Breaking the Blind. Blinding of drug kits must not be broken during the study unless it considered necessary by the investigator for the management of an adverse event or other medical emergency. In the event of such medical emergency, the identity of the study treatment is obtained by contacting the IVRS. Should unblinding of any subject’s treatment occur, VIVUS would be notified ***. Investigators are also required to ensure that any potential serious adverse events are reported according to the requirements outlined in Section 8.2, and to send a written report to VIVUS within *** days to *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. document the reason for unblinding. Should unblinding of any subject’s treatment occur, the subject must discontinue trial participation.
Breaking the Blind. Study medication must not be unblinded during the study unless it is considered absolutely necessary by the investigator for the management of an adverse event or other medical emergency. Under such conditions, the identity of the study treatment will be obtained by contacting the IVRS. Any subject who is unblinded during the study will be discontinued from participation in the trial. VIVUS, Inc. will be notified of any unblinding of subject treatment group ***. The investigators are also required to ensure that any potential serious adverse events are reported according to the requirements outlined in Sections 8.2 and 8.5 and to provide a written report to document the reason for unblinding within ***. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Breaking the Blind. Study medication must not be unblinded during the study unless it is considered absolutely necessary by the investigator for the management of an adverse event or other medical emergency. Under such conditions, the identity of the study treatment will be obtained by contacting the IVRS. Any subject whose treatment assignment has been unblinded must discontinue participation in the study. VIVUS will be notified of any unblinding of subject treatment group ***. Additionally, investigators are required to ensure that any potential serious adverse events are reported according to the requirements outlined in Sections 8.2 and 8.5 and to provide a written report on the reason for unblinding within ***.
