affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Drug Safety Research Unit, Drug Safety Research Unit, affiliation not provided to SSRN, affiliation not provided to SSRN, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, affiliation not provided to SSRN, affiliation not provided to SSRN, Drug Safety Research Unit, affiliation not provided to SSRN, University of Melbourne - Murdoch Children's Research Institute, affiliation not provided to SSRN, University of Auckland, Institute for Clinical Evaluative Sciences (ICES) and University Medical Center Utrecht - Department Datascience & Biostatistics