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5 All qualified for continuation with MR prednisone and 249 patients consented to continue, 219 of whom completed the entire 12-month study.
The main outcomes are whether the participant was successfully traced and whether they consented to continue in the ALSPAC study.
For those who consented to continue through the recruitment process, we used the Vulnerable Elders Survey (VES) [ 24] to determine at-risk participants for inclusion in the study.
The conversation took place in 25 out of the 27 face-to-face interviews where the participant had consented to continue in ALSPAC.
A greater proportion of subjects in the 15/92 treatment arm (85.5%) consented to continue with treatment than did subjects in the 7.5/46 treatment arm (79.4%), whereas the placebo group had the lowest proportion of subjects electing to continue in the protocol (69.4%).
Other variables available included the information provided to the fieldworkers on participation history (variables described above), the number of visits or phone calls made to each participant, whether neighbours were contacted (and their attitude towards being contacted), and finally whether the participant consented to continue in ALSPAC.
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All participants from the original study who consented to continued participation contributed additional blood samples between April and September 2010, as well as answered a questionnaire survey administered concurrently [ 4].
"To be victimized, and then consent to continue to be victimized, is ridiculous," Mr. Cohen said.
After completing the screening questionnaire participants are given a brief description of the study and asked whether they consent to continue.
Patients who opt to withdraw from the study are asked if they would consent to continue completing follow-up measures, and for any existing data to be included in analyses.
The remaining 36 women indicated verbally that they were consenting to continue with their participation in the study and were prepared to go through all the remaining activities of the current study (Note that at this time, the microbicide study had already been terminated).
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