diff --git a/DESCRIPTION b/DESCRIPTION index 257c988..523b1a7 100644 --- a/DESCRIPTION +++ b/DESCRIPTION @@ -1,6 +1,6 @@ Package: metalite.ae Title: Adverse Events Analysis Using 'metalite' -Version: 0.1.2 +Version: 0.1.3 Authors@R: c( person("Yilong", "Zhang", role = c("aut")), person("Yujie", "Zhao", email = "yujie.zhao@merck.com", role = c("aut", "cre")), @@ -14,6 +14,8 @@ Authors@R: c( person("Xuan", "Deng", role = c("aut")), person("Hiroaki", "Fukuda", role = c("aut")), person("Bing", "Liu", role = c("aut")), + person("Jeetender", "Chauhan", role = c("aut")), + person("Li", "Ma", role = c("ctb")), person("Merck Sharp & Dohme Corp", role = c("cph")) ) Description: Analyzes adverse events in clinical trials using the 'metalite' diff --git a/NEWS.md b/NEWS.md index adf1230..dc400a6 100644 --- a/NEWS.md +++ b/NEWS.md @@ -1,46 +1,65 @@ +# metalite.ae 0.1.3 + +## New features + +- `format_ae_specific()` now has new arguments `filter_method` and `filter_criteria` to control displayed rows in a table, `sort_order` and `sort_column` to sort an output table, and `hide_soc_stats` to control display of statistics for SOC rows (#191, #192, #203). +- Add `data/metalite_ae_adesxum.rda` (#189). +- Add event counts to `avg_count()` and `extend_ae_specific_events()` (#194). +- Add `empty_table()` to return an empty table object when data has no population (#200). + +## Bug fixes + +- Fix bug to correctly display the order of means of duration and means of event count in `extend_ae_specific_events()` and `extend_ae_specific_duration()`(#194, #199). +- Fix bug to avoid an error when a treatment group has no observation to calculate event counts and duration in `avg_event()` and `avg_duration()` (#199). +- Fix bug to avoid an error when there is no observation to summarize event counts and duration in `avg_event()`, `avg_duration()`, `extend_ae_specific_events()` and `extend_ae_specific_duration()` (#200). + +## Improvements + +- Update `fmt_est()` to change display of missing values from a character string of "NA" to a blank in an output table (#194). +- Update `extend_ae_specific_inference()` to pass additional arguments to `rate_compare_sum()` (#197). + # metalite.ae 0.1.2 ## New features -- `tlf_ae_summary()` now has a new argument `title` for a user-customized title (#133). -- Add new functions: `extend_ae_specific_subgroup()`, `prepare_ae_specific_subgroup()`, `format_ae_specific_subgroup()`, `tlf_ae_specific_subgroup()`, `extend_ae_summary_eaer()`, -`format_ae_exp_adj()` and `tlf_ae_exp_adj()` (#150, #161, #174, #180). -- Add `data/metalite_ae_adex.rda` (#164). -- Add new vignettes: `vignette("ae-specific-subgroup")` and `vignette("exposure-adjusted-event-rate")` (#167, #169). -- Add System Organ Classes (SOC) information to `outdata` in `prepare_ae_specific()` (#186). +- `tlf_ae_summary()` now has a new argument `title` for a user-customized title (#133). +- Add new functions: `extend_ae_specific_subgroup()`, `prepare_ae_specific_subgroup()`, `format_ae_specific_subgroup()`, `tlf_ae_specific_subgroup()`, `extend_ae_summary_eaer()`, `format_ae_exp_adj()` and `tlf_ae_exp_adj()` (#150, #161, #174, #180). +- Add `data/metalite_ae_adex.rda` (#164). +- Add new vignettes: `vignette("ae-specific-subgroup")` and `vignette("exposure-adjusted-event-rate")` (#167, #169). +- Add System Organ Classes (SOC) information to `outdata` in `prepare_ae_specific()` (#186). ## Bug fixes -- Fix bug to avoid warning messages when no comparison variables are requested in `format_ae_specific()` (#135). -- Fix bug to align the row order of output data with the input one in `avg_event()` and `avg_duration()` (#136). -- Fix bug to check missing grouping variable after a subset of input data in `prepare_ae_specific()` (#137). -- Fix bug to display item if AE term has `NA` in `prepare_ae_specific()` (#166). -- Fix bug to correctly assign treatment labels when a treatment variable has `NA` (#179). +- Fix bug to avoid warning messages when no comparison variables are requested in `format_ae_specific()` (#135). +- Fix bug to align the row order of output data with the input one in `avg_event()` and `avg_duration()` (#136). +- Fix bug to check missing grouping variable after a subset of input data in `prepare_ae_specific()` (#137). +- Fix bug to display item if AE term has `NA` in `prepare_ae_specific()` (#166). +- Fix bug to correctly assign treatment labels when a treatment variable has `NA` (#179). ## Improvements -- Update GitHub Actions workflow (#131, #163, #181). -- Add styler workflow (#134). -- Add CRAN download badge (#140). -- Remove dependencies on `dplyr` and `tidyr` from `avg_event()`, `avg_duration()` and `fmt_val()` (#136). -- Change the default value of the `title` argument in `tlf_ae_specific()` (#138). -- Remove `R/n_subject.R` and change to use `metalite::n_subject()` in `prepare_ae_specific()` (#144). -- Race values for adsl and adae are converted to title case in `meta_ae_exmple()` (#158). -- Organize files for utility functions (#159) - - Rename `R/rtf_output.R` to `R/utility.R`. - - Remove `rate_compare_sum.R`, `R/to_mock.R` and `R/to_sentence.R`. - - Move `to_rate_compare_sum()` to `R/rate_compare.R`, and move `to_mock()` and `to_sentence()` to `R/utility.R`. -- Remove library calls from tests (#183). -- Add `R/outdata.R` to control `outdata` object (#161). -- Add an installation section to `README.md` (#177). -- Improve style and formatting for vignettes and code (#158, #168). +- Update GitHub Actions workflow (#131, #163, #181). +- Add styler workflow (#134). +- Add CRAN download badge (#140). +- Remove dependencies on `dplyr` and `tidyr` from `avg_event()`, `avg_duration()` and `fmt_val()` (#136). +- Change the default value of the `title` argument in `tlf_ae_specific()` (#138). +- Remove `R/n_subject.R` and change to use `metalite::n_subject()` in `prepare_ae_specific()` (#144). +- Race values for adsl and adae are converted to title case in `meta_ae_exmple()` (#158). +- Organize files for utility functions (#159) + - Rename `R/rtf_output.R` to `R/utility.R`. + - Remove `rate_compare_sum.R`, `R/to_mock.R` and `R/to_sentence.R`. + - Move `to_rate_compare_sum()` to `R/rate_compare.R`, and move `to_mock()` and `to_sentence()` to `R/utility.R`. +- Remove library calls from tests (#183). +- Add `R/outdata.R` to control `outdata` object (#161). +- Add an installation section to `README.md` (#177). +- Improve style and formatting for vignettes and code (#158, #168). # metalite.ae 0.1.1 -- Updated the `DESCRIPTION` file to reformat the reference. -- Uncommented the previously commented code example. +- Updated the `DESCRIPTION` file to reformat the reference. +- Uncommented the previously commented code example. # metalite.ae 0.1.0 -- Initial submission to CRAN. -- Added a `NEWS.md` file to track changes to the package. +- Initial submission to CRAN. +- Added a `NEWS.md` file to track changes to the package. diff --git a/R/format_ae_specific.R b/R/format_ae_specific.R index 0ca1eca..ce29c32 100644 --- a/R/format_ae_specific.R +++ b/R/format_ae_specific.R @@ -19,6 +19,7 @@ #' Format AE specific analysis #' #' @inheritParams extend_ae_specific_inference +#' @param hide_soc_stats A boolean value to hide stats for SOC rows. #' @param digits_prop A numeric value of number of digits for proportion value. #' @param digits_ci A numeric value of number of digits for confidence interval. #' @param digits_p A numeric value of number of digits for p-value. @@ -84,6 +85,7 @@ #' head(tbl$tbl) format_ae_specific <- function(outdata, display = c("n", "prop", "total"), + hide_soc_stats = FALSE, digits_prop = 1, digits_ci = 1, digits_p = 3, @@ -333,6 +335,11 @@ format_ae_specific <- function(outdata, } } + # Control SOC stats + if (hide_soc_stats) { + res[outdata$order %% 1000 == 0, names(res)[!names(res) == "name"]] <- NA + } + # Transfer to Mock if (mock) { n_mock <- min(20, nrow(res), na.rm = TRUE) diff --git a/man/format_ae_specific.Rd b/man/format_ae_specific.Rd index 8e9e9a1..2c83da7 100644 --- a/man/format_ae_specific.Rd +++ b/man/format_ae_specific.Rd @@ -7,6 +7,7 @@ format_ae_specific( outdata, display = c("n", "prop", "total"), + hide_soc_stats = FALSE, digits_prop = 1, digits_ci = 1, digits_p = 3, @@ -35,6 +36,8 @@ format_ae_specific( \item \code{events_count}: Count number of adverse event per subject. }} +\item{hide_soc_stats}{A boolean value to hide stats for SOC rows.} + \item{digits_prop}{A numeric value of number of digits for proportion value.} \item{digits_ci}{A numeric value of number of digits for confidence interval.} diff --git a/man/format_ae_summary.Rd b/man/format_ae_summary.Rd index 9bda13b..485a3e1 100644 --- a/man/format_ae_summary.Rd +++ b/man/format_ae_summary.Rd @@ -7,6 +7,7 @@ format_ae_summary( outdata, display = c("n", "prop", "total"), + hide_soc_stats = FALSE, digits_prop = 1, digits_ci = 1, digits_p = 3, @@ -35,6 +36,8 @@ format_ae_summary( \item \code{events_count}: Count number of adverse event per subject. }} +\item{hide_soc_stats}{A boolean value to hide stats for SOC rows.} + \item{digits_prop}{A numeric value of number of digits for proportion value.} \item{digits_ci}{A numeric value of number of digits for confidence interval.} diff --git a/man/metalite.ae-package.Rd b/man/metalite.ae-package.Rd index a45af5e..ed963c2 100644 --- a/man/metalite.ae-package.Rd +++ b/man/metalite.ae-package.Rd @@ -34,11 +34,13 @@ Authors: \item Xuan Deng \item Hiroaki Fukuda \item Bing Liu + \item Jeetender Chauhan } Other contributors: \itemize{ \item Venkatesh Burla [contributor] + \item Li Ma [contributor] \item Merck Sharp & Dohme Corp [copyright holder] } diff --git a/vignettes/ae-specific.Rmd b/vignettes/ae-specific.Rmd index 06c572b..8b1eff1 100644 --- a/vignettes/ae-specific.Rmd +++ b/vignettes/ae-specific.Rmd @@ -172,12 +172,12 @@ tbl <- outdata |> head(tbl$tbl) ``` -We can use `extend_ae_specific_events()` to add average number of AE per subject. +We can use `extend_ae_specific_events()` to add number of AE and/or average of it per subject. ```{r} tbl <- outdata |> extend_ae_specific_events() |> - format_ae_specific(display = c("n", "prop", "events")) + format_ae_specific(display = c("n", "prop", "events_count", "events_avg")) head(tbl$tbl) ``` diff --git a/vignettes/fig/ae0specific.png b/vignettes/fig/ae0specific.png index 654e303..2062335 100644 Binary files a/vignettes/fig/ae0specific.png and b/vignettes/fig/ae0specific.png differ diff --git a/vignettes/pdf/ae0specific0sub0gender1.pdf b/vignettes/pdf/ae0specific0sub0gender1.pdf index c1d9ca4..95fd52b 100644 Binary files a/vignettes/pdf/ae0specific0sub0gender1.pdf and b/vignettes/pdf/ae0specific0sub0gender1.pdf differ diff --git a/vignettes/pdf/ae0specific1.pdf b/vignettes/pdf/ae0specific1.pdf index 841dc46..906b87a 100644 Binary files a/vignettes/pdf/ae0specific1.pdf and b/vignettes/pdf/ae0specific1.pdf differ diff --git a/vignettes/pdf/ae0specific2.pdf b/vignettes/pdf/ae0specific2.pdf index 86f97a9..9cad4d1 100644 Binary files a/vignettes/pdf/ae0specific2.pdf and b/vignettes/pdf/ae0specific2.pdf differ diff --git a/vignettes/pdf/mock_ae0specific1.pdf b/vignettes/pdf/mock_ae0specific1.pdf index 8b346fc..8ba85d4 100644 Binary files a/vignettes/pdf/mock_ae0specific1.pdf and b/vignettes/pdf/mock_ae0specific1.pdf differ diff --git a/vignettes/rtf/ae0specific0sub0gender1.rtf b/vignettes/rtf/ae0specific0sub0gender1.rtf index aa269c4..ec62f85 100644 --- a/vignettes/rtf/ae0specific0sub0gender1.rtf +++ b/vignettes/rtf/ae0specific0sub0gender1.rtf @@ -21,26 +21,26 @@ \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1749 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8743 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12240 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1493 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5075 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8657 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrdb\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12239 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 }\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 f}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 m}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Total}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1749 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2915 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx4081 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5247 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6413 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx7579 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8745 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx9911 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx11077 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12243 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1493 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2687 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx3881 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5075 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6269 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx7463 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8657 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx9851 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx11045 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12239 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 }\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Placebo}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 Low Dose}\cell @@ -53,25 +53,25 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 High Dose}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1749 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2332 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2915 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx3498 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx4081 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx4664 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5247 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5830 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6413 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6996 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx7579 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8162 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8745 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx9328 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx9911 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx10494 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx11077 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx11660 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12243 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalb\cellx1493 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2090 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx2687 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx3284 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx3881 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx4478 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5075 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5672 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\margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -553,26 +553,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Vision blurred}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx2455 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx3273 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx4091 @@ -582,15 +562,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Gastrointestinal disorders}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 4}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (4.7)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 8}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (9.5)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 10}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (11.9)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 22}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (8.7)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Vision blurred}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell \intbl\row\pard @@ -599,7 +579,7 @@ \margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -644,6 +624,26 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Gastrointestinal disorders}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 4}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (4.7)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 8}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (9.5)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 10}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (11.9)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 22}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (8.7)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Abdominal pain}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell @@ -1155,46 +1155,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Chest discomfort}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Chills}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx2455 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx3273 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx4091 @@ -1204,15 +1164,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Fatigue}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Chest discomfort}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 4}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (4.8)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 7}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell \intbl\row\pard @@ -1221,7 +1181,7 @@ \margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -1266,6 +1226,46 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Chills}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Fatigue}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 4}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (4.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 7}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.8)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Feeling abnormal}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell @@ -1717,66 +1717,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Shoulder pain}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Nervous system disorders}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 5}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (5.8)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 12}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (14.3)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 15}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (17.9)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 32}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (12.6)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Balance disorder}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx2455 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx3273 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx4091 @@ -1786,15 +1726,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Burning sensation}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Shoulder pain}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell \intbl\row\pard @@ -1803,7 +1743,7 @@ \margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -1848,6 +1788,66 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Nervous system disorders}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 5}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (5.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 12}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (14.3)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 15}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (17.9)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 32}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (12.6)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Balance disorder}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Burning sensation}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (2.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.8)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Complex partial seizures}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell @@ -2399,66 +2399,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Reproductive system and breast disorders}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Pelvic pain}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Respiratory, thoracic and mediastinal disorders}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (2.3)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx2455 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx3273 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx4091 @@ -2468,15 +2408,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8999 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Dyspnoea}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Reproductive system and breast disorders}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.4)}\cell \intbl\row\pard @@ -2485,7 +2425,7 @@ \margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -2530,6 +2470,66 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Pelvic pain}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs18{\f0\b Respiratory, thoracic and mediastinal disorders}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (2.3)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0\b (0.8)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Dyspnoea}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx2455 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx3273 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4091 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx4909 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5727 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6545 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7363 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8181 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8999 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs18{\f0 Emphysema}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs18{\f0 (1.2)}\cell diff --git a/vignettes/rtf/ae0specific2.rtf b/vignettes/rtf/ae0specific2.rtf index 20906fe..951425f 100644 --- a/vignettes/rtf/ae0specific2.rtf +++ b/vignettes/rtf/ae0specific2.rtf @@ -17,7 +17,7 @@ \margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -393,26 +393,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Ventricular extrasystoles}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 @@ -422,7 +402,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Wolff-parkinson-white syndrome}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Ventricular extrasystoles}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell @@ -439,7 +419,7 @@ \margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -484,6 +464,26 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Wolff-parkinson-white syndrome}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Congenital, familial and genetic disorders}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell @@ -795,46 +795,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.0)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b General disorders and administration site conditions}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 18}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (20.9)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 43}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (51.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 35}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (41.7)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 96}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (37.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Application site bleeding}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 @@ -844,15 +804,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Application site dermatitis}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 5}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (5.8)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 9}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (10.7)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 7}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (8.3)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 21}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (8.3)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b General disorders and administration site conditions}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 18}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (20.9)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 43}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (51.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 35}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (41.7)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 96}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (37.8)}\cell \intbl\row\pard @@ -861,7 +821,7 @@ \margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -906,6 +866,46 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Application site bleeding}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Application site dermatitis}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 5}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (5.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 9}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (10.7)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 7}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (8.3)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 21}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (8.3)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Application site desquamation}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell @@ -1197,66 +1197,6 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Chest discomfort}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Chills}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Fatigue}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 4}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (4.8)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 7}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 @@ -1266,7 +1206,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Feeling abnormal}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Chest discomfort}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell @@ -1283,7 +1223,7 @@ \margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -1328,13 +1268,13 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Malaise}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Chills}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard @@ -1348,15 +1288,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Oedema}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Fatigue}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 4}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (4.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 7}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1368,7 +1308,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Oedema peripheral}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Feeling abnormal}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell @@ -1388,7 +1328,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Pain}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Malaise}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell @@ -1408,15 +1348,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Injury, poisoning and procedural complications}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 3}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Oedema}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1428,7 +1368,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Excoriation}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Oedema peripheral}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell @@ -1448,15 +1388,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Fall}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Pain}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1468,15 +1408,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Skin laceration}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Injury, poisoning and procedural complications}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 3}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1488,14 +1428,14 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Wound}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Excoriation}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc @@ -1508,31 +1448,11 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Investigations}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 4}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (4.7)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.4)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 7}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.8)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Blood creatine phosphokinase increased}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Fall}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell @@ -1548,7 +1468,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Body temperature increased}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Skin laceration}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell @@ -1568,15 +1488,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Electrocardiogram st segment depression}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Wound}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1588,15 +1508,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Electrocardiogram t wave inversion}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Investigations}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 4}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (4.7)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.4)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 7}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1608,7 +1528,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Heart rate increased}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Blood creatine phosphokinase increased}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell @@ -1628,11 +1548,11 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Heart rate irregular}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Body temperature increased}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell @@ -1648,15 +1568,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Metabolism and nutrition disorders}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 3}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (3.5)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 4}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.6)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Electrocardiogram st segment depression}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 @@ -1668,15 +1588,15 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Decreased appetite}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Electrocardiogram t wave inversion}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 @@ -1688,7 +1608,7 @@ \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 -\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Food craving}\cell +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Heart rate increased}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell @@ -1705,7 +1625,7 @@ \margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc @@ -1750,6 +1670,86 @@ \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 \clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 \clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Heart rate irregular}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Metabolism and nutrition disorders}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 3}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (3.5)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 4}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.6)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Decreased appetite}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 2}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Food craving}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (1.2)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc 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\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Paraesthesia oral}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell @@ -2020,32 +2020,74 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard + + +{\pard\fs2\par}\page{\pard\fs2\par} +\paperw15840\paperh12240\landscape + +\margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 + +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} + + \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 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\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 @@ -2101,15 +2143,15 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (2.8)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 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\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard - - -{\pard\fs2\par}\page{\pard\fs2\par} -\paperw15840\paperh12240\landscape - -\margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 - -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} - - -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6995 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8744 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx10493 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12242 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 }\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 Placebo}\cell 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-\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 }\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell -\intbl\row\pard -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 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+\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi100\li100\ri0\ql\fs16{\f0 Transient ischaemic attack}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell @@ -2403,15 +2403,15 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 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\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell @@ -2422,16 +2422,58 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard + + +{\pard\fs2\par}\page{\pard\fs2\par} +\paperw15840\paperh12240\landscape + +\margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 + +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} + + \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 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Dose}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 High Dose}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 Total}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12238 +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 }\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 n}\cell +\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (%)}\cell +\intbl\row\pard +\trowd\trgaph108\trleft0\trqc +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Renal and urinary disorders}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 0}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.0)}\cell @@ -2523,15 +2565,15 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Respiratory, thoracic and mediastinal disorders}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (2.3)}\cell @@ -2542,58 +2584,16 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 2}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (0.8)}\cell \intbl\row\pard - - -{\pard\fs2\par}\page{\pard\fs2\par} -\paperw15840\paperh12240\landscape - -\margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 - -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} - - -\trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5246 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\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.0)}\cell @@ -2945,15 +2987,15 @@ \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.4)}\cell \intbl\row\pard \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6120 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx6994 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx7868 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx8742 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrs\brdrw15\clvertalt\cellx12238 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\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 (0.8)}\cell \intbl\row\pard - - -{\pard\fs2\par}\page{\pard\fs2\par} -\paperw15840\paperh12240\landscape - -\margl1440\margr1440\margt2880\margb1800\headery1800\footery1800 - -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} - - \trowd\trgaph108\trleft0\trqc -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx5246 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx6995 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx8744 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx10493 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalb\cellx12242 -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 }\cell -\pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0 Placebo}\cell 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-\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 -\clbrdrl\brdrs\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 -\clbrdrl\brdrw15\clbrdrt\brdrs\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx5246 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6120 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx6994 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx7868 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx8742 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx9616 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx10490 +\clbrdrl\brdrs\brdrw15\clbrdrt\brdrw15\clbrdrb\brdrw15\clvertalt\cellx11364 +\clbrdrl\brdrw15\clbrdrt\brdrw15\clbrdrr\brdrs\brdrw15\clbrdrb\brdrw15\clvertalt\cellx12238 \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\ql\fs16{\f0\b Vascular disorders}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b 1}\cell \pard\hyphpar0\sb15\sa15\fi0\li0\ri0\qc\fs16{\f0\b (1.2)}\cell diff --git a/vignettes/rtf/mock_ae0specific1.rtf b/vignettes/rtf/mock_ae0specific1.rtf index 0849578..bd79d23 100644 --- a/vignettes/rtf/mock_ae0specific1.rtf +++ b/vignettes/rtf/mock_ae0specific1.rtf @@ -17,7 +17,7 @@ \margl1800\margr1440\margt2520\margb1800\headery2520\footery1449 -{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} +{\pard\hyphpar\sb180\sa180\fi0\li0\ri0\qc\fs24{\f0 Participants With Drug-Related Adverse Events}\line\fs24{\f0 (Incidence > 0 % in One or More Treatment Groups)}\line\fs24{\f0 Weeks 0 to 12}\line\fs24{\f0 All Participants as Treated}\par} \trowd\trgaph108\trleft0\trqc