The present analysis deals only with baseline data gathered at entry.
The baseline error rates for data entry in each province are well below the 1% level of acceptability.
At trial entry baseline data and eligibility information will be collected and returned to the co-ordinating centre.
The baseline data (recorded at study entry) of the different groups were compared by the unpaired Student t test, Mann-Whitney U test, or χ test, as appropriate (JMP version 9.0.0; SAS Institute Inc., Tokyo, Japan).
MM and FA carried out the recruitment, baseline testing, training and data entry, MM performed the statistical analyses and drafted the manuscript, FA performed the pQCT scans and analyses, RO and MFS conceived of the study, participated in its design, co-ordination, recruitment and statistical analyses, and revised the manuscript, DG taught the pQCT technique and analysed the pQCT scans.
Further, another research assistant who had not conducted the interview was responsible for the data entry at baseline.
The CRF for IHD will require data entry at baseline, at 4 hours and at treatment end.
Although non-interventional and with retrospective entry of baseline data, we cannot exclude the possibility that investigators started insulin on occasion in the knowledge that the patient could be entered into the study.
Due to the necessity of having baseline data from physical examination at school entry the county offered free comprehensive physical examinations every fall for first graders, the youngest students entering elementary school in the Taiwan education system.
A MEDRIO electronic database (http://www.medrio.com) will be utilized for data entry after collection at baseline and every 6 weeks up to 24 weeks.
