An addition was made to the inclusion criteria to indicate that suitability for anticoagulant should be defined by a CHADS 2 or CHA 2 DS 2 VASc score ≥1, uncontrolled hypertension was added to the list of conditions for which anticoagulant therapy would be contraindicated and Hepatic impairment, as an exclusion criteria for subjects, was defined as alanine aminotransferase (ALT) >5 x upper limits normal (ULN) or ALT >3 x ULN plus total bilirubin >2 x ULN, using laboratory values from the screening period.

At the request of the Food and Drug Administration (FDA), rheumatic heart disease was added to the list of examples of conditions of cardiac valvular disease that does not meet the NVAF definition in the exclusion criteria. Changes were incorporated to clarify adverse event reporting requirements (all adverse events, serious or non-serious should be collected). Definitions of major bleeding and non-major bleeding were replaced with Thrombosis in Myocardial Infarction (TIMI) bleeding event for consistent classification of bleeding events by investigators. Definition of persistent NVAF was changed to remove the phrase <1 week. Rivaroxaban drug-drug interaction information was provided as an Attachment to the Protocol.

Change was made to allow subjects who met 1 of 3 protocol specified conditions to have their catheter ablation procedure performed after 1 to 7 days of exposure to randomized study drug (instead of waiting for 4 to 5 weeks after receiving the first dose of randomized study drug to undergo the ablation procedure). In order to more closely represent the patient population in real-world clinical practice, subjects with long standing persistent (≥1 year) NVAF were no longer excluded from participation in the study. In order to more closely represent the patient population in real-world clinical practice, subjects scheduled for a repeat catheter ablation procedure for NVAF were no longer excluded from participation in the study. In order to more closely represent the patient population in real-world clinical practice, for subjects taking acetylsalicylic acid (ASA) > 100 mg per day at screening, an allowance was made for a one time dose adjustment (reduction) to ≤ 100 mg ASA starting at randomization. In order to reduce unnecessary procedures, subjects with a recent usual care physical examination (within 4 weeks prior to screening visit) were not required to have another physical examination at screening.