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18.1
On-study materials - None.
18.2
Follow-up materials
18.21
Double blind study
Within
two weeks following completion of the double-blind study,
submit the following to the Operations Office:
-
Daily Patient Questionnaire (Appendix
III).
-
Nurse Work Sheet (Appendix
V), updated to contain information collected during
the first 9 weeks of study participation.
18.22
Optional continuation study
18.221
The following is to be mailed to the Operations Office within
two weeks after the patient goes off study:
18.222
The following is to be mailed to the Operations Office at
6, 12, and 24 months following start of optional continuation
study.
18.3
Off-study materials
No further
materials are required following submission of materials
in Section 18.2.
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