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. Author manuscript; available in PMC: 2019 Apr 18.
Published in final edited form as: N Engl J Med. 2018 Sep 16;379(16):1499–1508. doi: 10.1056/NEJMoa1800722

Figure 1. Randomization, Intervention, and Follow-up.

Figure 1.

The most common reasons for exclusion from the trial were a history of cardiovascular disease, an adherence rate of less than 80% during the 4-week placebo run-in period, a Modified Mini–Mental State Examination score of less than 78 (on a scale from 0 to 100, with higher scores indicating better function), a score of 4 or 5 for any one of the six basic activities of daily living (bathing, dressing, toileting, transferring, walking, and feeding) on the Katz Index of Independence in Activities of Daily Living (scores for each activity range from 1 [no difficulty] to 5 [unable to do]; a score of 4 indicates severe difficulty in performing the activity), a low hemoglobin level, high blood pressure, or the opinion of the general practitioner or primary care physician. Participants could have more than one reason for ineligibility. For participants who withdrew from the trial, all the information up to the point of withdrawal was included in the analyses. Vital status was obtained in all the participants who were lost to follow-up or withdrew consent.