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4.0
Double-blind Study
Continuation Study
(optional)
Tests and procedures
60 days
prior to randomization
Daily during baseline week and during treatment (9 weeks)
Study week 2, start of week 5, week 7, week 9
Daily during treatment (8 weeks)
6, 12, 24 months from start of continuation study
History and Exam
X
.
.
.
.
Patient Questionnaire
.
X
Appendix III
.
X
Appendix VI
.
Nurse
Worksheet
.
.
X
Appendix V
.
X
Appendix VII
Page 9 of
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