Data availability
Scientific and medical researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication have been approved by major health authorities (for example, the US Food and Drug Administration, the European Medicines Agency and the Pharmaceuticals and Medical Devices Agency), if there is legal authority to share the data, and there is not a reasonable likelihood of participant re-identification. Requests should be submitted to 