2.8. Compliance and Adverse Events
death, TEAE
EVENTS
Participants were asked to collect and return empty IP and CaD supplement containers at each visit. Compliance was calculated from the number of IP and CaD supplements returned. Compliance for both IP and CaD was calculated, in percentage, as: (100 × total number of capsules administered)/(theoretical number of capsules per day × extent of exposure in days) at each individual visit and for the entire study period. Participants were considered non-compliant for the IP if they had (1) an overall IP compliance <80% or >120%, or (2) an overall compliance within [80%; 120%], but at least one individual visit IP compliance <70% or >130%, or (3) an overall IP compliance missing and less than three available individual visit IP compliances within [80%; 120%].Adverse events (AEs) were collected on AE forms throughout the trial. AEs were considered as treatment emergent (TEAE) if they began or worsened from the date of the first IP administration. AEs were recorded in the eCRF at each visit; recordings included a description of the AE, the relationship to the intervention (“not related” or “related or suspected”), whether the AE was serious (i.e., resulted in death, life-threatening, required hospitalization, or resulted in persistent disability) or nonserious, and the intensity of the AE (mild, moderate, severe).