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Exact(7)
One patient withdrew the informed consent after week 48 for the main trial but not for this sub-study.
It would have been preferable for this information to have been gathered before the main trial, but this was not possible due to time restrictions.
These patients will not enter the main trial but will be treated appropriately and followed-up as part of the comprehensive cohort.
The changed arrangements for payment for management of CHD may impact on the intervention in the main trial but the current findings and awareness of the impact of background policy should assist in our interpretation of the findings.
All patients will be screened for G6PD status using the NADPH spot test and those found to be deficient will be excluded from the main trial but encouraged to enrol in a parallel G6PDd arm.
We had initially planned to use community workers for application of CHX for the main trial but based on these findings engaged the MCH workers for CHX application on day 0, 1, 4 and 10.
Similar(53)
An average of 3.1 3.3 calls were provided to patients as reported in the main trial paper, but structured psychological support was not provided.
The in-depth process evaluation practices were a group of practices in the QICKD trial which received the same intervention as the main trial practices but were also observed so we could learn about programme fidelity (i.e. the extent to which the intervention ran as planned) and intervention exposure (i.e. the extent to which members of trial practices were exposed to the intervention) [ 19, 15].
Both HPTN 039 and Mwanza reported median adherence >90%% in their main trial publications [ 21, 22], but used different assumptions in their calculations so the measures were not comparable.
As the main trial results demonstrated a small but statistically significant difference in mortality between the LCM and CDM groups [ 19], analyses were done separately for both groups, and estimates adjusted for relevant pre-ART confounding factors.
These accounts were given in pre-trial hearings, but were not pursued in the main trial for legal reasons.
Related(20)
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