Ethics
ADVERSE EVENTS, BLOOD, ADVERSE EVENT
This trial has been approved by Health Research Ethics Commitee–Universitas Indonesia and Cipto Mangunkusumo Hospital (HREC-FMUI/CMH) and registered in ClinicalTrials.gov (identification number 19-03-0272). Any amendments or modification regarding the protocol during the trial will be consulted and notified to HREC-FMUI/CMH. All participants are required to give their consent before joining the study. The consent form is written in Indonesian and is composed of the following details: participant’s name, date of birth, investigator contact, and explanation of the study purpose that is easily understood by non-medical personnel, course and duration of the study (as well as the freedom to withdraw at any time and guarantee of confidentiality), details of invasive procedures involved (blood collection), an explanation of blood remnant storage, the type of intervention (atorvastatin vs placebo), and possible side effects. The details of the informed consent form are explained by on-site research staff. Blood collections are collected by professional health workers and processed by lab analysts. The study team receives training on Good Clinical Practices (GCP) to ensure that sensitive research activities will be handled appropriately. The study maintains records of adverse events, as well as copies of the consent forms. All records are placed in a locked filing cabinet at the clinic that is only accessible by the research team. All team members are responsible for data security and record keeping. The datasets that will be used for analysis do not contain any identifying information, specifically, no names of participants are included in the datasets. Identifiers for the participants will be disposed of no more than three years after study completion. To protect confidentiality, identifiers are only accessible by the PI or project coordinator and are kept separated from other records with participants’ responses.Participants presenting complaints or adverse event related to the trial will have an extra visit to medical personnel.