Patients and methods
The protocol was approved by the Comité de Ética en Investigación (Institutional Research Ethics Committee) (015/031/INI) (CEI/950/15) under the Declaration of Helsinki and US Federal Policy for the Protection of Human Subjects and registered at NIH Clinical Trails ID NCT03296553. All participants signed written informed consent.The protocol was approved by the institutional IRB on July 2015, and we recruited the first patient on October 2015. The translated protocol was uploaded to Clinical Trials on March 2016, and learned one year later than submission to Clinical Trials was incomplete, so the official date for registration to clinical trials was September 2017.We conducted an open-label parallel-group randomized clinical trial of patients with DKS (all within the context of T