|
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 |
|
|
bid, id, randid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
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.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
|
level |
String |
10
|
Recommended |
Treatment level |
|
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
|
crcid |
String |
40
|
Recommended |
CRC ID/ROA ID |
|
|
|
Query
|
clinid |
Integer |
|
Recommended |
Clinician ID |
|
|
|
Query
|
clinicid |
Integer |
|
Recommended |
Clinic ID |
|
|
|
Query
|
update |
Integer |
|
Recommended |
Updated form |
0;1
|
1= yes; 0= no
|
|
Query
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
locale, phone |
Query
|
menop |
Integer |
|
Recommended |
Menopausal/post-hysterectomy/male |
0;1
|
0=No; 1=Yes
|
|
Query
|
mpdatm |
Integer |
|
Recommended |
Date of last menstrual period |
|
|
mpdate |
Query
|
medication1_name |
String |
500
|
Recommended |
Name first medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
admd1, llaa3a, stnm1 |
Query
|
medication2_name |
String |
500
|
Recommended |
Name second medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
admd2, llaa3b, stnm2 |
Query
|
medication3_name |
String |
500
|
Recommended |
Name third medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
admd3, llaa3c, stnm3 |
Query
|
medication4_name |
String |
500
|
Recommended |
Name fourth medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
admd4, llaa3d, llaada, stnm4 |
|
medication1_dosage |
String |
150
|
Recommended |
First medication dosage |
|
0 = No medication; 999 = Missing
|
adds1, llaa4a1 |
|
medication2_dosage |
String |
100
|
Recommended |
Second medication dosage |
|
0 = No medication; 999 = Missing
|
adds2, llaa4b1 |
Query
|
medication3_dosage |
String |
100
|
Recommended |
Third medication dosage |
|
0 = No medication; 999 = Missing
|
adds3, llaa4c1 |
Query
|
medication4_dosage |
String |
100
|
Recommended |
Fourth medication dosage |
|
0 = No medication; 999 = Missing
|
adds4, llaa4d1 |
Query
|
lithm |
Integer |
|
Recommended |
Patient taking Li/NTP |
0;1
|
0=No; 1=Yes
|
|
Query
|
mtype |
Integer |
|
Recommended |
Med type |
1::4
|
1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication
|
|
Query
|
serum |
Float |
|
Recommended |
Most recent serum level |
|
|
|
Query
|
drdat |
Integer |
|
Recommended |
Date blood drawn |
|
|
|
Query
|
liadj |
Integer |
|
Recommended |
Li or NTP dose adjustment needed |
0;1;-2
|
0=No; 1=Yes; -2=N/A
|
|
Query
|
litdy |
Integer |
|
Recommended |
Li or NTP serum level needed today |
0;1;-2
|
0=No; 1=Yes; -2=N/A
|
|
Query
|
suicd |
Integer |
|
Recommended |
Patient presently a suicide risk |
0;1
|
0=No; 1=Yes
|
risksui, risksuic |
Query
|
remsn |
Integer |
|
Recommended |
Patient in remission |
0;1
|
0=No; 1=Yes
|
|
Query
|
raise |
Integer |
|
Recommended |
Dose will be raised |
0;1
|
0=No; 1=Yes
|
|
Query
|
effct |
Integer |
|
Recommended |
Side effects prevent dose increase |
0;1
|
0=Not checked; 1=Checked
|
sideefct |
Query
|
cnmd |
Integer |
|
Recommended |
Concomitant meds prevent dose increase |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
cncn |
Integer |
|
Recommended |
Medical condition prevents dose increase |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
prtcl |
Integer |
|
Recommended |
Protocol prohibits dose increase |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
other |
Integer |
|
Required |
Other prevent dose increase |
0;1;999
|
0 = No; 1 = Yes
|
|
Query
|
stmed |
Integer |
|
Recommended |
Currently on STAR*D meds? |
0;1
|
0=No; 1=Yes
|
|
Query
|
stmd1 |
String |
100
|
Recommended |
Prescribed med code 1 |
|
|
|
Query
|
stmd2 |
String |
50
|
Recommended |
Prescribed med code 2 |
|
|
|
Query
|
stmd3 |
String |
50
|
Recommended |
Prescribed med code 3 |
|
|
|
Query
|
stmd4 |
String |
50
|
Recommended |
Prescribed med code 4 |
|
|
|
Query
|
stmd5 |
String |
50
|
Recommended |
Prescribed med code 5 |
|
|
|
Query
|
stmd6 |
String |
50
|
Recommended |
Prescribed med code 6 |
|
|
|
Query
|
stds1 |
Float |
|
Recommended |
Prescribed med daily dose 1 |
|
|
|
Query
|
stds2 |
Float |
|
Recommended |
Prescribed med daily dose 2 |
|
|
|
Query
|
stds3 |
Float |
|
Recommended |
Prescribed med daily dose 3 |
|
|
|
Query
|
stds4 |
Float |
|
Recommended |
Prescribed med daily dose 4 |
|
|
|
Query
|
stds5 |
String |
50
|
Recommended |
Prescribed med daily dose 5 |
|
|
|
Query
|
stds6 |
String |
50
|
Recommended |
Prescribed med daily dose 6 |
|
|
|
Query
|
adstart1 |
Integer |
|
Recommended |
Study med start date at this dose 1 |
|
|
|
Query
|
adstart2 |
Integer |
|
Recommended |
Study med start date at this dose 2 |
|
|
|
Query
|
adstart3 |
Integer |
|
Recommended |
Study med start date at this dose 3 |
|
|
|
Query
|
adstart4 |
Integer |
|
Recommended |
Study med start date at this dose 4 |
|
|
|
Query
|
stsd1 |
Float |
|
Recommended |
Prescribed med start date 1 |
|
|
|
Query
|
stpdate1 |
Float |
|
Recommended |
Study med stop date1 |
|
|
sted1 |
Query
|
stsd2 |
Float |
|
Recommended |
Prescribed med start date 2 |
|
|
|
Query
|
stpdate2 |
Float |
|
Recommended |
Study med stop date2 |
|
|
sted2 |
Query
|
stsd3 |
Float |
|
Recommended |
Prescribed med start date 3 |
|
|
|
Query
|
stpdate3 |
Float |
|
Recommended |
Study med stop date3 |
|
|
sted3 |
Query
|
stsd4 |
Float |
|
Recommended |
Prescribed med start date 4 |
|
|
|
Query
|
stpdate4 |
Float |
|
Recommended |
Study med stop date4 |
|
|
sted4 |
Query
|
stsd5 |
Integer |
|
Recommended |
Prescribed med start date 5 |
|
|
|
Query
|
stpdate5 |
Integer |
|
Recommended |
Prescribed med end date 5 |
|
|
sted5 |
Query
|
stsd6 |
Integer |
|
Recommended |
Prescribed med start date 6 |
|
|
|
Query
|
stpdate6 |
Integer |
|
Recommended |
Prescribed med end date 6 |
|
|
sted6 |
Query
|
trtmt |
Integer |
|
Recommended |
Treatment plan |
1::4
|
1=Continue current level; 2=Go to next level; 3=Go to follow up; 4=Exit study
|
|
Query
|
fnaid |
Integer |
|
Recommended |
Billed to third party |
0;1
|
0=No; 1=Yes
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
date |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, vtype |
Query
|
uvfa1a |
Integer |
|
Recommended |
Why did this visit occur:Assessment of possible change in psychiatric symptoms? |
0;1
|
0=No; 1=Yes
|
|
Query
|
uvfa1b |
Integer |
|
Recommended |
Why did this visit occur: Assessment of possible change in drug tolerability, adverse event? |
0;1
|
0=No; 1=Yes
|
|
Query
|
uvfa1c |
Integer |
|
Recommended |
Why did this visit occur: Assessment of possible change in medical status. |
0;1
|
0=No; 1=Yes
|
|
Query
|
uvfa1d |
Integer |
|
Recommended |
Why did this visit occur: Assessment of need for medication changes or adjustment or re-supply. |
0;1
|
0=No; 1=Yes
|
|
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
Query
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
llaa0b, uvfa0b, visitdt |
Query
|
llaa1 |
Integer |
|
Recommended |
Is the patient taking a lipid lowering agent? |
0;1
|
0=No; 1= Yes
|
|
Query
|
llaa2 |
Integer |
|
Recommended |
Since the last study visit, have there been any changes in the specific lipid-lowering agent the patient is taking or in the dose of that agent? |
0;1
|
0=No; 1= Yes
|
|
Query
|
medication5_name |
String |
500
|
Recommended |
Name fifth medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
llaa3e, stnm5 |
Query
|
medication6_name |
String |
500
|
Recommended |
Name sixth medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
llaa3f, stnm6 |
|
medication5_dosage |
String |
100
|
Recommended |
Fifth medication dosage |
|
0 = No medication; 999 = Missing
|
llaa4e1 |
Query
|
medication6_dosage |
String |
100
|
Recommended |
Sixth medication dosage |
|
0 = No medication; 999 = Missing
|
llaa4f1 |
Query
|
medication1_unit |
String |
100
|
Recommended |
Units of medication #1: |
|
|
llaa4a2 |
Query
|
medication2_unit |
String |
100
|
Recommended |
Units of medication #2: |
|
|
llaa4b2 |
Query
|
medication3_unit |
String |
100
|
Recommended |
Units of medication #3: |
|
|
llaa4c2 |
|
medication4_unit |
String |
100
|
Recommended |
Units of medication #4: |
|
|
llaa4d2 |
|
medication5_unit |
String |
100
|
Recommended |
Units of medication #5: |
|
|
llaa4e2 |
Query
|
medication6_unit |
String |
100
|
Recommended |
Units of medication #6: |
|
|
llaa4f2 |
Query
|
llaa5a |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #1? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa5b |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #2? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa5c |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #3? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa5d |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #4? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa5e |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #5? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa5f |
Integer |
|
Recommended |
Since your last appointment, on how many days did you NOT TAKE medication #6? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6a |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication #1? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6b |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication #2? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6c |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication #3? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6d |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication # 4? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6e |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication #5? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa6f |
Integer |
|
Recommended |
Since your last appointment, on how many days did you take MORE THAN or LESS THAN the prescribed dose of medication #6? |
0::50; -999
|
999=Legitimately skipped
|
|
Query
|
llaa7a |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to medication #1: (Choose one LLAA7A from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
llaa7b |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to the medication: (Choose one from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
llaa7c |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to medication #3: (Choose one from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
llaa7d |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to medication #4: (Choose one from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
llaa7e |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to medication #5: (Choose one from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
llaa7f |
Integer |
|
Recommended |
Based on the clinician's best judgment, please indicate the patient's adherence to the medication: (Choose one from A, B, C, D, or E below) |
1::5; 999
|
999=Legitimately skipped
|
|
Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
siteid |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
vis_q01 |
Integer |
|
Recommended |
Attended visit? |
0::3
|
0=No; 1=Yes;2=Yes, visit form entered; 3=Yes, data collected - visit form added later
|
|
Query
|
qccur_r |
Float |
|
Recommended |
QIDS-C current score (transcribed) |
|
|
qccur |
Query
|
hrsd_r |
Float |
|
Recommended |
HRS-D current score (transcribed) |
|
999=missing
|
hrsdcur |
Query
|
atmtsuic |
Integer |
|
Recommended |
Attempted suicide |
0;1
|
0=No; 1=Yes
|
|
Query
|
eeg012 |
Integer |
|
Recommended |
Women only: Still experiencing menstrual periods? |
0;1;9
|
0=No; 1=Yes; 9=N/A
|
menop_1 |
Query
|
qcbeg_r |
Float |
|
Recommended |
QIDS-C beginning score (transcribed) |
|
|
|
Query
|
qcimp_r |
Float |
|
Recommended |
QIDS-C percent improvement (transcribed) |
|
|
|
Query
|
fibser_1 |
Integer |
|
Recommended |
1. Choose the response that best describes the frequency (how often) of the side effects of the medication you have taken within the past week for your depression. |
0::7
|
0=No side effects; 1=Present 10% of the time; 2=Present 25% of the time; 3=Present 5-% of the time; 4=Present 75% of the time; 5=Present 90% of the time; 6=Present all the time; 7=refused
|
fiserf, fiserfrg, fiserfrq |
Query
|
fibser_2 |
Integer |
|
Recommended |
2. Choose the response that best describes the intensity (how severe) of the side effects that you believe are due to the medication you have taken within the last week for your depression |
0::6
|
0=No side effects; 1=Trivial; 2=Mild; 3=Moderate; 4=Marked; 5=Severe; 6=Intolerable
|
fideri, fiserint |
Query
|
fibser_3 |
Integer |
|
Recommended |
3. Choose the response that best describes the degree to which antidepressant medication side effects that you have had over the last week have interfered with your day to day functions. |
0::6
|
0=No impairment; 1=Minimal impairment; 2=Mild impairment; 3=Moderate impairment; 4=Marked impairment; 5=Severe impairment; 6=Unable to function due to side effects
|
grseb |
Query
|
cgi_sii_0_7 |
Integer |
|
Recommended |
CGI SII 0 - 7 Improvment/change |
0::7; 9
|
0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse; 9=NA
|
cgi_i |
Query
|
maq |
Integer |
|
Recommended |
0 = N/A, no prescribed meds;1 = Never missed;2 = Rarely;3 = Sometimes;4 = Less than half the time;5 = About half the time;6 = Somewhat more than half the time;7 = Very often;8 = Nearly all the time;9 = All the time |
|
|
|
Query
|
stmed_1 |
Integer |
|
Recommended |
0=No;1=Yes |
|
|
|
Query
|
stmd7 |
Integer |
|
Recommended |
|
|
|
|
Query
|
medication7_name |
String |
500
|
Recommended |
Name seventh medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
stnm7 |
Query
|
stsd7 |
Integer |
|
Recommended |
Prescribed med start date 7 |
|
|
|
Query
|
sted7 |
Integer |
|
Recommended |
|
|
|
|
Query
|
stds7 |
Float |
|
Recommended |
|
|
|
|
Query
|
phase |
Integer |
|
Recommended |
Phase |
|
9 =follow up
|
|
Query
|
response |
Integer |
|
Recommended |
1 = NonResponse(<30% reduction in HRSD scores and HRSD >15 for 2 consecutive visits and met the DSM-IV criteria for MDD for 2 consecutive visits during weeks 6, 8, 10, and 12) 2 = Partial Response(not meeting criteria for NonResponse or Remission) 3 = Remission(>60% reduction in HRSD scores and HRSD <8 for 2 consecutive visits and does not meet DSM-IV criteria for MDD for 2 consecutive visits during weeks 6, 8, 10, and 12)If the patient meets the criteria for NonResponse the patient will advance to the Randomization Phase (Phase II). If the patient has had a partial response, continue at the maximum tolerated dose of the current medication up to week 12 then advance to the Randomization Phase. If the patient meets the criteria for Remission at week 12, continue on current medications in Phase II with patient visits scheduled only once every 4 weeks. |
|
|
|
Query
|
pharma_time |
Integer |
|
Recommended |
|
|
time
|
time |
|
baseline_a_002 |
String |
100
|
Recommended |
Interview Start Time: |
|
|
|
|
minietm |
String |
10
|
Recommended |
Time interview ended |
|
|
|
|
urt_q02 |
String |
5
|
Recommended |
Time of last study med taken |
|
Q.2 Enter valid time using 24 hour clock in the following format: hh:mm; -888=NA
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cpbv01 |
Integer |
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Recommended |
Category of Eligibility at study entry: Participant status |
0::4
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0=Pre-manifest subject with known mutation, SARA score ? 2.5; 1=50%-at- risk subject, SARA score ? 2.5; 2=Early symptomatic subject SARA score > 3 to 9.5 inclusive; 3=Previously early-stage subject during 2009-2012, any SARA score; 4=Control Subject
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cpbv02 |
Float |
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Recommended |
Total SARA score at the baseline visit |
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cpbv03 |
Integer |
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Recommended |
Participant current status: |
0::4
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0=50% at risk subject; DNA status unknown; Sara score ? 2.5; 1=50%-at-risk subject, DNA status unknown, SARA score > 3.0; 2=Premanifest subject, with known mutation, SARA score ? 2.5; 3=Early phase subject, with known mutation, SARA score 3 to 9.5; 4=Clearly symptomatic subject SARA score ? 10
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cpbv04 |
Integer |
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Recommended |
Patricipant Status: Clearly symptomatic subject SARA score ? 10 |
0;1
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0=READISCA participant only; 1=Past participant of CRC-SCA, EUROSCA, ESMI or SPATAX as early-stage patient
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cpbv05 |
Float |
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Recommended |
Current SARA total score: |
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cpbv06 |
Integer |
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Recommended |
If subject was enrolled as premanifest subject with known genotype at the beginning of this study, does he/she want to know about Phenoconversion? |
0;1
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0=No; 1=Yes
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cpbv07 |
Integer |
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Recommended |
If subject is 50%-at-risk subject with unknown genotype, does he/she want to know about Phenoconversion and/or genotype? |
0::3
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0=Phenoconversion; 1=Genotype; 2=Both; 3=Neither
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cpbv08 |
Date |
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Recommended |
If premanifest or 50%-at-risk subject has shown SARA >3.0, what is the date of the phenoconversion? |
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