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Eligibility Form

1,744 Shared Subjects

Clinical Assessments
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Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project id, subject_id, subjectid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY date_eligibility_healthy, date_pt_eligible, visit_date
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0 :: 1260 Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month. elig_incl_age
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query elig_version_form Integer Recommended Form version 1::3 1=Clinical; 2=Healthy control; 3=Incl/Excl
Query beh_session_complete Integer Recommended Checks for complete BEH session 0;1 0=No; 1=Yes elig_beh_session_hc
Query chf_entered Integer Recommended Clinical History Form completion 0;1 0=No; 1=Yes elig_eeg_session_hc
Query rev_headeeg String 50 Recommended EEG
Yes; No; NK; NS
NK= Not known; NS = Not sure eeg_session_complete, elig_inclusion_check_hc
Query elig_inclusion_check Integer Recommended Checks for a pass/fail on Elig for Inclusion 0::3 0=Failed (Ineligible); 1=Passed (Eligible); 2=In screening; 3=NA elig_mri_session_hc, eligible, healthy_eligibile
Query elig_r_5 Integer Recommended Checks if QIDS score is >= to 14 0;1;9 0=No; 1=Yes; 9=N/A
elig_r_blood Date Recommended Date of blood samples collection elig_r_blood_hc
Query elig_r_blood_tube Integer Recommended Checks blood collection - number of tubes elig_r_blood_tube_hc
elig_r_eeg Date Recommended Date of successful data transfer EEG sessions elig_r_eeg_hc
elig_r_mri Date Recommended Date of MRI data transfer elig_r_mri_hc
elig_r_pheno Date Recommended Date of successful data transfer phenotype sessions elig_r_pheno_hc
elig_r_qids_eeg_date String 50 Recommended QIDS EEG date/time
Query qids_eeg_total Float Recommended QIDS EEG Total Score elig_r_qids_eeg_score
elig_r_qids_eval_date String 50 Recommended QIDS EVAL date/time
elig_r_qids_rand_date String 50 Recommended QIDS RAND date/time
Query qstot Float Recommended QIDS total score elig_qids_eval_score, elig_qids_hc, elig_r_qids_rand_score, qids_sr_score_random, qidssr_from_screening, qidssr_from_screening_hc
Query eligrnd_dysthymia_threshold Integer Recommended Dysthymia threshold 0;1 0=No; 1=Yes
Query eligrnd_mdd_threshold Integer Recommended MDD variable to indicate randomization 0;1 0=No; 1=Yes
Query hamd_score Float Recommended Pulls in score from HAM-D hamd_score_24
Query hamd_severity Integer Recommended message on severity 0::2 0=N/A; 1=High severity (>=20); 2=Low severity (<20)
Query mri_session_complete Integer Recommended Checks for complete MRI session 0;1 0=No; 1=Yes
Query sample_group Integer Recommended Sample group selection 1;2 1=Clinical; 2=Healthy control elig_sample_hc, sample_group_hc
Query scid_chron_indication Integer Recommended message on chronicity 0::2 0=N/A; 1=Chronic (4-6); 2=Non chronic (1-3)
scid_chron_rnd String 20 Recommended Pulls in SCID question 10f
Query screening_status Integer Recommended Message box that indicates status for randomization 1::3 1=In screening; 2=Not eligible for randomization; 3=Eligible for randomization
Query stg2_form_complete Integer Recommended Check Eligibility Stage 2 completed 0;1;9 0=No; 1=Yes; 9=N/A
Query ptcon Integer Recommended Patient consented
0=No; 1=Yes consented, elig_1, elig_consent_hc, icfsubj, inconc
Query elig_10 Integer Recommended Current primary diagnosis of OCD 0;1 0=No; 1=Yes exocd
Query elig_11 Integer Recommended Current substance dependence 0;1 0=No; 1=Yes elig_substance, exdetox
Query exdtx Integer Recommended EX: needs hospitalization for detox 0;1 0=No; 1=Yes elig_12, elig_hospital_psycho
Query elig_13 Integer Recommended Have unstable GMC 0;1 0=No; 1=Yes elig_unstable_gmc
Query elig_14 Integer Recommended Meds for GMC 0;1 0=No; 1=Yes elig_meds_gmc
Query elig_15 Integer Recommended Epilepsy 0;1 0=No; 1=Yes elig_epilepsy
Query elig_16 Integer Recommended Receive somatic treatment 0;1 0=No; 1=Yes
Query elig_17 Integer Recommended Currently taking exclusionary meds 0;1 0=No; 1=Yes elig_exclusion_meds
Query elig_18 Integer Recommended Liver disease 0;1 0=No; 1=Yes
Query elig_19 Integer Recommended Thyroid meds 0;1 0=No; 1=Yes elig_thyroid_meds, exthyroi
Query elig_2 Integer Recommended Current diagnosis of MDD 0;1 0=No; 1=Yes
Query elig_20 Integer Recommended Augmenting Agents 0;1 0=No; 1=Yes exagents
Query elig_21 Integer Recommended Therapy 0;1 0=No; 1=Yes
Query elig_22 Integer Recommended English fluency 0;1 0=No; 1=Yes elig_fluency
Query elig_23 Integer Recommended Suicidal 0;1 0=No; 1=Yes elig_suicidal
Query elig_24 Integer Recommended Alternate study 0;1 0=No; 1=Yes
Query elig_25 Integer Recommended Non listed reason 0;1 0=No; 1=Yes elig_nonlisted
Query elig_27 Integer Recommended Clinically abnormal lab results 0;1;9 1 = Yes; 0 = No; 9 = Unknown elig_abnorm_labs
Query elig_4 Integer Recommended Antidepressant trials 0;1 0=No; 1=Yes
Query elig_5 Integer Recommended Biomarkers 0;1 0=No; 1=Yes elig_biomarkers
Query elig_6 Integer Recommended History of inadequate response 0;1 0=No; 1=Yes
Query exprg Integer Recommended EX: pregnancy 0;1 0=No; 1=Yes elig_7, elig_pregnancy
Query elig_8 Integer Recommended Plan to be pregnant 0;1 0=No; 1=Yes expreg
Query elig_9 Integer Recommended History of psychotic disorders 0;1 0=No; 1=Yes elig_psycho_disor
Query elig_dysthymia Integer Recommended Eligibility variable for dysthymia 0::2 0=No; 1=Yes; 2=Unknown
Query elig_ecg_1 Integer Recommended Checks if subject is over 60 0;1 0=No; 1=Yes
Query elig_ecg_2 Integer Recommended Checks for ECG 0;1 0=No; 1=Yes
Query elig_metal_screen Integer Recommended pulls in metal screen pass/fail 0;1 0=Fail; 1=Pass elig_metal_hc
Query elig_scid_1 Integer Recommended Onset of MDE <=30 0;1 0=No; 1=Yes
Query elig_scid_2 Integer Recommended MDD duration meets Eligibility 0;1 0=No; 1=Yes
Query elig_alternate_study_hc Integer Recommended Checks if in alternate study 0;1 0=No; 1=Yes
Query elig_dsm Integer Recommended No past or present DSM-IV Axis I disorder 0;1 0=No; 1=Yes
elig_qids_score_hc_display String 30 Recommended display for qids HC eval
Query stg2_anorex Integer Recommended Checks for Anorexia 0;1;9 0=No; 1=Yes; 9=N/A
Query stg2_bulimia Integer Recommended Checks for Bulimia 0;1;9 0=No; 1=Yes; 9=N/A
Query stg2_seizure Integer Recommended Checks for Seizure risk 0;1;9 0=No; 1=Yes; 9=N/A
subject_description String 4,000 Recommended Subject related information (e.g the affection, phenotype, disease information, etc.).
Query site String 101 Recommended Site Study Site site_uid
session_id String 20 Recommended session ID/screening ID screeningid
version_form String 121 Recommended Form used/assessment name form_name, formid, version_ic_signed
Query visit String 60 Recommended Visit name time, visit_name
Query elgrr Integer Recommended Subject passed independent rater review 1;2 1=Yes; 2=No
Query elgmmapp Integer Recommended Medical Monitor approved subject for randomization 1;2 1=Yes; 2=No
Query elgmdrs Integer Recommended Baseline MADRS in eligible range 1;2 1=Yes; 2=No
Query elgsibq Integer Recommended Baseline SIBQ clear of Suicidal Ideation Behavior 1;2 1=Yes; 2=No
Query elgadstb Integer Recommended Current pharmacotherapy stable 1;2 1=Yes; 2=No
Query elgadprt String 50 Recommended Prescribed anti-depressant
Query elgadoth String 50 Recommended Other prescribed anti-depressants
Query elgwsh Integer Recommended Prohibited pharmacotherapy wash out 1;2;999 1=Yes; 2=No; 999=N/A
Query ecbmi Integer Recommended Subject baseline weight recorded and BMI 18-35 1;2 1=Yes; 2=No
icfdat Date Recommended ICF Received Date ic_signed_date
Query elgrcvcf Integer Recommended Subject received signed dated copy of consent form 1;2 1=Yes; 2=No
Query subjelgb Integer Recommended Subject satisfies all eligibility criteria 1;2 1=Yes; 2=No eligibility
sign_button String 10 Recommended Patient Eligibility Sign Off by PI date_pi_sign_off
study String 100 Recommended Study; The code for each individual study
Query week Float Recommended Week in level/study 99=week 10-week 14
Query days_baseline Integer Recommended Days since baseline date
Query vis_type Integer Recommended Visit type 0::2 1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview phone
Query incare Integer Recommended Enrolled at primary or specialty site 0;1 0=No; 1=Yes
Query inage Integer Recommended IN: age 18-75 0;1 0=No; 1=Yes
Query inmdd Integer Recommended IN: meets DSM-IV criteria 0;1;-7;-9 0=No; 1=Yes; -9=unknown; -7=refused
Query inhrd Integer Recommended IN: HRS-D score 14 or higher 0;1 0=No; 1=Yes
Query indepmed Integer Recommended Antidepressant med is acceptable 0;1 0=No; 1=Yes
Query insuic Integer Recommended Treatment clinically appropriate 0;1 0=No; 1=Yes
Query exbreast Integer Recommended Pregnant or breastfeeding 0;1 0=No; 1=Yes exclusion_bdd_g
Query exlife Integer Recommended Lifetime of Axis I disorder 0;1 0=No; 1=Yes
Query expsych Integer Recommended Current psychotic symptoms 0;1 0=No; 1=Yes
Query exanorex Integer Recommended Anorexia or bulimia last 2 years 0;1 0=No; 1=Yes
Query exhosp Integer Recommended Requires hospitalization for psych disorder 0;1 0=No; 1=Yes
Query exallerg Integer Recommended History of allergy to protocol meds 0;1 0=No; 1=Yes
Query exnonfda Integer Recommended Nonresponse to adequate FDA trial: current 0;1 0=No; 1=Yes
Query exnoncit Integer Recommended Nonresponse to trial of protocol drugs 0;1 0=No; 1=Yes
Query exstumed Integer Recommended Currently taking study medication 0;1 0=No; 1=Yes
Query exmaoi Integer Recommended Taken prozac or MAOI last 2 weeks 0;1 0=No; 1=Yes
Query exgmchos Integer Recommended Has GMC might require hospitalization 0;1 0=No; 1=Yes
Query extakmed Integer Recommended Current meds contraindicate study meds 0;1 0=No; 1=Yes
Query exreqmed Integer Recommended Require meds that contraindicate study meds 0;1 0=No; 1=Yes
Query exreqant Integer Recommended Condition requiring anticonvulsant 0;1 0=No; 1=Yes
Query exseiz Integer Recommended History of having a seizure 0;1 0=No; 1=Yes
Query exstim Integer Recommended Have received somatic antidepressant treatment 0;1 0=No; 1=Yes
Query ex30med Integer Recommended Have taken exclusionary meds last 30 days 0;1 0=No; 1=Yes
Query expsycho Integer Recommended Antidepressant med for MDD or other purposes 0;1 0=No; 1=Yes
Query exglauc Integer Recommended Uncontrolled narrow-angle glaucoma 0;1 0=No; 1=Yes
Query exthera Integer Recommended Therapy that is depression specific 0;1 0=No; 1=Yes
Query exflaked Integer Recommended Changed mind about study after starting forms 0;1 0=No; 1=Yes
date_updated Date Recommended Date record updated edit_date
Query time_pt Integer Recommended Collection time point (weeks) 0::52 0=baseline tpid
Query rand_num Integer Recommended Randomization Number 0::2
Query call_num Integer Recommended Site Eligibility Call Number for a Given Day 1::99
Query se_symptom String 3 Recommended Active psychotic symptom of moderateseverity 0;1 1=yes; 0=no
Query se_age String 3 Recommended Age 8 - 19 years 0;1 1=yes; 0=no
Query se_iq String 3 Recommended IQ > 65 0;1 1=yes; 0=no
Query se_diagnosis String 3 Recommended Diagnosis of a PDD or ASQ score >= 15 0;1 1=yes; 0=no
Query se_schizo String 3 Recommended Meets criteria for schizophrenia, Schizophreniform, schizoaffective 0;1 1=yes; 0=no
Query se_priorhist String 3 Recommended Prior history of suicide attemps or serious violence 0;1 1=yes; 0=no
Query se_endocrin String 3 Recommended Endocrinology or neurologic illness 0;1 1=yes; 0=no
Query se_suicide String 3 Recommended Serious acute risk for suicide 0;1 1=yes; 0=no
Query se_contracep String 3 Recommended Willing to practice contraception 0;1 1=yes; 0=no
Query se_depot String 3 Recommended Depot antipsychotics within past 6 months 0;1 1=yes; 0=no
Query se_molind String 3 Recommended Use molindone during current episode 0;1 1=yes; 0=no
Query se_molinda String 3 Recommended Use molindone--dose >= 140mg 0;1 1=yes; 0=no
Query se_molindb String 3 Recommended Use molindone--duration of treatment >= 8 weeks 0;1 1=yes; 0=no
Query se_molindc String 3 Recommended Use molindone--dose >= 140mg and duration >= 2 weeks 0;1 1=yes; 0=no
Query se_olana String 3 Recommended Use olanzapine 0;1 1=yes; 0=no
Query se_olanaa String 3 Recommended Use olanzapine--Dose >= 20 mg 0;1 1=yes; 0=no
Query se_olanab String 3 Recommended Use olanzapine--duration of treatment >=8 weeks 0;1 1=yes; 0=no
Query se_olanac String 3 Recommended Use olanzapine--dose >= 20 mg and duration >= 2 weeks 0;1 1=yes; 0=no
Query se_risper String 3 Recommended Use risperidone 0;1 1=yes; 0=no
Query se_rispera String 3 Recommended Use risperidone--Dose >= 6mg 0;1 1=yes; 0=no
Query se_risperb String 3 Recommended Use risperidone--duration of treatment >=8 weeks 0;1 1=yes; 0=no
Query se_risperc String 3 Recommended Use risperidone--dose >= 6mg 0;1 1=yes; 0=no
Query se_allergy String 3 Recommended Allergy to molindone 0;1 1=yes; 0=no
Query se_epse String 3 Recommended Severe EPSE or NMS 0;1 1=yes; 0=no
Query se_blood String 3 Recommended Persistent significant blood chemistry abnormalities 0;1 1=yes; 0=no
Query se_moodst String 3 Recommended Use of antidepressant or mood stabilizer 0;1 1=yes; 0=no
Query se_stab30 String 3 Recommended Use of antidepressant or mood stabilizer. If yes, has the dose been stable for 30 days 0;1 1=yes; 0=no
Query se_majdep String 3 Recommended Experiencing major depressive episode 0;1 1=yes; 0=no
se_nocons String 25 Recommended Why Consent Form was Not Signed Actual reason_other
Query daysrz Integer Recommended days since randomization
time_ic_signed String 5 Recommended Time Informed Consent Signed? HH:MM
Query elig_criteria Integer Recommended Did patient meet all eligibility criteria? 1::4 1 = Yes 2 = No (waiver) 3 = No (excluded) 4 = Unsure
lab020 Date Recommended Date of PI/clinician signature healthy_eligibilty_pi_sign
Query inclusion_bdd_a Integer Recommended Inclusion Criteria: Able to give voluntary informed consent 0;1 0= Unchecked; 1= Checked inclusion_healthy_a
Query inclusion_bdd_e Integer Recommended Inclusion Criteria: No psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks 0;1 0= Unchecked; 1= Checked inclusion_healthy_e
Query inclusion_bdd_f Integer Recommended Inclusion Criteria: No lithium treatment for past 6 months 0;1 0= Unchecked; 1= Checked inclusion_healthy_f
Query inclusion_bdd_h Integer Recommended Inclusion Criteria: Willing to complete the MRI scan and provide RNA sample at baseline 0;1 0= Unchecked; 1= Checked inclusion_healthy_h
Query inclusion_bdd_g Integer Recommended Inclusion Criteria: Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire; 8) able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale < 5 (i.e.= moderately ill) and no significant suicidal or homicidal ideation or gross disability 0;1 0= Unchecked; 1= Checked
Query exclusion_bdd_b Integer Recommended Exclusion Criteria: Requiring inpatient treatment 0;1 0= Unchecked; 1= Checked exclusion_healthy_b
Query exclusion_bdd_d Integer Recommended Exclusion Criteria: Positive urinary toxicology screening at baseline 0;1 0= Unchecked; 1= Checked exclusion_healthy_d
Query exclusion_bdd_e Integer Recommended Exclusion Criteria: Use of alcohol in the past 1 week 0;1 0= Unchecked; 1= Checked exclusion_healthy_e
Query exclusion_bdd_f Integer Recommended Exclusion Criteria: Serious medical or neurological illness 0;1 0= Unchecked; 1= Checked exclusion_healthy_f
Query reconsent Integer Recommended Is this a reconsent? 0;1 0= No; 1= Yes
Query inclusion_bdd_b Integer Recommended Inclusion Criteria: Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD type II or I= current Depressive Episode 0;1 0= Unchecked; 1= Checked inclusion_healthy_b
Query inclusion_bdd_c Integer Recommended Inclusion Criteria: 17-item Hamilton Depression Rating Scale (HAM-D) score >15 and < 25 0;1 0= Unchecked; 1= Checked inclusion_healthy_c
Query inclusion_bdd_d Integer Recommended Inclusion Criteria: Young Mania Rating Scale (YMRS) < 8 0;1 0= Unchecked; 1= Checked inclusion_healthy_d
Query exclusion_bdd_a Integer Recommended Exclusion Criteria: Meeting DSM-IV criteria for schizophrenia= schizoaffective disorder= or an anxiety disorder as a primary diagnosis 0;1 0= Unchecked; 1= Checked exclusion_healthy_a
Query exclusion_bdd_c Integer Recommended Exclusion Criteria: Meeting DSM-V criteria for substance dependence within the past year= except caffeine or nicotine 0;1 0= Unchecked; 1= Checked exclusion_healthy_c
Query exclusion_bdd_g Integer Recommended Exclusion Criteria: Current pregnancy or breast feeding 0;1 0= Unchecked; 1= Checked exclusion_healthy_g
Query exclusion_bdd_h Integer Recommended Exclusion Criteria: Metallic implants or other contraindications to MRI 0;1 0= Unchecked; 1= Checked exclusion_healthy_h
ccc2datecomp Date Recommended Date Completed date_pt_eligible
faec01 Integer Recommended Presence of symptomatic ataxic disease 0;1 0=No; 1=Yes
faec02 Integer Recommended Person who is premanifest or at risk for SCA1 or SCA3 with no symptoms 0;1 0=No; 1=Yes
faec03 Integer Recommended Definite molecular diagnosis of SCA 1 or 3 either in the subject or another affected family member 0;1 0=No; 1=Yes
faec04 Integer Recommended Willingness to participate in the study and ability to give informed consent 0;1 0=No; 1=Yes
faec05 Integer Recommended Age criteria met (has to be yes for specific category): If symptomatic (SARA ? 3) ages 18-65 years 0;1 0=No; 1=Yes
faec06 Integer Recommended Age criteria met (has to be yes for specific category): If premanifest (SARA ? 2.5) ages 27-65 years 0;1 0=No; 1=Yes
faec07 Integer Recommended Age criteria met (has to be yes for specific category): If at risk (SARA ? 2.5) ages 27-50 years 0;1 0=No; 1=Yes
faec08 Integer Recommended Age criteria met (has to be yes for specific category): If past participant, any age 0;1 0=No; 1=Yes
faec09 Integer Recommended SARA score (one of the following must be yes): Past participant: SARA score ? 9.5 at last visit of prior study (it can be higher now) 0;1 0=No; 1=Yes
faec10 Integer Recommended SARA score (one of the following must be yes): New participant to U01: SARA score ? 9.6 0;1 0=No; 1=Yes
faec11 Integer Recommended Changes in physical/occupational therapy status have not occurred for 2 months prior to enrollment 0;1 0=No; 1=Yes
exc4prioruseofinvsdrug Integer Recommended Exclusion 4 Use of investigational drugs in 2 months prior to enrollment 0;1 1=Yes; 0=No
sca1repeatsnormalallele Integer Recommended DNA Test Yes SCA1 number repeats in normal allele
sca1repeatsexpandallele Integer Recommended DNA Test Yes SCA1 number repeats in expanded allele
sca3repeatsnormalallele Integer Recommended DNA Test Yes SCA3 number repeats in normal allele
sca3repeatsexpandallele Integer Recommended DNA Test Yes SCA3 number repeats in expandedl allele
dxbyfamhist Integer Recommended Diagnosed by positive family history only 0;1 1=Yes; 0=No
dxbyfamhistspecify Integer Recommended Diagnosed by positive family history DNA 0;1 0=SCA1; 1=SCA3
dxbyfamhistparentgender Integer Recommended Gender of transmitting parent 0;1;-9 0=Female; 1=Male; -9=Unknown
consentcsf Integer Recommended Consent for optional spinal tap andor MR substudy Consent to CSF 0;1 1=Yes; 0=No
lumbarpuncturecompleted Integer Recommended Was Lumbar Puncture completed during this visit 0;1 1=Yes; 0=No
interestedmrstudy Integer Recommended Interested in participating in MR substudy 0;1 1=Yes; 0=No
inc5bcomment String 100 Recommended Inclusion 5b Comment
controlinc1nosymptoms Integer Recommended Inclusion 1 for Control Subjects No symptoms of neurologic deficits including ataxia 0;1;-9 1=Yes; 0=No; -9=NA
controlinc2normalgait Integer Recommended Inclusion 2 for Control Subjects Normal gait 0;1;-9 1=Yes; 0=No; -9=NA
controlinc2sarale25 Integer Recommended Inclusion 3 for Control Subjects SARA score le 25 0;1;-9 1=Yes; 0=No; -9=NA
exc1genotypeotheria Integer Recommended Exclusion 1 Genotype consistent with other inherited ataxias 0;1;-9 1=Yes; 0=No; -9=Unknown
exc2concomitantdisorder Integer Recommended Exclusion 2 Concomitant disorders that affects assessments of ataxia or severity of ataxia 0;1 1=Yes; 0=No
exc3lackofwillingness Integer Recommended Exclusion 3 A lack of willingness to participate in the study 0;1 1=Yes; 0=No
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
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