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 In this study, subjects were randomized to one of three 24-week conditions.  At the baseline visit, they receiving either an ENDS  device that used  0, 8 or 36 mg/ml nicotine liquid . Self-reported daily cigarette consumption  were measured at all study visits  (Weeks 1, 2, 4, 8, 12, ). The subjects were supplied replacement nicotine cartridges.  The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked.  The subject used their normal brand cigarettes , and these were not supplied by the sponsor. Each cartridge was 8 mL. 

Since, the subject regular cigarettes were not supplied by the sponsor, the sponsor elected to report this data as a Concomitant medication, in the CM domain. The ENDS device exposure use was represented in EC.        

 

ec.xpt

ec.xpt

RowSTUDYIDDOMAINUSUBJIDECSEQECTRTECDOSEECDOSUECROUTEECSTDTCECENDTC
1TENDS01EC10001 1Electronic Nicotine Delivery System  1CONTAINERINHALED2020-06-272020-07-01
2TENDS01EC10001 2Electronic Nicotine Delivery System 1CONTAINERINHALED2020-07-012020-07-05
3TENDS01EC10001 3Electronic Nicotine Delivery System 1CONTAINERINHALED2020-07-052020-07-10
4TENDS01EC100021Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-012020-09-07
5TENDS01EC10002 2Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-072020-09-14
6TENDS01EC10002 3Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-142020-09-21
7TENDS01EC10002 4Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-212020-09-28
8TENDS01EC10002 5Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-282020-09-31
9TENDS01EC10002 6Electronic Nicotine Delivery SystemP1CONTAINERINHALED2020-10-312020-10-08
10TENDS01EC10002 7Electronic Nicotine Delivery System 1CONTAINERINHALED2020-10-082020-10-15
11TENDS01EC10002 8Electronic Nicotine Delivery System 1CONTAINERINHALED2020-10-152020-10-22

Dataset Debug Messages

  • There are 21 leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

EX would report the unblinded exposure to nicotine.  What should be reported????  We do not really have the real exposue... 

$titleHtml

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXROUTEEXSTDTCEXENDTC
1TENDS01EX10001 1Electronic Nicotine Delivery System  0 mg nicotine liquid
INHALED2020-06-272020-07-01
2TENDS01EC10001 2Electronic Nicotine Delivery System 0 mg nicotine liquidCONTAINERINHALED2020-07-012020-07-05
3TENDS01EC10001 3Electronic Nicotine Delivery System 0 mg nicotine liquidCONTAINERINHALED2020-07-052020-07-10
4TENDS01EC100021Electronic Nicotine Delivery System 8x36 ml  nicotine liquidCONTAINERINHALED2020-09-012020-09-07
5TENDS01EC10002 2Electronic Nicotine Delivery System 8x36 mg  nicotine liquid0 mg nicotine liquidCONTAINERINHALED2020-09-072020-09-14
6TENDS01EC10002 3Electronic Nicotine Delivery System 8x36 mg  nicotine liquidCONTAINERINHALED2020-09-142020-09-21
7TENDS01EC10002 4Electronic Nicotine Delivery System 8x36 mg  nicotine liquid1CONTAINERINHALED2020-09-212020-09-28
8TENDS01EC10002 5Electronic Nicotine Delivery System 8x36 ml  nicotine liquid1CONTAINERINHALED2020-09-282020-09-31
9TENDS01EC10002 6Electronic Nicotine Delivery SystemP8x36 ml  nicotine liquid1CONTAINERINHALED2020-10-312020-10-08
10TENDS01EC10002 7Electronic Nicotine Delivery System 8x36 ml  nicotine liquid1CONTAINERINHALED2020-10-082020-10-15
11TENDS01EC10002 8Electronic Nicotine Delivery System 8x36 ml  nicotine liquid1CONTAINERINHALED2020-10-152020-10-22

Dataset Debug Messages

  • There are 29 leading, trailing, or non-breaking spaces in the dataset.
  • There seem to be multiple domains (EX, EC) present in the dataset.
  • Please remove all formatting (see How to Clear Formatting).
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