{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":30,"description":"Randomly assigned participants receive a stepped dose escalation until target daily dose of 1500mg Metformin XR is reached (3 x 500mg pills/day). The intervention duration will last an additional 6 months.\n\nMetformin Extension:\n\nParticipants will have the option of unblinding at the end of their 6months treatment and those who were randomly assigned to the metformin experimental arm can continue taking metformin if they opt in. The extended intervention duration will last an additional 6 months. (1500mg Metformin XR or highest tolerated dose ) Metformin XR: Orally by mouth","id":"EG000","otherNumAffected":26,"otherNumAtRisk":30,"seriousNumAffected":1,"seriousNumAtRisk":30,"title":"Metformin"},{"deathsNumAffected":1,"deathsNumAtRisk":30,"description":"Randomly assigned participants receive a stepped dose escalation until target daily dose of 3 pills/day is reached. The intervention duration will last 6 months.\n\nPlacebo: Orally by mouth","id":"EG001","otherNumAffected":18,"otherNumAtRisk":30,"seriousNumAffected":1,"seriousNumAtRisk":30,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":30},{"groupId":"EG001","numAffected":9,"numAtRisk":30}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":30}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":30}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":30}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":30}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":30}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":30}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":30}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":30}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":30}],"term":"Belching"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":30}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":30}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":30}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Sepsis"}],"timeFrame":"Adverse events were collected from the time of informed consent, through 30 days after the last dose of study drug, up to 7 months for the initial randomized placebo-controlled phase and up to 13 months for participants who continued onto the extension phase"}