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 The program was impl_ented as follows: Patients
 were recommended to the program by their personal physician° A
 ..... prerequisite was that the patient must have failed on other
 antiemetic therapies. Then_ patients underwent a
 medical/psychological screening process before being admitted to
 i_ .... the program° This process i_volved a number of physical exams
 and psychological tests pre-established by a group of
 oncoloqists. _74/ Also_ complete information on the drug and the
 protocol were provided to the patients through interviews with
 the research nurse. Once it was determined that the patient met
 the pre-established criteria to enter into the program, an
 approval followed from the Board of Reviewers. o77_/
 Once admitted in the programs the patients could Melect
 to take either oral THC capsules or marijuana cigarettes. 7_/ If
 /__/ (.._continued)
 Protocol at 13 (quoting from Hearings Before the Select Committee
 on Narcotic Abuse & Controls Therapeutic Uses of Marihuana and
 Schedule ! Drugs_ U.S. House of Representatives 96th Congress_
 May 20, 1980, at 773 opinion of Dro Richard Crout, Director of
 the Bureau of D_gs_ Federal Food and Drug Administration.
 (SINew Mexico program was] a careful comparison between
 [marijuana] cigarettes and the THC capsules_).
 7_/ Cross-examination of Madelyn Brazis, Tr._ 7-15. Many
 psychological forms were involved (SCL 90}_ blood tests and liver
 function tests_ /_. at 7-14 & 7-15_
 175/ /__o at 7-11.
 I/_/ /Z_- at 7_la_ Initially patients were randomized between
 _i_ the two drugs. Subsequently_ and within a very short period, a
 third category was created in which patients were free to select
 their form of therapy and to shift from one mode of treatment to
 the other. Affidavit of Dro Daniel Dansaks _ 39. The Food and
 Drug Administration approved the study as having sufficient
 controls and specifically did not object to the design of the
 third category. Cross_examination of Dr. Daniel Dansak, Tro ii-
 90. FurtherF researchers from the National Cancer Institute and
 (continued°°°)
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