Ethics approval and consent to participate
This study was conducted in accordance with the Helsinki declaration and after regulatory and ethical approvals were obtained from the Institutional Review Board (IRB), Ethics Committee NCCHK (LB 02.01/VII/076/KEP. 032/2016). The assigned IRB consists of 5 members: Erlin Listianingsih, Renan Sukmawan, Suko Adiarto, Sunu Budhi Rahardjo, and Bambang Budi Siswanto. All subjects signed the written informed consents before the intervention. The trial was also registered under 