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Eight patients received post-protocol DC vaccination after completion or termination of protocol treatment.
After completion or termination of the protocol, post-protocol DC vaccination continued with patients' consent.
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Surgery in the D arm was performed 3 4 weeks after completion or early termination of chemotherapy.
Completion or trial termination for any reason will be fully documented in the Case Record Form.
Surgery (lobectomy or pneumonectomy with systematic lymph node dissection) was performed 4 5 weeks after completion or early termination of the chemotherapy.
Haemoglobin levels, transfusion data, and QOL scores were obtained within 7 days prior to the first dose of study medication and at study completion or early termination.
The primary outcome measure was extension of PD technique survival, which was regarded as the time interval between commencement of icodextrin and either PD completion or study termination.
At study completion or early termination, mean changes in Hb level from baseline were 1.6±1.5 and 0.3±1.3 g dl−1, respectively, for the epoetin alfa and BST groups.
If this means that disorders that are now untreatable become treatable in utero, prenatal screening for those disorders will give the woman or the couple more options than only the choice between completion and termination of pregnancy, including treatments that may benefit the health prospects of the future child.
§ 1160.502 Proceedings after suspension or termination.
§ 225.113 Suspension or Termination of IRB Approval of Research.
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