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Interestingly, we found that none of the manuscripts described change of the methods after trial commencement (Subitem 3b), change of trial outcomes after the trial commenced (Subitem 6b), interim analyses and stopping guidelines (Subitem 7b), premature discontinuation of the trial (Subitem 14b) and additional analyses (Subitem 18).
In 14/28 (50%%) a fixed number of clusters were identified at trial commencement and the number of patients required to achieve a pre-specified effect size was then identified; 8/14 (57 %) achieved these numbers.
In 3/28 (11 %) a fixed number of clusters and an anticipated number of patients were identified at trial commencement and a range or point estimate of detectable effect sizes were identified; 2/3 (66 %) achieved these numbers.
If the sick visit and positive RDT occurred at the 10- or 14-week or 9-month visit when study drug was due, then IPTi and a paired 7-day treatment (prepared for each arm prior to trial commencement) was given such that the arms containing active study drugs were paired with placebo, whereas the placebo arm was paired with quinine.
After trial commencement there were no important changes in methods.
After trial commencement, no change of original protocol occurred.
Similar(7)
No changes were made to the trial after commencement.
Prior to the treatment trial's commencement, all had rated it as worth a try.
The institutional ethical committee approved the trial before commencement (protocol number: 20-366 ex 08/09; EudraCT 2009-012080-34, DRKS00000750).
Both institutional ethics committees (EC) approved the trial before commencement, but the informed consent procedure differed: at the Medical University of Graz, the EC provided surrogate informed consent for study inclusion.
We published the protocol of the trial prior to commencement [ 11].
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