional status of patients with colorectal cancer
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Design
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A randomized, double-blind, parallel-group, controlled clinical trial on 92 patients with colorectal cancer. Randomization was performed using random allocation software with a block size of 4 and a ratio of 1:1:1:1.
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Settings and conduct
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Patients with colorectal cancer referred to Amir Hospital, Mehr Clinic, Pardis Clinic, Hazrat Abolfazl Chemotherapy Center, and Motahari Clinic will be included in the study through convenience sampling method upon informed consent, according to the inclusion criteria and the absence of exclusion criteria. Blinding: The appearance, packaging, color, and size of the supplements and the dosage will be similar. At the beginning and end of the study, inflammatory factors, hand muscle strength, quality of life questionnaire, body composition analysis, and dietary components will be measured.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Colorectal cancer patients
At least 3-month life expectancy
Using chemotherapy method
Nonallergic to turmeric
Exclusion criteria:
Unwillingness to participate in the study
Not continuing chemotherapy
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Intervention groups
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Curcumin group: 80 mg of nanocurcumin daily and one placebo vitamin D tablet per week; Vitamin D group: one tablet of vitamin D (50,000) per week and two placebo nanocurcumin tablets per week; Curcumin and vitamin D group: 80 mg of nanocurcumin daily and one tablet of vitamin D (50,000) per week; Placebo group: Two tablets of curcumin daily and one placebo vitamin D tablet per week.
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Main outcome variables
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Interleukin 6, tumor necrosis factor alpha, C-reactive protein to albumin ratio, quality of life, body fat, lean body mass, body mass index, hand muscle strength, basal metabolism, dietary components
General information
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Reason for update
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Actual Start and End Dates of Patient Recruitment
Actual start date: May 23, 2025 (1404/03/02)
Actual end date: July 11, 2026 (1405/04/20)
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20250110064340N1
Registration date:
2025-03-27, 1404/01/07
Registration timing:
prospective
Last update:
2026-10-29, 1405/08/07
Update count:
3
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Registration date
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2025-03-27, 1404/01/07
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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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2025-05-21, 1404/02/31
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Expected recruitment end date
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2026-05-21, 1405/02/31
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Actual recruitment start date
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2025-05-23, 1404/03/02
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Actual recruitment end date
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2026-07-11, 1405/04/20
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Trial completion date
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empty
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Scientific title
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The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial
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Public title
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The Effect of Curcumin and Vitamin D Supplementation on Inflammatory Biomarkers and Nutritional Status in Patients with Colorectal Cancer: A Randomized Clinical Control Trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with colorectal cancer
18-60 years of age
At least 3 months of life expectancy
Using chemotherapy
BMI=18-30 kg/m2
Nonallergic to turmeric
Not suffering from hypertension or renal, hepatic, or parathyroid disorders
Exclusion criteria:
Unwillingness to participate in the study
Not continuing chemotherapy
Fever greater than 38.5°C in three days before receiving the first dose of the supplementary drugs
Known positive HIV serology
Patients with other malignancies, Pregnancy and lactation
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
92
More than 1 sample in each individual
Number of samples in each individual:
23
Curcumin group: This group will receive 2 capsules of 40 mg of nanocurcumin daily (80 mg daily) and a placebo of vitamin D (500,000 IU) once a week, for 8 weeks. Vitamin D group: This group will receive one vitamin D tablet (500,000IU) weekly, and two placebo capsules (40 mg of nanocurcumin) daily (80 mg daily), for 8 weeks. Curcumin + Vitamin D group: This group will receive 2 capsules of 40 mg of Nano-curcumin (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly, for 8 weeks. Curcumin + Vitamin D group: This group will receive 2 capsules of 40 mg of Nano-curcumin (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly, for 8 weeks
Actual sample size reached:
89
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using random allocation software with a block size of 4 and a ratio of 1:1:1:1,
the groups assigned to each participant will be labeled as A, B, C, D in identical sealed envelopes by an outsider.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The appearance, packaging, color, and size of the supplements and placebos will be similar. The supplements and placebos will be labeled by an outsider in line with the names of the groups with letters A, B, C, and D. Therefore, both the participants and the researcher will be unaware of the study groups and the use of the drug and placebo until the end of the study.
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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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The intervention will last for 8 weeks. The study participants will be divided into four groups:1- Curcumin group; 2- Vitamin D group; 3- Curcumin and vitamin D group; 4- Placebo group
Ethics committees
1
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Ethics committee
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Approval date
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2024-10-13, 1403/07/22
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Ethics committee reference number
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IR.SUMS.SCHEANUT.REC.1403.063
Health conditions studied
1
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Description of health condition studied
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colorectal cancer
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ICD-10 code
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C18.9
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ICD-10 code description
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Malignant neoplasm of colon
Primary outcomes
1
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Description
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Tumor necrosis factor alpha
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using laboratory kit and ELISA method
2
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Description
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Interleukin 6
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using laboratory kit and ELISA method
3
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Description
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C-reactive protein to albumin ratio
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using a laboratory kit
4
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Description
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Hand muscle strength
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using handgrip
5
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Description
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Quality of life
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Quality of life questionnaire
6
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Description
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Body mass index, basal metabolic rate, fat mass, fat-free mass, weight
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Timepoint
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At the beginning of the study (before the intervention) and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using BIA
7
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Description
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Dietary components include energy, carbohydrates, protein, fat, and fiber
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Timepoint
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At the beginning of the study (before the intervention), 4 weeks after taking curcumin and vitamin D and 8 weeks after taking curcumin and vitamin D
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Method of measurement
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Using a 24-hour food recall questionnaire
Intervention groups
1
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Description
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First intervention group: Curcumin group: They will receive 2 capsules of 40 mg of nano-curcumin daily (80 mg daily) and one vitamin D placebo weekly for 8 weeks. Manufacturer: Exir Nano Sina Company-Tehran
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Category
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Treatment - Drugs
2
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Description
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Second intervention group: Vitamin D group: They will receive one vitamin D tablet (50000IU) per week and 2 nanocurcumin placebo capsules per day. Manufacturer: Zahravi Company-Tabriz
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Category
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Treatment - Drugs
3
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Description
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The third intervention group (Curcumin + Vitamin D group): Two capsules of 40 mg of nano-curcumin daily (80 mg daily) and one tablet of vitamin D (500,000 IU) weekly for 8 weeks
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Category
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Treatment - Drugs
4
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Description
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Control group: This group will receive two capsules of the nanocurcumin placebo daily and one capsule of the vitamin D placebo weekly for 8 weeks. The vitamin D placebo contains food grade paraffin, which is similar in shape and color to a vitamin D tablet. Manufacturer: Zahravi Company, Tabriz The curcumin placebo contains lecithin and food grade yellow dye E104, which is similar in shape and color to a curcumin tablet. Manufacturer: Exir Nano Sina Company, Tehran
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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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Shiraz 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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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not 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