Traduction de «but the update » (Néerlandais → Français) :

Unfortunately, Baker, ANAES and Armstrong did not include this RCT, but the update of Baker made for USPTSF and written by Nelson 9 did it. We selected finally the two SR and the HTA including Moss for critical appraisal.
Unfortunately, Baker, ANAES and Armstrong did not include this RCT, but the update of Baker made for USPTSF and written by Nelson 10 did it. We selected finally the two SR and the HTA including Moss for critical appraisal.

The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies.
Les discussions de la FDA portent sur la notice du produit et sur la stratégie de la gestion des risques (Risk Evaluation Mitigation Strategy ou REMS) ainsi que sur la mise à jour des données sur son innocuité, mais ne requiert pas plus d’études cliniques.