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SASFieldName="healthy"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[healthy = 0]]></FormalExpression><ErrorMessage>'The subject may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="healthy" /></ItemDef><ItemDef OID="bmiok" Name="body mass index" DataType="text" Length="3" SASFieldName="bmiok"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[bmiok = 0]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="bmiok" /></ItemDef><ItemDef OID="consent" Name="subject consent" DataType="text" Length="3" SASFieldName="consent"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[consent = 0]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="consent" /></ItemDef><ItemDef OID="history" Name="history of disease" DataType="text" Length="3" SASFieldName="history"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="history" /></ItemDef><ItemDef OID="intake" Name="intake medication" DataType="text" Length="3" SASFieldName="intake"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="intake" /></ItemDef><ItemDef OID="investdrug" Name="investigational drug" DataType="text" Length="3" SASFieldName="investdrug"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="investdrug" /></ItemDef><ItemDef OID="physexam" Name="deviance" DataType="text" Length="3" SASFieldName="physexam"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="physexam" /></ItemDef><ItemDef OID="gastro" Name="gastrointestinal" DataType="text" Length="3" SASFieldName="gastro"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="gastro" /></ItemDef><ItemDef OID="donation" Name="blood donation" DataType="text" Length="3" SASFieldName="donation"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="donation" /></ItemDef><ItemDef OID="tobacco" Name="smoking" DataType="text" Length="3" SASFieldName="tobacco"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="tobacco" /></ItemDef><ItemDef OID="hepborc" Name="Hep B or C" DataType="text" Length="3" SASFieldName="hepborc"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="hepborc" /></ItemDef><ItemDef OID="drugsofa" Name="drug abuse" DataType="text" Length="3" SASFieldName="drugsofa"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="drugsofa" /></ItemDef><ItemDef OID="otherdis" Name="disease" DataType="text" Length="3" SASFieldName="otherdis"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="otherdis" /></ItemDef><ItemDef OID="prevadmin" Name="previous treatment" DataType="text" Length="3" SASFieldName="prevadmin"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1]]></FormalExpression><ErrorMessage>'This person may be ineligible for the trial'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="prevadmin" /></ItemDef><ItemDef OID="participate" Name="subject participation" DataType="text" Length="3" SASFieldName="participate"><Description></Description><CodeListRef CodeListOID="participate" /></ItemDef><ItemDef OID="consent1" Name="date of consent" DataType="date" Length="10" SASFieldName="consent1"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[consent1 isafter datenow]]></FormalExpression><ErrorMessage>'The date cannot be in the future!'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="reason" Name="non participation reason" DataType="text" Length="100" SASFieldName="reason"><Description></Description></ItemDef><ItemDef OID="event" Name="event" DataType="text" Length="100" SASFieldName="event"><Description></Description></ItemDef><ItemDef OID="serious" Name="serious" DataType="text" Length="3" SASFieldName="serious"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[serious = 1]]></FormalExpression><ErrorMessage>'Check that the monitor has been informed within 24 hours!, i.e. by '  &amp; format_date( if( isknown( aedate ), aedate, datenow ) + 1 day, 'dd/mm/yyyy' )</ErrorMessage></RangeCheck><CodeListRef CodeListOID="serious" /></ItemDef><ItemDef OID="onset" Name="onset" DataType="datetime" Length="16" SASFieldName="onset"><Description></Description></ItemDef><ItemDef OID="intensity" Name="intensity" DataType="text" Length="8" SASFieldName="intensity"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[initinten > intensity]]></FormalExpression><ErrorMessage>'The most extreme intensity cannot be less than the initial intensity.'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="intensity" /></ItemDef><ItemDef OID="initinten" Name="initinten" DataType="text" Length="8" SASFieldName="initinten"><Description></Description><CodeListRef CodeListOID="initinten" /></ItemDef><ItemDef OID="adjust" Name="adjust" DataType="text" Length="12" SASFieldName="adjust"><Description></Description><CodeListRef CodeListOID="adjust" /></ItemDef><ItemDef OID="eventtreat" Name="eventtreat" DataType="text" Length="3" SASFieldName="eventtreat"><Description></Description><CodeListRef CodeListOID="eventtreat" /></ItemDef><ItemDef OID="relation" Name="relation" DataType="text" Length="9" SASFieldName="relation"><Description></Description><CodeListRef CodeListOID="relation" /></ItemDef><ItemDef OID="outcome" Name="outcome" DataType="text" Length="22" SASFieldName="outcome"><Description></Description><CodeListRef CodeListOID="outcome" /></ItemDef><ItemDef OID="resolved" Name="resolved" DataType="datetime" Length="19" SASFieldName="resolved"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[onset isafter resolved]]></FormalExpression><ErrorMessage>'The date and time resolved cannot be before the date of onset'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="AEcomment" Name="AEcomment" DataType="text" Length="100" SASFieldName="AEcomment"><Description></Description></ItemDef><ItemDef OID="AEtreat" Name="AEtreat" DataType="text" Length="100" SASFieldName="AEtreat"><Description></Description></ItemDef><ItemDef OID="studyend" Name="studyend" DataType="text" Length="3" SASFieldName="studyend"><Description></Description><CodeListRef CodeListOID="studyend" /></ItemDef><ItemDef OID="startdate" Name="startdate" DataType="date" Length="10" SASFieldName="startdate"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[onset isafter startdate]]></FormalExpression><ErrorMessage>'The start date cannot be before the date of onset of the adverse event.'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="enddate" Name="enddate" DataType="date" Length="10" SASFieldName="enddate"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[startdate isafter enddate]]></FormalExpression><ErrorMessage>'The end date cannot be before the start date ( ' &amp; format_date( startdate, 'dd/mm/yyyy' ) &amp; ' ).'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="sex" Name="subject sex" DataType="text" Length="6" SASFieldName="sex"><Description></Description><CodeListRef CodeListOID="sex" /></ItemDef><ItemDef OID="race" Name="race" DataType="text" Length="15" SASFieldName="race"><Description></Description><CodeListRef CodeListOID="race" /></ItemDef><ItemDef OID="raceother" Name="other race" DataType="text" Length="50" SASFieldName="raceother"><Description></Description></ItemDef><ItemDef OID="statusother" Name="other status" DataType="text" Length="50" SASFieldName="statusother"><Description></Description></ItemDef><ItemDef OID="smoke" Name="smoker" DataType="text" Length="3" SASFieldName="smoke"><Description></Description><CodeListRef CodeListOID="smoke" /></ItemDef><ItemDef OID="smokeequiv" Name="number cigarettes" DataType="integer" Length="3" SASFieldName="smokeequiv"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[smokeequiv > 10]]></FormalExpression><ErrorMessage>'This subject may not be eligible to participate in the study'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="diseases" Name="significant diseases" DataType="text" Length="3" SASFieldName="diseases"><Description></Description><CodeListRef CodeListOID="diseases" /></ItemDef><ItemDef OID="scheddatetime" Name="scheddatetime" DataType="datetime" Length="19" SASFieldName="scheddatetime" MethodDefOID="scheddatetime"><Description></Description></ItemDef><ItemDef OID="acttime" Name="acttime" DataType="time" Length="8" SASFieldName="acttime"><Description></Description></ItemDef><ItemDef OID="Systolic" Name="Systolic" DataType="integer" Length="3" SASFieldName="Systolic"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value  <  70]]></FormalExpression><ErrorMessage>'Systolic blood pressure is low'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="Diastolic" Name="Diastolic" DataType="integer" Length="3" SASFieldName="Diastolic"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value  >  130]]></FormalExpression><ErrorMessage>'Diastolic is too high'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[systolic( this )  <  me:value]]></FormalExpression><ErrorMessage>'Systolic blood pressure cannot be lower than Diastolic blood pressure'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="pulse" Name="pulse" DataType="integer" Length="3" SASFieldName="pulse"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value > 140 or me:value < 40]]></FormalExpression><ErrorMessage>'Please check that the value for the pulse is correct'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="heart" Name="heart rate" DataType="integer" Length="3" SASFieldName="heart"><Description></Description><MeasurementUnitRef MeasurementUnitOID="bpm" /><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value > 120 or me:value < 40]]></FormalExpression><ErrorMessage>'The heart rate value of ' &amp; me:value &amp; ' is outside the expected range of 40 to 120. '</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="abnormal" Name="ECG abnormalities" DataType="text" Length="3" SASFieldName="abnormal"><Description></Description><CodeListRef CodeListOID="abnormal" /></ItemDef><ItemDef OID="ECGspecify" Name="specify abnormalities" DataType="text" Length="100" SASFieldName="ECGspecify"><Description></Description></ItemDef><ItemDef OID="QT" Name="QT" DataType="float" Length="4" SignificantDigits="2" SASFieldName="QT"><Description></Description><MeasurementUnitRef MeasurementUnitOID="mm" /><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value < 0.2 or me:value > 0.7]]></FormalExpression><ErrorMessage>'This value is outside the expected range of 0.2 to 0.7 - please check'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="QTc" Name="QTc" DataType="float" Length="4" SignificantDigits="2" SASFieldName="QTc"><Description></Description><MeasurementUnitRef MeasurementUnitOID="mm" /><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[not (me:value between (0.3, 0.5))]]></FormalExpression><ErrorMessage>'This is outside the expected range of 0.3 to 0.5 - please check'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="studycomplete" Name="study completion" DataType="text" Length="3" SASFieldName="studycomplete"><Description></Description><CodeListRef CodeListOID="studycomplete" /></ItemDef><ItemDef OID="studyreason" Name="noncompletion reason" DataType="text" Length="100" SASFieldName="studyreason"><Description></Description></ItemDef><ItemDef OID="contact" Name="subject contact" DataType="date" Length="10" SASFieldName="contact"><Description></Description></ItemDef><ItemDef OID="picture" Name="subject picture" DataType="base64Binary" Length="0" SASFieldName="picture"><Description></Description></ItemDef><ItemDef OID="mainauthorise" Name="certification" DataType="text" Length="9" SASFieldName="mainauthorise"><Description></Description><CodeListRef CodeListOID="mainauthorise" /></ItemDef><ItemDef OID="Height" Name="Height" DataType="float" Length="6" SignificantDigits="2" SASFieldName="Height"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[(me:value > 250 or me:value < 80) and height_unit = 1 ]]></FormalExpression><ErrorMessage>'The value for height of ' &amp; me:value &amp; ' is out of range'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[(me:value > 98.42 or me:value < 31.49) and height_unit = 2]]></FormalExpression><ErrorMessage>'The value for height of ' &amp; me:value &amp; ' is out of range'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="Weight" Name="Weight" DataType="float" Length="6" SignificantDigits="2" SASFieldName="Weight"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[(me:value > 150 or me:value < 40) and weight_unit = 1]]></FormalExpression><ErrorMessage>'Please check that the value for the weight is correct - the value ' &amp; me:value &amp; ' is out of range.'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[(me:value > 176 or me:value < 88) and weight_unit = 2]]></FormalExpression><ErrorMessage>'Please check that the value for the weight is correct - the value ' &amp; me:value &amp; ' is out of range.'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="BMI" Name="Calculated BMI" DataType="float" Length="6" SignificantDigits="2" SASFieldName="BMI" MethodDefOID="BMI"><Description></Description></ItemDef><ItemDef OID="treatmentsyesno" Name="treatment" DataType="text" Length="3" SASFieldName="treatmentsyesno"><Description></Description><CodeListRef CodeListOID="treatmentsyesno" /></ItemDef><ItemDef OID="mainauthorize2" Name="Investigator certification" DataType="text" Length="25" SASFieldName="mainauthorize2"><Description></Description><CodeListRef CodeListOID="mainauthorize2" /></ItemDef><ItemDef OID="visitd_calc1" Name="visit from" DataType="date" Length="10" SASFieldName="visitd_calc1" MethodDefOID="visitd_calc1"><Description></Description></ItemDef><ItemDef OID="inv_date" Name="certification date" DataType="date" Length="10" SASFieldName="inv_date" MethodDefOID="inv_date"><Description></Description></ItemDef><ItemDef OID="childb_pot" Name="childbearing" DataType="text" Length="3" SASFieldName="childb_pot"><Description></Description><CodeListRef CodeListOID="childb_pot" /></ItemDef><ItemDef OID="preg_test" Name="pregnancy test" DataType="text" Length="3" SASFieldName="preg_test"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[preg_test = 0]]></FormalExpression><ErrorMessage>'The pregancy test needs to be performed before the patient can be enrolled into the study.'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="preg_test" /></ItemDef><ItemDef OID="testresult" Name="pregnancy test result" DataType="text" Length="8" SASFieldName="testresult"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[testresult = 2]]></FormalExpression><ErrorMessage>'This person is not eligible for the trial!'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="testresult" /></ItemDef><ItemDef OID="preg_date" Name="pregnancy test date" DataType="date" Length="10" SASFieldName="preg_date"><Description></Description></ItemDef><ItemDef OID="visitd_calc2" Name="visit to" DataType="date" Length="10" SASFieldName="visitd_calc2" MethodDefOID="visitd_calc2"><Description></Description></ItemDef><ItemDef OID="medadmin" Name="medication administered" DataType="text" Length="3" SASFieldName="medadmin"><Description></Description><CodeListRef CodeListOID="medadmin" /></ItemDef><ItemDef OID="admind" Name="administration date" DataType="date" Length="10" SASFieldName="admind"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[admind isafter screening:eligibility2:consent1]]></FormalExpression><ErrorMessage>'Medication cannot be administered before written informed consent is given!'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="admint" Name="administration time" DataType="time" Length="8" SASFieldName="admint"><Description></Description></ItemDef><ItemDef OID="reason_noadmin" Name="administration reason" DataType="text" Length="13" SASFieldName="reason_noadmin"><Description></Description><CodeListRef CodeListOID="reason_noadmin" /></ItemDef><ItemDef OID="specify" Name="specify reason" DataType="text" Length="100" SASFieldName="specify"><Description></Description></ItemDef><ItemDef OID="other_yn" Name="other_yn" DataType="text" Length="3" SASFieldName="other_yn"><Description></Description><CodeListRef CodeListOID="other_yn" /></ItemDef><ItemDef OID="spec_abn_other" Name="other abnormalities" DataType="text" Length="140" SASFieldName="spec_abn_other"><Description></Description></ItemDef><ItemDef OID="breakfast_time" Name="breakfast_time" DataType="datetime" Length="19" SASFieldName="breakfast_time"><Description></Description></ItemDef><ItemDef OID="height_unit" Name="height unit" DataType="text" Length="6" SASFieldName="height_unit"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1 and (Height > 250 or Height < 80)]]></FormalExpression><ErrorMessage>'Please check that the value for height is correct - the value ' &amp; Height &amp; ' is out of range'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 2 and (Height > 98.42 or Height < 31.49)]]></FormalExpression><ErrorMessage>'Please check that the value for height is correct - the value ' &amp; Height &amp; ' is out of range'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="height_unit" /></ItemDef><ItemDef OID="weight_unit" Name="weight unit" DataType="text" Length="6" SASFieldName="weight_unit"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 1 and (Weight > 150 or Weight < 40)]]></FormalExpression><ErrorMessage>'Please check that the value for the weight is correct - the value ' &amp; Weight &amp; ' is out of range.'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value = 2 and (Weight > 176 or Weight < 88)]]></FormalExpression><ErrorMessage>'Please check that the value for the weight is correct - the value ' &amp; Weight &amp; ' is out of range.'</ErrorMessage></RangeCheck><CodeListRef CodeListOID="weight_unit" /></ItemDef><ItemDef OID="height_cm" Name="derived height" DataType="float" Length="6" SignificantDigits="2" SASFieldName="height_cm" MethodDefOID="height_cm"><Description>Convert height to cm (if inches, x 2.54)</Description></ItemDef><ItemDef OID="weight_kg" Name="derived weight" DataType="float" Length="6" SignificantDigits="2" SASFieldName="weight_kg" MethodDefOID="weight_kg"><Description>Convert weight to kg (if lbs, divide by 2.2)</Description></ItemDef><ItemDef OID="gender" Name="gender" DataType="text" Length="10" SASFieldName="gender" MethodDefOID="gender"><Description></Description></ItemDef><ItemDef OID="WBC" Name="White Blood Count result" DataType="float" Length="3" SignificantDigits="0" SASFieldName="WBC"><Description></Description><MeasurementUnitRef MeasurementUnitOID="10**9/l" /></ItemDef><ItemDef OID="WBCdate" Name="White Blood Count date" DataType="date" Length="10" SASFieldName="WBCdate"><Description></Description></ItemDef><ItemDef OID="Platelets" Name="Platelets result" DataType="float" Length="3" SignificantDigits="0" SASFieldName="Platelets"><Description></Description><MeasurementUnitRef MeasurementUnitOID="10**9/l" /></ItemDef><ItemDef OID="Plateletsdate" Name="Platelets date" DataType="date" Length="10" SASFieldName="Plateletsdate"><Description></Description></ItemDef><ItemDef OID="Haemo" Name="Haemoglobin result" DataType="float" Length="3" SignificantDigits="0" SASFieldName="Haemo"><Description></Description><MeasurementUnitRef MeasurementUnitOID="G/100ML" /></ItemDef><ItemDef OID="Haemodate" Name="Haemoglobin date" DataType="date" Length="10" SASFieldName="Haemodate"><Description></Description></ItemDef><ItemDef OID="WBCyesno" Name="White Blood Count" DataType="text" Length="3" SASFieldName="WBCyesno"><Description></Description><CodeListRef CodeListOID="WBCyesno" /></ItemDef><ItemDef OID="Plateletsyesno" Name="Platelets" DataType="text" Length="3" SASFieldName="Plateletsyesno"><Description></Description><CodeListRef CodeListOID="Plateletsyesno" /></ItemDef><ItemDef OID="Haemoyesno" Name="Haemoglobin" DataType="text" Length="3" SASFieldName="Haemoyesno"><Description></Description><CodeListRef CodeListOID="Haemoyesno" /></ItemDef><ItemDef OID="clinname1" Name="clinician first name" DataType="text" Length="15" SASFieldName="clinname1"><Description></Description></ItemDef><ItemDef OID="clinname2" Name="clinician surname" DataType="text" Length="20" SASFieldName="clinname2"><Description></Description></ItemDef><ItemDef OID="type" Name="subject status" DataType="text" Length="17" SASFieldName="type"><Description></Description><CodeListRef CodeListOID="type" /></ItemDef><ItemDef OID="temperature" Name="temp" DataType="float" Length="4" SignificantDigits="1" SASFieldName="temperature"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value > 45 or me:value < 34]]></FormalExpression><ErrorMessage>'Please check that the value for the temperature is correct'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="NewVDateQues" Name="NewVDateQues" DataType="date" Length="10" SASFieldName="NewVDateQues" MethodDefOID="NewVDateQues"><Description></Description></ItemDef><ItemDef OID="Covformdate" Name="Covformdate" DataType="date" Length="10" SASFieldName="Covformdate"><Description></Description></ItemDef><ItemDef OID="aedate" Name="aedate" DataType="date" Length="10" SASFieldName="aedate"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[me:value isafter datenow]]></FormalExpression><ErrorMessage>'Date cannot be in the future!'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="BodyPart" Name="BodyPart" DataType="text" Length="6" SASFieldName="BodyPart" MethodDefOID="BodyPart"><Description>This derives to the name of a particular body part</Description><CodeListRef CodeListOID="BodyPart" /></ItemDef><ItemDef OID="Spec_Abn" Name="Specify abnormality" DataType="text" Length="140" SASFieldName="Spec_Abn"><Description></Description></ItemDef><ItemDef OID="Abn" Name="Normality" DataType="text" Length="8" SASFieldName="Abn"><Description></Description><CodeListRef CodeListOID="Abn" /></ItemDef><ItemDef OID="Treat" Name="Name of treatment" DataType="text" Length="25" SASFieldName="Treat"><Description></Description></ItemDef><ItemDef OID="TreatStart" Name="Start treatment" DataType="date" Length="10" SASFieldName="TreatStart"><Description></Description><RangeCheck SoftHard="Hard"><FormalExpression Context="Arezzo 7"><![CDATA[me:value isafter datenow]]></FormalExpression><ErrorMessage>'Date cannot be in the future!'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="TreatOngoing" Name="Status of treatment" DataType="text" Length="9" SASFieldName="TreatOngoing"><Description></Description><CodeListRef CodeListOID="TreatOngoing" /></ItemDef><ItemDef OID="TreatStop" Name="Stop treatment" DataType="date" Length="10" SASFieldName="TreatStop"><Description></Description><RangeCheck SoftHard="Soft"><FormalExpression Context="Arezzo 7"><![CDATA[Treatstart( this ) isafter me:value]]></FormalExpression><ErrorMessage>'Treatment stop date cannot be before treatment start date'</ErrorMessage></RangeCheck><RangeCheck SoftHard="Hard"><FormalExpression Context="Arezzo 7"><![CDATA[me:value isafter datenow]]></FormalExpression><ErrorMessage>'Date cannot be in the future!'</ErrorMessage></RangeCheck></ItemDef><ItemDef OID="DiseaseName" Name="Disease name" DataType="text" Length="60" SASFieldName="DiseaseName"><Description></Description></ItemDef><ItemDef OID="DiseaseActive" Name="Disease active" DataType="text" Length="10" SASFieldName="DiseaseActive"><Description></Description><CodeListRef CodeListOID="DiseaseActive" /></ItemDef><ItemDef OID="CertifiedBy" Name="CertifiedBy" DataType="text" Length="24" SASFieldName="CertifiedBy" MethodDefOID="CertifiedBy"><Description>The name of the person authorising the Certification question</Description></ItemDef><ItemDef OID="SubjectID" Name="SubjectID" DataType="text" Length="40" SASFieldName="SubjectID" MethodDefOID="SubjectID"><Description></Description></ItemDef><ItemDef OID="CertifiedDate" Name="CertifiedDate" DataType="datetime" Length="19" SASFieldName="CertifiedDate" MethodDefOID="CertifiedDate"><Description></Description></ItemDef><ItemDef OID="treatwhy" Name="Treatment reason" DataType="text" Length="100" SASFieldName="treatwhy"><Description></Description></ItemDef><ItemDef OID="signname" Name="signname" DataType="text" Length="30" SASFieldName="signname" MethodDefOID="signname"><Description></Description></ItemDef><CodeList DataType="text" OID="bp" Name="blood pressure"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="rightage" Name="age"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="healthy" Name="health"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="bmiok" Name="body mass index"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="consent" Name="subject consent"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="history" Name="history of disease"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="intake" Name="intake medication"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="investdrug" Name="investigational drug"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="physexam" Name="deviance"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="gastro" Name="gastrointestinal"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="donation" Name="blood donation"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="tobacco" Name="smoking"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="hepborc" Name="Hep B or C"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="drugsofa" Name="drug abuse"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="otherdis" Name="disease"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="prevadmin" Name="previous treatment"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="participate" Name="subject participation"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="serious" Name="serious"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="intensity" Name="intensity"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>Mild</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Moderate</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>Strong</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>Severe</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="initinten" Name="initinten"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>Mild</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Moderate</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>Strong</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>Severe</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="adjust" Name="adjust"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>none</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>discontinued</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="eventtreat" Name="eventtreat"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="relation" Name="relation"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>unrelated</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>remote</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>possible</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>probable</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="outcome" Name="outcome"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>resolved - no sequelae</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>resolved - sequelae</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>unresolved</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>death</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="studyend" Name="studyend"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="sex" Name="subject sex"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Female</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>Male</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="race" Name="race"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>Caucasian/white</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>black</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>oriental</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>other</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="smoke" Name="smoker"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="diseases" Name="significant diseases"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="abnormal" Name="ECG abnormalities"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="studycomplete" Name="study completion"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="mainauthorise" Name="certification"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>certified</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="treatmentsyesno" Name="treatment"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="mainauthorize2" Name="Investigator certification"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>certified by Investigator</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="childb_pot" Name="childbearing"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="preg_test" Name="pregnancy test"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="testresult" Name="pregnancy test result"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>negative</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>positive</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="medadmin" Name="medication administered"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="reason_noadmin" Name="administration reason"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Laboratory</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>Adverse event</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="3"><Decode><TranslatedText>Other</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="other_yn" Name="other_yn"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="height_unit" Name="height unit"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>cm</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>inches</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="weight_unit" Name="weight unit"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>kg</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>pounds</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="WBCyesno" Name="White Blood Count"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="Plateletsyesno" Name="Platelets"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="Haemoyesno" Name="Haemoglobin"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Yes</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>No</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="type" Name="subject status"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>Inpatient</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Outpatient</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="3"><Decode><TranslatedText>Healthy volunteer</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="4"><Decode><TranslatedText>Other</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="BodyPart" Name="BodyPart"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Head</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>Eyes</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="3" Rank="3"><Decode><TranslatedText>Nose</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="4" Rank="4"><Decode><TranslatedText>Ears</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="5" Rank="5"><Decode><TranslatedText>Mouth</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="6" Rank="6"><Decode><TranslatedText>Throat</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="7" Rank="7"><Decode><TranslatedText>Neck</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="8" Rank="8"><Decode><TranslatedText>Lungs</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="Abn" Name="Normality"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>Normal</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>Abnormal</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="TreatOngoing" Name="Status of treatment"><CodeListItem CodedValue="1" Rank="1"><Decode><TranslatedText>completed</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="2" Rank="2"><Decode><TranslatedText>ongoing</TranslatedText></Decode></CodeListItem></CodeList><CodeList DataType="text" OID="DiseaseActive" Name="Disease active"><CodeListItem CodedValue="0" Rank="1"><Decode><TranslatedText>Not active</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="1" Rank="2"><Decode><TranslatedText>Active</TranslatedText></Decode></CodeListItem></CodeList><ConditionDef OID="adverse/resolved" Name="resolved"><Description>Skip condition for resolved</Description><FormalExpression Context="Arezzo 7"><![CDATA[outcome <> 2]]></FormalExpression></ConditionDef><ConditionDef OID="adverse/AEtreat" Name="AEtreat"><Description>Skip condition for AEtreat</Description><FormalExpression Context="Arezzo 7"><![CDATA[eventtreat = 1]]></FormalExpression></ConditionDef><ConditionDef OID="adverse/startdate" Name="startdate"><Description>Skip condition for startdate</Description><FormalExpression Context="Arezzo 7"><![CDATA[eventtreat = 1]]></FormalExpression></ConditionDef><ConditionDef OID="adverse/studyend" Name="studyend"><Description>Skip condition for studyend</Description><FormalExpression Context="Arezzo 7"><![CDATA[eventtreat = 1]]></FormalExpression></ConditionDef><ConditionDef OID="adverse/enddate" Name="enddate"><Description>Skip condition for enddate</Description><FormalExpression Context="Arezzo 7"><![CDATA[studyend = 0]]></FormalExpression></ConditionDef><ConditionDef OID="demography/raceother" Name="raceother"><Description>Skip condition for raceother</Description><FormalExpression Context="Arezzo 7"><![CDATA[race = 3]]></FormalExpression></ConditionDef><ConditionDef OID="demography/statusother" Name="statusother"><Description>Skip condition for statusother</Description><FormalExpression Context="Arezzo 7"><![CDATA[type = 3]]></FormalExpression></ConditionDef><ConditionDef OID="demography/smokeequiv" Name="smokeequiv"><Description>Skip condition for smokeequiv</Description><FormalExpression Context="Arezzo 7"><![CDATA[smoke = 1]]></FormalExpression></ConditionDef><ConditionDef OID="demography/childb_pot" Name="childb_pot"><Description>Skip condition for childb_pot</Description><FormalExpression Context="Arezzo 7"><![CDATA[screening:cover:sex = 1]]></FormalExpression></ConditionDef><ConditionDef OID="demography/preg_test" Name="preg_test"><Description>Skip condition for preg_test</Description><FormalExpression Context="Arezzo 7"><![CDATA[childb_pot = 1]]></FormalExpression></ConditionDef><ConditionDef OID="demography/testresult" Name="testresult"><Description>Skip condition for testresult</Description><FormalExpression Context="Arezzo 7"><![CDATA[preg_test = 1]]></FormalExpression></ConditionDef><ConditionDef OID="demography/preg_date" Name="preg_date"><Description>Skip condition for preg_date</Description><FormalExpression Context="Arezzo 7"><![CDATA[preg_test = 1]]></FormalExpression></ConditionDef><ConditionDef OID="Disease/NewDiseases" Name="NewDiseases"><Description>Skip condition for NewDiseases</Description><FormalExpression Context="Arezzo 7"><![CDATA[diseases = 1]]></FormalExpression></ConditionDef><ConditionDef OID="Disease/DiseaseActive" Name="DiseaseActive"><Description>Skip condition for DiseaseActive</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( DiseaseName( this ) )]]></FormalExpression></ConditionDef><ConditionDef OID="ECG1/ECGspecify" Name="ECGspecify"><Description>Skip condition for ECGspecify</Description><FormalExpression Context="Arezzo 7"><![CDATA[abnormal = 1]]></FormalExpression></ConditionDef><ConditionDef OID="Complete/studyreason" Name="studyreason"><Description>Skip condition for studyreason</Description><FormalExpression Context="Arezzo 7"><![CDATA[studycomplete = 0]]></FormalExpression></ConditionDef><ConditionDef OID="Complete/contact" Name="contact"><Description>Skip condition for contact</Description><FormalExpression Context="Arezzo 7"><![CDATA[studycomplete = 0]]></FormalExpression></ConditionDef><ConditionDef OID="eligibility2/consent1" Name="consent1"><Description>Skip condition for consent1</Description><FormalExpression Context="Arezzo 7"><![CDATA[participate = 1]]></FormalExpression></ConditionDef><ConditionDef OID="eligibility2/reason" Name="reason"><Description>Skip condition for reason</Description><FormalExpression Context="Arezzo 7"><![CDATA[participate = 0]]></FormalExpression></ConditionDef><ConditionDef OID="eligibility2/mainauthorise" Name="mainauthorise"><Description>Skip condition for mainauthorise</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( participate )]]></FormalExpression></ConditionDef><ConditionDef OID="eligibility2/CertifiedBy" Name="CertifiedBy"><Description>Skip condition for CertifiedBy</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( mainauthorise )]]></FormalExpression></ConditionDef><ConditionDef OID="eligibility2/CertifiedDate" Name="CertifiedDate"><Description>Skip condition for CertifiedDate</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( mainauthorise )]]></FormalExpression></ConditionDef><ConditionDef OID="treatments/ConMeds" Name="ConMeds"><Description>Skip condition for ConMeds</Description><FormalExpression Context="Arezzo 7"><![CDATA[treatmentsyesno = 1]]></FormalExpression></ConditionDef><ConditionDef OID="treatments/TreatStart" Name="TreatStart"><Description>Skip condition for TreatStart</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( Treat( this ) )]]></FormalExpression></ConditionDef><ConditionDef OID="treatments/TreatOngoing" Name="TreatOngoing"><Description>Skip condition for TreatOngoing</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( Treat( this ) )]]></FormalExpression></ConditionDef><ConditionDef OID="treatments/TreatStop" Name="TreatStop"><Description>Skip condition for TreatStop</Description><FormalExpression Context="Arezzo 7"><![CDATA[TreatOngoing( this ) = 1]]></FormalExpression></ConditionDef><ConditionDef OID="signature/inv_date" Name="inv_date"><Description>Skip condition for inv_date</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown( mainauthorize2 )]]></FormalExpression></ConditionDef><ConditionDef OID="Generalphysexam/spec_abn_other" Name="spec_abn_other"><Description>Skip condition for spec_abn_other</Description><FormalExpression Context="Arezzo 7"><![CDATA[other_yn=1]]></FormalExpression></ConditionDef><ConditionDef OID="Generalphysexam/Spec_Abn" Name="Spec_Abn"><Description>Skip condition for Spec_Abn</Description><FormalExpression Context="Arezzo 7"><![CDATA[abn( this ) = 2]]></FormalExpression></ConditionDef><ConditionDef OID="medication/admind" Name="admind"><Description>Skip condition for admind</Description><FormalExpression Context="Arezzo 7"><![CDATA[medadmin = 1]]></FormalExpression></ConditionDef><ConditionDef OID="medication/admint" Name="admint"><Description>Skip condition for admint</Description><FormalExpression Context="Arezzo 7"><![CDATA[medadmin = 1]]></FormalExpression></ConditionDef><ConditionDef OID="medication/reason_noadmin" Name="reason_noadmin"><Description>Skip condition for reason_noadmin</Description><FormalExpression Context="Arezzo 7"><![CDATA[medadmin = 0]]></FormalExpression></ConditionDef><ConditionDef OID="medication/specify" Name="specify"><Description>Skip condition for specify</Description><FormalExpression Context="Arezzo 7"><![CDATA[reason_noadmin = 3]]></FormalExpression></ConditionDef><ConditionDef OID="blood/WBC" Name="WBC"><Description>Skip condition for WBC</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown(WBCdate)]]></FormalExpression></ConditionDef><ConditionDef OID="blood/WBCdate" Name="WBCdate"><Description>Skip condition for WBCdate</Description><FormalExpression Context="Arezzo 7"><![CDATA[WBCyesno = 1]]></FormalExpression></ConditionDef><ConditionDef OID="blood/Platelets" Name="Platelets"><Description>Skip condition for Platelets</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown(Plateletsdate)]]></FormalExpression></ConditionDef><ConditionDef OID="blood/Plateletsdate" Name="Plateletsdate"><Description>Skip condition for Plateletsdate</Description><FormalExpression Context="Arezzo 7"><![CDATA[Plateletsyesno = 1]]></FormalExpression></ConditionDef><ConditionDef OID="blood/Haemo" Name="Haemo"><Description>Skip condition for Haemo</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown(Haemodate)]]></FormalExpression></ConditionDef><ConditionDef OID="blood/Haemodate" Name="Haemodate"><Description>Skip condition for Haemodate</Description><FormalExpression Context="Arezzo 7"><![CDATA[Haemoyesno = 1]]></FormalExpression></ConditionDef><ConditionDef OID="PhysMeas/BMI" Name="BMI"><Description>Skip condition for BMI</Description><FormalExpression Context="Arezzo 7"><![CDATA[isknown(height) and isknown(weight) and isknown(height_unit) and isknown(weight_unit)]]></FormalExpression></ConditionDef><MethodDef Type="Computation" OID="Subjectno" Name="Subject number"><Description>Derivation for Subjectno</Description><FormalExpression Context="Arezzo 7"><![CDATA[screening:cover:subject]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="Subinitials" Name="Subject initials"><Description>Derivation for Subinitials</Description><FormalExpression Context="Arezzo 7"><![CDATA[screening:cover:initials]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="DOB" Name="Date Of Birth"><Description>Derivation for DOB</Description><FormalExpression Context="Arezzo 7"><![CDATA[screening:cover:dobirth]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="scheddatetime" Name="scheddatetime"><Description>Derivation for scheddatetime</Description><FormalExpression Context="Arezzo 7"><![CDATA[breakfast_time + question:cycle hours]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="BMI" Name="Calculated BMI"><Description>Derivation for BMI</Description><FormalExpression Context="Arezzo 7"><![CDATA[weight_kg/( ( height_cm/100 )*( height_cm/100 ) )]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="visitd_calc1" Name="visit from"><Description>Derivation for visitd_calc1</Description><FormalExpression Context="Arezzo 7"><![CDATA[visitd + 6 days]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="inv_date" Name="certification date"><Description>Derivation for inv_date</Description><FormalExpression Context="Arezzo 7"><![CDATA[dateof( mainauthorize2 )]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="visitd_calc2" Name="visit to"><Description>Derivation for visitd_calc2</Description><FormalExpression Context="Arezzo 7"><![CDATA[visitd + 8 days]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="height_cm" Name="derived height"><Description>Derivation for height_cm</Description><FormalExpression Context="Arezzo 7"><![CDATA[if( height_unit = 1,Height, Height*2.54)]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="weight_kg" Name="derived weight"><Description>Derivation for weight_kg</Description><FormalExpression Context="Arezzo 7"><![CDATA[if( weight_unit = 1,Weight,Weight/2.2)]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="gender" Name="gender"><Description>Derivation for gender</Description><FormalExpression Context="Arezzo 7"><![CDATA[case( ( screening:cover:sex = 1,'female' ),(screening:cover:sex = 2, 'male'))]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="NewVDateQues" Name="NewVDateQues"><Description>Derivation for NewVDateQues</Description><FormalExpression Context="Arezzo 7"><![CDATA[screening:visitdate:visitd]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="BodyPart" Name="BodyPart"><Description>Derivation for BodyPart</Description><FormalExpression Context="Arezzo 7"><![CDATA[question:cycle]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="CertifiedBy" Name="CertifiedBy"><Description>Derivation for CertifiedBy</Description><FormalExpression Context="Arezzo 7"><![CDATA[mainauthorise: username]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="SubjectID" Name="SubjectID"><Description>Derivation for SubjectID</Description><FormalExpression Context="Arezzo 7"><![CDATA[ if(isknown(person:subjectidentifier), person:subjectidentifier, 'Not Registered')]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="CertifiedDate" Name="CertifiedDate"><Description>Derivation for CertifiedDate</Description><FormalExpression Context="Arezzo 7"><![CDATA[dateof( mainauthorise )]]></FormalExpression></MethodDef><MethodDef Type="Computation" OID="signname" Name="signname"><Description>Derivation for signname</Description><FormalExpression Context="Arezzo 7"><![CDATA[mainauthorize2:username ]]></FormalExpression></MethodDef></MetaDataVersion></Study></ODM>