The case notes of all patients who had died since the previous publication or who had been designated as a non-lymphoma death in the trial database were reviewed by two authors (AC, JR).
The electronic databases MEDLINE, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases were reviewed by the primary author.
The analyses using the Optum and CCAE databases were reviewed by the New England Institutional Review Board NEIRBB) and determined to be exempt from board IRB approval as this research project involved no risk to the subjects and does not meet the definition of human subject research (NEIRB 12-284 & NEIRB# 12 286).
The quality of the cancer registry database was reviewed and approved by the committee, which consisted of radiologists, oncologists, pathologists, surgeons and epidemiologists with special expertise in breast cancer.
Before entry into the computer database, each case report was reviewed by a member of the study committee (senior intensivist or coworker).
The database of EEG recordings was reviewed by three EEG experts who have trained and practiced at different institutions (I. R., R. C., and S. V.; referred to as observers in the remaining text).
All events retrieved from the database were reviewed and validated by two clinicians highly experienced in the management of HIV infection, one clinician from Brazil and another from France.
Mosaic events were assessed for pathogenicity using genomic disorder databases, and exome sequence analysis was reviewed by a multidisciplinary team of molecular scientists and Clinical Geneticists.
All medical charts of patients identified by the administrative database were reviewed using a standardized, a priori defined electronic data extraction form.
Only records with triggers indicating at least one potential AE were marked by the RNs in the database to be reviewed by the physicians.
