Project amendment

Amendment to the project requested on 8/4/2016.<br>To: nstitutional Review Board, Albert Sabin Children's Hospital,<br> The current political and socio-economic situation in our country is of much concern to us, particularly the economic crisis and widespread lack of resources in public administration. We believe there is no guarantee that the proposed protocol will be carried on rigorously. Specifically, the need for imaging studies at scheduled intervals can be greatly impaired, since these studies (magnetic resonance imaging) are costly. We have no budget to cover these image studies, depending on their availability for patients through the National Health System. There is a significant risk that we cannot carry out the necessary procedures in this study. Moreover, the current political and economic uncertainty poses additional risks to our ability to take the project forward. Because of this, we chose to delay the start of patient accrual to January 2017. At this time, we are confident that there will be a better definition about the viability of the project as a whole. We appreciate your confidence in our group.<br>Sincerely,<br>Francisco Helder Cavalcante FelixProject design<br>This letter to the IRB was published in the project repository:https://vlky.re/2awIc8N