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The fourth sample tested from SC7 did not produce a reliable mtDNA sequence but produced an IS6110 sequence and was not included in the study thereafter.
An insufficient number of subjects remained in the study thereafter to complete longer term assessment of clinical status.
Finally, in our study girls were never asked if they had once given birth as some subjects missed measurements sessions more than one occasion and rejoined the study thereafter.
On average 1.05% of participants were permanently lost due to death and 11.47% subjects lost due to teenage pregnancy, illness, migration to urban areas and school drop-out were a temporary issue as the affected participants rejoined the study thereafter.
Participants can withdraw wholly from the study, but data obtained up to the point of withdrawal will be included in the final analysis of the study; thereafter, no further data will be collected for that participant.
Or participants can withdrawal wholly from the study and only data obtained up until the point of withdrawal will be included in the final analysis of the study; thereafter no further data will be collected for that participant.
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Confidentiality was maintained throughout the study and thereafter.
Patients 3 and 62 provided one sample each and withdrew from the study immediately thereafter.
Haematological parameters were assessed weekly for the the first 12 weeks of the study and thereafter every 4 weeks.
Permission to conduct the study was thereafter obtained from CCBRT hospital and the Municipal director, Temeke municipality; Dar es Salaam.
We ensured reliability of our study instrument by pre-testing it and discussing pre-test results among the study team thereafter.
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