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The International Society for Pharmacoepidemiology's Commen..:

Pottegård, Anton ; Klungel, Olaf ; Winterstein, Almut...
https://researchonline.lshtm.ac.uk/id/eprint/4656222/1/ISPEs%20response%20to%20EMA%20%28for%20PDS%29%20v2.docx.  , 2019