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If either of these occurs, the volunteer must undergo an end of study assessment and be given appropriate care under medical supervision, by referral to their GP, until symptoms cease or the condition becomes resolved or is stable.
If either of these occurs, the participant must undergo an end of study assessment and be given appropriate care under medical supervision until symptoms cease or the condition becomes stable.
For this analysis, participants were followed for an average of 3.4 years with the end of study assessment ranging from 2.4 to 5.4 years, a period 4 months longer than that reported previously (13) to maximize the available data that were collected during the masked phase of the DPP.
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For example, of the 931 ILS participants who had a baseline and end-of-study assessment for ACR, 62 (6.7%) had elevated levels at baseline.
A total of 319 patients from Study A and 359 patients from Study B had both a baseline and end-of-study assessment for the DLQI total score.
Usually it is impossible to determine the exact reasons for patients not showing up at a control visit or an end-of-study assessment.
EQ-5D data were not reported on all patients or at all visits, and fewer than half of the patients had an end-of-study assessment.
Patients who discontinued the treatment early completed all end-of-study assessments.
In case of patient withdrawal, the investigator will attempt to perform all protocol-defined end of study assessments and document the main reason for withdrawal in the case report form (if known).
The end-of-study outcome assessments are made at 10 12 months after the first intervention workshop.
Safety assessments in this end-of-study analysis were as described previously, including SAEs, NOCDs, NOADs, MSCs, and pregnancy outcomes.
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