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Due to inconsistent recording in the remote setting, participants' birth dates will be documented using multiple sources: midwife birth notification forms, hard copy medical records and Communicare electronic health records.
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29 Deaths will be documented.
At the point of exclusion, study results up to this date and reasons for exclusion will be documented.
The following details on adverse events will be documented: date of occurrence; time lost; measures taken related to the acupuncture; causal relationship to acupuncture; treatment for adverse event.
Patients randomised to receive treatment in either community setting may be transferred at any time to continue treatment in hospital, and the date and reason for transfer will be documented.
13 14 Protocol amendments will be documented by date and rationale, and published with the results of the review.
The date of the first assessment of a plasma viral load more than 400 copies/ml will be documented as the date of virological failure.
If an eligible patient refuses to participate, their date of birth, sex and reason for refusing participation will be documented.
In addition, complications related to the in situ tumor that could delay the date of surgery or require emergency colonic surgery or stenting, will be documented.
All applications of PFS will be documented on a treatment record form, which will capture the date, batch number, patient ID number and number of sealants (i.e. teeth) applied.
All applications of FV will be documented on a treatment record form, which will capture the date, batch number, patient ID number and number of applications (i.e. teeth) performed.
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