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Confirmation of responses was required after 12 weeks.
Interview data were entered directly into a Microsoft Access database that contained internal consistency checks as well as confirmation of responses given during previous interviews.
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST, v1.0), with confirmation of responses performed at least 4 weeks later.
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In case of partial or complete response, a second assessment 4 weeks later was required for confirmation of response; all tumour measurements were reviewed and confirmed by an independent panel of radiologists (IRC).
Confirmation of response by consecutive CT scans was required.
Confirmation of response by consecutive CT scans was not required.
Confirmation of response was required at no earlier than 4 weeks.
Confirmation of response was performed four weeks after it was first documented.
Complete and partial responses required subsequent confirmation of response after an interval of at least 4 weeks.
After the third amendment, a radiologic confirmation of response after 4 weeks was introduced in case of response or SD.
Additionally, in selected cases biopsies were taken after the completion of therapy for histopathological confirmation of response.
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