The examples in this section illustrate various methods for displaying study product exposure data, as well as data that may be collected on the use of other nicotine sources. These examples are provided to illustrate specific exposure based on how it was measured (e.g., by volume, by weight, number of product consumed).

Example

In this study, subjects were randomized to different doses of a nicotine inhaler. The recommended usage instructions for the nicotine inhaler were provided to the subject at each visit. At visits 1-3, subjects were to use 6-10 cartridges per day, and during visits 4-6 subjects were to use 3-6 cartridges per day. Subjects were encouraged not to use any other tobacco products, nicotine replacement therapies, or alcohol during the study. Data on usage of these products were collected using an e-diary, where subjects provided information on the products used each day. Only days where a product was used were represented. 

Alcohol usage and tobacco product usage were represented in the Substance Use (SU) domain. SUCAT allows the records to be grouped into tobacco-related data and alcohol-related data. In this example, the products were prespecified so SUTRT does not require a standardized SUDECOD equivalent. The applicant only includes SUSTDTC and SUENDTC as timing variables.   

Row 1:Shows the cigarettes used for the day of assessment. SUDOSFRQ was represented using the controlled terminology for per day, QD.
Rows 2-3:Show 2 other records for a subject's usage of tobacco products on 2 other days.
Row 4:Shows the subject's use of alcohol. Note: The applicant collected the ounces of the product used using a prespecified amount per drink.

su.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDSUSEQSUTRTSUCATSUDOSESUDOSU

SUDOSFRQ

SUSTDTCSUENDTC
1TIN111SUTIN7011CIGARETTETOBACCO1CIGARETTE

QD

2020-06-262020-06-26
2TIN111SUTIN7012CIGARTOBACCO2CIGARQD2020-07-272020-07-27
3TIN111SUTIN8011CIGARETTETOBACCO1CIGARETTEQD2020-07-152020-07-15
4TIN111SUTIN8012BEERALCOHOL24OZQD2020-07-202020-07-20
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Drugs used to treat nicotine dependency are considered drugs and were represented in the Concomitant Medication (CM) domain. This subject used a 14 mg nicotine replacement patch. The applicant included the CMCLASS, CMDECOD, and CMMODIFY. These were included to reflect standardized coding of the medication.  

cm.xpt

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMMODIFYCMDECODCMCLASCMDOSECMDOSU

CMDOSFRM

CMSTDTCCMENDTC
1TIN111CMTIN7011Nicotine Replacement PatchNicotineNICOTINEDRUGS USED IN NICOTINE DEPENDENCE14mg

PATCH

2020-06-262020-06-27
$warningHtml

The Product Accountability (DA) domain was used to represent the amount of study product transferred to or from the study subjects. At each visit, each subject was supplied with 90 cartridges per week for weeks 1-3, and 50 cartridges per week for weeks 4-6. The number of cartridges returned were counted. DACAT was used to indicate that the product of interest was the study product. DASPID and DAREFID can be used for code numbers that appeared on the study product label; in this case, no code numbers were included on the labels. The applicant included VISITNUM and DADTC as these variables are expected in this domain. DADTC was the date the supplies were dispensed or returned, these corresponded to the dates of the visits.   

Rows 1, 3:Show the number of cartridges dispensed to the subject.
Rows 2, 4:Show the number of cartridges returned by the subject.

da.xpt

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TIN111DATIN701

1

DISPAMTDispensed AmountSTUDY PRODUCT90CARTRIDGE9090CARTRIDGE12004-06-26
2TIN111DATIN701

2

RETAMTReturned AmountSTUDY PRODUCT13CARTRIDGE1313CARTRIDGE22020-07-06
3TIN111DATIN701

3

DISPAMTDispensed AmountSTUDY PRODUCT50CARTRIDGE5050CARTRIDGE22020-07-06
4TIN111DATIN701

4

RETAMTReturned AmountSTUDY PRODUCT10CARTRIDGE1010CARTRIDGE32020-07-14
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The applicant used a patient diary (not shown here) to determine how many cartridges the subject used on each day, then created the EC data to represent the collected exposure data. Usage recommendations were represented in ECDOSRGM, which is the intended dose regimen. The ECMOOD permissible variable was used to reflect the prescribed and the actual usage of the inhaled nicotine. When this variable is used, it must be populated for all records. This variable cannot be used in EX.   

Row 1:Shows the scheduled usage recommendation for the inhaled nicotine. Note: The details on the scheduled records are described at a different level than the performed records. ECDOSRGM shows that for these start and end dates the subject was recommended to use 6-12 cartridges every day.
Rows 2, 3:Show the actual "performed" amount of inhaled nicotine used by the subject each day. Only a few rows of the performed records are shown.
Row 4:Shows the scheduled usage recommendation for the inhaled nicotine. ECDOSRGM shows for these start and end dates the subject was recommended to use 3-6 cartridges per day.
Row 5:Shows the actual performed amount of inhaled nicotine used by the subject each day. Only a few rows of the performed records are shown.

ec.xpt

ec.xpt

RowSTUDYIDDOMAINUSUBJIDECSEQECTRTECMOODECDOSEECDOSUECDOSFRMECDOSRGMECROUTEEPOCHECSTDTCECENDTC
1TIN111ECTIN7011INHALED NICOTINESCHEDULED
CARTRIDGECARTRIDGE6 -10 cartridges per dayRESPIRATORY (INHALATION)PRODUCT EXPOSURE2004-06-262004-07-06
2TIN111ECTIN7012INHALED NICOTINEPERFORMED7CARTRIDGECARTRIDGE
RESPIRATORY (INHALATION)PRODUCT EXPOSURE2004-06-262004-06-26
3TIN111ECTIN7013INHALED NICOTINEPERFORMED2CARTRIDGECARTRIDGE
RESPIRATORY (INHALATION)PRODUCT EXPOSURE2004-06-272004-06-27
4TIN111ECTIN7014INHALED NICOTINESCHEDULED
CARTRIDGECARTRIDGE3-6 cartridges per dayRESPIRATORY (INHALATION)PRODUCT EXPOSURE2004-07-062004-07-14
5TIN111ECTIN7015INHALED NICOTINEPERFORMED3CARTRIDGECARTRIDGE
RESPIRATORY (INHALATION)PRODUCT EXPOSURE2004-07-072004-07-07
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The EX dataset shows actual administrations. Scheduled records are not included, and only a few rows are shown for illustration purposes. The pharmaceutical strength was included to identify the dose of the nicotine inhaler used by the subject. Because EXENDTC is an expected variable, the applicant populated this timing variable with the start date.    

  

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEPOCHEXSTDTCEXENDTC
1TIN111EXTIN7011INHALED NICOTINE7CARTRIDGECARTRIDGERESPIRATORY (INHALATION)6mgPRODUCT EXPOSURE2004-06-262004-06-26
2TIN111EXTIN7012INHALED NICOTINE2CARTRIDGECARTRIDGERESPIRATORY (INHALATION)6mgPRODUCT EXPOSURE2004-06-272004-06-27
3TIN111EXTIN7011INHALED NICOTINE3CARTRIDGECARTRIDGERESPIRATORY (INHALATION)4mgPRODUCT EXPOSURE2004-07-072004-07-07
$warningHtml

In this example, the EC domain is not used by the applicant to represent collected exposure. Exposure is represented based on the volume of the e-nicotine liquid cartridges.  TOBA-122 - Getting issue details... STATUS

Example

In this study, subjects were randomized to 1 of 3 nicotine dosage levels. At the baseline visit (week 0), they received an ENDS device that used 0, 8, or 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption was recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The applicant used an e-diary to track when cartridges were inserted and removed, and the daily number of cigarettes smoked. Subjects used their normal brand of cigarettes; these were not supplied by the applicant, and are not considered a study product. Each cartridge was 8 mL. No other nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.   

The applicant represented the cigarettes used in the SU domain. After the first visit, the number of cigarettes smoked for each day of the study were represented. If no cigarettes were smoked,(although "0" records are typically not included), 0 was recorded as the data was collected. Only a few rows are shown.    

su.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDSUSEQSUTRTSUCATSUDOSESUDOSUSUDOSFRQSUSTDTCSUENDTC
1TENDS01SUTEN010011CIGARETTESTOBACCO6CIGARETTEQD2020-06-272020-06-27
2TENDS01SUTEN010012CIGARETTESTOBACCO1CIGARETTEQD2020-06-282020-06-28
3TENDS01SUTEN010013CIGARETTESTOBACCO0CIGARETTEQD2020-06-292020-06-29
$warningHtml

The DA domain was used to represent dispensed and returned amounts. The ENDS product used in the study was assigned a product identifier (VAPE-Z27), and each cartridge had a uniquely assigned number. This unique number was represented in DAREFID. Multiple cartridges were dispensed at weekly visits, and each cartridge was tracked. At each weekly visit, all previously dispensed cartridges were returned and new cartridges dispensed. Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed. Cartridges not used were recorded as having the full volume returned.     

da.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQSPTOBIDDAREFIDDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TENDS01DATEN01001

1

VAPE-Z27CRT8754DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL12020-06-26
2TENDS01DATEN01001

2

VAPE-Z27CRT8768DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL12020-06-26
3TENDS01DATEN01001

3

VAPE-Z27CRT8769DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL12020-06-26
4TENDS01DATEN01001

4

VAPE-Z27CRT8754RETAMTReturned AmountSTUDY PRODUCT2mL22mL22020-07-06
2TENDS01DATEN01001

5

VAPE-Z27CRT8768RETAMTReturned AmountSTUDY PRODUCT1.6mL1.61.6mL22020-07-06
3TENDS01DATEN01001

6

VAPE-Z27CRT8769RETAMTReturned AmountSTUDY PRODUCT8mL88mL22020-07-06
5TENDS01DATEN01001

7

VAPE-Z27CRT9756DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL22020-07-06
6TENDS01DATEN01001

8

VAPE-Z27CRT9756RETAMTReturned AmountSTUDY PRODUCT1mL11mL32020-07-10
$warningHtml

Because the data in EC would be practically identical to the summarized EX domain, the applicant did not submit the EC domain. The applicant unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT; here, a dummy name is used for the tobacco product.

The applicant used an e-diary to collect the start and end date of the insertion and removal date of each cartridge in the ENDS device. For simplicity, in this example the actual times of insertion/removal were not collected, although this may often be collected.    

The total amount of liquid product used from each cartridge was determined using the data in the DA domain. The associated nicotine pharmaceutical strength of each cartridge was known. The applicant used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposure from the cartridges per day.    

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQSPTOBIDEXREFIDEXTRTEXDOSEEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TENDS01EXTEN010011VAPE-Z27CRT8754Nicotine e-liquid6mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-06-262020-07-01
2TENDS01EXTEN010012VAPE-Z27CRT8768Nicotine e-liquid6.4mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-012020-07-06
3TENDS01EXTEN010013VAPE-Z27CRT9756Nicotine e-liquid7mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-062020-07-10
3TENDS01EXTEN010014VAPE-Z27CRT9778Nicotine e-liquid8mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-102020-07-14
4TENDS01EXTEN100021VAPE-Z27CRT8000Nicotine e-liquid5mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-09-012020-09-07
5TENDS01EXTEN100022VAPE-Z27CRT9006Nicotine e-liquid7mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-09-072020-09-14
6TENDS01EXTEN100023VAPE-Z27CRT9008Nicotine e-liquid8mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-09-142020-09-21
7TENDS01EXTEN100024VAPE-Z27CRT9017Nicotine e-liquid6mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-09-212020-09-28
8TENDS01EXTEN100025VAPE-Z27CRT9089Nicotine e-liquid7mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-09-282020-09-31
9TENDS01EXTEN100026VAPE-Z27CRT9128Nicotine e-liquid8mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-10-312020-10-08
10TENDS01EXTEN100027VAPE-Z27CRT6868Nicotine e-liquid6.7mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-10-082020-10-15
11TENDS01EXTEN100028VAPE-Z27CRT7868Nicotine e-liquid5.5mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2020-10-152020-10-22
$warningHtml

In this example, both the EC and EX domains are used. Exposure is based on the weight of the e-nicotine liquid cartridges. 

Example

In this study, subjects were randomized to either nicotine replacement patches or ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied, at rotating sites, and the nicotine cartridge was replaced every day. The cartridge was weighed when dispensed and upon return. On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4-hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.     

The SU domain was used to represent the number of cigarettes used, but is not shown.  

In this study, the weight of the contents in the cartridge was tracked. The DA domain was used to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.    

da.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001

2

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001

4

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414g22020-06-08
5TEDP07DA10001

5

CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-08
$warningHtml

EC was used to represent the collected exposure data since a double-blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.           

$titleHtml

ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSTXT

ECDOSU

ECDOSFRM

ECROUTE

ECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  10
PUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-01T08:002020-06-01T08:10
2TEDP07EC10001 2

 PATCH 

1
PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE2020-06-012020-06-02
3TEDP07EC10001 3ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-01T12:102020-06-02
4TEDP07EC10001 4ENDS  
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-022020-06-03
5TEDP07EC100015PATCH 1
PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE2020-06-022020-06-03
6TEDP07EC100016ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC100017PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 8ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 9PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC1000110ENDS 10
PUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T8:302020-06-10T8:40
10TEDP07EC1000111 PATCH 1
PATCH PATCH TRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC1000112ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T12:402020-06-11
$warningHtml
 Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.
$titleHtml

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

EXSTDTC

EXENDTC

1TEDP07EX10001 1e nicotine liquid 1.7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T08:002020-06-01T:8:10
2TEDP07EX10001 2e nicotine liquid 15.1gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-01T12:102020-06-02
3TEDP07EX10001 3e nicotine liquid 13gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-022020-06-03
4TEDP07EX100014e nicotine liquid 12gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-032020-06-04
5TEDP07EX10001 5e nicotine liquid 9gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-042020-06-05
6TEDP07EX100016e nicotine liquid 7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T08:302020-06-10T08:40
7TEDP07EX100017e nicotine liquid 5gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%2020-06-10T12:402020-06-11
8TEDP07EX20001 1

nicotine replacement therapy

1PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE14mg2020-06-012020-06-02
9TEDP07EX200012nicotine replacement therapy1PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE14mg2020-06-022020-06-03
10TEDP07EX200013nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE14mg2020-06-032020-06-04
11TEDP07EX20001 4nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH PATCHTRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE14mg2020-06-102020-06-11
$warningHtml

In this example, subjects were exposed to multiple study products. The actual dates and times of use for each product are represented. 

Example

This is an example of a crossover study testing 7 smokeless tobacco products. All products contain nicotine except for product F, which was a nicotine-/tobacco-free product. Each subject first used the product ad libitum; the next day, the product usage was evaluated in the morning, as specified in the protocol. Subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a DA domain, nor an EC domain. The name of the actual product would be used, but a dummy name is used in this example.            

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXCATEXDOSEEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUVISITNUMVISITVISITDYEPOCHEXSTDTCEXENDTC
1ALCS-REG-STUDYEXALCS-REG-STUDY_100011PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg10DAY -1-1PRODUCT EXPOSURE2019-06-27T13:10:332019-06-27T13:38:49
2ALCS-REG-STUDYEXALCS-REG-STUDY_100012PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg10DAY -1-1PRODUCT EXPOSURE2019-06-27T14:29:132019-06-27T14:54:53
3ALCS-REG-STUDYEXALCS-REG-STUDY_100013PRODUCT CCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg11DAY 11PRODUCT EXPOSURE2019-06-28T08:00:122019-06-28T08:30:21
4ALCS-REG-STUDYEXALCS-REG-STUDY_100014PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg11DAY 11PRODUCT EXPOSURE2019-06-28T14:01:522019-06-28T14:55:27
5ALCS-REG-STUDYEXALCS-REG-STUDY_100015PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg11DAY 11PRODUCT EXPOSURE2019-06-28T15:18:352019-06-28T15:57:33
6ALCS-REG-STUDYEXALCS-REG-STUDY_100016PRODUCT ECONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg12DAY 22PRODUCT EXPOSURE2019-06-29T08:00:082019-06-29T08:30:13
7ALCS-REG-STUDYEXALCS-REG-STUDY_100017PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg12DAY 22PRODUCT EXPOSURE2019-06-29T14:01:502019-06-29T14:50:11
8ALCS-REG-STUDYEXALCS-REG-STUDY_100018PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg12DAY 22PRODUCT EXPOSURE2019-06-29T15:24:332019-06-29T15:59:46
9ALCS-REG-STUDYEXALCS-REG-STUDY_100019PRODUCT BCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg13DAY 33PRODUCT EXPOSURE2019-06-30T08:00:002019-06-30T08:30:00
10ALCS-REG-STUDYEXALCS-REG-STUDY_1000110PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg13DAY 33PRODUCT EXPOSURE2019-06-30T14:12:322019-06-30T14:47:47
11ALCS-REG-STUDYEXALCS-REG-STUDY_1000111PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg13DAY 33PRODUCT EXPOSURE2019-06-30T15:24:462019-06-30T16:04:57
12ALCS-REG-STUDYEXALCS-REG-STUDY_1000112PRODUCT DCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg14DAY 44PRODUCT EXPOSURE2019-07-01T08:00:002019-07-01T08:30:00
13ALCS-REG-STUDYEXALCS-REG-STUDY_1000113PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg14DAY 44PRODUCT EXPOSURE2019-07-01T14:02:362019-07-01T14:47:33
14ALCS-REG-STUDYEXALCS-REG-STUDY_1000114PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg14DAY 44PRODUCT EXPOSURE2019-07-01T15:37:452019-07-01T15:58:15
15ALCS-REG-STUDYEXALCS-REG-STUDY_1000115PRODUCT ACONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg15DAY 55PRODUCT EXPOSURE2019-07-02T08:00:002019-07-02T08:30:01
16ALCS-REG-STUDYEXALCS-REG-STUDY_1000116PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg15DAY 55PRODUCT EXPOSURE2019-07-02T14:11:002019-07-02T14:54:08
17ALCS-REG-STUDYEXALCS-REG-STUDY_1000117PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg15DAY 55PRODUCT EXPOSURE2019-07-02T15:38:522019-07-02T15:59:50
18ALCS-REG-STUDYEXALCS-REG-STUDY_1000118PRODUCT FCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg16DAY 66PRODUCT EXPOSURE2019-07-03T08:00:002019-07-03T08:30:00
19ALCS-REG-STUDYEXALCS-REG-STUDY_1000119PRODUCT GUNCONTROLLED PRODUCT USE3.37gQUIDORAL4mg16DAY 66PRODUCT EXPOSURE2019-07-03T14:13:142019-07-03T14:57:40
20ALCS-REG-STUDYEXALCS-REG-STUDY_1000120PRODUCT GUNCONTROLLED PRODUCT USE3.2gQUIDORAL4mg16DAY 66PRODUCT EXPOSURE2019-07-03T15:35:012019-07-03T16:07:25
21ALCS-REG-STUDYEXALCS-REG-STUDY_1000121PRODUCT GCONTROLLED PRODUCT USE2gQUIDORAL4mg17DAY 7/EARLY TERMINATION7PRODUCT EXPOSURE2019-07-04T08:00:042019-07-04T08:30:05
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