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. 2022 Oct 14;17(10):e0270543. doi: 10.1371/journal.pone.0270543

Fig 1. CONSORT diagram for Single Ascending (SAD) and Multiple Ascending Dose (MAD) Stages I and II pilot study.

Fig 1

In Stage I (pharmacokinetics) eligible patients administered one dose (2 sprays) on day 1 and three doses (6 sprays) on day 2. In Stage II after baseline assessments, patients commenced with one spray of the cannabis-based medicine (1.25 mg each of Δ9-THC and CBD in 0.15 mL) every 4 to 8 hours while awake for 3 days, then dose escalated to two sprays every 4–8 hours while awake for 3 days, and finally dose escalated to three sprays every 4–8 hours while awake for 3 days.