Occurrence of serious adverse event
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
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Number of SAE
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Pregnancy information
If you tick yes, complete the pregnancy notification form. Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
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Elimination criteria
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
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Elimination criteria, specification
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Withdraw from study
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18 "A subject is withdrawn from the CORE analysis 1/2 if he/she did not come for the CORE analysis 1/2 timepoint visit."
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(tick one box only). If you tick SAE, please complete and submit SAE report. If you tick AEX please complete Non-serious Adverse Event section.
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Fill in if you ticked SAE as reason for withdrawal.
integer
Fill in if you ticked AE as reason for withdrawal.
integer
Fill in if you ticked AE as reason for withdrawal.
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Fill in if you ticked Protocol violation as reason for withdrawal.
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Fill in if you ticked other as reason for withdrawal.
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Decision maker
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day month year
date
If you tick No, please give details in Adverse Events section.
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Investigator's signature
"I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below."
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Printed Investigator's name
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day month year
date