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Ten supplemental indications were approved with no clinical efficacy trials (9 expanded population supplements and 1 modified indication supplement).
Two supplemental indications and one original indication were supported by historical controlled trials; in addition, 10 supplemental indications were approved with no clinical efficacy trials (9 expanded population supplements and 1 modified indication supplement).
Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29).
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The recent development of a bioengineered skin substitute containing human dermal fibroblasts with an epidermal layer of human keratinocytes derived from a stable cell line affords the opportunity to develop genetically modified, indication-specific tissues.
The introduction of PET-CT further modified these indications, reducing the percentage of unnecessary biopsies [2].
Progressive technical advances and good outcomes in patients with aneurysms treated with endovascular techniques have modified surgical indications for aneurysm clipping [ 1, 2].
If the surgery supply is insufficient to cover unmet needs, it seems reasonable to introduce prioritization systems, which involve modifying the indication thresholds in accordance with the resources available in the system.
As a result, this could increase our concerns about fungal infections and modify the indications and the way we use them.
Therefore, the aims of the present study was to evaluate the relevance of the sentinel node (SN) procedure in women with endometrial cancer and to discuss whether the use of the 2009 FIGO classification could modify the indications for SN procedure.
Therefore, the aims of the present study were to evaluate the relevance of the sentinel node (SN) procedure in women with endometrial cancer and to discuss whether the use of the 2009 FIGO classification could modify the indications for SN procedure.
They have widely modified the surgical indications in our unit.
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