Conduct and oversight
Hospital Sírio‐Libanês was the only study site. All participants gave written informed consent before enrolment. The trial was conducted under the principles of the Declaration of Helsinki and the protocol was reviewed and approved by the institutional review board and ethics committee of Hospital Sírio‐Libanês and by the Comissão Nacional de Ética em Pesquisa. After completion of planned enrolment, the Hospital Sírio‐Libanês ethics committee approved an ongoing compassionate access program following the same protocol with an amended consent form. The trial was registered at 