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Therefore, it is unlikely that the lack of reporting of the trial protocol before completion of recruitment may be a source of bias.
The recent removal of refecoxib (a cyclo-oxygenase II inhibitor), a drug involved in a large prostate cancer chemoprevention trial, and the completion of recruitment for the SELECT cancer chemoprevention trial utilizing selenium and vitamin E should lead researchers to ponder a similar question in cancer chemoprevention.
Estimated completion of recruitment is December 2013.
Background data will be analysed following completion of recruitment to ascertain homogeneity of the three groups.
All relevant hospital and laboratory pathology reports were reviewed daily to ensure the completion of recruitment.
This report describes completion of recruitment, the intervention and current follow-up status.
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We estimated a random sample of 10% of available recruitment sites to be sufficient for completion of planned recruitment, based on an average attendance of ∼30 participants on an assigned antenatal day each week, and expected eligibility and response rates of ∼80%, respectively.
The DSM will conduct interim analyses of the safety data, by randomization group, pertaining to the occurrence of Adverse Events (AE); (i) following recruitment of one half of antenatal cases, (ii) on completion of antenatal recruitment, and (iii) once half the infants have reached the final point in the trial, at 12 months of age.
Previously, when the LIP was thought to represent the completion of alveolar recruitment, the PEEP that corresponded to the LIP was thought to sustain alveolar recruitment and prevent alveolar shear stress.
As the follow-up for the primary endpoint is 36 months, and the planned recruitment time 24 months, the results of an interim analysis would arise after completion of the recruitment and treatment period.
This paper documents 224 tongue assessments, 22 of which were from infants included in the feasibility trial 10 and the remainder were from term infants (37+ weeks gestation) with feeding difficulties but not recruited during the trial period and for 5 months following the completion of trial recruitment, between July 2012 and November 2013.
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