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 (b) _s,_r_uh_Res_ts
 r_ The Michigan program involved the use of valid,
 generally recognized research controls, and permitted patients to
 elect to alter the course of their randomized antiemetic therapy
 and move to the other arm of the study. _0_/ In order to enter
 the program, the patient had to be unde_oing chemotherapy and
 experience nausea and vomiting in relation to the administration
 -.._ of such chemot_herapyo 29-_/ Chemotherapy-naive patients were not
 allowed to participate in the Michigan program unless they were
 to receive a chemotherapeutic agent known to cause intense
 nausea and vomiting° 2_Q//
 Upon admission into the Michigan program, patients
 were randomized into control groups with some randomized onto the
 conventional antiemetic drug, Torecan, while the remainder were
 randomized to marijuana° When failure on the initial, randomized
 drug occurred, patients could elect to crossover to the alterna _
 tire therapy. This control allowed the Michigan Department of
 Public Health to evaluate howwell patients responded to both
 forms of antiemetic therapy_ and permitted patients to register
 a preference for one mode of antiemetic therapy or the other.
 2_Q_/ /_. at 5. UThis study will be randomized prospectively
 between initial therapy in Group I [marijuana] or Group II
 [Torecan3 .... A crossover to the other arm of the study will
 be done when the patient has failed the initial arm following a
 minimum of 24 hour trial. _
 2Q6/ !do at 4_
 _931/ /__. at 4. In order to gain entry into the Michigan
 program the patient _[h]as experienced or is reasonably expected
 to experience nausea and vomiting in relation to the
 administration of such chemotherapy, n
 61 =

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