Author: Arabi, Yaseen M.; Asiri, Ayed Y.; Assiri, Abdullah M.; Aziz Jokhdar, Hani A.; Alothman, Adel; Balkhy, Hanan H.; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M.; Memish, Ziad A.; Ghazal, Sameeh; Al Faraj, Sarah; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Al Mekhlafi, Ghaleb A.; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Almotairi, Abdullah; Al Bshabshe, Ali; Kharaba, Ayman; Jose, Jesna; Al Harthy, Abdulrahman; Al Sulaiman, Mohammed; Mady, Ahmed; Fowler, Robert A.; Hayden, Frederick G.; Al-Dawood, Abdulaziz; Abdelzaher, Mohamed; Bajhmom, Wail; Hussein, Mohamed A.
Title: Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-ß1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial Document date: 2020_1_3
ID: 0cah15lg_4
Snippet: In this article, we describe the MIRACLE trial statistical analysis plan (SAP) in advance of trial completion. We identify the procedures to be followed for the primary and secondary analyses for the trial. The SAP was written by the study steering committee members led by the principal investigator, who remains blinded to both group allocation and to study results until after completing patient recruitment, patient follow-up, and completion and .....
Document: In this article, we describe the MIRACLE trial statistical analysis plan (SAP) in advance of trial completion. We identify the procedures to be followed for the primary and secondary analyses for the trial. The SAP was written by the study steering committee members led by the principal investigator, who remains blinded to both group allocation and to study results until after completing patient recruitment, patient follow-up, and completion and locking of the database. The final study report will follow the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) for reporting randomized controlled trials [9, 10] .
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