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_46
Snippet: In order to stay consistent with the method that was used in calculating the boundaries for the trial, we will not account for stratification in the primary outcome analysis. In general, this approach is acceptable and it preserves both type I and type II errors as long as the weighted average of the effect size stays close to the hypothesized effect size [15] . Furthermore, as long as the sample size re-estimation at the interim analysis was bas.....
Document: In order to stay consistent with the method that was used in calculating the boundaries for the trial, we will not account for stratification in the primary outcome analysis. In general, this approach is acceptable and it preserves both type I and type II errors as long as the weighted average of the effect size stays close to the hypothesized effect size [15] . Furthermore, as long as the sample size re-estimation at the interim analysis was based on the weighted average of the effect size, the overall power of the trial will be preserved.
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