Section G

Section G contains data related to treatment arm allocation, study medication compliance and use of prescription and non-prescription medications.

G.1 Study Medication Data

Description

This section contains the allocated treatment arm for each participant along with a measure of study medication compliance during each follow-up year. Exposure to the study medication was derived using the pill count, the date of study medication receipt by the participant and the date that the study medication was returned to study staff.

Timing of Data Collection

An annual pill count was performed upon receipt of the study medication bottle by study staff (this usually occurred at each annual visit). When study medication bottles were retrieved, the returned date and number of remaining pills was recorded in AWARD-Data. If study medication was not returned, the reason the bottle was not returned was recorded.

Summary of Data Dictionary

This section contains nominal and continuous data. Study medication compliance has been represented as the percent of exposure to study medication based on the timing of study medication distribution and the number of pills remaining upon return of the study medication (usually at each annual visit).

G.2 Study Medication (Milestone Questionnaire)

Description

This section contains additional, self-reported participant information relating to the study medication, current use of aspirin and prescribed or non-prescribed anti-inflammatory medications as well as use of prescription medications. Participants were asked about their habits and opinions regarding study medication consumption. For example, how often they took their study medication and at what time of day. Participants were also asked whether they take aspirin and, if yes, other relevant details such as dosage. For example, participants were asked how often and for how long they have been taking aspirin. Participants were also asked how often they take prescribed or non-prescribed anti-inflammatory medications. Participants were asked about their use of prescription medications, including details such as the number of prescription pills that will be taken that day, how many different types of prescription pills will be taken that day and how often they miss taking prescription medications.

Timing of Data Collection

Data collection occurred at the Milestone Visit only.

Summary of Data Dictionary

This section contains nominal and ordinal data. Each variable is linked with a commentary code that aims to provide additional data with regard to missing data, out of range data, alterations to data collection methods and other special considerations.

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